Monthly Archives: February 2011

Shot in the arm for Russia’s ailing drug industry

Foreign manufacturers are racing to secure positions in Russia’s burgeoning pharmaceuticals market while the Kremlin gets tough on imported medicines

The Russian government has unveiled a new plan to modernise Russia’s pharmaceutical industry and give local firms a greater presence in international markets, injecting £2.4bn of state funds into the sector.

In late 2010, Prime Minister Vladimir Putin set the target of domestically producing 90pc of Russia’s vital medicines and 50pc of its medical equipment by 2020, while increasing exports eight times. Foreign pharmaceutical companies and medical equipment manufacturers in Russia would face sales restrictions if they were not prepared to share their expertise, he warned.

“We will have restrictions for them on our market if there are no imports of manufacturing facilities and technologies,” Mr Putin said, adding that the trade barriers would be gradually implemented.

Dmitry Genkin, CEO of Russia’s Pharmsynthez, which raised £10.9m in an initial public offering (IPO) last November, said Russia had struggled with the Soviet legacy of building most of Eastern Europe’s pharmaceutical industry while neglecting its own needs: “It left a huge gap between fundamental sciences and applied science like medicine when the Soviet Union collapsed.”

Russian firms have long awaited government support, but current spending levels in the country fall far short of the money spent to support research and development in Europe and America, Mr Genkin noted. “The money being spent by the Russian government is still peanuts compared to spending by the European Commission or the US National Institutes of Health,” he said.

Nevertheless, Russia’s pharmaceutical market is growing twice as fast as US and European markets and has already become a key battleground for pharmaceutical companies whose sales have stalled in Western markets as patents expire. The Russian brokerage Uralsib said: “The pharmaceutical market, boosted by consumer and government spending, is set to outperform Russian GDP while the fragmented regional pharmacy segment offers big consolidation potential to leading chains.”

To cash in on the market’s growth potential, Western drug giants are determined that they will not be caught out by import barriers and are already setting up domestic manufacturing bases in Russia.

Just before Christmas, the Swiss giant Novartis said it would invest £310m in Russia over the next five years, building a production plant in St Petersburg to focus on local manufacturing and research and development partnerships with local firms. Switzerland’s Nycomed and Denmark’s Novo Nordisk have also announced plans to start producing in Russia, while Britain’s GlaxoSmithKline struck a vaccine deal in November with Moscow-based Binnopharm.

And the French giant Sanofi-Aventis in January appointed a new emerging markets management team to boost its market share in Russia, which is considered one of its key markets.

Meanwhile, Russian companies are also looking at markets overseas. Pharmsynthez said it will use part of its IPO funds to purchase pharmaceutical producers in Europe, as well as in the US and Israel. The drug manufacturer is looking for small, growing and profitable companies which own production facilities, Mr Genkin says.

With the push to promote domestic pharmaceuticals, the Kremlin has opened up a new front in the war to diversify the Russian economy.

Analysts are excited by the government’s initiative as it gives them a new sector in which to invest. In the last week of January, Uralsib launched research into the pharmaceutical sector with a report entitled Just what the doctor ordered .

“Russian pharma producers offer an excellent domestic story and access to defensive market niches and strong cash flows,” the Uralsib analyst Tigran Hovhannisyan wrote. “The relative underperformance of Russia’s pharmaceutical market by comparison to other Bric markets is compensated for by the market leaders’ higher margins and consolidation potential.”

Pharmacy Benefit Management Institute Recognizes Innovation in Drug Benefit Industry

The Pharmacy Benefit Management Institute ( PBMI : ) has awarded four 2011 Rx Benefit Innovation Awards : to the Center for Health Value Innovation, Cigna Pharmacy Management, CVS Caremark / Arcelor Mittal, and InformedRx, an SXC company. The awards were announced today at PBMI’s 16th Annual Drug Benefit

The recipients of this year’s awards were selected based on the project’s overall originality, strength of reported results, and potential to improve patient outcomes. “Our 2011 award recipients have demonstrated creative thinking by designing solutions to address numerous challenges in prescription drug programs,” says Tim Watson, PharmD, MBA, Executive Director of PBMI. “Their example will inspire other plan sponsors to implement one or more of these approaches in their own populations.”
The Center for Health Value Innovation is being recognized for their pioneering work in the design, implementation and measurement of Value Based Insurance Designs. The center’s co-founder and Chief Medical Officer, Jack Mahoney led the charge behind Value Based Design with a firm resolve to prove that lowering access barriers to health care services could ultimately engage the most at risk populations, thereby improving care and lowering costs. The center’s work to measure and disseminate outcomes associated with these design strategies continues to provide guidance to others who wish to implement these programs in their population.

Cigna Pharmacy Management Online pharmacy viagra
Cigna Pharmacy Management is being recognized for their creative approach to contracting for pharmaceuticals that is based on achievement of specific therapeutic outcomes. In 2009, Cigna Pharmacy Management and Merck & Co., Inc. entered into the pharmacy benefit management industry’s first national outcomes based contract between a PBM and a pharmaceutical firm. A year after the contract was implemented, results showed that there was improved blood sugar control and blood sugar testing during the study. The company stated that “estimated savings for individuals and employers could be almost $8,000 per person who has diabetes per year when that individual increases adherence to over 80%.”

CVS Caremark / ArcelorMittal
CVS Caremark / ArcelorMittal are being recognized for their efforts to improve the treatment of diabetes in the steel company’s population. More than half of people diagnosed with a chronic disease, including diabetes, are either non-adherent to the prescribed medication or have a gap in care. The program designed and implemented by the companies sought to improve medication adherence in diabetics by engaging pharmacists who are expertly trained in medication therapy management principals. The program included both telephonic counseling, and face-to-face interventions, according to the patient’s preference. After six months, the program demonstrated significant improvements in closing gaps in care and increasing medication adherence compared to a control group. In addition, the program results demonstrated health care savings of nearly $1,700 annually for patients with diabetes.

InformedRx, an SXC company
InformedRx is being recognized for their efforts to minimize inappropriate prescribing of controlled substances. Use of multiple narcotics can have adverse effects on both members and plan sponsors, including: compromised patient safety, risk of addiction and diminished quality of life, risk of on the job injuries and wasting scarce health plan resources. InformedRx designed a program of pharmacist review and intervention in which targeted interventions were sent to physicians with the goal of improving prescribing patterns for this important class of medications. The program demonstrated strong results, including: 58% fewer narcotic prescriptions written, 57% fewer prescribers writing narcotic prescriptions, and an average savings per case of $105.16.

Pharma supply chain changes recommended by GPs

The changing face of NHS procurement could mean further changes to the way processors involved in the pharmaceutical supply chain operate.

Eight out of ten GPs believe that pharmacists should have a bigger role in commissioning orders, according to a new survey by Pfizer.

Half of those polled indicated that closer involvement of pharmacists in commissioning decisions would improve the effectiveness of patient-focused care, while improving cost-efficiency.

The publication of these findings follows the release of a report by PricewaterhouseCoopers earlier this week, which indicated that the global pharmaceutical industry will need to adapt to meet the sector’s emerging needs.

Consultancy global pharmaceutical and life sciences leader Simon Friend suggested that the industry will have to develop a new supply chain model if it is to successfully address changing demands.

According to the Chemist and Druggist, Pfizer pharmacy strategy development manager Ian Hunter explained: “However with the government’s vision for the NHS, it is of paramount importance that steps are taken to enhance this relationship.”

Typical Guttridge equipment used in the pharmaceutical industry includes; Hoppers – mobile loading hoppers – flexible bulk containers

Pharma must rethink manufacturing, says PwC

The pharmaceutical industry needs to undertake a radical overhaul in its approach to manufacturing which at present is “inefficient, under-utilised and ill-equipped to cope with new medicines”, according to PricewaterhouseCoopers.

The latest instalment in the consultants’ Pharma 2020 series notes that drugmakers have invested little effort in modernising their manufacturing and distribution processes to date, focusing instead on issues such as R&D productivity and marketing challenges.

“By 2020, many of the medicines the industry makes will be specialist therapies that require totally different manufacturing and distribution techniques from those used to produce small molecules,” says the report.

For example, biologic drugs are generally more susceptible to impurities during production and damage during shipping than chemical drugs and have shorter shelf lives, and this difference becomes even more stark with gene- and tissue-based therapies.

PwC suggests this will mean new medicines may have to be finished near the patient, for example at the pharmacy or point-of care.

A shift in the way medicines are licensed away from a binary approved/rejected model towards ‘live licenses’ – in other words initially limited registrations that can be broadened as experience with a medicine grows – will also have an impact.

Peak sales will be reached over a longer period, so companies will need to build a supply chain that adjusts according to demand and avoids a large upfront investment. Pharmaceutical manufacturers will therefore need to develop adaptable cost structures “that preserve gross margins at each stage of the product lifecycle”, according to PwC.

Health reforms – and a movement towards outcomes-based measures of a drug’s success – will demand that pharmaceutical manufacturers distribute products alongside diagnostics, data and support services. Meanwhile, greater use of electronic health records, e-prescribing and remote monitoring is driving a preference for self-administered medicines delivered in patients’ own homes and communities.

As a result, “pharmaceutical companies will need real-time information to manage wider distribution networks and demand-driven manufacturing and distribution processes”, says the report.

Added to the mix is the opening up of emerging markets which require understanding of patients’ needs and preferences, as well as greater public and regulatory scrutiny of medicine quality that is bringing issues such as traceability to the fore.

Overall, PwC is predicting three major changes to pharmaceutical manufacturing and distribution over the coming decade: the supply chain will become more fragmented, with different models used for different product types and patient segments; distribution and manufacturing will be a differentiator in the marketplace and source of economic value; and information will flow both up and down the supply chain.

“The most successful pharma companies will be those that recognise the underlying value locked in their supply chain and can leverage it as a value and brand differentiator rather than just a cost,” commented Steve Arlington, global advisory pharmaceutical and life sciences leader at PwC.

“Companies that recognise information is the currency of the future, will be those that go the final mile and stand out by 2020.”

