Mylan sues US FDA over Lipitor launch by Ranbaxy

US pharmaceutical company Mylan Inc is suing the US Foods and Drugs Administration for an injunction on the launch of Ranbaxy�s cholesterol treatment drug, which is a generic version of Pfizer�s Lipitor. Ranbaxy shares fell more than 4% following the news and at 11:35 hrs the stock was trading at Rs 447.50 down 4.5%. It had touched a low of Rs 444.05 earlier in the session. Lipitor will go off-patent in the US in November 2011. Ranbaxy is expected to begin selling Lipitor in November with 180 days exclusivity, and is awaiting approval from the US FDA. Mylan has reached a settlement with Pfizer and is expected to launch its own version of Lipitor in 2012. Lipitor has sales worth over USD 5 billion in US and the drug is estimated to contribute USD 500-600 million to Ranbaxy during the exclusivity period.

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.

Heather Bresch named president of Mylan

Heather Bresch has been promoted to president of generic drug giant Mylan Inc. and Rajiv Malik was named to fill Bresch’s previous role as chief operating officer, the Canonsburg-based company announced Wednesday.

Bresch has served in a number of executive positions during her 17-year tenure with the company, including senior vice president of strategic corporate development and head of North American operations.

Bresch has faced controversy in the past several years, mostly related to an MBA degree she received from West Virginia University. A panel concluded in April 2008 that Bresch did not complete the required credits, and the school rescinded the degree.

Malik previously headed Mylan’s global technical operations where he oversaw research and development and manufacturing, supply chain and sourcing, and quality and regulatory affairs. Malik has more than 25 years of experience in the generic pharmaceutical industry, including most recently as CEO of Matrix.

Also, Timothy Sawyer was hired by Mylan (NYSE:MYL) as senior vice president of strategic corporate development and he will report to Bresch. Sawyer has 16 years’ experience in the generic pharmaceutical industry, mostly in commercial operations.

He joins Mylan from Teva Pharmaceuticals, where he served most recently as an executive vice president at Barr Laboratories, whose parent company, Barr Pharmaceuticals, was acquired by Teva.

Mylan is currently under investigation by the Food & Drug Administration over reports of production irregularities at its plant in Morgantown, W.Va.

The company is scheduled to report second-quarter earnings Thursday.

Teva, Servier Face EU Antitrust Probe for Drug Delays

Teva Pharmaceutical Industries Ltd., France’s Les Laboratoires Servier and other generic-drug makers face European Union antitrust probes of agreements that may have delayed the sale of a blood pressure medication.

The investigations, which also include Krka Group d.d., India’s Lupin Ltd., Mylan Inc.’s Matrix Laboratories unit and Unichem Laboratories Ltd.’s Niche Generics unit, concern deals that may have hindered the market entry of a generic version of Servier’s perindopril, the European Commission said today.

The probes come as antitrust regulators on both sides of the Atlantic focus on how settlements between brand-drug companies and generics might harm consumers. The U.S. Congress is considering legislation that would ban settlements that involve financial incentives given to generic-drug companies.

“Both brand and generic pharma companies will be keeping a careful eye on the next steps taken by regulators,” said Suzanne Rab, a lawyer at Hogan & Hartson in London. The EU focus on patent settlements “mirrors to a certain extent developments in the U.S.”

The commission said in a related report today that companies use a variety of techniques to delay the introduction of generics “for as long as possible.” The commission, the EU’s executive arm, said it will continue to probe whether the use of patents to delay generics violates antitrust rules.

Something ‘Rotten’

“Overall, it’s indeed a conclusion that there is something rotten in the state,” European Competition Commissioner Neelie Kroes told journalists at a press conference in Brussels. “We will not hesitate to apply the antitrust rules where such delays result from anticompetitive practices.”

The commission’s final report follows an 18-month probe that began after raids at GlaxoSmithKline Plc, AstraZeneca Plc, Sanofi-Aventis SA and several competitors. The commission conducted additional raids in November at some of the companies that are the subject of today’s heightened investigations.

Teva, based in Petah Tikva, Israel, said in a statement that it’s “committed to competing strongly in a fair and open market” and will cooperate with the investigation.

Servier, a closely held company based in Neuilly-sur-Seine, France, said in a statement that it will “continue to defend its rights.”

Simona Gorjup, a spokeswoman for Novo Mesto, Slovenia-based Krka, said the company never made arrangements with other drugmakers to delay generics.

“As soon as a patent situation enables it, Krka comes on the market with its own versions,” Gorjup said in an e-mail.

‘Sigh of Relief’

Spokesmen for Lupin and Unichem didn’t immediately respond to requests for comment.

Gareth Williams, a partner at Marks & Clerk, said in a statement that the drug industry will be “breathing a sigh of relief” because the commission decided to probe individual cases “rather than using the blunt instrument of wholesale patent reform which would undermine innovation.”

