Merck plans Quebec pharmaceutical fund

Merck Canada is partnering with Lumira Capital and other venture capital firms to launch a multimillion-dollar research and development fund to attract pharmaceutical firms to Quebec. The Montreal-based subsidiary of the U.S. pharmaceutical giant is set to announce an investment Monday to create the Merck-Lumira BioScience Fund. The fund will initially be worth several tens of millions of dollars, The Canadian Press has learned. Merck has committed to investing $100 million through 2015 in biopharmaceutical research and development collaborations with Quebec-based companies and academic institutions. It announced in mid-2010 the elimination of 200 jobs with the closure of its Montreal lab, once the largest research facility in Canada. Merck has developed several drugs in Canada and markets 530 pharmaceutical, consumer and animal health products. It has focused on expanding offerings in virology, oncology and diabetes. Quebec Economic Development Minister Sam Hamad is expected to participate in the announcement Monday, but the provincial government isn't immediately providing funding, sources said. Lumira Capital invests in market-leading health and life sciences companies and works with them to maximize profitable returns. Jacques Bernier, managing partner of Teralys Capital, who has urged companies to support Quebec entrepreneurs and technology, is also expected at the event. Teralys Capital's funds are focused on technology companies in the life sciences, information technology and cleantech sectors.

Merck plans Quebec pharmaceutical fund

Merck Canada is partnering with Lumira Capital and other venture capital firms to launch a multimillion-dollar research and development fund to attract pharmaceutical firms to Quebec. The Montreal-based subsidiary of the U.S. pharmaceutical giant is set to announce an investment Monday to create the Merck-Lumira BioScience Fund. The fund will initially be worth several tens of millions of dollars, The Canadian Press has learned. Merck has committed to investing $100 million through 2015 in biopharmaceutical research and development collaborations with Quebec-based companies and academic institutions. It announced in mid-2010 the elimination of 200 jobs with the closure of its Montreal lab, once the largest research facility in Canada. Merck has developed several drugs in Canada and markets 530 pharmaceutical, consumer and animal health products. It has focused on expanding offerings in virology, oncology and diabetes. Quebec Economic Development Minister Sam Hamad is expected to participate in the announcement Monday, but the provincial government isn't immediately providing funding, sources said. Lumira Capital invests in market-leading health and life sciences companies and works with them to maximize profitable returns. Jacques Bernier, managing partner of Teralys Capital, who has urged companies to support Quebec entrepreneurs and technology, is also expected at the event. Teralys Capital's funds are focused on technology companies in the life sciences, information technology and cleantech sectors

Pharmaceutical giant to settle Canadian class action suit on Vioxx

Merck, the American based pharmaceutical giant, announced on January 19 it will settle class action suits in Canada connected to its controversial pain medication Vioxx.The company’s announcement, which comes five years after the firm settled similar claims in the US with a payment of over $4.5 Billion, indicates Merck will pay between $21 and 36.8 million to a group of affected Canadians, estimated by Mike Peerless, a lawyer involved in the case, as ranging between one and two thousand patients.But before the Canadian victims of Vioxx see any shares of the money Merck has agreed to pay, at least $10 million in fixed and legal costs will be deducted.The drug, withdrawn from the world market in 2004, had been promoted as a new “super aspirin”. But critics maintain Merck did not move quickly enough to end its sales after studies in 2000 suggested use of the blockbuster drug, which was eventually taken by more that 20 million patients, created elevated risks of cardiovascular problems and death.According to one estimate, over 55,000 deaths world wide were associated with Vioxx use. The drug generated huge revenues for Merck, which sold $2.5 billion worth of Vioxx each year until it was finally recalled.In BC, the UBC based Therapeutics Initiative was credited with saving over 600 lives by issuing an early warning about Vioxx dangers."This agreement is structured to provide certainty and finality toward resolving Vioxx cases in Canada for a fixed amount," said Bruce N. Kuhlik, executive vice president and general counsel of Merck. "Under the agreement, there will be an orderly, documented and objective process to examine individual claims to determine qualification."A company press release emphasized that Merck is not admitting any culpability in the case.“Merck continues to believe that the evidence shows the company acted responsibly with Vioxx,” the statement says, “ from the careful study in clinical trials involving about 10,000 patients before its approval by regulatory authorities around the world, through the careful safety monitoring while Vioxx was on the market, right up through the decision to voluntarily withdraw the medicine in September 2004.This agreement in Canada does not include any statement to the contrary and does not constitute any admission of liability.”

