Pharmaceutical News Today

Beck Suggests Federal Support Of Drug Research Means Government Will Be “In Charge Of The Life-Saving Drugs”

Beck: “[I]s Anybody Else Concerned With The Government Being In Charge Of Our Life-Saving Drugs?” On the January 24 edition of his Fox News program, Beck mocked the announcement of a $1 billion government drug development center to help create new medicines, asking his listeners, “[D]o you believe the federal government is the answer to speeding up production of new medicine? Me neither.” He further stated, “Maybe it’s just me, but is anybody else concerned with the government being in charge of our life-saving drugs?” From the broadcast:

BECK: Next headline. The Obama administration has become so concerned about the slowing pace of new drugs coming out of the pharmaceutical industry that officials have decided to start a billion-dollar government drug development center to help create medicines. Well, that is fantastic. No, seriously — they’re concerned about the time it takes to get new drugs to the market. Reason: do you believe the federal government is the answer to speeding up production of new medicine? Yeah, me neither. So why is this happening?

Well, I mean, let’s start with this. Why would the drug manufacturers have any problems, you know, making new drugs and getting them to the market. You know, they have to wait for the FDA approval and go through — and this is all fine print. You know, go through the new regulations and the rules of, you know, all this stuff from the FDA. It’s pretty cumbersome, right? I mean, can you imagine? By the way, this isn’t the FDA. These are just the 165 new [Food and Drug Administration] regulations that Cass Sunstein has put in with Obama since 2009. Now it takes an average of 12 years and over $350 million, U.S. dollars, to get a new drug from the lab — laboratory to the pharmacy shelf.

So, they’re serious. What they’re going to do now is add incompetence. Maybe it’s just me, but is anybody else concerned with the government being in charge of our life-saving drugs? Remember, when they want to have a solution to something, they get serious. Remember when there were long lines at the post office? I am not making this up. Do you know what their solution was? Do you know, Erin? She knows. She knows. Take the clocks out of the lobby so nobody could see the clock. That was it. Like you don’t have watches or a cell phone? While we’re at the post office, by the way, the U.S. Postal Service is going to start the process of closing additional 2,000 branches operating in a deficit now, but they have to lobby Congress to allow it to change the law so it can close the most unprofitable post offices. The law currently allows the Postal Service to close post offices but only for maintenance problems, lease expirations, or other reasons that don’t include profitability.

Record Number of Pharmacy Technicians Seek Certification Through PTCB

Certification as a pathway to new job opportunities and expanded responsibility.

WASHINGTON, Jan. 25, 2011 /PRNewswire/ — Record numbers of pharmacy technicians continue to seek certification through the Pharmacy Technician Certification Board (PTCB), a pioneer in the credentialing industry. Over 400,000 pharmacy technicians nationwide have earned the PTCB Certified Pharmacy Technician (CPhT) credential since 1995 and more than 55,000 candidates sat for the Pharmacy Technician Certification Exam (PTCE) in 2010 alone.

As medication regimens become more complex and cost-conscious insurers rely on pharmacists to provide direct-patient care and medication therapy management, PTCB certified pharmacy technicians will continue to be relied upon to keep pharmacy operations running smoothly.

The Bureau of Labor and Statistics (BLS), Occupational Outlook Handbook 2010–11 Edition, projects that pharmacy technician employment is expected to increase more than 31 percent by 2018. The BLS also suggests that pharmacy technicians with formal education or training, previous work experience, and national certification will be specifically sought after to meet these demands.

“Certification through PTCB represents an excellent pathway to employment for pharmacy technicians practicing in the United States,” said Melissa Murer Corrigan, RPh, Executive Director and CEO of PTCB, “It also enables pharmacy technicians to meet the growing demands of a changing pharmacy landscape.”

An increasing number of states have decided to allow only pharmacy technicians certified through PTCB to be employed by pharmacies. Pharmacy technicians assist pharmacists in dispensing medications and are accountable to the supervising pharmacist who is legally responsible through state licensure for the care and safety of patients served by the pharmacy.

“America’s evolving health care system calls for qualified support personnel that will enable pharmacists to provide patient-centered care with authority and autonomy,” said Thomas E. Menighan, BSPharm, MBA, FAPhA, Chair, PTCB Board of Governors. “PTCB’s certification program not only assesses technicians’ knowledge up front, but also requires ongoing commitment to the profession by requiring technicians to maintain certification through continuing education.”

PTCB’s certification program offers flexible testing at more than 200 Pearson Professional Centers nationwide; efficient score reporting of pass/fail results available to candidates immediately after completing the PTCE; and certification verification for employers who require current certification for technician employment. Pharmacy technicians may apply to take the PTCE online at www.ptcb.org, and may follow PTCB on Facebook, LinkedIn, and Twitter to connect with others dedicated to PTCB certification and patient safety.

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Pharmacy and Drug Industry News

Unintended direct conflict between pharmaceutical marketing and public health

Medical ethicists examine aggressive marketing tactics’ influence on medical practice and outline strategies to protect patients

Drugs that pharmaceutical companies market most aggressively to physicians and patients tend to offer less benefit and more harm to most patients – a phenomenon described as the “inverse benefit law” in a paper from the University of Texas Medical Branch at Galveston.

Published online Thursday, Jan. 13 in the American Journal of Public Health, the article explores recent withdrawals of blockbuster drugs due to safety concerns and finds a clear pattern of physician-focused marketing tactics that ultimately exposed patients to a worsening benefit-to-harm ratio. Potential patient safety and public health implications include unnecessary exposure to adverse side effects, high medical costs and competition for scarce resources.

“This is not a random occurrence, but rather a repeating, planned scenario in which drugs, discovered with good science for a specific set of patients, are marketed to a larger population as necessary, beneficial and safer than other alternatives,” said co-author Dr. Howard Brody, a professor and director of the Institute for the Medical Humanities at UTMB Health. “Marketers are just doing their jobs. However, the reality is that for most new drugs, safety and efficacy are scientifically proven for only a small subset of patients. It’s time for physicians to take a stand and not prescribe them so readily.”

Macrolides Mixed With BP Drugs Can Lead to Hypotension

Simultaneous use of calcium-channel blockers and some macrolide antibiotics may result in hypotension, which may require hospital admission, according to a study published online Jan. 17 in CMAJ, the journal of the Canadian Medical Association.