Companies may have received indirect payments via broader commercial transactions with Servier that effectively resulted in them being unable to launch generic versions of perindopril, said Frances Cloud, a London-based independent analyst.

“The commission can reform the patent situation, and they can certainly directly ban out-and-out payments, which will presumably make originator companies a lot more cautious, but it’s not totally going to get rid of the deals,” Cloud said.

‘Red Flag’

Makers of brand-name drugs face a decline in revenue starting in 2011 when products generating $150 billion a year will have generic competition, analysts and investment advisers said last year. The EU spends 214 billion euros on medicines a year, or 430 euros a person, the commission’s preliminary report in November said.

While the investigation is a “red flag” for the industry, it’s unlikely to pose a direct risk to Teva’s business in Europe, said Gilad Sarig, a Tel Aviv-based analyst for Bank Hapoalim. “Innovative companies are more the focus,” Sarig said in an e-mail.

The European Federation of Pharmaceutical Industries and Associations, which represents brand name drug companies, said in a statement that the commission acknowledged that generic market drug delays are also caused by administrative and regulatory hurdles.

“We welcome the statement that there should be competition in the off-patent markets,” said Thomas Cueni, head of the industry group’s task force on the probe.

The commission called for a “community” patent that would be valid in all of the EU’s 27 member states. The current system is a patchwork of national patents that are enforced in national courts. The regulator said EU governments should “significantly accelerate” the approval procedures for generic drugs.

“Tightening up Europe’s legislative framework in the four areas of patent law, pharmaceutical legislation, price and reimbursement rules and competition law will result in a properly functioning pharmaceutical market,” Greg Perry, of the of the European Generic Medicines Association, said in a statement.

Lawmakers, Drug Makers Spar Over Patent Settlements

WASHINGTON -Executives for Mylan Inc. (MYL) and Endo Pharmaceuticals Inc. (ENDP) faced a grilling on Capitol Hill Wednesday from lawmakers who support legislation to bar pharmaceutical patent settlements that delay the introduction of generic drugs.

Critics in Congress and at the U.S. Federal Trade Commission say the deals are anticompetitive because branded drug makers pay their generic counterparts to abandon patent challenges that could lead to early market entry of competing generic medicines.

"Generic companies are getting paid handsomely to sit on the sidelines," said Richard Feinstein, head of the FTC's Bureau of Competition.

Feinstein, speaking before a House subcommittee that examines antitrust issues, said the settlements are a "win-win for the drug companies" but "impose enormous costs on the health care system."

A different House subcommittee voted Wednesday afternoon in favor of the legislation to ban the settlements. The bill will now move forward for full committee consideration by the U.S. House Committee on Energy and Commerce.

Guy Donatiello, Endo's vice president for intellectual property, took a very different view than the FTC, saying the settlements often were good for consumers.

Donatiello, whose company makes branded and generic drugs, said the settlements often allow generic drugs on the market before a branded drug-maker's patent ends, while also removing the uncertainty of litigation.

"While it's a delicate balance, the current system works," he said.

Mylan's chief operating officer, Heather Bresch, said her company and other generic makers were sometimes forced into settlements by branded companies that exploit a loophole in the federal law Congress passed to encourage generic companies to challenge questionable drug patents.

That loophole, Bresch said, essentially allows a brand-name drug maker to re-label one of its medicines and market the very same product as an "authorized generic" version.

Branded drug makers threaten this preemptive move when a competing generic company mounts a legal challenge to one of their patented medicines, she said.

"It definitely serves as a huge detriment to the generic industry," Bresch said.

In written testimony, Bresch singled out Eli Lilly & Co. (LLY) and GlaxoSmithKline PLC (GSK) as advocates of this practice.

The FTC's Feinstein said the agency was studying the issue of authorized generics and planned on issuing preliminary findings soon.

Lawmakers voiced competing views on whether patent settlements that delay generic drugs should be banned.

"Look folks, drugs are too expensive," said House Judiciary Committee Chairman John Conyers, D-Mich. "Generics are cheaper. Settlements make drugs more expensive."

Rep. Bob Goodlatte, R-Va., said most courts to consider the issue have ruled that the settlements are not anticompetitive. Modern antitrust law, he said, has moved away from rules to make certain business practices automatically illegal.

The FTC has challenged some drug agreements in court but has had limited success.

Most recently, the agency sued three drug makers in February, alleging that Brussels-based Solvay Pharmaceuticals Inc. (SVYSY), the maker of the testosterone drug AndroGel, entered into an illegal agreement with generic drug companies Watson Pharmaceuticals Inc. (WPI) and Par Pharmaceutical Cos. (PRX) to delay the introduction of a generic competitor.