Merck to settle Vioxx suits in Canada for CAN$36.8m

Merck & Co has agreed to pay up to CAN$36.8m (US$36.5m) to resolve all lawsuits brought against it in Canada over its former arthritis drug Vioxx.

Merck voluntarily withdrew the medicine from the market in 2004 after clinical trials linked the anti-inflammatory drug to a higher risk of heart attack, stroke and death.

Under an agreement with plaintiffs in Canada, Vioxx users will share a payment of between CAN$11.3m and $26.4m depending on the number of final claimants. A further CAN$10.5m will be set aside for legal fees.

Merck said an independent administrator would evaluate claims for heart attack and sudden cardiac death on an individual basis according to the duration of Vioxx use, age and presence of risk factors. Individual awards for stroke claims will be up to CAN$5,000, the firm said.

Merck said it continues to believe that the evidence shows the company acted responsibly with Vioxx, from the careful study in clinical trials involving about 10,000 patients before its approval by regulatory authorities around the world.

‘This agreement is structured to provide certainty and finality toward resolving Vioxx cases in Canada for a fixed amount,’ said Bruce Kuhlik, executive vice president and general counsel of Merck.

The Canada deal will still have to be approved by the courts.

Merck KGaA, Ono Pharmaceutical to Develop Oral Drug for MS

Merck KGaA said its Merck Serono unit will develop and market a pill for multiple sclerosis with Japan’s Ono Pharmaceutical Co. to compete with a similar product made by Novartis AG.The experimental therapy, ONO-4641, is in the second of three stages of clinical trials usually required for regulatory approval, Merck said in a statement today. The companies will also collaborate in Japan on the development and marketing of Merck’s Stimuvax, a cancer treatment in the final stage of trials, according to the statement.ONO-4641 is Darmstadt, Germany-based Merck’s second attempt to develop a tablet for MS after it decided not to seek approval of its cladribine pill in June. Novartis’s Gilenya, the first oral drug for MS, was approved last year and Israel’s Teva Pharmaceutical Industries Ltd. is developing a competing laquinimod pill.“There’s a huge unmet clinical need,” said Gustav Ando, a London-based analyst at consulting company IHS Global Insight. With a pill, “the patient doesn’t have to go to the hospital for monthly injections, which significantly impedes quality of life.”Novartis has 13,000 patients on Gilenya, the Basel, Switzerland-based company said in July. The drug may reach $1.2 billion in sales by 2013 and $2.1 billion by 2015, according to analysts’ estimates compiled by Bloomberg.

Merck, Novartis Invest in Mobile Phone Apps to Track Diabetes, Cancer

Drugmakers led by Merck & Co. and Novartis AG boosted investments in mobile phone applications and educational websites by 78 percent to get patients to take their drugs, eat right and exercise, an Ernst & Young report found.

Pharmaceutical companies initiated 97 projects last year aimed at using information technologies to improve patient health, according to the report by the New York-based consulting firm, which relied on analyst reports and press releases to reach its tally. That compares with 124 projects started in the four prior years combined. About 41 percent of the projects were smartphone applications, an increase from 11 percent since 2006.

Government-run health plans are pressuring drugmakers to prove their products are worth the prices charged, so companies are taking a greater role in making sure patients succeed with treatments. France’s 2011 budget reduced drug spending by 560 million euros ($755 million), mostly by cutting medications with marginal benefits, researchers said. The U.K. plans to set drug payments to match product benefits beginning in 2014.

“Pharma can’t exist the way they have existed; what is surprising is the pace of change,” said Carolyn Buck Luce, Ernst & Young’s global pharmaceutical leader, in a telephone interview. “The next big change in health outcomes is behavioral change, where medicines play an important part but not the only part.”

Merck opens its new Application and Technology Centre in India

Global Pharmaceutical and Chemical Company, Merck Limited, opened its new Application and Technology Centre at Nerul, Navi Mumbai. Spread over 1700 sq. ft., the state-of-the-art Centre will enable Merck to offer customized application and technology solutions to its customers in fields ranging from drug discovery to automobile and decorative paints. Mr. Klaus Bischoff, Head of Laboratory Solutions Business Unit, Merck Millipore and Dr. Marek Dziki, Managing Director, Merck Ltd [India] officially inaugurated the new facility in the presence of senior members and guests.