MONDAY, Jan. 17 (HealthDay News) — Simultaneous use of calcium-channel blockers and some macrolide antibiotics may result in hypotension, which may require hospital admission, according to a study published online Jan. 17 in CMAJ, the journal of the Canadian Medical Association.

Alissa J. Wright, M.D., from the University of Toronto, and colleagues conducted a population-based study involving patients aged 66 and older who were prescribed a calcium-channel blocker between 1994 and 2009. The investigators identified which of the patients had been hospitalized for low blood pressure and whether they had been prescribed a macrolide antibiotic shortly before their admission.

The investigators identified 7,100 patients who were hospitalized with hypotension during treatment with a channel-blocker, of whom 176 had been prescribed a macrolide antibiotic. Erythromycin and clarithromycin were associated with hypotension (odds ratios, 5.8 and 3.7, respectively). Azithromycin was not associated with an increased risk of hypotension.

“Clinicians should be aware of the potential interaction between these drugs. When a macrolide is required, preferential use of azithromycin should be considered in patients already receiving a calcium-channel blocker,” the authors write.

Two of the study authors disclosed financial ties with pharmaceutical companies.

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Pharmaceutical and HealthCare Industry Today

Healthcare industry bodies unite to form LifeSciencesUK

Four healthcare industry bodies have united to form a new initiative to advocate and support greater life sciences research and development in the UK.

LifeSciencesUK, which consists of the Association of British Healthcare Industries (ABHI), the Association of the British Pharmaceutical Industry (APBI), the BioIndustry Association (BIA) and the British In Vitro Diagnostics Association (BIVDA) aims to increase investment in UK life sciences companies in developing new medicines and healthcare technology.

Pharmacy minister Earl Howe praised the “exciting initiative” as allowing the industry to work closer with the NHS in providing quality care and improving productivity through new technologies and innovations.

Global Biotechnology Reagents Market to Reach US$33 Billion by 2015, According to a New Report by Global Industry Analysts, Inc.

The market for biotechnology reagents is witnessing a paradigm shift from providing reagents to being suppliers of highly integrated systems featuring a range of reagents, labels, dyes, and protocols. Besides, in terms of ultimate product users, the market is witnessing a pronounced shift towards the corporate sector while use by academic sector is declining. Pre-packaged kits continue to gain popularity due to highly integrated combination of reagents, accessories and related software. With focus shifting from the gene to the protein, the industry is increasingly turning towards novel technologies that determine the activation state of a protein rather than unraveling the gene. Highly automated instrumentation is a key factor tempering use of reagents. Automation results in highly efficient and optimal utilization of reagents and minimizes wastage. However, continued popularity of manual procedures and a marked reluctance by scientists to upgrade their software skills is likely to ensure robust consumption of biotech reagents. Increase due to the continued use of reagent-intensive manual techniques will offset decline in reagent-use due to the high level of system automation.

Demand for biotechnology reagents and supplies is largely dependent upon the performance of biotechnology instrumentation market. Demand for biotechnology instrumentation continues to witness significant growth. Continual product developments are being witnessed in various industries, such as pharmaceutical/bio-pharmaceutical, agri-biotech, and food and beverages, which are expected to facilitate market growth. Pharmaceutical industry is a principal force driving the biotechnology revolution. A constant search for new drugs is a catalyst that stimulates interest in the public, biotech investors and instrument companies. Emerging sectors in drug discovery arena such as genomics, proteomics, DNA chips, combinatorial chemistry, and high throughput screening, are fuelling demand for bioinstrumentation. Agriculture and food and beverage sectors are also registering increased market demand.

The United States represents the largest market for biotechnology reagents, as stated by the new market research report on Biotechnology Reagents. With the first phase of Human Genome Mapping project completed successfully and ahead of schedule, the market for instruments and related supplies is on an upsurge in the US. Asia-Pacific represents the fastest growing market for biotechnology reagents, exhibiting a CAGR of more than 7.0% during the analysis period.

Immunoassay Reagents represents the largest segment. Cell Culture Reagents is the fastest growing segment, and is expected to grow at a compounded annual growth rate of 12% during the analysis period. Nucleic-Acid reagents, particularly DNA sequencing reagents, are expected to witness significant growth in the US. Approximately 10,000 US laboratories perform sequencing, and of these, one-third mainly uses automatic techniques. Manual sequencing uses slab gels, electrophoresis, and radioisotope (or alternative) labels for tracing.

Major players profiled in the report include Abbott Diagnostics, Beckman Coulter Inc., Becton Dickinson and Company, BioMérieux SA, Chemicon International Inc., EMD Biosciences Inc., EMD Millipore Corp., Fitzgerald Industries International, GE Healthcare, Life Technologies Corp., Ortho-Clinical Diagnostics, PerkinElmer Inc., Promega Corp., Roche Diagnostics Ltd., Siemens Healthcare Diagnostics Inc., Sigma-Aldrich, among others.

The research report titled “Biotechnology Reagents: A Global Strategic Business Report” announced by Global Industry Analysts Inc., provides a comprehensive review of the biotechnology reagents market, current market trends, key growth drivers, new product innovations/launches, recent industry activity, and profiles of major/niche global market participants. The report provides annual sales estimates and projections for the global Biotechnology Reagents market for the years 2007 through 2015 for the regions, including US, Canada, Japan, Europe, Asia-Pacific, and Latin America. Key product segments analyzed include Cell/Tissue Culture Reagents, DNA Sequencing/Synthesis Reagents, Electrophoresis Reagents, Flow Cytometry Reagents, Immunoassay Reagents, Liquid Chromatography Reagents, Polymerase Chain Reaction Reagents, and Protein Synthesis Reagents.

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Pharmacuetical Industry News

Court Takes Up Drug-Data Case

The Supreme Court agreed to decide whether states can bar the sale of doctors’ prescription data to drug companies, setting the stage for a ruling likely to affect one of the pharmaceutical industry’s most powerful marketing tools.

Currently, data companies such as IMS Health Inc. gather information from pharmacies on which medicines doctors are prescribing and how often. Drug makers buy the data, using it to refine their marketing pitches and measure which salespeople are the most effective.