Independent pharmacies must unify to fight PBM industry

The independent pharmacy industry needs to unite and develop an internal public relations campaign to mobilize pharmacy store owners and patients to fight for their prescription rights. This was one of the suggestions made during a PBM Discussion Panel for Independent Pharmacy, a live discussion from the 2011 PDS Conference in Orlando, Fla., on Friday.

In recent years, independents have lost ground to the pharmacy benefit management (PBM) industry despite lobbying efforts to regulate the practices of pharmacy benefit administrators, according to Dan Benamoz, RPh, CEO and owner, Pharmacy Development Services Inc. (PDS), the sponsor and moderator of the PBM discussion panel and author of a white paper about how to combat PBM abuses, such as manufacturer rebates, spread pricing, repackaging, and the development of PBM-sponsored mail-order programs that compete directly with retail pharmacies. The white paper is posted at www.pharmacyowners.com/preservepharmacy.

“Over the course of the past decade, retail pharmacists have spent tens if not hundreds of millions of dollars on Capitol Hill, lobbying Congress unsuccessfully to classify pharmacy benefit managers as fiduciaries [persons to whom property or power is entrusted for the benefit of another] or at a minimum, for government regulation of this industry,” wrote Benamoz in the white paper. “Under the ‘watchful eye’ of these unregulated guardians of the United States healthcare system, prescription drug costs have escalated over the last 15 years at such an unprecedented rate that basic healthcare is rapidly becoming less and less affordable for individuals and corporations alike.”

More than 200 participants in the PDS Conference and more than 150 online attendees listened to the 5-member panel discuss ways for independent pharmacies to fight back. The panel included Jennifer Bacon, Esq, an antitrust attorney with Poisinelli Shughart PC; Rich Masters, partner, Qorvis Communications, a specialist in media relations; Douglas Hoey, RPh, MBA, senior vice president, NCPA; Mark Riley, PharmD, a member of the NCPA Executive Committee and executive vice president, Arkansas Pharmacists Association; and Dave Gilmore, PhD, president of KeyCentrix Inc.

“You [the independents] have all the elements of a really good campaign — a single message, an energized base, and a really good enemy [the PBM industry],” said Masters in his opening remarks. “This is your fight. You must have the will, desire, and business acumen to engage pharmacies, customers, and your communities. You have the best story to tell — go tell it.”

Getting the membership involved is probably the most difficult step, said Masters. “You need to create an environment that will get the pharmacies and patients involved. Once an initiative is started, do news events across the country, and coverage [by the media] should be funneled into the online world,” he said.

Some strategies addressing PBM practices that were mentioned during the panel discussion included state and federal regulatory efforts, the development of a super network, education of the public with talking points, and the direct engagement of small business owners who are affected by PBM practices.

In the state of Mississippi, a bill introduced in the House proposes to move the regulatory authority (over PBMs) from the Department of Insurance to the State Board of Pharmacy, which will be responsible for overseeing and issuing permits to every PBM. Fortunately, the State Board of Pharmacy understands the industry and some of its members are friends of independent pharmacy, according to a pharmacist in the audience who spoke during the panel discussion.

The NCPA has lobbied for greater PBM transparency requirements, which will be implemented in 2014 with the state health insurance exchanges established by the Patient Protection and Affordable Care Act of 2010. “We need a strong offense to keep constant pressure on the PBM industry despite the fact that they are always changing their business models and adapting,” said Hoey.

Another possible strategy is the development of a network to inform other pharmacies of the local initiatives that are taking place across the country. “Grassroots efforts are critical, and you need to demand your GPOs [group purchasing organizations] are part of this network,” Hoey continued.

Another pharmacist in the audience suggested that pharmacies recognize the value of social media in reaching out to the public. “We need talking points to inspire the public. We need to explain that these PBM practices are screwing employers, and some organization needs to spearhead this,” the pharmacist said.

“We also need to educate business owners about their mail-order programs and PBM contracts. Pharmacists need to engage them about their prescription drug program and become a sales force,” said Riley. “We need to be active messengers pushing state legislatures, city governments, and the FTC [to get the word out] about the PBM industry.”

Buyouts skew Indian drug industry

Tie-ups between Indian drug companies and multinational pharmaceutical firms, which initially received a lot of media attention, have proven to be more beneficial for big pharma than for Indian companies, according to a recent study.

The study authors found that co-operation between multinational pharmaceutical companies and Indian manufacturers had not boosted the R & D capacity of Indian pharmaceutical businesses.

They also found that there had not been any significant transfer of technology from developed countries.

In the report, Médicins Sans Frontières (MSF), a medical non-governmental organisation, describes India as the pharmacy of the developing world.

MSF relies on Indian companies to supply 80% of all generic HIV drugs it distributes abroad. Cialis professional no prescription

It is not the first time that Indian officials have begun to suspect that such co-operation between drug companies is ultimately not beneficial for Indians.

When a foreign firm buys an Indian drug company, that firm inheirits the intellectual property of the foreign company.

But quite often, the same Indian companies have already benefited from patent waivers on research done by Indian technical institutes, or from Indian tax incentives.

In essence, multinational firms are benefiting from previous investments of Indian taxpayers’ money when they buy Indian drug companies.

Last year, the Indian commerce ministry said some analysts were concerned that foreign companies would steer Indian companies away from the Indian market, weakening competition and ultimately opening up a new price range for more expensive drugs, thus driving up prices overall.

The researchers found that clinical research organisations in India failed to raise their technological standards after being integrated with high-grossing pharmaceutical firms.

They found that most of the drug discovery efforts of such firms were aimed at Western markets.

While some Indian drug companies have also acquired foreign firms in the mean while, foreign firms have also bought Indian companies.

Study author Dinesh Abrol, of the National Institute of Science, Technology and Development Studies (NISTADS), said that buying domestic Indian companies would give multinational companies fewer challenges over proprietary technology.

He said that the buyouts would ultimately lead to decreased manufacturing capacity for Indian-made generic drugs.

The Indian commerce ministry said that alliances between local and global pharmaceutical companies had also been seen in Brazil, Egypt, and Pakistan.

Pharmacists must send coherent message to GP commissioners, industry leaders warn

Pharmacists do not know how to discuss service commissioning with local GPs and the sector must formulate a more coherent message, the C+D Senate has warned.

One area that pharmacists should push for was a greater role in medicines management, the think tank agreed.

Industry leaders discussed the issue, among others, at the C+D Senate earlier this month.

Pharmacists needed to identify a core message to take to GPs, Devon LPC pharmacist Mark Stone and PSNC chief executive Sue Sharpe said.
Mr Stone said the community pharmacy sector must come up with five clear points it could take to NHS commissioners when discussing pharmacy-based services.

One of those points should be getting pharmacy more involved in clinical pathways, he said.

“We have to be there so we can get directed MURs,” Mr Stone warned.

Pushing for a greater medicines management role was also key, according to the Senators.

Senior pharmaceutical adviser for Havering PCT Mohamed Kanji told the Senate that it was clear there were problems with medicines management.

“We know that is not being done as 30 per cent to 50 per cent of medicines are not being used as directed, so [ask GPs] how can we work together to ensure that the medicines are being used in that way,” Mr Kanji advised.

NHS commissioning lead for Rowlands Pharmacy Liz Stafford agreed that pharmacists needed to raise medicines management as a potential area that pharmacists could get more involved in.

Senators also discussed the importance of up-skilling staff, measuring quality and outcomes and working with NHS bodies to develop the role of pharmacy in the “new world” NHS.

Recommendation of the Concil

Following their survey, the Consumer Council made a number of recommendations, which included the following:

* That the Pharmacy and Poisons Board needs to take a more proactive role in regulating the industry and its practices. The governing legislation, Pharmacy and Poisons Act appears to regulate registration and de-registration of the pharmacists under Section 5 and 33 respectively. The law needs to be better enforced and the board revamped to make it more effective and efficient in enforcing the laws and in attending to complaints. Membership should include representatives from enforcement agencies, consumer groups and NGOs for transparency and effectiveness of the board.

* The law also establishes the Fiji Pharmaceutical Society (Section 32B). The Fiji Pharmaceutical Society need to strengthen their code of ethics and monitor market practices. The society also needs to undertake regular training and education to up skill its members and ensure that they are up to date with the changing role of pharmacists in the health sector. They should have merit system to acquire certain points to qualify for annual registration. Registration requirements should be made clearer in the legislation including bad market practices taken into consideration.

* Ministry of Health to develop National List of Essential Medicines to be prominently displayed at the pharmacies. PIB/Commerce Commission to list these in a revised price order.

* Ministry of Health to impose a strict “Code of Conduct” to be practiced by all pharmacies. The Code of Conduct to be a binding document and any breaches to the Code of Conduct should lead to fines or cancellation of the license depending on the seriousness of the case.

* Fiji Islands Revenue and Customs Authority (FIRCA) should conduct thorough investigation on money trail to establish whether shareholders are being used to deceive the Government in controlling pharmaceutical sector through single ownership.

* Pharmacists and Poisons Board should look at the shareholding structure of each pharmacy to ensure all shareholders are registered pharmacist according to section 32.

* Educating consumers on the different categories of medicines – generics, branded generics and originator brands, including labelling information, and trade practices.

* FPS to ensure its members wear professional attire (white coat) so that the public can differentiate a pharmacist from other staff present in the pharmacy. FPS should also encourage pharmacies to display the name of the pharmacist on duty.

* The Government to implement the recommendations of the study so as to empower the citizens of Fiji to protect their health interests.

Drug shortages cause hospitals to use older types of medicines

Part of the shortage is being caused by manufacturing issues and quality-control problems at a number of companies that include Lake Forest, Ill.-based Hospira Inc., one of the primary makers of generic injectable prescription medicines, as they respond to the federal government’s crackdown on drug safety. The quality issues can range from finding toxins and “particulate matter” in medicines to workers inaccurately filling out the required paperwork to verify that the drugs, as well as the devices used to intravenously deliver the products to patients, are safe and effective.

Even after a company restarts production of a drug, it takes time for a plant to catch up to the back orders. And injectable drugs in particular, unlike pills and tablets, tend to require long lead times to produce.