"Following the acquisition of Millipore, a leading life sciences company, earlier last year; Merck Chemicals consolidated its position by covering the entire value chain for our pharma and biopharma customers, offering integrated solutions beyond chemicals. Supported by over 300 years of experience, the new Application and Technology Centre will be an ideal platform to showcase Merck's capabilities in the high growth fields of Biopharmaceutical Process Solutions, Laboratory Essentials as well as Pigments and Cosmetics for our customers in India", remarked Mr. Bischoff on the occasion.

Commenting on the sidelines, Dr. Dziki said, "Merck Chemicals offers over 15,000 products that cater to various industries which are demonstrating a double-digit growth rate, like pharmaceuticals, biotechnology, chemicals industries, academia, food and beverages, automobiles and cosmetics. In this fiercely competitive environment, customization alone is the key. With the new Application and Technology Centre, Merck will develop different formulations and new methods as per our customers' needs; thereby giving them the necessary edge over competition."

Earlier, the Indian pharmaceutical industry had been characterized by a core competency in generics' manufacturing and relatively immature capabilities in R&D. This outlook has evolved substantially since the 1990s and Indian companies have been making investments towards expanding drug discovery and development capabilities.

Mr. Prantik Mukherjee, Head - Merck Millipore, added, "The facility is equipped with state-of-the-art application, demonstration and quality control laboratories that meet stringent international standards. We will also offer resources for sales force training, for Merck as well as our customers. The aim is to anticipate and not just meet customer needs; thereby verifying our claim of being a true partner in their business. For example, with respect to our pharmaceutical and biotechnology customers, our goal is to help them reduce time to market through our products and services."

The Application and Technology Centre has 8 laboratories where Merck can create and demonstrate its customized solutions. In addition to chromatography analysis, there are laboratories for separation analysis, a critical method in the identification and separation of new chemical entities and new biological entities. Four of the labs address cosmetic actives, cosmetic pigments, printing and coating applications. These will provide technical services like colour and shade matching where market samples can be evaluated and suitable options recommended. Basic formulations and concepts for all applications and promotional demo tools for coatings, printing, packaging and cosmetics will also be provided at these labs. The lab will also undertake experiments to create new customized solutions for its customers unanticipated needs.

Besides, this Centre will open up new vistas in water and chemical analysis capabilities in India. By bringing in the cutting edge global technology and benchmark in India, Merck Millipore would provide much needed support to Industrial and public customers and help them benefit by developing customized products for both domestic and international markets. These products will be exported from India to countries across the world.

Merck is a global pharmaceutical and chemical company with total revenues of € 7.7 billion in 2009, a history that began in 1668, and a future shaped by approximately 40,000 (including Merck Millipore) employees in 64 countries. Its success is characterized by innovations from entrepreneurial employees. Merck's operating activities come under the umbrella of Merck KGaA, in which the Merck family holds an approximately 70% interest and free shareholders own the remaining approximately 30%. In 1917 the U.S.subsidiary Merck & Co. was expropriated and has been an independent company ever since.

Mylan: generic blood pressure drugs approved

Mylan Inc. said Friday it received approval to start selling generic versions of Merck and Co.'s blood pressure drugs Cozaar and Hyzaar.

The drugmaker from Canonsburg, Pa., has now received marketing approval for several doses of the drugs, but it was not able to sell them until this month. Its competitor Teva Pharmaceutical Industries Ltd. was the first company to file for approval of generic versions of the drug, so other versions were barred from the market for six months. Teva received FDA clearance in April.

The newly approved versions of the drug are ready for shipping immediately, Mylan said.

Combined, Cozaar and Hyzaar were Merck's second best selling product. Mylan said U.S. sales of Cozaar totaled $940 million over the 12 months ended June 30, while Hyzaar sales totaled $570 million. Merck's sales fell by almost half after Teva started selling its generics.

Mylan shares rose 2 cents to $18.96 in morning trading Friday.