A 2007 Vermont law effectively banned the practice in the state. It says data-mining companies can’t sell the prescription information for marketing purposes, and drug makers can’t use it, unless the prescribing doctor consents.

Vermont lawmakers said the measure would protect the privacy of doctors and patients and help to control health-care costs on expensive brand-name drugs. The state said the pharmaceutical industry spends nearly $8 billion a year on marketing efforts directed at doctors.

IMS Health and two other data-mining companies, along with a leading drug-industry trade group, challenged the law on First Amendment grounds and won a key ruing in November. A federal appeals court in New York found the Vermont law an unconstitutional restriction on the commercial free-speech rights of the plaintiffs.

That ruling conflicted with a ruling by a different federal appeals court upholding similar laws in Maine and New Hampshire. Now the Supreme Court will settle the issue.

Vermont Attorney General William Sorrell said he looks forward to the Supreme Court arguments, which could come in April. “Vermont doctors pressed for this law because of their concerns about privacy and because they view this data mining practice as an intrusion into the way doctors practice medicine,” he said.

IMS Health and the other data-mining companies said the laws in Vermont and elsewhere “harm patients by making it more difficult to communicate timely and often vital information about new medicine and safety updates on existing medicine.”

Separately, the Supreme Court said it will consider whether investors can proceed with a securities-fraud lawsuit against Halliburton Co.

A federal appeals court in New Orleans blocked the class-action lawsuit last year, saying plaintiffs failed to show that the company’s alleged misstatements inflated its share price.

In their petition the Supreme Court, the investors said the lower-court ruling erected a new, higher standard that could make it more difficult for some securities lawsuits to move forward. The investors said the appeals court wrongly required them to prove essential pieces of their case at early stages of the litigation. The Obama administration, siding with the investors, filed a brief that urged the high court to hear the case.

Halliburton said there was nothing unusual about the legal approach the lower court used to reject the shareholder lawsuit, which alleges that Halliburton misled investors about its asbestos liabilities and other matters roughly a decade ago.

Importance of nanotechnology in formulation and drug delivery

The Nanotechnology Knowledge Transfer Network (NanoKTN), one of the UKs primary knowledge-based networks for Micro and Nanotechnologies, today announced it has partnered with the School of Pharmacy to host an event exploring the ways in which nanotechnology can help with the formulation and delivery of drugs. The conference will provide a forum for industry professionals to discuss and highlight best practise and to encourage collaborative working.

The biopharmaceutical industry is one sector guaranteed to see the benefits that nanotechnology has to offer, with the nanotechnology-enabled drug delivery market predicted to rise in value from $3.39bn to $26bn by 2012. Drug delivery systems that utilise nanotechnology are increasingly being adopted by industry as the drugs they are developing become more difficult to formulate. Issues such as solubility, labile moiety stability and transport across biological barriers can all be addressed by nanotechnology-based systems.

This event will look at where nanotechnology can help with the formulation and delivery of the drugs currently in development that would benefit from such improvements. With presentations from leading industry professionals, the event will look at where key technologies are yet to be established, with the aim to identify gaps in the market where UK companies can invest and become involved.

Dr Peter Luke, Senior Director, Strategic Alliances, Worldwide Business Development at Pfizer will look at the current changes in pharmaceutical research and how the concept of Open Innovation is being far more widely accepted and acted upon. Peters presentation will discuss recent trends in open innovation, using examples that demonstrate the scientific value that such collaborations bring to both the pharmaceutical and the academic communities.

There will also be an opportunity to discuss the next round of funding in nanotechnology for healthcare by the Technology Strategy Board.
Other speakers include Dr Bill Lindsay of The School of Pharmacy, University of London, Professor Ijeoma Uchegbu of The School of Pharmacy, University of LondonandProfessor Stephen Hart of Genex BioSystems.

The field of bionanotechnology is resolving some significant problems. It has enabled new formulations for drugs that are commercially available and there are a number of drugs and drug-delivery systems in the R pipeline and at the regulatory approval stage, comments Dr Mike Fisher, Theme Manager at the NanoKTN.

Fisher continues, Nanotechnology has a lot to offer right now and events like this are crucial to ensure the UK is kept at the forefront of developing the next generation of products for drug formulation.

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Pharmacy Industry Today

Pharmacy Industry Veteran Joins Millennium Pharmacy Systems as COO

Millennium Pharmacy Systems, Inc. has announced that Philip J. Keough, IV has joined the company as Executive Vice President and Chief Operating Officer based in its Shared Services Center in Cranberry Township, Pennsylvania, effective November 29, 2010.

Mr. Keough brings over twenty years of pharmacy leadership in operations, customer service, and consulting experience to Millennium. He most recently led Keoco, LLC, a successful consulting practice specializing in high-growth, early-stage pharmacy industry businesses. Phil has experience in hospital and independent pharmacies, as well as in the chain-drug industry, where he rapidly advanced into roles of significantly greater responsibility, culminating in leading all pharmacy operations for national leaders, CVS and Rite Aid. Phil honorably served in the U.S. Army Reserve and holds a Bachelor of Science, Pharmacy degree from Auburn University.

“The depth and breadth of Phil’s experience and leadership in the pharmacy industry, coupled with his intense focus on the customer experience, will make him an outstanding addition to Millennium’s executive team,” said Chief Executive Officer, Richard P. Scardina.

“Millennium’s innovative and cost effective medication management approach offers critically needed solutions to the long-term care market. By eliminating drug waste, enhancing administrative processes and improving patient safety, Millennium is changing the face of pharmacy solutions in the marketplace. I could not be more excited to join this leadership team and am committed to helping Millennium deliver on the promise of care, cost and compliance to its long-term care customers,” Phil said.

About Millennium Pharmacy Systems

Millennium Pharmacy Systems is a leading pharmacy services provider to the long-term care industry. Offering a new approach to pharmacy services, Millennium delivers on the promise of “the right drug, for the right patient, at the right time, for the right price” so its customers can deliver the best patient care while reducing costs, and more easily meeting compliance demands. Only Millennium combines Just-In-Time Dispensing with electronic medication and treatment ordering, administration, documentation, and reporting. Millennium backs up this commitment with delivery timeliness and medication accuracy customer guarantees. Millennium is headquartered in Chicago, Illinois.