“These are the worst shortages I have ever seen,” said Thomas Wheeler, a hospital pharmacist for three decades and director of pharmacy for Advocate Illinois Masonic Medical Center in Chicago. “The most troubling aspect is that it is critical drugs for which there are limited alternatives. Many are involved in cancer care and surgery.”

About 150 drugs are in short supply — triple the number from just five years ago — according to the American Society of Health-System Pharmacists, a trade group that works with hospital pharmacists on ways to deal with the shortage. About 60 of those are considered by federal health officials “medically necessary,” and they include prescription medicines used to treat or prevent a serious disease or medical condition.

Drugmakers say they are obliging tougher safety rules put in place by the Food and Drug Administration, which has intensified scrutiny to avoid allowing unsafe medicines on the market. The FDA came under fire for its role in monitoring the blockbuster pain pill Vioxx, which was pulled off the market in 2004 by its manufacturer, Merck & Co., after the drug was linked to heart attacks and strokes.

The drug shortage is being exacerbated by consolidation in the pharmaceutical industry, which leaves fewer companies making drugs. For example, Teva Pharmaceuticals makes generic forms of certain cancer medications. So when quality issues temporarily closed its plant in Irvine in April, medical professionals were faced with limited supplies of an array of cancer drugs.

In addition, some drug companies have exited the business of making older, generic injectable drugs, which typically aren’t as profitable as newer brand-name medicines. That puts additional production pressure on the remaining makers of these generic treatments.

Take propofol, a popular anesthetic for surgeries and other medical procedures. Teva decided to exit the propofol business last year after a quality issue with the drug in 2009. In a statement, the company said it believed its “existing, approved technology is not suitable to ensure that we can consistently produce the product to Teva’s high quality standard.”

Teva’s decision came around the time another propofol maker, Hospira, had to stop shipping the drug because of quality issues in its production process. Last summer, the FDA allowed Hospira to begin production again. But the company said its new manufacturing process needed a certain amount of time to ramp up production and fill back orders.

The drug shortages have gained the attention of members of Congress. This month, Sens. Amy Klobuchar (D-Minn.) and Bob Casey (D-Pa.) introduced legislation that would require drugmakers to give the FDA an early notification “when a factor arises that may result in a shortage,” according to a joint statement.

Hospitals are finding ways to deal with the lack of availability.

At Provena Health, which has six facilities in Illinois, products in short supply have had to be moved “from one hospital to another,” spokeswoman Lisa Lagger said.

Other hospitals are dealing with the supply problem by turning to older medicines. Although these drugs can be just as effective, the lack of familiarity among medical professionals can lead to improperly calculated dosages.

About 35% of the healthcare professionals responding to a survey on drug shortages said they “experienced an error that could have led to patient harm during the past year,” according to an Institute for Safe Medication Practices study released in September.

There were more than 1,000 “errors and adverse patient outcomes” reported by those surveyed. Those errors and adverse outcomes were tied to more than 50 drugs on the shortage list that became abruptly unavailable, the institute said at the time the study was released.

Some hospitals are escalating the training of doctors, nurses and others who administer these older drugs, which can require larger dosages or have different side effects than newer treatments.

If Illinois Masonic’s intensive care unit can no longer get propofol, critical care pharmacist Aaron Hoffman said, patients will have to be given benzodiazepines or fentanyl, a shorter-acting narcotic.

For most patients, this would “not be a huge issue,” he said. But in the case of patients with severe liver failure, there could be toxicity concerns with the older drugs.

Some medical facilities have turned to secondary suppliers when their primary source for drugs has run out of needed medicines. And that has caused hospitals to pay double or more for certain drugs because they are working with a supplier that normally doesn’t sell them large volumes of a product.

The drug industry believes the issue will resolve itself relatively soon, and companies say the government’s tougher rules should make consumers and medical professionals feel more confident about their products.

Teva said its Irvine facility would begin producing cancer medications, including many in short supply, next month.

And Hospira has ratcheted up spending on its manufacturing facilities and quality systems. The company hopes to be caught up with production by the second quarter.

On a conference call with analysts and investors this month, Hospira Chief Executive Christopher Begley said the company’s efforts to meet the FDA’s “higher benchmark” would help the company long term.

“We see light at the end of the tunnel,” Begley said.

CIGNA Receives Pharmacy Benefit Management Institute Innovation Award

CIGNA’s (NYSE: CI) outcomes-based approach to pharmacy contracting was recognized with an award for innovation in the drug benefit industry by the Pharmacy Benefit Management Institute (PBMI). The award was presented today at PBMI’s 16th Annual Drug Benefit Conference in Phoenix. CIGNA was selected as one of this year’s award recipients based on the program’s overall originality, strength of reported results and potential to improve medical outcomes.

“Our 2011 award recipients have demonstrated creative thinking by designing solutions to address numerous challenges in prescription drug programs,” said Tim Watson, PharmD, MBA, executive director of PBMI. “Their example will inspire other plan sponsors to implement one or more of these approaches in their own populations.”

In 2009, CIGNA Pharmacy Management and Merck entered into the pharmacy benefit management (PBM) industry’s first national outcomes-based contract between a PBM and a pharmaceutical company. The contract was designed to improve medication adherence and improve blood sugar levels for CIGNA customers who have type 2 diabetes.

A year after the contract was implemented, results showed that there was improved blood sugar control and blood sugar testing during the contract period. According to a study published in the June 2005 edition of Medical Care, quality of life improves dramatically and estimated savings for individuals and employers could be up to $8,000 per person who has diabetes when medication adherence is between 80 and 100 percent. Medication adherence was 87 percent for the CIGNA-Merck outcomes based contract.

“CIGNA is pleased to be recognized for our efforts to focus our work and that of the health care system as a whole on improving people’s health,” said C. Daniel Haron, president, CIGNA Pharmacy Management. “Though this award is specific to the pharmacy benefits management industry, we would also like to recognize Merck. Without their willingness to be the first pharmaceutical company to pilot an outcomes-based contract, this recognition would not have been possible.”

Pharmacy Benefit Management Institute Recognizes Innovation in Drug Benefit Industry

The Pharmacy Benefit Management Institute (PBMI) has awarded four 2011 Rx Benefit Innovation Awards to the Center for Health Value Innovation, Cigna Pharmacy Management, CVS Caremark / Arcelor Mittal, and InformedRx, an SXC company. The awards were announced today at PBMI’s 16th Annual Drug Benefit Conference in Phoenix.

The recipients of this year’s awards were selected based on the project’s overall originality, strength of reported results, and potential to improve patient outcomes. “Our 2011 award recipients have demonstrated creative thinking by designing solutions to address numerous challenges in prescription drug programs,” says Tim Watson, PharmD, MBA, Executive Director of PBMI. “Their example will inspire other plan sponsors to implement one or more of these approaches in their own populations.”

Center for Health Value Innovation
The Center for Health Value Innovation is being recognized for their pioneering work in the design, implementation and measurement of Value Based Insurance Designs. The center’s co-founder and Chief Medical Officer, Jack Mahoney led the charge behind Value Based Design with a firm resolve to prove that lowering access barriers to health care services could ultimately engage the most at risk populations, thereby improving care and lowering costs. The center’s work to measure and disseminate outcomes associated with these design strategies continues to provide guidance to others who wish to implement these programs in their population.

Cigna Pharmacy Management
Cigna Pharmacy Management is being recognized for their creative approach to contracting for pharmaceuticals that is based on achievement of specific therapeutic outcomes. In 2009, Cigna Pharmacy Management and Merck & Co., Inc. entered into the pharmacy benefit management industry’s first national outcomes based contract between a PBM and a pharmaceutical firm. A year after the contract was implemented, results showed that there was improved blood sugar control and blood sugar testing during the study. The company stated that “estimated savings for individuals and employers could be almost $8,000 per person who has diabetes per year when that individual increases adherence to over 80%.”

CVS Caremark / ArcelorMittal
CVS Caremark / ArcelorMittal are being recognized for their efforts to improve the treatment of diabetes in the steel company’s population. More than half of people diagnosed with a chronic disease, including diabetes, are either non-adherent to the prescribed medication or have a gap in care. The program designed and implemented by the companies sought to improve medication adherence in diabetics by engaging pharmacists who are expertly trained in medication therapy management principals. The program included both telephonic counseling, and face-to-face interventions, according to the patient’s preference. After six months, the program demonstrated significant improvements in closing gaps in care and increasing medication adherence compared to a control group. In addition, the program results demonstrated health care savings of nearly $1,700 annually for patients with diabetes.

InformedRx, an SXC company
InformedRx is being recognized for their efforts to minimize inappropriate prescribing of controlled substances. Use of multiple narcotics can have adverse effects on both members and plan sponsors, including: compromised patient safety, risk of addiction and diminished quality of life, risk of on the job injuries and wasting scarce health plan resources. InformedRx designed a program of pharmacist review and intervention in which targeted interventions were sent to physicians with the goal of improving prescribing patterns for this important class of medications. The program demonstrated strong results, including: 58% fewer narcotic prescriptions written, 57% fewer prescribers writing narcotic prescriptions, and an average savings per case of $105.16.

Canada Drugs Pharmacy has popularity all over the world

Among all the issues which are there for the American government to deal there are two significant- the healthcare coverage and rising cost of prescription drugs.

With the changing times and ever increasing inflation it has become difficult for an average American to purchase prescription drugs without an insurance. He is led to choose between his daily needs and these prescribed medicines.

These circumstances has led to the increasing in the industry of Canada drugs pharmacy and more and more people are getting attracted to the Canada online pharmacy industry which is significantly lower at around 40- 90 %. Before purchasing any medicines it is very essential to ensure the right online pharmacy which has a license and is selling the right and authentic stuff. There are some websites which give the exact information about the prescription drugs online availability along with its US counterpart which gives the customer a chance to settle their choice. It was astonishing for the US government to find out that a report of the GAO (government accountability office) stated lesser problems with Canadian drugs pharmacy than that of the US. In another report by Paul Doering of university of Florida college of pharmacy, it was observed that there could not be any instance found of someone getting hurt by Canadian pharmacy drugs.

An important drawback about the Canadian drugs pharmacy is that it cannot be called during an emergency as the usual time of delivery is 4-21 days depending on the kind of requirements. So the customers need to give the order before they require the medicine.