State Reaches $82M Drug Settlement

The state of Hawaii has reached an $82 million settlement with pharmaceutical companies accused of over-charging the state's Medicaid program.In 2006, the state sued more than 40 pharmaceutical companies in an effort to stem soaring drug prices. The state accused the companies of fraudulently submitting inflated average wholesale prices to Hawaii.The case dragged on for four years before the drug companies settled."This scheme went on for more than a decade, but the feds didn't see it. We didn't see it," Hawaii Attorney General Mark Bennett said. "We did go after it vigorously and I think the recovery is a deterrent to this happening again."

Settlement Breakdown:

Merck Sharp & Dohme Corp. $28 million
AstraZeneca Pharmaceuticals LP, AstraZeneca LP, GlaxoSmithKline LLC, and Novartis Pharmaceuticals Corp. will collectively pay $10 million
Pfizer Inc. and Pharmacia Corp. will collectively pay $8.2 million
Teva Pharmaceuticals USA Inc., Barr Laboratories Inc., Ivax Corp., Ivax Pharmaceuticals Inc., and Sicor Pharmaceuticals Inc. will collectively pay $6.5 million
Johnson & Johnson, Janssen Pharmaceutical Products, Ortho Biotech Products, McNeil-PPC Inc. and Centocor Inc. will collectively pay $5.2 millionMore than $12 million will go toward attorneys' fees.A substantial portion will of the settlement will also go to the federal government, which paid a large amount of the drug costs. It is unclear how much the state will receive, but any settlement money will go into the state's general fund.

Merck's Loss Is Aveo's Gain

Aveo Pharmaceuticals (AVEO) announced on Thursday that its three-year deal with Big Pharma has come to a close. While this sort of news is usually bad news (it often happens when a drug doesn’t work), Aveo could be the one lucking out.

The Cambridge, Massachusetts-based biotech entered into the agreement in April 2007 with Schering-Plough -- now Merck (MRK) -- for the larger company to partner on its then preclinical cancer treatment. At the time, Aveo received a $7.5 million upfront payment, as well as $10 million in equity investments. The biotech was also eligible to receive another $460 million in milestone payments.

The deal was structured so that Aveo made out like a bandit and doesn’t really lose anything now that Merck has decided to end the collaboration. The only downside is that Schering/Merck was funding all of the research and development, but Aveo was able to get the drug into phase II trials on the Big Pharma’s dime (Merck will provide funding for the program through the end of the year). The biotech now has the option to find a new partner who can take over that funding.

"Aveo is very pleased to regain worldwide rights for the development and commercialization of AV-299," said Aveo CEO Tuan Ha-Ngoc. "Aveo now holds significant commercialization rights to all oncology products in our pipeline, and we believe that we are well-positioned to move toward our goal of becoming a fully-integrated commercial organization.”

Aveo presented positive phase I results for the drug at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO) held in Chicago earlier this year. The drug was shown to be effective in several different tumor types and was safe at all doses. The biotech moved into its first phase II study of the drug, AV-299, in patients with non-small cell lung cancer and results are expected towards the end of next year.

If the drug looks so promising then why is Merck pulling out? Simple; the Big Pharma has finally gotten around to cleaning out the excess it has in its pipeline since purchasing Schering-Plough. "Merck is pleased with our history of collaborating with AVEO, and would welcome the opportunity to work with AVEO again in the future," said David Nicholson, Ph.D., senior vice president and head of worldwide licensing and knowledge management at Merck. "The decision to return this program to AVEO is a result of portfolio prioritization."

Some critics might say that Merck dropped the drug because the phase II study wasn’t panning out as the pharmaceutical giant had expected, but this scenario is highly unlikely, largely due to the phase II testing being in such early stages of the program. Aveo is also handling all of the development of the drug, thus it’s unlikely that Merck has had a clear picture of what is really going on there.

“We do not believe Merck's decision was due to negative findings of the ongoing Phase II trial of AV-299 in lung cancer,” said Leerink Swann analyst Howard Liang in a note to investors. “In our opinion, regaining rights to this agent bolsters Aveo's pipeline and it now has two agents, one in Phase III and one in Phase II, to which it has broad commercial rights.”