Business News: Bause’s provides free flu shots through anonymous donor

BOYERTOWN — Courtesy of an anonymous local donor, Bause’s Super Drug Store Inc. is providing flu vaccines at no charge through Jan. 7, 2011, to area residents age 18 and older.

“The donor intended that the vaccines would be administered to those who do not have the financial means to pay for the vaccine themselves,” said Jane Mellott, president of Bause’s Super Drug Store.

According to Mellot, the donor asked to remain anonymous.

“Requests to receive the vaccination on a ‘financial needs basis’ will be on the honor system,” Mellott said.

Immunizations are also available to children under 18 years of age by appointment. Home-bound adults or businesses who desire to have pharmacy manager Rebecca Kuns come to their location to administer the flu shot at no additional charge should call Bause’s at 610-367-8641 to schedule an appointment.

Almac prepares to open Souderton headquarters

SOUDERTON — The Almac Group, a global provider of drug development services to the pharmaceutical industry, has added 173 jobs to the Philadelphia region as it prepares to formally open its new U.S. headquarters in Souderton in spring 2011. The new facility, which is now operational, will employ nearly 1,000 people in its support of Almac’s research and pharmaceutical development activities.

The $120 million, 240,000-square-foot facility brings together clinical trial services and clinical technology under one roof, as well as hosts analytical support services for the first time in the U.S.

Based in Craigavon, Northern Ireland, Almac has seen particular growth in its clinical services division. Chief Executive Alan Armstrong is confident that 2011 will see further growth as Almac continues to expand its customer numbers and product range. In addition to opening the new headquarters in Souderton, the company has plans for increased development at its Craigavon headquarters, where more than 300 jobs have been added in the last 12 months.

“In the 12 months between October 2009 and October 2010, we grew our employee numbers by 16 percent across our U.K. and American operations,” Armstrong said. “And we are still actively recruiting. Almac’s growth in all sectors is a testament to the quality of service we provide to the global pharmaceutical sector.”

The Almac Group offers a broad range of services from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply and IXRS technology (IVRS/IWRS), to commercial-scale manufacture. Almac provides services to more than 600 companies, including all the world leaders in the pharmaceutical and biotech sectors. The company employs almost 3,000 individuals and is headquartered in Craigavon. U.S. operations are based in Pennsylvania, North Carolina and California. Almac has officially gained full possession of its new $120M North American Headquarters, which started in July 2008, and employees will relocate during the fall.

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Pharmaceutical News and New Drugs

Drug Firm to Pay Feds $280 Million to Settle Pricing Claims

Dey Pharma, LP, maker of several drugs has agreed to pay $280 million to settle U.S. Justice Department accusations that it violated the False Claims Act by artificially inflating prices for drugs reimbursed with federal funds.

The settlement is the fourth involving a pharmaceutical manufacturer this month, following agreements with Abbott Laboratories, B. Braun Medical Inc. and Roxane Laboratories, which totaled $421.1 million. Justice officials say they have recovered more than $2 billion from pharmaceutical companies for similar “unlawful drug pricing schemes.”

In the Dey allegation, which was related by whistleblower Ven-A-Care of the Florida Keys, a home-infusion company, Justice officials said that the manufacturer overpriced the drugs Albuterol Sulfate, Albuterol MDI, Cromolyn Sodium, and Ipratropium Bromide.

“The difference between the resulting inflated government payments and the actual price paid by healthcare providers for a drug is referred to as the ‘spread’,” the DoJ said in a statement. “The larger the spread on a drug, the larger the profit for the healthcare provider or pharmacist who is reimbursed by the government.” The government alleges that Dey created artificially inflated spreads to market, promote and sell the drugs to existing and potential customers.

As a result, Justice officials said, “the government paid millions of claims for far greater amounts than it would have if Dey had reported truthful prices.”

The case stems information provided by Ven-A-Care under qui tam provisions that allow entities who witness or become aware of fraud to file suit on behalf of the U.S. government and share a percentage of money recovered. Ven-A-Care will receive $67.2 million.

Justice officials said the pharmaceutical practice of fraudulently overpricing drugs is a major area being targeted by HEAT, the Health Care Fraud Prevention and Enforcement Action Team set up in 2009 to form collaborations between the Department of Health and Human Services and the U.S. Attorney General.

New kidney cancer drug fast-tracked

A new drug to treat advanced kidney cancer has been fast-tracked for use on the NHS, a health watchdog said.

The National Institute for Health and Clinical Excellence (Nice) recommends Votrient (pazopanib) for patients with advanced cancer if they meet certain criteria, including no previous cytokine therapy.

Pharmaceutical giant GlaxoSmithKline (GSK) has agreed to offer a 12.5% discount on the list price to the NHS and a possible future rebate following the outcome of a clinical trial comparing the drug to another, sunitinib (Sutent), which is already approved.

It comes after Nice came under fire in November for turning down everolimus (Afinitor) for advanced kidney cancer, despite a risk-sharing scheme proposed by manufacturer Novartis.

Nice said the drug did not give patients enough benefit to justify its cost. Research suggests everolimus extends life by three months on average but at £99 per day per patient, it was deemed too expensive.

Sutent is already recommended in some cases for advanced kidney cancer, but other drugs including bevacizumab (Avastin), sorafenib (Nexavar) and temsirolimus (Torisel) are not.

Dr Carole Longson, health technology evaluation centre director at Nice, said: “Sunitinib is recommended by Nice for first-line treatment of advanced renal cell carcinoma.

“Pazopanib will offer patients an additional option and, for some, a more favourable side effect profile.

“The manufacturer has offered a straight discount on the list price of pazopanib, as well as providing a possible future rebate linked to the outcome of the head-to-head trial comparing pazopanib and sunitinib; making pazopanib a cost-effective option for the NHS.”

Every year more than 8,000 new cases of kidney cancer are diagnosed in the UK and almost half will lead to death – around four out of 10 patients are diagnosed when their cancer is at an advanced stage.

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Pharmaceutical News: N.C. pharma Pozen files court challenge to block generic competitor

N.C. pharma Pozen files court challenge to block generic competitor

Looming patent expiration on the migraine drug Treximet has led pharmaceutical company Pozen to take further legal action to fend off generic competition.

