PHARMACY

Astellas vies for OSI Pharmaceuticals

BY Alaric DeArment

TOKYO A Japanese drug maker hopes to buy up a pharmaceutical company based in New York state.

Astellas Pharma announced Monday that it had made a $3.5 billion tender offer for all outstanding shares of common stock in Melville, N.Y.-based OSI Pharmaceuticals. Astellas said the offer, amounting to $52 a share, was a premium of more than 40% over OSI’s Friday closing price of $37.02.

OSI develops and sells drugs for treating cancer, diabetes and obesity, such as the lung and pancreatic cancer drug Tarceva (erlotinib), which it co-markets with Genentech, now a part of Switzerland’s Roche Group.

OSI said in a company statement that it would review the offer, but noted that it turned down an offer of $52 per share that Astellas made in February, saying it “significantly undervalues” the company.

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Report: Lawmakers seek to revise patent system

BY Alaric DeArment

NEW YORK Lawmakers in Washington have taken steps to reform the U.S. patent system, according to published reports.

Reuters reported Thursday that Senate Judiciary Committee chairman Sen. Patrick Leahy, D-Vt., and other members Congress had reached an agreement on patent reform, introducing a bill that would allow the patent office to set its own fees and allow judges decide the importance of an infringed patent as part of a product.

Drug companies, which depend on small numbers of patents, have opposed the effort, while large computer and hardware companies have supported it, Reuters reported.

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KV’s Ethex to plead guilty to criminal charges

BY Alaric DeArment

ST. LOUIS The generic drug marketing and distribution division of KV Pharmaceuticals will plead guilty to criminal charges and close shop under a deal between KV and the Department of Justice, KV announced Thursday.

The generic drug maker said Ethex will plead guilty to two felony counts and pay $27.6 million to resolve a criminal investigation of the company that began amid allegations that it failed to file field alerts to inform regulators of manufacturing problems with the drugs dextroamphetamine and propafenone in 2008. The payment includes a fine, $2.3 million in restitution to the federal government and an administrative forfeiture of $1.8 million.

“This settlement marks an important milestone in our efforts to restore normalized business operations at KV, regain full regulatory and legal compliance and set KV on a new path moving forward,” KV interim CEO David Van Vliet said in a statement. “Management and the board have been working diligently to address this issue, and we are looking forward to having this matter resolved.”

Ethex recalled a large number of generic drugs in late 2008 and early 2009 due to problems such as possibly oversized tablets and manufacturing deficiencies. In March 2009, the Food and Drug Administration filed an injunction against KV to prevent it from making or distributing adulterated and unapproved drugs and forced it to destroy all the drugs it had recalled, forbidding it from resuming manufacturing until the FDA was satisfied that it had been brought back into compliance with regulations. KV said the current settlement would allow it to continue manufacturing once it had regained compliance with the FDA’s current good manufacturing practices regulations, also known as cGMP.

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