Aveo’s stock is already up 10% on the news to trade around $12 per share on Friday afternoon. Expect the biotech to gain further exposure in mid-2011 when it announces late-stage trial data for its lead product, Tivozanib, and then again toward the end of the year when it announces the results of the phase II study for AV-299. Aveo could be pushed further into the limelight as its competitors announce data for their drugs that are in the same class as AV-299 – specifically ArQule’s (ARQL) ARQ-197.

Walgreen names Berkowitz to pharmacy market role

Drugstore operator Walgreen Co. said Thursday it has hired former Schering-Plough executive Jeffrey Berkowitz to take charge of its pharmacy contracting strategy.

The company said Berkowitz will be senior vice president of pharmaceutical development and market access. His responsibilities will include forming strategic relationships with other companies, and overseeing growth initiatives with drugmakers.

Berkowitz held a series of marketing and sales-related positions with Schering-Plough Corp. from 2002 until 2009, when the company was acquired by Merck & Co. He later became Merck's senior vice president of global market access.

He will report to Kermit R. Crawford, president of Walgreens pharmacy services division.

Merck Gets US Inquiries Over Practices In Foreign Countries

U.S. drug maker Merck & Co. (MRK) said Friday it has received letters from the federal government seeking information about its activities in foreign countries, in connection with a U.S. anti-foreign bribery law.

Merck disclosed in a regulatory filing it has received letters from the Justice Department and Securities and Exchange Commission. The company said it is cooperating with the requests.

The Whitehouse Station, N.J., company said it believes the inquiries are part of a broader review of pharmaceutical industry practices in foreign countries.

The U.S. Foreign Corrupt Practices Act prohibits U.S. companies from paying foreign government officials to assist in obtaining or retaining business.

Merck spokesman Ron Rogers said the company hasn't been charged with an FCPA violation, and Merck has a policy to act in accordance with FCPA and other laws.

The Justice Department has said it has been looking into whether pharmaceutical companies are complying with the law. Eli Lilly & Co. (LLY) disclosed earlier this year the Justice Department and SEC had expanded an investigation into whether Lilly has complied with FCPA.

Merck Patent on Singulair Asthma Medicine Upheld

Merck & Co. won a court ruling that prevents Teva Pharmaceutical Industries Ltd. from selling a copy of Merck’s best-selling drug, the asthma and allergy treatment Singulair, until August 2012.

U.S. District Judge Garrett E. Brown Jr. in Trenton, New Jersey, today rejected Teva’s arguments that the patent on the main ingredient of the medicine is invalid or unenforceable. The judge said Teva can’t sell a generic version of the drug until the patent expires. Teva, the world’s biggest generic-drug maker, said it is reviewing the decision.

The ruling involving a medicine that had 2008 sales of $4.3 billion gives Merck a needed victory as it faces the loss of patent protection in the next five years on drugs with more than $8 billion in annual sales. The Whitehouse Station, New Jersey- based company is buying rival Schering-Plough Corp. and cutting jobs to boost profits.

The patent covers montelukast, the active ingredient in Singulair. The medicine, approved by the U.S. Food and Drug Administration in 1998, is based on research that showed one way to treat the disease is to block leukotrienes, compounds that cause muscle contraction and increase secretions in the lungs.

Merck “put forth sufficient evidence of the failed attempts of others to develop a leukotriene antagonist,” Brown said in his opinion.

Patent Review

The U.S. Patent and Trademark Office is taking a second look at the patent to see if there’s prior know-how indicating it didn’t cover a new invention. Merck told the court the agency almost always grants requests to reconsider patents. The patent remains valid throughout that process.

“We invest heavily in the research and development that is needed to discover innovative medicines like Singulair, and we will vigorously defend our intellectual property rights,” Merck General Counsel Bruce Kuhlik said in a statement after the ruling.

Merck rose 77 cents, or 2.5 percent, to $31.48 in New York Stock Exchange composite trading. Teva’s American depositary receipts, each representing one ordinary share, rose 66 cents to $51.45.

More than 22 million people in the U.S. have asthma, a chronic disease caused by inflammation of the bronchial tubes, according to the American Lung Association. Narrowed airways can cause coughing and chest tightness and hamper breathing, and in extreme cases it may limit the flow of oxygen to vital organs and lead to death. There is no cure.

Merck Cuts

Teva, based in Petah Tikva, Israel, said in a statement that it’s “currently reviewing the court’s decision to determine its next course of action.”