European drug deal could cost Canada $2.8 billion

Europe’s massive pharmaceutical industry, feeling the squeeze as governments around the world try to contain health care spending, sees potentially lucrative new horizons in countries such as Canada and India. That’s why the industry has lobbied the European Union to seek expanded patent protection for brand-name drugs in ongoing free-trade negotiations with both countries. If successful, that effort would cost Canada’s health care system $2.8 billion a year, according to a critical report released Monday that was funded by the Canadian Generic Pharmaceutical Association. “Canada would have the most extensive structural protection of innovative drugs of any country in the world,” wrote the authors, University of Calgary economist Aidan Hollis and Paul Grootendorst, of the University of Toronto’s faculty of pharmacy. “Payers -consumers, businesses, unions and government insurers -would face substantially higher drug costs as exclusivity is extended on topselling prescription drugs.” Ontario would bear the brunt, ith $1.2 billion in extra costs, ccording to the study. Quebec is next at $773 million, followed by B.C. at $249 million and Alberta at $212 million

Mexican pharmacy

Pharma staff get clean bill

A HIGH-ranking UAE Ministry of Health (MoH) official has given a passing grade for the professionalism of pharmaceutical industry practitioners across the country. However, Assistant Undersecretary for Medical Practice and License Dr Amin Hussain Al Amiri, on Tuesday morning, also admonished them to keep up and give “respect to the profession and white gown,” especially as they are doctors themselves. “They are perfectly well. They are following guidelines,” Al Amiri told The Gulf Today, when he met the press at the Sharjah Cultural Palace. In his opening statement, Al Amiri expressed disappointment that out of the 1,432 private pharmacies, nine pharmaceutical factories and 199 medical stores throughout the UAE, attendees were less than the expected of more than 1,000 participants, because the government office had not been updated with contact details. This reporter asked him of the rating he would give the group, particularly that of the pharmacists and their staff, since he cited violations committed by some. “Yes, violations could happen that is why we are meeting with them and will be meeting with them again so we can (jointly strategise the best for all of us here in the UAE),” said Al Amiri, who then related two cases of violations he himself was a witness of. The first case was about one pharmacy employee in Sharjah, who he saw giving a bagful of medicines to three Asians without asking for the prescription and billing them without the proper receipt. Al Amiri then pose as a buyer of Tamiflu “at that time when there was a swine flu threat.” Just the same, he was given the drug even though he did not present a prescription, and was billed Dhs175 without being provided with a proper receipt. Probing, he asked for the staff’s professional identification card. The staff member gave the card, which, Al Amiri noted, is another violation since one must only do so with proper authorities. Next thing that Al Amiri did was disclose his real identity as an MoH official and was surprised when the staff informed him that he was a porter and that the pharmacist was out for “kadak chai” (strong tea). “I called up the person concerned to close down the shop immediately,” he said. He added that in another case, he also had one pharmacy, which was owned by an Emirati and a family friend, shut down because he found that the pharmacists had not been wearing their white gowns. “I have great respect for the white gown. Respect the profession. You are doctors,” he said. In the course of the interaction, Al Amiri mentioned companies in free zones and elsewhere in the country being closed down, as they were confirmed to be the source of locally sold and re-exported counterfeit drugs. One was located at a free zone where the owner had his brothers in Saudi Arabia and Egypt jailed for the same offence of distributing fake drugs locally and regionally. His message to his audience was “zero tolerance” on all violations and circumvention of laws. Al Amiri assured the sector of a strong support from the government. Yet, he stressed that individuals working in the sector must also do their share in ensuring that they help improve the quality of life of the 7.56 million UAE residents through their astuteness in the delivery of professional service of updated registered, approved and genuine medicines. Al Amiri said the UAE serves as the hub of all medical supplies to the Middle East and North Africa and so industry players must be conscious of and strictly follow pharmaceutical rules and regulations. At stake is the country’s reputation, he emphasised. Meanwhile, Al Amiri said that starting March 1, expatriates can take their exams for the pharmacy licence to practise in the UAE through electronic smart technologies anywhere they are in the world.

Indian pharmaceutical grads face ‘changing employment landscape

Indian pharmaceutical graduate skills may need to change in the near future as the industry adapts to ongoing changes. Indian online pharmacy – The quality of training received by those aiming for careers in the sector will be key as the industry adapts to the changing flexible benefits and employment strategy challenges it faces. Rob Darracott, chief executive of the industry trade association Pharmacy Voice, explained that one of the greatest challenges faced by the industry is the UK immigration cap, which is due to be introduced in April. He noted: “Pharmacist graduate numbers continue to increase year on year … but the matching of supply and demand is subject to continuing shifts. “Our ambitions for community pharmacy, and the services it will deliver in the future, means that graduate skills will continue to change over time.” UK business secretary Vince Cable last month sought to reassure Indian graduates about the impact of the immigration cap on their ability to find jobs in the country. On a trade mission to the country, he explained that the cap will not apply to intra-company transfers from overseas.

N.D. LEGISLATURE: Pharmacy bill gets do-not pass recommendation

BISMARCK — Chain retailers may not want to think about opening pharmacies in North Dakota just yet.

The House Industry, Business and Labor Committee gave a 10-3 do-not pass recommendation to the idea on Wednesday.

House Bill 1434 deletes wording in North Dakota law that requires pharmacies to be majority-owned by pharmacists licensed in the state. This would have allowed retailers such as Target and Wal-Mart to open pharmacies in the state.

Committee Chairman Rep. George Keiser, R-Bismarck, said he voted against the bill based on testimony that current law serves the state’s residents well.

Rep. Thomas Beadle, R-Fargo, said he sponsored the bill on behalf of more than 40 constituents who want to see the law changed.

The issue came up during the 2009 Legislature and failed to make it on the 2010 ballot due to a flaw in the way petitions were circulated. North Dakota is the only state in the nation with the law.

The bill now goes to the House floor for a full vote.

Social host

The state Senate killed the “social host” bill on Wednesday that would have punished those providing a location for underage drinking.

Senate Bill 2257 states someone who possesses or controls private property may not knowingly allow minors to drink on that property. They must also make a reasonable effort to stop the underage drinking, including calling the police.

Those who violated the proposed law would face a $500 fine.

Sen. Margaret Sitte, R-Bismarck, called the bill a “well-intentioned effort to find a solution to underage drinking.” But she said the Judiciary Committee had concerns and many questions about putting the responsibility on property owners.

“What we’re doing is shifting the responsibility from the guilty underage drinker to the property owner,” she said.

Bill sponsor Sen. Jim Dotzenrod, D-Wyndmere, said the bill resulted from a series of meetings that involved residents, law enforcement and legislators in southeastern North Dakota.

He said North Dakota has a problem with underage drinking, and other states and cities have similar social host regulations.

“I do think eventually we’ll go this way,” he said.

The bill failed on an 11-34 vote.

Internet hunting

The North Dakota Senate voted Wednesday to ban Internet hunting.

Senate Bill 2352 bans hunting wildlife in real time using Internet services to remotely control firearms and discharge live ammunition, thus allowing someone not physically present to kill wildlife.

This includes using any remotely controlled device to hunt.

The bill also bans hosting an Internet hunt, enabling someone else to hunt through the Internet and importing, exporting or possessing wildlife that’s been killed by an Internet hunt.

A violation of the proposed law would be a Class C felony.

The Senate passed the bill on a 43-2 vote. It now moves to the House.

Divorce study

North Dakota senators think it’s worthwhile to study divorce.

On a 41-4 vote, the Senate approved a 2011-12 interim state study looking into the physical, emotional and financial effects associated with divorces involving dependent children.

The study asks for legislative policy solutions, including divorce reform legislation and marriage education.

Sen. Margaret Sitte, R-Bismarck, said there’s data showing divorce costs the government money due to increased use of food stamps and public housing, and increased juvenile delinquency. She said it’s in the state’s interest to study the matter.

However, Sen. Carolyn Nelson, D-Fargo, said there have already been a number of family law studies.

“We’ve discussed this topic. I don’t think we need to discuss it again,” she said.

The bill now moves to the House.

Autism program

A proposed program to help those with autism spectrum disorder and their families unanimously passed the state Senate on Wednesday.

Senate Bill 2268 seeks to establish an autism spectrum disorder Centers of Achievement pilot program.

The bill requires the Department of Human Services to establish the pilot program in the next two years. Like Centers of Excellence in higher education, these centers would involve public-private partnerships.

Those interested in working with the state would submit an application with a plan to fund, develop and deliver skilled services to individuals with autism spectrum disorder.

The proposed regional centers would be in cities with populations of more than 10,000.

The bill provides $600,000 to implement the pilot program and study.

The bill also recommends legislators conduct a comprehensive study of the system for the diagnosis, treatment, care and education of individuals with autism spectrum disorder.

Senate Bill 2268 now moves to the House for consideration.

Zetes to present solutions for pharmaceutical supply chain at industry events

Today, the European Parliament is voting on a proposal to prevent the entry and dissemination of falsified medicines through the pharmaceutical supply chain. The objective of the directive is to improve the traceability of medicines throughout the whole value chain and increase consumer safety.

Whatever the outcome of today’s vote, Zetes is ready to help the pharmaceutical industry comply with existing and upcoming regulations on the traceability of their products with a range of specialised goods identification and mobility solutions.

Ensuring compliance, improving traceability, increasing security
Zetes ensures that medicines and medical goods are traced alongside the pharmaceutical supply chain and across multiple stakeholders. The company can make this possible by combining several advanced identification technologies:

Secure Datamatrix identification and serialisation
Zetes offers high-speed marking systems for secure identification and serialisation of the secondary packaging of medicines and medical goods at the production line. Identifying these goods with a Datamatrix code (which includes information, such as expiration date, lot number, and product number) and a serialisation number helps combat counterfeiting, facilitates problem resolution of claims and recalls, and helps prevent theft. In addition to this, Zetes’ extended experience and solutions for labelling ensure perfect data aggregation from item to pallet.

