PHARMACY

Patent office sends Pfizer “non-final” rejection letter for Lipitor

BY Adam Kraemer

NEW YORK The U.S. Patent and Trademark Office has preliminarily rejected Pfizer’s request for the reissue of a patent for its Lipitor (atorvastatin) cholesterol drug that would preserve its U.S. market exclusivity until 2011, the Wall Street Journal reported.

The U.S. Court of Appeals for the Federal Circuit invalidated in 2006 one of two patents at issue in a legal fight with generic competitor Ranbaxy, which moved up Lipitor’s June 2011 patent expiration and maintaining it instead to March 2010.

Ranbaxy had taken its case to the Supreme Court after the Federal U.S. Circuit Court of Appeals denied the company’s request to rehear the decision. The Supreme Court refused a hearing, preserving the March 2010 date.

Pfizer applied to the patent office in January to have the 2011 patent reissued, and to correct a “technical defect” in the original patent. A reissue would extend Pfizer’s market exclusivity through June 2011.

A Pfizer spokesman told the Journal on Thursday that the company was awaiting a letter from the patent office explaining the decision. Because it’s not a final rejection, Pfizer still has an opportunity to persuade the patent office to reissue the patent.

“An initial rejection is not uncommon in reissue application proceedings,” said Pfizer spokesman Bryant Haskins. “Once we receive the decision we’ll review it and respond appropriately to address any issues that were raised by the examiner.”

Lipitor is the best-selling drug in the world, with $12.9 billion in sales last year. However, it has faced pressure not only from ongoing patent challenges worldwide, but also from competition from generic versions of other anti-cholesterol drugs.

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P&G announces Gorman, 70, to step down from board of directors

BY Antoinette Alexander

CINCINNATI Procter & Gamble has announced that Joseph T. Gorman, in accordance with the company’s customary retirement age for directors, has announced his intention to retire effective October 2007 Gorman, who has been a director since 1993, will turn 70 on Oct. 1.

“Joe Gorman has served P&G’s board with distinction for more than 14 years. Among his many contributions, he has served as chair of the Fnance Committee and a member of the Compensation & Leadership Development Committee,” stated A.G. Lafley, P&G’s chairman and chief executive. “We have benefited greatly from his long experience and seasoned counsel. We will miss him, and wish him continued success.”

Gorman is the retired chairman and chief executive of TRW, an automotive, aerospace and information systems company. He currently serves as chairman and chief executive officer of Moxahela Enterprises LLC, a venture capital firm. He also serves as a director of Alcoa Inc., Imperial Chemical Industries plc, Tonsburg Magnesium Group International AB, and Vector Intersect Security Acquisition Corp.

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Eli Lilly looking to new blood-thinner to be best seller

BY Adam Kraemer

By early November, Eli Lilly hopes to release results of a large patient trial of prasugrel, the most important experimental drug in its pipeline. Prasugrel is a blood-thinning agent designed to prevent recurring heart attacks and strokes in people with cardiovascular disease, The Wall Street Journal reported this week.

Plavix, the current leading blood thinner, generated nearly $6 billion in sales last year for its co-marketers, Sanofi-Aventis and Bristol-Myers Squibb. Lilly and its Japanese development partner, Daiichi Sankyo Co., hope their drug will steal some market share from Plavix—if it receives regulatory approval.

Lilly hopes to submit prasugrel for Food and Drug Administration approval by the end of this year. If the drug gets timely FDA approval, it could hit the market in 2008. Initially, the approved uses for prasugrel would be narrower than those for Plavix, but Lilly and Daiichi might seek additional approvals later.

One reason that Lilly is betting so much on prasugrel is that its current best seller, the antipsychotic Zyprexa, is set to lose U.S. patent protection in 2011. Zyprexa generated more than one-fourth of Lilly’s total revenue last year, or about $4.4 billion. Lilly needs another big seller on the market before much of Zyprexa’s sales are lost to cheaper, generic competition.

Lilly is trying to downplay prasugrel’s importance in their pipeline. “While it’s a very important compound in late-stage development, it’s not the only product in late-stage development,” chief financial officer Derica Rice told the Journal. He said the company is developing an inhaled form of insulin for diabetics, as well as an injectable form of Zyprexa.

In the meantime, Bristol-Myers Squibb is watching as closely as Lilly at the prasugrel study results. Plavix last year accounted for approximately 18 percent of its revenue, according to the Journal.

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