Singulair accounted for about 18 percent of Merck’s $23.9 billion in 2008 revenue. Schering-Plough shareholders approved Merck’s $46.7 billion takeover offer this month.

Schering-Plough has said it plans to file for approval of seven drugs, which may each generate more than $1 billion in peak annual sales. Merck plans to eliminate 16,000 positions as part of the merger and to help stem the generic losses.

The case is Merck Sharp & Dohme Pharmaceuticals SRL v. Teva Pharmaceuticals USA, 07cv1596, U.S. District Court, District of New Jersey (Trenton).

Pharmerging Versus Mature Pharmaceutical Markets: Where Is Pharma Going? Where Is Pharma Growing? -- an Industrial Info News Alert

SUGAR LAND, TX- Reported by Annette Kreuger, Industrial Info Resources (Sugar Land, Texas) -- One of the latest trendy phrases zipping around the Pharmaceutical Industry is "pharmerging markets." The phrase was coined to refer to the emerging world markets that are expected to experience double-digit growth, which, in turn, will unfortunately be offset by the lackluster performance predicted in established markets. The pharmerging areas are poised to receive the next major influx of capital activity from all of the Pharmaceutical Industry majors, e.g. Pfizer Incorporated (NYSE:PFE), GlaxoSmithKline plc (NYSE:GSK), Merck & Company Incorporated (NYSE:MRK), albeit with a definite risk of losing both intellectual and physical property.

FDA extends Takeda's alogliptin-Actos drug review

TOKYO, - Takeda Pharmaceutical Co Ltd (4502.T), Japan's largest drugmaker, said U.S. health authorities have extended their review of a diabetes drug combining its top-selling Actos and experimental medicine alogliptin until September.

The combination pill is not expected to be approved after alogliptin last month failed to gain approval, with the U.S. Food and Drug Administration asking for additional safety tests, a process Takeda says could take two years.

Alogliptin, which belongs to a new class of diabetes drugs called DDP-4 inhibitors, has been positioned by Takeda as a successor to Actos, which will lose U.S. patent protection in 2011.

"The approval process for alogliptin by itself is separate from that of the fixed-dose combination," said Takeda spokeswoman Hisako Nagata.

"But it is difficult to think that the combination drug would receive approval prior to alogliptin by itself," she said.

There is currently only one DPP-4 diabetes drug on the U.S. market, Merck & Co's (MRK.N) Januvia.

The FDA said it will respond to Takeda's application for approval on Sept. 4, instead of July 22 as previously planned.

Shares of Takeda were down 0.5 percent at 3,670 yen, while the benchmark Nikkei average .N225 was up 0.4 percent.

Drug industry, Pfizer lead in health lobbying

WASHINGTON — The drug industry's trade group and one of the nation's biggest pharmaceutical companies reported spending more money than other health care organizations on lobbying in the second quarter of this year.

With the fight over President Barack Obama's effort to revamp the nation's health care system escalating, the Pharmaceutical Research and Manufacturers of America said it spent $6.2 million lobbying in April, May and June, according to reports to Congress due Monday. Pfizer Inc., the New York-based producer of numerous drugs, ranked second in the health care sector at $5.6 million.

In reports filed by 11 p.m. Monday, 22 health-related associations and companies had reported spending at least $1 million each lobbying during the quarter.

The stakes are huge for the health industry. Congressional Democrats are pushing legislation that could cost roughly $1 trillion over the coming decade, paid for in part by cuts in federal health care programs such as Medicare. Lobbyists have been flooding Capitol Hill for months, and many interest groups have already invested millions of dollars in ad campaigns favoring or opposing various portions of the emerging bills.

According to the nonpartisan Center for Responsive Politics, the health sector reported spending $127 million in lobbying during the first three months of this year, more than any other area.

It can take many days for all the reports to be filed. In the second quarter of 2008, 28 health care concerns reported spending at least $1 million lobbying.

Of the thousands of reports filed by Monday evening covering lobbying on all subjects, only three organizations reported spending more during the second quarter than PhRMA, the drug industry trade group. The American Coalition for Clean Coal Electricity reported spending $11.3 million lobbying at a time when Congress is considering energy legislation. The U.S. Chamber of Commerce, the nation's largest business group, reported spending $7.4 million, and the General Electric Co. reported $7.2 million in lobbying expenditures.