Chapel Hill, North Carolina-based Pozen (NASDAQ:POZN) said Tuesday it has filed a preliminary injunction to prevent Par Pharmaceuticals from launching a Treximet generic. Pozen made the filing in the U.S. District Court for the Eastern District of Texas, where Pozen’s ongoing patent litigation against Par and several other generic companies is pending. The company holds three patents on the drug; two that expire in 2017 and one that expires in 2025. Treximet’s regulatory exclusivity on Treximet expires much sooner — April 15. In the absence of a court decision stating otherwise, Par would be able to market its generic Treximet after that date.

The U.S. Food and Drug Administration approved Treximet in 2008 for the treatment of migraines. Treximet generated $15.4 million in 2010 royalty revenue for Pozen. The drug was developed and marketed in partnership with British pharmaceutical company GlaxoSmithKline (NYSE:GSK), which has its U.S. headquarters in Research Triangle Park, North Carolina.

Pozen has tried to get the FDA to extend the regulatory exclusivity of Treximet. But the company last month disclosed that the FDA did not accept clinical study data regarding pediatric use of Treximet. The company was seeking an additional six months of pediatric exclusivity.

Including Par, four generics makers have filed applications with the FDA seeking approval to market generic versions of Treximet. A settlement with Teva Pharmaceuticals was reached last year. Litigation with Par, Alphapharm and Dr. Reddy’s Laboratories has been consolidated into one suit, which is still pending.

Treximet is not the only Pozen product facing a generic challenge. The company disclosed in a regulatory filing earlier this month that Dr. Reddy’s, a generics company based in India, sent a letter notifying the company it had filed an application with the FDA seeking approval to market a generic version of Vimovo.

Bayer hit with discrimination suit by six current, ex-employees

Six current and former employees of Bayer Corp.’s HealthCare Pharmaceuticals unit filed a class-action lawsuit against the company yesterday alleging they suffered systematic gender discrimination at the Bayer business in Wayne, N.J.

The women claim they and “hundreds” of other female workers at Bayer were denied adequate pay and promotions, especially if they became pregnant, despite having a history of achievement at Bayer.

“High-ranking company officials within the predominantly male management team foster an environment hostile to the success and advancement of female employees,” the lawsuit stated.

Bayer spokesman Bryan Iams said the Robinson-based corporation denies the allegations of gender discrimination and will vigorously defend itself.

“(Bayer) is committed strongly to a policy of non-discrimination and equal treatment for all employees,” said Iams.

The 12-count complaint, filed in U.S. District Court in New Jersey, seeks unspecified money damages of well over a million dollars for alleged violations of the Equal Pay Act, the Family and Medical Leave Act and Title VII of the Civil Rights Act of 1964.

The lawsuit also seeks back pay and other remuneration, and demands Bayer take steps to follow equal employment practices.

For example, one of the six plaintiffs, who became interim director of a division, became so distraught under “undue levels of criticism and hostility” that she experienced a miscarriage in March 2009, the complaint stated.

Another plaintiff, a consumer marketing manager, was publicly “humiliated” by a male vice president when she started to make a company presentation while pregnant, the lawsuit stated. The vice president said she need not use the podium “because her belly was so large.”

The lawsuit asks the court to certify the lawsuit as a class-action on behalf of “hundreds” of female employees in lower to mid-level management positions at Bayer HealthCare Pharmaceutical who have worked there since Nov. 21, 2009.

Biostar Pharmaceuticals, Inc. to Host Fiscal 2010 Fourth Quarter and Year End Earnings Conference Call on Friday, March 25, 2011 at 10:00 a.m. ET

Biostar Pharmaceuticals, Inc. (Nasdaq: BSPM) (“Biostar” or “the Company”), Xianyang-based manufacturer of a leading over-the-counter Hepatitis B medicine, XinAoxingOleanolic Acid Capsules (“XinAoxing Capsules”), today announced that its 2010 fourth quarter and year-end financial results will be released before the market open on Friday, March 25, 2011. A conference call to discuss the results is scheduled at 10:00 a.m. ET, Friday, March 25, 2011.

About Biostar Pharmaceuticals, Inc.

Biostar Pharmaceuticals, Inc., through its wholly-owned subsidiary and controlled affiliate in China, develops, manufactures and markets pharmaceutical and health supplement products for a variety of diseases and conditions. The Company’s most popular product is its XinAo Xing Oleanolic Acid Capsule, an over-the-counter (“OTC”) medicine for chronic hepatitis B, a disease affecting approximately 10% of the Chinese population. In addition to its hepatitis product, Biostar currently manufactures two broad-based OTC products, two prescription-based pharmaceuticals, one medical device and five health supplements.

Cautions about Forward Looking Statements

This press release contains forward-looking statements, including forecasts of Biostar’s future expected financial results; its prospects for the business in fiscal 2010, which fall within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. They use words such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe” or words of similar meaning. They may also use words such as, “would,” “should,” “could” or “may.” Factors that may cause our actual results to differ materially from those described in forward-looking statements which involve a number of risks and uncertainties that could cause actual results to differ materially from those in such forward-looking statements. The risks and uncertainties relating to these statements include, but are not limited to, risks and uncertainties regarding the success of our investments, risks and uncertainties regarding fluctuations in earnings, our ability to sustain our previous levels of sales and profitability including on account of our ability to manage growth, intense competition, wage increases in China, our ability to attract and retain highly skilled professionals, time and cost overruns on fixed-price, fixed-time frame contracts, client concentration, our ability to continue our expansion in the rural areas, our ability to successfully complete and integrate potential acquisitions, withdrawal of governmental fiscal incentives, political instability and regional conflicts and legal restrictions on raising capital or acquiring companies outside China. Additional risks that could affect our future operating results are more fully described in our United States Securities and Exchange Commission filings including our most recent Annual Report on Form 10-K for the fiscal year ended December 31, 2009, our most Quarterly Report on Form 10-Q for the quarter ended September 30, 2010, and other recent filings. We may, from time to time, make additional written and oral forward-looking statements, including statements contained in our filings with the Securities and Exchange Commission and our reports to shareholders. These forward-looking statements are not guarantees of future performance and speak only as of the date hereof, and, except as required by law, Biostar disclaims any obligation to update these forward-looking statements to reflect future events or circumstances.