Optimise order preparation
To supply pharmacies with the right order in a timely manner, often multiple times daily and at short notice, pharmaceutical wholesalers and logistics companies can optimise their order preparation processes with Zetes’ 3i Voice solutions. This solution helps optimise efficiency, reduces mistakes, and allows for flexible resource management at peak times.

100% accuracy of shipped pallets
Visidot, Zetes’ automatic shipment verification solution which uses Image-based technology, ensures the right medicines are sent to the right pharmacy or hospital, achieving 100% accuracy of the shipped pallets. This solution can also be used to inspect items when preparing boxes/crates on the production line, or to manage returns from pharmacies.

Cold chain management
Some medicines must be stored at a constant temperature along the supply chain. Making use of special RFID tags, Zetes’ solution enables pharmaceutical companies to ensure that the temperature level remains optimal from the moment medicines are produced until they are delivered to the end customer.

Alain Wirtz, CEO of Zetes says: “As it is the case in other market segments, the end consumes – and, more particularly, an ever increasing concern for their health and safety – has become central to the pharmaceutical supply chain. Therefore, there is pressure from legislators on the producers from this sector to invest in better product identification and traceability. Zetes has years of experience in supply chain optimisation and an extended portfolio of automatic identification solutions. Based on this strong know-how, we can help pharmaceutical companies comply with the latest regulations but also enable them to transform inherent traceability challenges into a competitive advantage.”

Zetes’ existing customer references within the pharmaceutical industry include leading European pharmaceutical manufacturers and wholesale distributors such as Bristol-Myers Squibb, GSK, Pfizer, UCB, CERP, Merck, and Pharmamar, among others.

Zetes will present its solutions for the pharmaceutical supply chain at several pharmaceutical industry events across Europe, including Pharmapack in Paris, (February 23-24, 2011) and Logipharma in Geneva (March 29-31, 2011).

Pharmacy Benefit Management Institute Recognizes Innovation in Drug Benefit Industry

SCOTTSDALE, AZ–(Marketwire – February 17, 2011) – The Pharmacy Benefit Management Institute (PBMI) has awarded four 2011 Rx Benefit Innovation Awards to the Center for Health Value Innovation, Cigna Pharmacy Management, CVS Caremark / Arcelor Mittal, and InformedRx, an SXC company. The awards were announced today at PBMI’s 16th Annual Drug Benefit Conference in Phoenix.

The recipients of this year’s awards were selected based on the project’s overall originality, strength of reported results, and potential to improve patient outcomes. “Our 2011 award recipients have demonstrated creative thinking by designing solutions to address numerous challenges in prescription drug programs,” says Tim Watson, PharmD, MBA, Executive Director of PBMI. “Their example will inspire other plan sponsors to implement one or more of these approaches in their own populations.”
The Center for Health Value Innovation is being recognized for their pioneering work in the design, implementation and measurement of Value Based Insurance Designs. The center’s co-founder and Chief Medical Officer, Jack Mahoney led the charge behind Value Based Design with a firm resolve to prove that lowering access barriers to health care services could ultimately engage the most at risk populations, thereby improving care and lowering costs. The center’s work to measure and disseminate outcomes associated with these design strategies continues to provide guidance to others who wish to implement these programs in their population.

Cigna Pharmacy Management
Cigna Pharmacy Management is being recognized for their creative approach to contracting for pharmaceuticals that is based on achievement of specific therapeutic outcomes. In 2009, Cigna Pharmacy Management and Merck & Co., Inc. entered into the pharmacy benefit management industry’s first national outcomes based contract between a PBM and a pharmaceutical firm. A year after the contract was implemented, results showed that there was improved blood sugar control and blood sugar testing during the study. The company stated that “estimated savings for individuals and employers could be almost $8,000 per person who has diabetes per year when that individual increases adherence to over 80%.”

CVS Caremark / ArcelorMittal
CVS Caremark / ArcelorMittal are being recognized for their efforts to improve the treatment of diabetes in the steel company’s population. More than half of people diagnosed with a chronic disease, including diabetes, are either non-adherent to the prescribed medication or have a gap in care. The program designed and implemented by the companies sought to improve medication adherence in diabetics by engaging pharmacists who are expertly trained in medication therapy management principals. The program included both telephonic counseling, and face-to-face interventions, according to the patient’s preference. After six months, the program demonstrated significant improvements in closing gaps in care and increasing medication adherence compared to a control group. In addition, the program results demonstrated health care savings of nearly $1,700 annually for patients with diabetes.

InformedRx, an SXC company
InformedRx is being recognized for their efforts to minimize inappropriate prescribing of controlled substances. Use of multiple narcotics can have adverse effects on both members and plan sponsors, including: compromised patient safety, risk of addiction and diminished quality of life, risk of on the job injuries and wasting scarce health plan resources. InformedRx designed a program of pharmacist review and intervention in which targeted interventions were sent to physicians with the goal of improving prescribing patterns for this important class of medications. The program demonstrated strong results, including: 58% fewer narcotic prescriptions written, 57% fewer prescribers writing narcotic prescriptions, and an average savings per case of $105.16.

Drug’s belated recall a bitter pill

Tammy and John Gilbert had read the medical pamphlet. They examined the prescription bottle for risks and warnings.

They assumed the drug was safe.

But what the family believed was a routine prescription to ease their 22-year-old daughter’s pain from a knee injury nearly two years ago has since brought them nothing but sorrow.

Now, the Gilberts find themselves at the front of mounting lawsuits against Newport-based Xanodyne Pharmaceuticals Inc., former distributor of Darvon and Darvocet, two popular painkillers once prescribed across the globe. The Gilberts claim Darvocet caused heart failure that killed their daughter in April 2009.

Xanodyne officials did not return phone calls or e-mails for comment. They withdrew the drugs from pharmacy shelves last November after their own clinical trials showed potential risks outweighed the benefits.

As lawsuits unfold, Xanodyne is playing a central role in growing debate over how well the nation’s regulatory agencies protect public health and safety.

The U.S. Food and Drug Administration says new rules allowed it to order Xanodyne’s clinical trials of a drug that had been widely distributed for generations. Critics say the risks were well known for decades and the recall was more than 30 years too late. They want a congressional investigation.

For Tammy and John Gilbert, the heartbreak began when their only child, Kira Nicole, was found dead in her White Oak apartment on April 9, 2009, eight days after she began taking Darvocet.

“Nikki,” a Colerain Township honor student and Mount St. Joseph graduate, died of acute cardiac failure with evidence of pulmonary edema, or fluid build-up in her lungs, according to a federal lawsuit filed by her parents against Xanodyne and Eli Lilly and Co., the original manufacturer of the drugs.

Tammy Gilbert says her daughter was prescribed the painkiller after she suffered a torn ligament in her knee while working at St. Joe’s Orphanage in Green Township. Nikki took the drug as prescribed and had no history of heart conditions, her mother says.

The Gilberts’ lawsuit, filed Jan. 7 in U.S. District Court in Cincinnati, is one of nine wrongful-death suits filed against Xanodyne in six states. Judges in New York and Louisiana are being asked to consolidate the cases into one, an action being fought by Xanodyne.

In court filings, the company argues that some plaintiffs took versions of Darvon and Darvocet that were not marketed or made by Xanodyne, and therefore the company could not be held accountable.

The Gilberts say Xanodyne knew or should have known about potentially fatal side effects.

“I took the doctor’s word, and I took the information on that medicine that it was safe. It wasn’t,” Tammy Gilbert says. “This has destroyed our life.”
FDA’s new powers

Xanodyne’s withdrawal of Darvon and Darvocet from the market was part of a nationwide recall by the FDA of all products containing propoxyphene. The opiate narcotic, the main ingredient in Darvon and Darvocet, is used to treat mild to moderate pain and has been on the U.S. market for more than 50 years.

Up to 10 million people in the U.S. received prescriptions for Darvocet and related drugs in 2009, the Gilberts’ lawsuit maintains.

Britain and the European Union banned Darvon and Darvocet in 2005 and 2009, respectively, because of a long trend of suicides and accidental overdoses.

Public Citizen, a consumer watchdog group, petitioned the FDA to ban the drugs in the U.S., arguing that their benefits were not enough to justify the risks, which included several hundred deaths a year. In January 2009, less than four months before Nikki’s death, an FDA advisory board agreed.

But in July 2009, the FDA overruled its advisers, instead ordering that a boxed warning be placed on the drug’s label and that patients receive a special pamphlet stressing the hazards of taking too much.

The FDA also required Xanodyne to conduct clinical studies and provide data to evaluate the drugs’ risks and cardiac safety.

The FDA’s actions were the result of new powers the agency had been given in 2007, says Ellen Kelso, CEO of Goodwyn IRB, a Montgomery-based clinical research firm.

The FDA is now authorized not only to approve drugs before they can be sold, but to monitor drugs “across their whole lifetime,” Kelso says. “Now they can ask companies to conduct clinical trials at any time after a product is marketed.”

Before 2007, the FDA’s oversight powers were limited to spontaneous reporting by physicians as they prescribed a product, she says.

For the industry, the case “underlines the fact that this new FDA authority is obviously very real, and very useful in protecting the public,” Kelso says.

Others argue that the cases against Xanodyne illustrate the need for more stringent consumer protections against harmful drugs.

“We had originally petitioned the FDA 32 years ago to ban (propoxyphene-containing drugs),” says Dr. Sidney Wolfe, director of Public Citizen’s health research group.

Wolfe argues that the FDA long stalled in calling for the drugs’ withdrawal, despite studies that have been available for decades that linked them to thousands of deaths.

The FDA-ordered study in 2009 “was a pitiful excuse and the harm in doing it is that it left (propoxyphene) on the market even longer,” he says.

Xanodyne is not the first company to be asked to produce tests and data as the FDA exercises its “new super powers,” Kelso says.

“But it is the first one that has gone all the way through a clinical trial well after the product was on the market and the FDA has determined that the risks outweigh the benefits,” she says.

Xanodyne was the first company to respond to the FDA’s request to withdraw the drugs from pharmacy shelves in November. But because more than 90 percent of the propoxyphene market is supplied by generic-drug manufacturers, other propoxyphene-containing products may still be on the market, Kelso says.

“I don’t know that every single one of them is off the market yet, although they’ve got to be on the way,” she says. “The FDA is communicating loudly to consumers about this.”