Including its latest report, PhRMA has now spent $13.1 million lobbying so far this year. Pfizer has reported $11.7 million in lobbying expenses for 2009.

Other top lobbying spenders among health-related organizations for this year's second quarter included the American Medical Association, $4 million; Eli Lilly and Co., $3.6 million; the American Hospital Association, $3.5 million, and the Blue Cross and Blue Shield Association, $2.8 million.

Also, GlaxoSmithKline, $2.3 million; CVS Caremark Inc., $2 million; Bayer Corp. and America's Health Insurance Plans, representing the health insurance industry, $1.9 million each; Novartis and the Biotechnology Industry Organization, each $1.8 million, and Metlife Group Inc., $1.7 million.

Also, Sanofi-Aventis U.S. Inc. reported spending $1.6 million in the second quarter; Johnson & Johnson Services Inc. $1.6 million; Merck & Co. Inc. $1.5 million; F. Hoffman-La Roche Ltd. and its affiliates, $1.5 million; the American College of Radiology Association, Wellpoint Inc. and Astrazeneca Pharmaceuticals LP, each $1.2 million, and Siemens Corp. and UnitedHealth Group Inc., $1 million each.

Attorney General Abbott Joins Multi-State Agreement With Pharmaceutical Giants 7/15/09

Austin, Texas - Texas Attorney General Greg Abbott and 35 other state attorneys general today reached a multi-million dollar agreement with pharmaceutical manufacturers Merck & Co. Inc., Schering-Plough Corp., and a joint venture between the two companies, MSP Singapore Company, LLC.

Together, the three manufacturers agreed to pay $5.4 million to resolve the states’ investigation, which examined the manufacturers’ delayed release of negative clinical trial results. Texas will receive $300,000 for its efforts to investigate this matter.

The manufacturers’ clinical trial indicated that the cholesterol lowering drug Vytorin – which is a combination of the drugs Zetia and simvastatin – was no more effective reducing formation of plaque in carotid arteries than the cheap, generic alternative, simvastatin. Although the study ended in May 2006, complete results were not published until April 2008. In the meantime, the companies heavily promoted Vytorin in direct-to-consumer advertisements.

Today’s settlement requires the companies to follow several requirements when promoting Vytorin and Zetia, including:

• Obtain pre-approval from the U.S. Food and Drug Administration (FDA) for all direct-to-consumer television advertisements;

• Comply with FDA suggestions to modify drug advertising;

• Register clinical trials and post their results;

• Prohibit ghost writing of articles;

• Reduce conflicts of interest for Data Safety Monitoring Boards that ensure the safety of participants in clinical trials; and,

• Comply with detailed rules prohibiting the deceptive use of clinical trials.

The investigation was led by Oregon Attorney General John R. Kroger and an Executive Committee including the Attorneys General of Arizona, California, Florida, Illinois, New Jersey, Ohio, Pennsylvania, South Carolina, Texas, and the District of Columbia.

The 36 states participating in today’s agreement are Arizona, Arkansas, California, Colorado, Delaware, the District of Columbia, Florida, Hawaii, Idaho, Illinois, Iowa, Kentucky, Louisiana, Maine, Massachusetts, Michigan, Mississippi, Missouri, Montana, Nebraska, New Jersey, Nevada, New Mexico, North Carolina, North Dakota, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Vermont, West Virginia, Washington and Wisconsin.

Portola Pharmaceuticals Announces Several Scientific Presentations at International Society on Thrombosis and Haemostasis XII Congress

SOUTH SAN FRANCISCO, - Portola Pharmaceuticals, Inc. today announced several scientific presentations at the International Society on Thrombosis and Haemostasis (ISTH) XII Congress in Boston that will feature its investigational antiplatelet drug elinogrel, a P2Y(12) ADP receptor antagonist currently in Phase II clinical development, and its oral Factor Xa inhibitor anticoagulant antidote in pre-clinical development, as well as a presentation by Portola co-founder David Phillips on new directions in antithrombotic drug discovery.

In the past six months, Portola has announced global development and commercialization agreements with Novartis for elinogrel and with Merck & Co., Inc. for betrixaban, an investigational oral Factor Xa inhibitor anticoagulant currently in Phase II clinical development.