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Pharmaceutical Industry News

Research and Markets: China Pharmaceutical Chain Industry Report, 2010

Recent years have seen rapid growth of China’s pharmaceutical retail market, with expanding scale of chain enterprises and increasing number of drugstores, thanks to a fast-growing pharmaceutical industry and an aging population in China. In 2009, China’s pharmaceutical retail market scale reached RMB 153.1 billion, up 18.2% year-on-year. In particular, China’s top 100 pharmaceutical chain enterprises reaped RMB 58.1 billion in total, accounting for 37.9% of the total sales of the pharmaceutical retail industry. By the end of 2009, China had 2,099 pharmaceutical chain enterprises and 160,000 chain drugstores, up 5.7% and 24.0% year-on-year respectively.

This report not only highlights both the overall development and regional development of China’s pharmaceutical chain industry, but also elaborates on the operation of 14 pharmaceutical chain enterprises including Nepstar Drugstore, LBX Pharmacy, Guangdong Da Shen Lin and Hubei Ready Medicine Industry.

A case in point is Nepstar Drugstore, whose single-store profit decreased by 14.6% year on year to RMB 45,000 in 2009. Compared with the single-store profit of RMB 52,000 and year-on-year decline of 42.2% in 2008, the single-store profit in 2009 showed a downward trend, but at a slower rate, which can be attributable to three aspects: firstly, the proportion of self-owned brand drugs with higher gross profit margin has been increasing; secondly, the cost has been lowered through centralized procurement; thirdly, the profitability has been improved through increasing the sales revenue from non-drug products like nourishments.

Google, Microsoft, Others Join Obama to Fight Phony Pharmacies

On Tuesday, high-tech heavy hitters–including Google and Microsoft–announced support for a new non-profit organization pledged to back the Obama administration’s effort to crackdown on illegal internet pharmacies.

The group, composed of companies that service “choke points” on the internet, is being formed in response to the President’s call for private efforts to police online drug peddlers, according to Bloomberg/Businessweek.

The government hopes to financially strangle the purveyors of fraudulent drugs on the internet by restricting access to credit card approvals and domain names.

Other companies supporting the effort include Yahoo, MasterCard, Visa, American Express, GoDaddy, Neustar, eNom, and Paypal.

According to the National Association of Boards of Pharmacy, an estimated 1-2 percent of drugs in North America are fraudulent, and worldwide drug counterfeiting is expected to grow from being a $32 billion industry to a $75 billion industry in 2010 alone.

“Those who sell prescription drugs online without a valid prescription are operating illegally, undercutting the laws that were put in place to protect patients, and are thereby endangering the public health,” U.S. Intellectual Property Enforcement Coordinator Victoria Espinal said in a statement. “It is a real wake-up call that so many Americans have engaged in this dangerous behavior.”

Counterfeit drugs are often bought via official- and legitimate-looking web sites and are dangerous because they are often composed of various substances–including everything from glue, chalk, and sugar to nearly exact chemical replicas of real pharmaceuticals.

“As the administration has made clear, no one company can solve this problem,” Hilary Ware, managing counsel for litigation and regulatory affairs at Google said in a statement. “So this new cross-industry group is a welcome step forward that we are pleased to support.”

The announcement of the new non-profit was made at a health and safety forum held today at the White House. Illegal online drug sellers have provided tens of millions of Americans prescription medication via the internet without a valid prescription, according to a report released at the forum by The Partnership for a Drugfree America.

“These rogue sellers have preyed upon 36 million people, or one in six Americans, exposing them to the potential of taking counterfeit and unapproved medications,” the report noted.

In June, the Obama Administration submitted to Congress a strategic plan to combat intellectual property theft, including the production and sale of counterfeit medications. Since that time the OMB’s intellectual property office has been working to increase cooperation between the government and the private sector to protect consumers from counterfeit medications sold on the internet by illegal online drug sellers.

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Pharmaceutical Markets News

Thousands of life sciences jobs lost in N.J.

The pharmaceutical and medical device industries in New Jersey lost 4,900 jobs last year as business pressures led to a dramatic wave of consolidation that cost the state two venerable drug makers, according to the latest economic impact report by the industry’s trade group.

The severe job losses did not diminish the industry’s impact on the state economy, which reached a record level of $29.2 billion. The industry’s economic impact is calculated based on such things as payroll, vendor spending and capital spending. In 2008, the industry’s economic impact amounted to $28.6 billion.

The Healthcare Institute of New Jersey, which works on behalf of the prescription drug and medical device makers, started doing the study in 1997 to provide a snapshot of one of the key drivers of the state economy. The latest report was completed by Deloitte.

The stature of the state’s pharmaceutical industry changed dramatically in 2009 when acquisitions erased two large drug makers. Pfizer paid $68 billion to bring Madison-based Wyeth into its folds and Merck merged with Schering-Plough in a transaction valued at $41.1 billion.

Roche, the Swiss pharmaceutical giant which had its U.S. offices in Nutley, also diminished its footprint in the state last year when it moved its headquarters to South San Francisco. The Nutley campus now serves predominantly as a research facility.

Steve Issenman, senior vice president of the healthcare institute, said the industry’s significance to the economy inspite of the hemorrhaging of jobs should serve as a “wake-up call’’ to state lawmakers to take steps to keep New Jersey competitive.

The state Legislature has already taken some steps. Officials in the state assembly are proposing to compile an inventory of lab space, research projects and other assets at all of the state’s universities and colleges. State officials are also encouraging more collaborations between academia and the industry, which have enabled states like California and Massachusetts to create “life science hubs.”

Ernest Landante, a spokesman for the healthcare institute, said such collaborations are “an area New Jersey needs to address.’’

Research and Markets: The Pharmaceutical Market: Norway

The macroenvironment for the pharmaceutical industry is improving. Politically, the centre-left coalition is expected to hold together for at least the first two years of the parliamentary term up to 2011, despite a number of policy disagreements. The recession was far less pronounced in Norway than in most other European countries and the economy is now recovering at a moderate rate. Legally, laws on intellectual property and patent provision are in line with WTO/TRIPS regulations. However, Norway remains on the USTRs Watch List in 2010 for concerns over patent protection. Demographically, the population is ageing, increasing demand for pharmaceuticals in the near term.