At Public Citizen, the agency has called for a congressional investigation into why the FDA “belatedly banned” propoxyphene.
Signs of trouble

Founded in 2001, Xanodyne acquired Darvon and Darvocet in 2005 for $209 million from insolvent aaiPharma Inc. of Wilmington, N.C.

In 2007 the firm had hinted at making a public offering. That year it posted revenue of $74 million, of which $26 million was attributable to sales from Darvon and Darvocet. The company also markets prenatal vitamins; Zipsor, a drug for mild pain; and Oramorph, a painkiller whose active ingredient is morphine sulfate, according to Xanodyne’s website.

Given the FDA’s actions in 2009, the recent request to pull Darvon and Darvocet from the market “didn’t come as a surprise to Xanodyne,” says Brad Mitchell, a Cincinnati-based consultant to pharmaceutical firms and manufacturers.

Last September, just two months before the FDA’s request, the firm announced it was laying off 60 percent of its more than 200 employees.

“What the company would now need to be thinking about is how best to use their infrastructure,” Mitchell says. “My guess is that they have a healthy balance sheet.”

In 2009, the firm announced two separate equity financing efforts totaling $88 million.

While Xanodyne sells and markets prescription drugs, it is not a manufacturer. Instead it has a supply agreement with a manufacturer, “which means they don’t have to deal with fixed structured costs of expensive equipment and a lot of highly skilled people dedicated to manufacturing,” Mitchell says.

With Darvon and Darvocet off the market, Xanodyne may consider looking for other pharmaceutical products, perhaps in the painkiller arena, to purchase and market, Mitchell says.

But the biggest uncertainty for Xanodyne now remains the liabilities it faces with lawsuits – all of which are asking for punitive and compensatory damages that could amount to millions of dollars.

“When a company is faced with a significant issue like this, they’ve really got to evaluate their strategy,” Mitchell says. “There are certainly instances where companies have had to fold because the cost of liability and the cost of litigation and settling claims were in excess of their asset base.”
A family’s pain

As for the Gilberts, the couple visit their daughter’s grave site nearly every day.

“We spend every minute thinking about her,” Tammy Gilbert says. “Her laugh. Her love. She was amazing.”

The family has launched an annual memorial walk and fundraiser to benefit the Kira Nicole Gilbert Memorial Scholarship Fund. This year, the walk is slated for April 16 at Heritage Park in Colerain Township.

“We want to keep her memory alive,” Tammy Gilbert says.

Likewise, she hopes her family’s lawsuit and the others send a lasting message.

“People need to be aware that the medicines out there are not always as safe as we’re led to believe,” she says. “These drug companies need to know that there are more important things in this world than money.

“To them, it’s just a number. Our daughter was taken from us, and we’ll never be the same.”

European drug deal could cost Canada $2.8 billion

Europe’s massive pharmaceutical industry, feeling the squeeze as governments around the world try to contain health care spending, sees potentially lucrative new horizons in countries such as Canada and India.

That’s why the industry has lobbied the European Union to seek expanded patent protection for brand-name drugs in ongoing free-trade negotiations with both countries.

If successful, that effort would cost Canada’s health care system $2.8 billion a year, according to a critical report released Monday that was funded by the Canadian Generic Pharmaceutical Association.

“Canada would have the most extensive structural protection of innovative drugs of any country in the world,” wrote the authors, University of Calgary economist Aidan Hollis and Paul Grootendorst, of the University of Toronto’s faculty of pharmacy.

“Payers -consumers, businesses, unions and government insurers -would face substantially higher drug costs as exclusivity is extended on topselling prescription drugs.”

Ontario would bear the brunt, ith $1.2 billion in extra costs, ccording to the study.

Quebec is next at $773 million, followed by B.C. at $249 million and Alberta at $212 million.

Higher Percentage of Surveyed Physicians Than Surveyed MCO Pharmacy Directors Select Advair/Seretide/Adoair as the Most Efficacious Therapy for the Treatment of Asthma

BURLINGTON, Mass.–(BUSINESS WIRE)–Decision Resources, one of the world’s leading research and advisory firms for pharmaceutical and healthcare issues, finds that a notably higher percentage of surveyed physicians (68 percent) than surveyed managed care organizations pharmacy directors (MCO) (45 percent) select GlaxoSmithKline’s Advair/Seretide/Adoair (salmeterol/fluticasone propionate) as the most efficacious therapy for the treatment of asthma. The lower percentage of surveyed MCO pharmacy directors selecting Advair/Seretide/Adoair may reflect payers’ lower level of familiarity with asthma maintenance treatment and/or their misreading of the emphasis that treatment guidelines have placed on single-agent inhaled corticosteroids (ICSs) as the optimal first-line therapy.

The findings from Decision Resources’ analysis of the asthma drug market reveal that surveyed physicians who identified Advair/Seretide/Adoair or AstraZeneca/Astellas’s Symbicort (formoterol/budesonide) as the most efficacious asthma therapy indicate high levels of satisfaction across all efficacy attributes for these combination therapies.

The findings also reveal that payers who selected GlaxoSmithKline’s Flovent/Flixotide/Flutide (fluticasone propionate) as the most efficacious therapy reported higher levels of satisfaction across all efficacy attributes, relative to payers who selected Symbicort. Although both clinical data and interviewed thought leaders indicate that LABA/ICS combinations offer efficacy superior to that of single-agent ICSs across all efficacy attributes, Flovent/Flixotide/Flutide generally occupies the same formulary tier as LABA/ICS combinations in commercial and Medicare plans because the agent is less expensive and is adequate for providing disease control in many persistent asthmatics.

“The disparity between payer-assigned satisfaction for fluticasone propionate and formoterol/budesonide speaks to payers’ more limited familiarity with clinical data relative to that of primary care physicians,” said Decision Resources Analyst Martin Quinn. “This finding indicates an opportunity for drug developers to communicate the evidence-based benefits of combinations to decision makers in managed care.”

Multiple factors will constrain the asthma market over the next decade as generic and/or branded-generic price erosion, increased product competition and restrictive reimbursement environments will temper major-market sales. As a result, the asthma drug market will decrease from $13.4 billion in 2009 to $12.6 billion in 2019 in the United States, France, Germany, Italy, Spain, United Kingdom and Japan. The principal driver of the eroding sales in asthma will be the loss of brand exclusivity of Merck/Kyorin’s Singulair (montelukast) upon entry of generic versions of the drug, beginning in the U.S. and European markets in 2012.

Decision Resources’ Robust Market Forecast and Opportunities Analysis

Decision Resources provides a comprehensive view of what is happening in a specific drug market now and in the decade ahead. The research includes analysis of the unmet need and near-term drug development opportunities that exist within a drug market powered by primary research from physicians and payers. The robust market forecast and opportunities analysis is comprised of the Pharmacor 2011 advisory service and the DecisionBase 2011 report series.

Drug shortages frustrate pharmacists

A shortage of a number of commonly used prescription drugs is being felt across the country, including here in St. Albert where one pharmacist says the scarcity of certain drugs is frustrating to both pharmacists and patients.

Ryan Diprose, a pharmacist at the Grandin Medical Clinic, said drug shortages are nothing new but in recent years he’s seen more shortages of commonly used drugs like penicillin.

“There’s always been shortages but sometimes they’re oddball medications. But in this case, there are more common ones that we’ve never had shortages of in recent history,” Diprose said.

Last fall, the Canadian Pharmacists Association surveyed its members about the extent of drug shortages across Canada.

Outside of Ontario and Quebec, 89 per cent of respondents had trouble locating medication to fill a prescription during their last shift and 87 per cent said drug shortages had greatly increased over the last year.

Pharmacists in Canada were most often short of Amitriptyline, Cephalexin 500 mg capsules and Metroclopramide in 2010, according to the report.

Diprose said his pharmacy has experienced shortages of all three of those drugs, as well as many others including an antidepressant called Elevil and Fluconazole, which is used to treat yeast infections.

He said drug company representatives will sometimes let him know in advance when a drug is going to be unavailable so he can stock up or when a drug will be available again.

“They try to do that. Sometimes it’s accurate, sometimes it’s not,” he said.

While some prescriptions can easily be substituted with other drugs, others cannot.

“Antibiotics are your biggest problem because you’re limited in your choices sometimes.” Diprose said.

If there is a shortage of a particular drug, he said pharmacists can phone doctors to suggest an alternative or ask patients to try filling their prescription at a different pharmacy.

“That’s all you can say. Most patients are understanding that there is nothing we can do. We do everything we can to get it in,” Diprose said.

He said some pharmacies, including his, can also purchase raw materials and make capsules and liquids in-house.

If a drug is desperately needed, Diprose said pharmacists can also contact both the Alberta College of Pharmacists and the Pharmacists Association of Alberta, who can then send emails to all the pharmacies in Alberta in an effort to locate the drug.

However, when a three-month shortage of penicillin occurred two years ago, Diprose said there was little anybody could do.

“No one had any. It was pointless to tell people to go to other pharmacies.”

While he’s heard many theories regarding drug shortages in Canada, including regulatory and manufacturing changes, no one has given him a straight answer.

“No one has really come out and said what the problem is, that’s the frustrating part,” Diprose said, adding it takes additional manpower to locate scarce supplies or find alternatives.

“It’s frustrating because it takes people out of their regular medication and then it takes a lot more time and energy to make changes, to find other options,” he said.

Steve Long, executive director of Pharmaceutical Funding & Guidance for Alberta Health and Wellness said the reasons for Canada’s recent drug shortages are threefold.

“Manufacturers are going through a change in standards as to how they go about producing products and that change in standards I think has taken them longer than anticipated and therefore they’re not getting batches and lots of their products approved as time goes on,” said Long.

He said the pharmaceutical industry is also rationing itself internationally and as a result, fewer people are producing raw materials than in the past and the supply chain is more vulnerable to disruption.

While some chemicals for prescription drugs are produced in Canada, Long said many come from India, China and Israel.

“I think it’s becoming more competitive,” he noted.

“We don’t have six producers of a single molecule anymore. We’ve got one or two producers for penicillin for instance and if that company has a problem, it goes through the whole system because they become sole supplier,” Long said.