Merck Acquires Rights to Anticoagulant

Merck & Co. on Thursday said it has obtained world-wide rights to co-develop and commercialize an experimental drug in a crowded race to replace the anticoagulant warfarin, one of the oldest pills in medicine.

The Whitehouse Station, N.J., drug company will pay closely held Portola Inc., of South San Francisco, Calif., $50 million to license the drug. The medication, called betrixaban, is in midstage, or Phase II, human studies to prevent the formation of blood clots in a variety of conditions.

Portola said it may receive additional payments totaling as much as $420 million connceted if the drug meets certain regulatory and commercial milestones, as well as royalties if the drug reaches the market.

Other companies have similar compounds further in development to prevent or treat potentially life-threatening clots in heart and surgery patients.

Boehringer Ingelheim GmbH's dabigatran anticoagulant is on the market in Europe for clot prevention after hip- and knee-replacement surgery, and data are expected soon from a large trial in heart patients with atrial fibrillation. Rivaroxaban, from Johnson & Johnson and Bayer AG, is on the market in Europe for hip- and knee-replacement patients and is under consideration for Food and Drug Administration approval. Pfizer Inc. and Bristol-Myers Squibb Co. are jointly developing a drug called apixaban.

Analysts have estimated that annual sales of a successful new anticoagulant or class of such medicines could exceed $10 billion by the middle of the next decade. Warfarin is taken by several million patients, but it requires frequent monitoring and often reacts with other drugs, making it difficult to take. By some estimates, doctors prescribe it for fewer than 50% of patients who need it.

Charles Homcy, president and chief executive at Portola, says he expects nearly 200,000 patients will soon be participating in clinical trials involving such compounds. The intense interest "is a reflection of the market opportunity and what the unmet medical need is," he says.

Despite its problems, warfarin, which is available in generic versions, has proven staying power. Late Tuesday, Aryx Therapeutics Inc., a Fremont, Calif., biopharmaceutical company, reported that its tecarfarin drug failed to prove superior to warfarin in a 612-patient study. Tecarfarin, designed to act like warfarin without the dosing challenges, is different from most other agents in development, but the news reflects years of frustration drug developers have experienced in the quest for a better anticoagulant pill.

For Merck, the new pact adds another compound to its pipeline of nearly a dozen cardiovascular drugs. It also gives the company a potential two-pronged attack against atrial fibrillation, a heart-rhythm disorder that is a common cause of strokes and that afflicts 2.2 million Americans and more than five million people world-wide. In April, Merck signed a separate licensing agreement with Cardiome Pharma Corp., of Canada, to develop a drug called vernakalant to treat the rhythm condition.

Depending on the results of a Phase II study expected later this year, Merck and Portola say they plan to launch a late-stage trial of betrixaban to reduce blood-clot risk in atrial fibrillation, possibly in late 2010. If all goes well, the drug could reach the market by 2013, Portola says.

Luciano Rossetti, a Merck senior vice president for atherosclerosis and cardiovascular research, says that while betrixaban trails rivals in development, he believes certain characteristics of the drug will give it advantages in the marketplace if it eventually wins regulatory approval.

For Portola, the agreement is the second major licensing deal with a pharmaceutical company this year. In February, Novartis AG, of Switzerland, agreed to pay $75 million plus additional milestone payments and royalties for a different type of anticlotting drug.

Merck & Co. and Portola Pharmaceuticals enter license agreement for betrixaban

Merck & Co., Inc., a pharmaceutical company, and Portola Pharmaceuticals, Inc. have signed an exclusive global collaboration and license agreement for the development and commercialization of betrixaban, an investigational oral Factor Xa inhibitor anticoagulant used for the prevention of stroke in patients with atrial fibrillation (SPAF). Portola is a biopharmaceutical company. Both the companies are based in the US.

Merck will pay Portola an initial fee of $50 million, in return for an exclusive worldwide license to betrixaban. Portola is eligible to receive additional cash payments totaling up to $420 million upon achievement of certain development, regulatory, and commercialization milestones, as well as double-digit royalties on worldwide sales of betrixaban, if approved.

Merck will assume all development and commercialization costs, including the costs of phase III clinical trials. Portola has retained an option to co-fund phase III clinical trials in return for additional royalties and to co-promote betrixaban with Merck in the US.