The introduction of international reference pricing has had a moderating effect on Norwegian pharmaceutical price levels, and a step-price system for off-patent drugs has ensured that prices for all generics have fallen. Important steps towards cost-containment have also been taken for reimbursable pharmaceuticals, including the use of a first-choice system. A report by the Business Research Foundation (SNF) has shown that Norwegian pharmaceutical prices are among the lowest in Western Europe. Therefore, market growth is a result of increased consumption, largely due to the ageing population and the introduction of new drugs on the market. Norway is receptive to new drugs, as long as they are cost-effective and have proven therapeutic benefits.

Although Norway is not part of the European Union, the process for pharmaceutical registration has been aligned to EU regulations. The 2004 regulatory reforms made the centralised procedure mandatory for all new active substances, and all drugs in a number of drug categories, including all biotech products. In June 2010, the Oslo city court issued a ruling preventing the Norwegian Medicines Agency (NoMA) from placing the biosimilar filgrastim on its list of switchable medicines (byttelisten). In November 2009, it was announced that Clavis Pharma had signed a licensing deal with a US-based company for its investigational anti-cancer drug, which was extended in November 2010. In September 2009, Algeta signed an agreement with a multinational company for the development and global commercialisation of its leading drug to treat bone metastases in cancer patients.

Medical School Professors Violate Rules By Accepting Paid Speaking Roles

GHARIB: Many medical schools and teaching hospitals have new policies to put your interests first. Those rules ban faculty members from serving as paid speakers for drug products. A new investigation by the independent newsroom Propublica found those policies look good on paper, but don`t always work in practice. Tonight Darren Gersh continues our “Dollars for Doctors” coverage, with an ongoing examination of the monetary ties between drug companies and your doctor.

DARREN GERSH, NIGHTLY BUSINESS REPORT CORRESPONDENT: They are some of the most prestigious medical schools in the country: Stanford University, the University of Pennsylvania, the University of Pittsburgh, the University of Colorado Denver. But reporters for the independent newsroom Propublica found dozens of faculty members at these schools were accepting payments to speak on behalf of drug companies, an apparent violation of university policies banning the practice. The names were found by searching a new database developed by Propublica, which tracks payments to doctors from some of the nation`s largest drug companies.

CHARLES ORNSTEIN, SR. REPORTER, PROPUBLICA: At Stanford we identified more than a dozen doctors who were giving drug industry talks and Stanford`s policy is very clear on banning that sort of thing.

GERSH: Propublica`s Charles Ornstein says the violations at Stanford are surprising, given that the university has taken the lead in restricting drug company sales reps on its campus and put in place a ban on speakers` programs last year.

ORNSTEIN: We`re not talking about $1,000 or $2,000. One of the doctors who was the vice chair of the medicine department and he brought in more than $50,000 speaking on behalf of Eli Lilly. Then there were two doctors who each took in more than $100,000 in their speeches.

GERSH: In an email to faculty, Stanford Dean Philip Pizzo called the conduct unacceptable.

PHILIP PIZZO, DEAN, STANFORD UNIVERSITY SCHOOL OF MEDICINE: We simply do not believe, do not advocate for or affirm in any way that physicians, particularly on our faculty, should be involved in marketing for industry.

GERSH: Pizzo says there`s no question some faculty violated Stanford policy and he says the university is evaluating what the consequences should be.

PIZZO: Across the board, everyone who has seen their names on the list has been very, very remorseful and very apologetic, didn`t realize that they were violating the policy and very quick to say that they were going to be ceasing and desisting this going forward. That`s important. That`s how change occurs.

GERSH: The Association of American Medical Colleges advises its members to ban drug- company sponsored talks. But its President Dr. Darrell Kirch, says the group doesn`t have the power to monitor enforcement of those policies.

DR. DARRELL KIRCH, CEO, ASSN. OF AMERICAN MEDICAL COLLEGES: Have we attained the degree of adherence that we want? Not yet. But we`re moving much more quickly than I and others thought we might be able to given the complexity of the national health care system.

GERSH: For some medical schools, the key issue is not how much drug companies pay faculty to speak, but how much control the professor has over his or her presentation. In response to Federal lawsuits charging illegal marketing, drug companies have gotten much stricter, requiring speakers to stick to carefully crafted company-provided slides. But critics told Propublica in the academic world, that`s like using someone else`s work.

ORNSTEIN: And here you are teaching students not to take other peoples` work, but yet at the same time, you`re using somebody else`s slides to make a presentation and they see sort of an inherent disconnect in that.

GERSH: Medical schools argue they are striking a balance — banning drug company marketing while encouraging industry to bring discoveries that begin here to the patients who need them here.

PIZZO: We want those kinds of connections to occur. We can`t, as a university, bring things to the public good in terms of products. We can develop ideas that others can work on to develop further. What we don`t want to do is use our name and our reputation to serve as the marketing for industry.

GERSH: But critics of drug company marketing practices say if medical schools want to protect their reputation, they will have to rely less on the honor system if they want to make sure some faculty member names don`t end up on a database like this.

ORNSTEIN: And this is sort of the quintessential surprise is when you discover somebody on a list that you didn`t know about.

GERSH: Tomorrow we`ll learn why medical students are grading their own schools and changing the relationship between doctors and industry in the process. Darren Gersh, NIGHTLY BUSINESS REPORT, Washington.

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Pharmacy News

Pharmacy Industry Veteran Joins Millennium Pharmacy Systems as COO

CHICAGO, Dec. 17, 2010 /PRNewswire/ — Millennium Pharmacy Systems, Inc. has announced that Philip J. Keough, IV has joined the company as Executive Vice President and Chief Operating Officer based in its Shared Services Center in Cranberry Township, Pennsylvania, effective November 29, 2010.

Mr. Keough brings over twenty years of pharmacy leadership in operations, customer service, and consulting experience to Millennium. He most recently led Keoco, LLC, a successful consulting practice specializing in high-growth, early-stage pharmacy industry businesses. Phil has experience in hospital and independent pharmacies, as well as in the chain-drug industry, where he rapidly advanced into roles of significantly greater responsibility, culminating in leading all pharmacy operations for national leaders, CVS and Rite Aid. Phil honorably served in the U.S. Army Reserve and holds a Bachelor of Science, Pharmacy degree from Auburn University.