While the manufacturing of pharmaceuticals is a federal issue, Long said if the province is aware of a shortage, pharmacists can substitute brand products for a generic brand.

In addition, he said Alberta Health and Wellness will add other products to their drug benefit list as substitutes for the missing product.

Quebecers’ disposable income inched higher in 2010

MONTREAL – Quebec retail sales increased 6.6 per cent to almost $100 billion in 2010 – the strongest growth in this sector since 2005.

The results were released as part of an annual survey conducted by Groupe Altus for Quebec’s retail council.

The study found that retail sales in Canada as a whole increased 5.1 per cent to $436.4 billion in 2010. Overall, retail sales in Quebec and the rest of the country grew at a faster rate than they did before the economic crisis that clobbered the industry in 2008 and 2009.

Quebecers’ personal disposable income grew from $26,031 in 2009 to $26,725 in 2010. However, it is still lower than the personal disposable income of $29,499 for the country as a whole, the study found.

While consumer confidence in Canada has improved, “we are still at a relatively low level,” said Francis Boucher of Groupe Altus at a news conference.

The overall surge in retail sales was partly because of the sector recovering from the losses incurred during the recession and the rate of growth is expected to slow down, said Gaston Lafleur, president of the Conseil Québécois du commerce de detail (CQCD).

In light of continued weak employment and consumer confidence, retail sales in Quebec are forecasted to grow by three to 3.5 per cent in 2011, he said.

Four retail sub-sectors in Quebec had better-than-average growth in 2010. Retail sales at service stations grew by 20.9 per cent, home furnishings stores saw their sales rise by 11.6 per cent, sales at automobile and auto parts dealers grew by 10 per cent and sporting goods, hobby, book and music stores experienced sales growth of 8.6 per cent.

The report found retail sales of food and beverages rose five per cent. The increased price of certain basic food items contributed to this hike in sales in sector, the study found. The opening of three price-competitive Walmart Superstores in Quebec this year is expected to bring down the cost of some food items. The arrival of U.S.-based Target in Quebec is also expected to provoke reactions from retail establishments that sell diverse merchandise.

While pharmacy and personal care retail sales grew only 2.3 per cent in 2010, the purchasing patterns of an aging population is expected to increase sales in this sector in coming years, the CQCD said.

Purdue University Researcher’s Technology “Listens” to Cancer Cells, Shows Effects of Drug Therapies

A Purdue physicist has created technology to detect motion inside three-dimensional tumor spheroids, which may enhance the pharmaceutical industry’s early drug discovery capabilities.

David Nolte has developed Holographic Tissue Dynamics Spectroscopy, a technology that allows researchers to look inside cells using holography and lasers. The technology was highlighted in a letter in the peer-reviewed Journal of Biomedical Optics. The work is done in collaboration with John Turek, professor of basic medical sciences at Purdue.

“This technique measures living motion inside a cell,” Nolte said. “We’re picking up all the activity and seeing how the cell modifies its activities in response to applied drugs.”

The first process used by Nolte’s technology is holography, which shows tumor tissue in three dimensions.

“We make digital holograms of thetumor, which can grow up to one millimeter,” Nolte said. “This holographic technique using lasers lets us see all the way through the tumor, not just the surface.”

The tissue dynamics spectroscopy used in Nolte’s technology creates an image that shows changes taking place inside cells.

“After making the hologram, we use spectroscopy to measure the time-dependent changes in the hologram,” Nolte said. “Fluctuation spectroscopy breaks down the changes into different frequencies, and we can tell how a cell’s membranes, mitochondria, nucleus and even cell division respond to drugs. We measure the frequency of light fluctuations as a function of time after a drug is applied.”

The resulting colorful frequency-versus-time spectrogram represents a unique voice-print of the drug used on the cells.

“Individual drugs have different spectrograms, but with similarities within specific classes,” Nolte said. “By looking at how cell motion responds to drugs, we can differentiate very fine mechanistic points between them.”

Drug researchers and manufacturers may benefit from the technology by being able to more quickly determine which drug candidates are most effective in battling tumors and other tissue diseases.

“This technology, with its high-throughput aspect, allows manufacturers to place a different tumor into 384 plates, test 384 different drug compounds and create 384 spectrograms in six hours,” Nolte said.

The State of Life Science Research

R&D Magazine asked research leaders from three life science industry sectors—big pharma, medical devices, and independent research organizations—to discuss the present and the future of life science.

Q: Tell us about some of the recent important research/developments at your organization.

Ven Manda, vice president MDT Ventures and New Therapies at Medtronic, Inc.: We are at a moment of convergence in medicine and technology with immense opportunities. At Medtronic, we specialize in an array of high-tech solutions—examples include resynchronization therapy for specific heart failure patients, neurostimulation for specific Parkinson’s patients; devices and therapies for spinal procedures; continuous glucose monitoring for diabetic patients; novel therapies for atrial fibrillation and valvular heart disease; and many others. These core technologies, combined with several emerging and innovative new therapies, including integrated biologic/drug delivery technologies for these and other chronic conditions, position us well for the future. Coupled with expanding infrastructure of enabling technologies, such as wireless systems, electronic medical records and our own strong history of developing sensors and diagnostic technologies to improve care, we envision a unique place for Medtronic at the epicenter of this ongoing change in health care delivery and meeting the needs of patients, doctors, and health care providers globally.

Dr. Marc Bonnefoi, deputy head, U.S. Research & Development for sanofi-aventis, Bridgewater, N.J.: Transforming R&D and fostering increased innovation is the first pillar of our group’s strategy and core to our commitment to provide hope and solutions to the potential 6.8 billion people in need. A new R&D model has been implemented to strengthen creativity and innovation while being centered on patients’ needs. It focuses on openness of our research teams towards large public research institutes, biotechs, and other external partners and on the creation of more flexible entrepreneurial units that foster the emergence of innovation. Through these partnerships, our goal is to advance scientific knowledge in areas that will have direct impact on providing patients with healthcare solutions that address unmet medical needs. By creating entrepreneurial units such as Aging, for example, we take the perspective of the patients to design our strategy. Our new Business Divisions in diabetes, oncology, and ophthalmology represent our strong and sustainable commitment in this area.

Kristina Vuori, President, Sanford-Burnham Medical Research Institute, and Director of Sanford-Burnham’s National Cancer Institute-designated Cancer Center One of our primary missions is to come up with scientific discoveries, and we probably do that on an almost daily basis. Out of all of these highlights for 2010, one major discovery that a Sanford-Burnham scientist, Erkki Ruoslahti, has made is that he has found a peptide, which is a small chain of amino acids or a protein, that can recognize and penetrate tumor tissues, and deliver therapeutics deep inside the tumor without affecting normal tissues.

One of the major breakthroughs for us as a scientific organization is that at the end of 2010 we announced two major partnering deals with pharmaceutical companies: Takeda and Johnson & Johnson. These are truly collaborative efforts where our scientists with the help of our chemical genomics center will team up with pharmaceutical companies and work together in moving our scientific laboratory discoveries forward for human benefit. This represents a big milestone in how we would like to do business in the future.

Q2) What impact has the poor economy had on the medical device market?

Manda: Clearly, 2010 was a challenging year for the entire medical device sector, and, in fact, the overall healthcare sector. However, we have seen sequential momentum in out key businesses, especially in emerging markets and in new business segments. Our diverse therapeutic and geographic portfolio serves us well at a time where the global economy is not yet on stable footing. Because our technology solutions primarily serve patients with moderate-to-advanced chronic disease (as in heart failure, CV disease, diabetes, etc.), the demand for our therapies worldwide far outstrips current penetration levels.

Q2) How has your research investment strategy been affected by recent economic changes?

Bonnefoi: Sanofi-aventis continues to focus on delivering therapies to patients that provide value to patients as well as payers and providers. As a percent of sale, our investment in R&D has not changed significantly.

Vuori: About 80% of our budget in La Jolla (Calif.) comes from the National Institutes of Health (NIH). Institute-wide, about 67% to 70% of our budget is from government sources. In Florida, we have a significant state funding component, so in Florida we are a little less dependent on government funding, but it’s very fair to say we live and die based on where the NIH’s budget is.

There are two things we have looked at with the reality that the government’s funding is very unlikely to increase in near future. One of them, of course, is how we can be more competitive for government grants and contracts. We continue to invest in high-end technologies that move our science forward within our organization. We provide seed funding and catalyze collaborative efforts where scientists team up to do science, seeking opportunities where complementary skills can be brought to bear. NIH’s funding for collaborative efforts in has been very favorable for us. We have been very competitive in getting large, team-based government grants.

The other reality for us is to diversify our revenue portfolio and be less dependent on NIH funding. We are seeking opportunities for funding from government agencies outside NIH, for example, the Department of Defense, which has medical research programs. We are increasingly paying attention to those, and, certainly continuing to expand our business transfer programs and continuing our efforts to bring in funding outside of government.

Q3)Have recent government policy changes affected the way your company does research or develop products? If so, please tell us how.

Manda: As requirements from regulatory bodies in various parts of the world evolve, we acknowledge and have felt the impact on our product development and approval timelines. That said, our experience and commitment to what we do best—providing high-tech, specialized solutions for patients with specific, advancing diseases—is grounded in conducting solid clinical trials and establishing the clinical evidence for appropriate use of our therapies. We are extremely well positioned to work with government agencies and support policy that ultimately enables innovation to accelerate and patients to receive the best set of choices that they can for their care. The case for accelerated and novel breakthrough concepts has never been stronger.

Bonnefoi: Our research continues to be focused on delivering healthcare solutions that address unmet medical needs to patients around the world. Recent government policy changes have not impacted this commitment.

Vuori: There hasn’t been much affect at this specific time. Obviously, we are looking very closely as to where the current challenges are to federally-funded embryonic stem cell research. At the present time, federal funding is allowable for stem cell research. We, of course, hope that viewpoint will prevail and continue. Other than that, I don’t think there have been big policy changes at the federal government level that have affected us.

Q4) Tell us about your organization’s notable research collaborations or new business opportunities that have taken place outside of the U.S.

Manda: We continue to determine how we best meet the unique need of patients and health-care delivery systems around the world. Clearly, no one country has a monopoly on innovation, therefore, it is imperative we take advantage of our global presence, strong depth of understanding of basic and applied research, product development, and efficient manufacturing and distribution systems to serve this increasing global demand for health care.

At present, 41% of our revenue comes from outside the U.S. We expect, in the next five years, that about 20% of our revenue will come from emerging markets specifically. We are very excited about our international business and the global collaborations we have embarked on, as important elements of our future growth.

Bonnefoi: Emerging markets are one of the growth pillars of sanofi-aventis. We have a well-established presence in emerging markets with activities in over 100 countries, including local manufacturing capabilities and clinical development units as well as a broad product portfolio adapted to local needs.

Within R&D, we have benefited from this global presence through the formation of partnerships and alliances with universities, research institutes, and biotechs throughout Europe and Asia. For example, we have a strategic research agreement with Shanghai Institutes for Biological Sciences (SIBS) that focuses on identifying innovative drugs for the treatment of neurological diseases, diabetes and cancer while also strengthening our R&D presence in China. We are also members of several academic consortia in Europe, including AVIESAN (French Life Sciences and Healthcare Alliance) and the Innovative Medicines Initiative (European public-private partnership). These partnerships aim to enhance scientific knowledge in the areas of life sciences and healthcare and to develop projects benefiting patients in research areas like immuno-inflammatory diseases, infectious diseases, and regenerative medicine. The partnerships also foster a spirit of collaboration and exchange between public and pharmaceutical industry researchers.

Finally, one of the entrepreneurial unit of our new R&D organization is entirely dedicated to Asia-Pacific.

Vuori: At a grass roots or individual investigator level, we have always been collaborative both nationally and internationally. Out of our some 800 scientists, a significant portion–some 30% to 40%–come from outside the United States and some 40 nationalities are represented here, so international collaboration comes naturally to our scientists. At the institute-wide level, I had mentioned the pharmaceutical arrangement made at the end of last year with the pharmaceutical company called Takeda, which is the largest pharmaceutical company in Japan. We seek larger technology transfer opportunities within the U.S. and outside in a manner consistent with the Bayh-Dole Act, since we receive a lot of NIH funding. We see a lot of opportunities to expand further our activities overseas and like many other organizations are thinking about opportunities in Asia and China.

Q5) What do you see as the next big breakthrough in life science and the medical device industry?

Manda: One of the great things about Medtronic is the opportunity to pursue the latest technical developments in medicine and access to the newest thinking about how to address significant, unmet clinical risk for a variety of medical conditions. In addition to a robust R&D pipeline, we have carved out a separate $100 million annual internal “venture” fund which allows us to incubate, test and accelerate novel, internal R&D concepts for diagnosis, monitoring, or treating a disease—concepts that may not necessarily fit into one of our existing businesses, but, if successful, can significantly advance standard-of-care for specific conditions, deliver long-term growth for the company, and enable new businesses to emerge.

Indeed this was the basis for several of our organically generated $1 billion product-lines such as cardiac resynchronization therapy. In addition to this “internal” fund, we also have a very active early-stage investment portfolio of more than 60 companies which gives us a first look at promising emerging technologies.

Our strong balance sheet allows us to invest in tuck-in acquisitions to get into new therapeutic areas and add adjacencies to our existing portfolio.

While it may be difficult to predict where the next “big thing” is going to come from, we are confident that Medtronic’s ability to invest in early and late-stage R&D concepts will allow us to lead the way in bringing breakthrough innovation to our customers.

Bonnefoi: With the explosion of genomics leading to knowledge of potential targets and mechanisms, we should increasingly have the ability to develop targeted therapies and get the right therapy to the right patient at the right time. However, the promise of translational medicine has not borne fruit yet to the extent that many expected. We believe this is due in part to an incomplete understanding of human diseases. We are seeking better and quicker ways to obtain human validation of our hypothesis. In addition, we have reoriented to focus on targeted therapies, viewing the needs of a patient and developing services and devices that help them manage the diseases.

Vuori: I suspect that many people would hope that the next breakthrough will come from our collective capability to leverage the knowledge that can be obtained from the human genome sequence. The blueprint for life has been uncovered, if you will. Collectively, I don’t think scientists have put that knowledge to very good use yet, but I do expect the breakthrough will come from understanding the difference between a healthy and diseased human genome, and how those changes can be detected. This is probably a key for coming up with the concept of personalized medicine, in which we can tailor disease diagnosis, prognosis, and treatment based on the information the individual will have in his or her genome and epigenome. I think at Sanford-Burnham what we are very decisively doing is taking this knowledge of the human genome, understanding how the genes and their products—the proteins—work with them, and trying to come up with the chemical tools and chemical compounds that can be used for two things: one, to further the laboratory use of those compounds to study and understand what the genes and products are doing and their association with various diseases; and, two, to find a way that these chemical compounds can serve as prototypes of medicines.

Shoppers Drug upped, Canadian Tire cut

Fourth quarter earnings from two of Canada’s biggest retailers left Desjardins Securities analyst Keith Howlett with much different viewpoints.
Canadian viagra no prescription
For Canadian Tire Corp., which failed to see weather-related strength in same-store sales at its Canadian Tire and Mark’s Work Wearhouse stores, he downgraded the stock to Hold from Buy.

Mr. Howlett also cut his price target to $69 from $73, noting that the cyclical earnings recovery is proving less robust than anticipated.

“We remain unconvinced that management’s strategy will drive meaningful EPS growth,” the analyst told clients.

Shoppers Drug Mart Corp. was a different story, with fourth quarter EPS of 79¢ coming in ahead of consensus of 75¢. The company also hiked its dividend by 11.1% to 25¢ per quarter and announced a share buyback of as much as 8.7 million shares.

The strong quarterly operating results and management’s confidence has Mr. Howlett believing that Shoppers will again be increasing quarterly EPS by the third quarter of 2011.

The analyst also expects that the retail pharmacy industry will begin to consolidate more rapidly into the hands of the largest players in the second half of 2011, “as more independent pharmacies and small chains reach their tolerance for financial pain.”

He upgraded his recommendation on Shoppers shares to Buy from Hold and raised his price target to $43 from $39.

Radical reform needed in pharmaceutical industry

A research centre funded by the Economic and Social Research Council (ESRC) has shown that radical reform of the drugs industry regulatory system must be an important part of the solution to ensure a productive and profitable pharmaceutical sector, both globally and in the UK.

Researchers from the ESRC’s Innogen centre, in Edinburgh, UK, have studied the innovation models in the pharmaceutical industry and how the industry has been able to remain sustainable for so long.

The results of their research show that the lengthy and expensive regulatory system that now applies to most products for the life sciences is causing innovation failure.

Regulation has a large impact on the kinds of product that are developed by any industry sector: it is designed to ensure that products are safe, effective and of high quality.

Innogen’s research demonstrates that the impacts of regulation in pharmaceuticals are especially far reaching.

They determine overall company strategies; which types of companies succeed; and ultimately the structure and dynamism of the sector as a whole.

Under current circumstances, regulation prevents the development of the radically innovative technologies that could provide opportunities for the sector to become more effective in developing innovative products.

Innogen research has predicted that the industry is approaching a tipping point in the not too distant future.

Professor Joyce Tait said: “We do not need less regulation, but smarter regulation that can deliver expected standards of safety and efficacy, is flexible enough to respond to new scientific discoveries and can do so more efficiently than our current systems within a shorter time frame.”

Innogen research also shows that policymakers and governments need an understanding of all the major causes and relevant options available.

Radical regulatory reform for the life science industries needs to be a priority in discussions regarding the future of the industry.

Reform could provide the lever to profitably unleash the creativity that has been so effectively generated from public funding of basic science, leading to something closer to the innovative performance that we have seen in information and communication technologies over the past twenty years.

Monitor Clipper Buys Minority Stake in ScriptSave

Private equity shop Monitor Clipper Partners has acquired a minority interest in ScriptSave. Tuscon-based ScriptSave provides customized prescription drug benefit products for consumers, which are delivered through retail pharmacies, health insurance companies and employers. McColl Partners LLC, an independent investment banking firm specializing in middle-market companies, served as financial advisor to ScriptSave. Monitor Clipper Partners is based in Cambridge, Mass.

PRESS RELEASE:
Today, ScriptSave announced that Monitor Clipper Partners (MCP) has purchased a minority interest in the company. MCP, a private equity investment firm, has a strategic relationship with the Monitor Group, a leading global strategy consulting firm.

Commenting on the transaction, Lori Bryant, President and CEO of ScriptSave, said, “ScriptSave is pleased by the confidence that Monitor Clipper Partners has in our business and we look forward to the expertise, insight and industry relationships that MCP brings to us. We are excited to work with MCP to bring even greater value to our clients.”

Adam Doctoroff, Partner, MCP, added that “the capabilities and historical success of ScriptSave were key factors in our decision to invest in the company’s future. We believe that ScriptSave’s leadership role in working with pharmacy retailers across the country to provide consumers with real value and savings is an unparalleled platform for growth. We look forward to working with the Company’s management team to continue to enhance their industry-leading offerings.”

McColl Partners LLC, an independent investment banking firm specializing in the needs of management and owners of middle-market companies, served as financial advisor to ScriptSave.

About ScriptSave – Founded in 1994, ScriptSave pioneered the U.S. unfunded drug benefit market and has saved consumers over $2.5 billion in health care costs. The company provides customized prescription drug benefit solutions for consumers; delivered through retail pharmacies, health insurance companies, employers and PBMs. ScriptSave is headquartered in Tucson, Arizona. For more information about ScriptSave, visit www.scriptsave.com. For inquiries on this release, contact Lori Bryant at lbryant@scriptsave.com or 520-888-8070.

About Monitor Clipper Partners – Monitor Clipper Partners is a Cambridge, MA-based independent private equity firm formed in 1998. MCP has invested in over 35 businesses in North America and Western Europe over the past decade and has a close strategic relationship with the Monitor Group, a leading international strategy consulting firm. MCP targets growth-oriented businesses with strong management teams and currently manages over US$2.0 billion in capital.