“The depth and breadth of Phil’s experience and leadership in the pharmacy industry, coupled with his intense focus on the customer experience, will make him an outstanding addition to Millennium’s executive team,” said Chief Executive Officer, Richard P. Scardina.

“Millennium’s innovative and cost effective medication management approach offers critically needed solutions to the long-term care market. By eliminating drug waste, enhancing administrative processes and improving patient safety, Millennium is changing the face of pharmacy solutions in the marketplace. I could not be more excited to join this leadership team and am committed to helping Millennium deliver on the promise of care, cost and compliance to its long-term care customers,” Phil said.

About Millennium Pharmacy Systems

Millennium Pharmacy Systems is a leading pharmacy services provider to the long-term care industry. Offering a new approach to pharmacy services, Millennium delivers on the promise of “the right drug, for the right patient, at the right time, for the right price” so its customers can deliver the best patient care while reducing costs, and more easily meeting compliance demands. Only Millennium combines Just-In-Time Dispensing with electronic medication and treatment ordering, administration, documentation, and reporting. Millennium backs up this commitment with delivery timeliness and medication accuracy customer guarantees. Millennium is headquartered in Chicago, Illinois.

Research and Markets: The Outlook for Pharmaceuticals to 2012 – Huge Potential in the E7 Markets

The E7 economies represent increasing opportunities for pharmaceutical companies constrained by maturing markets in the west.

Less reliance on mature markets:

A report from Pricewaterhouse Coopers (Pharma 2020: The vision: Which path will you take?) highlighted the dangers for the pharmaceutical industry of relying on existing mature markets such as the USA in the period to 2020. Pressures on pricing and greater payor influence will reduce the relative profitability of the USA, meaning that the industry will do well to look elsewhere for growth.

Huge potential in E7 markets:

The emerging ‘E7′ countries represent the best prospect for growth. The potential of these countries is huge: they have a combined population of over three billion people, and their economies are recovering from the economic downturn. One consequence of this increasing wealth is a growing financial capacity to treat previously unmet health needs. Another is increasing incidence of ‘affluence’ diseases such as diabetes, as people live longer and have more sedentary lifestyles.

Highlights from the report:

BRAZIL Brazil is the second most attractive BRIC market for pharmaceutical producers. Controlled drug prices are growing at below inflational levels but price controls are not directly linked to consumption levels. In fact, between 1997 and 2008, the pharmaceutical market by volume increased significantly only in 2004. Demand should increase as the country is emerging from the economic downturn much quicker than anticipated, therefore the outlook is very positive compared to other Latin American markets. The exchange rate of the real against the US dollar fell in early 2009, but it has now recovered. This is good news for producers as imports are now cheaper; Brazil, in contrast with other BRIC countries such as India, still relies on raw material imports, which diminishes its market strength.

CHINA Chinas pharmaceutical market looks set to grow even further in the short-term, with the establishment of an Essential Medicines System during the 2009-2011 period. The plan calls for an estimated 300-400 essential medicines to be made available at all public facilities, starting at the grassroots level. In October 2009, the NDRC reduced the prices of 2,349 drugs by an average 12%. These drugs represent around 45% of drugs on the Essential Medicines System. The prices of 49% of drugs on the list will not be reduced while the remaining 6% that are in short supply will see their prices increased moderately in order to encourage their manufacture.

INDIA India has a huge population in excess of one billion people and a growing middle class with access to high quality healthcare. Conversely, in this geographically vast country plagued by natural disasters, the majority of the population is both rural and poor and western style pharmaceuticals are not even an issue for millions of people. India has an established domestic industry, responsible for around 8% of world pharmaceutical production. The larger domestic companies are striving to compete in the global market for both generics and original products. The market is dominated by low priced, domestically-produced generics and relatively low per capita expenditure on pharmaceuticals.

INDONESIA The domestic pharmaceutical manufacturing industry is strong and the country has become an attractive base for many multinational producers to operate. This is largely down to a cheap labour force and generally inexpensive production costs. In March 2009, the government announced the merger between PT Indofarma and PT Kimia, saying the partnership, once materialised, will enable them to control a 15% stake of the market. PT Kimia president Sjamsul Ariffin said feasibility studies and legal processes would take at least six to nine months before the merger can be finalised. IPR protection is generally regarded as inadequate and counterfeiting is a major problem. The country has been placed on the US governments Priority Watch List in 2009.

MEXICO The current exchange rate of the Mexican peso against the US dollar is causing uncertainty, with increasing pharmaceutical import costs. This is expected to affect previously registered import levels. The overall pharmacy sector is facing stagnation, if not negative growth, in 2009. Pfizers acquisition of Wyeth and the merger of Merck Sharp & Dohme and Schering Plough will change the sector, with sanofi-aventis being pushed down. On a positive note, the downturn and an evolving regulatory environment are fuelling generics consumption. This market is expected to double in size in 2010. The latest foreign company to enter the generic market is Valeant which acquired a local producer in July 2009; sanofi-aventis acquired a local producer in early 2009. The local company Genomma Lab launched its generic product portfolio in August 2009.

RUSSIA In population terms, Russia is a potentially vast market. Health spending is generally very low, however, in comparison with Western countries. Around 75% of the pharmaceutical market is supplied by imports. The domestic generic industry is sizeable, but the local production of innovative drugs is negligible. Russian manufacturers are small and under-funded, often making do with outdated equipment. The market environment remains challenging for overseas companies. Major problems reported in Russia include corruption, bureaucracy, counterfeiting and poor data confidentiality. Government officials and politicians often discriminate in favour of the domestic industry, and enforcement of existing rules is often weak.

TURKEY As part of Turkey’s bid to join the EU, national legislation regarding pharmaceutical regulation is becoming more aligned with that of the EU. Partly as a result of previous efforts, but also of this harmonisation, the regulatory environment in Turkey is far more complex and the processes much more comprehensive in Turkey than elsewhere in the Middle East. However, there are still concerns within the international community over Turkey’s poor patent protection and intellectual property provision. Turkey has a considerable number of domestic producers, including Abdi Ibrahim, Bilim Pharmaceuticals, Eczacibasi, Embil Pharmaceutical Company, Fako Ilaclari, Milen Pharmaceuticals, Mustafa Nevzat Pharmaceuticals, Sanovel and the Turgut Group.

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