PHARMACY

Pfizer wins decision in key Celebrex case

BY Adam Kraemer

NEW YORK Pfizer announced Thursday that a New York state court ruled in favor of the company on an important motion relating to litigation over the company’s anti-inflammatory medication, Celebrex. New York Supreme Court Justice Shirley Kornreich ruled that the plaintiffs suing Pfizer in New York failed to present reliable scientific evidence necessary to prove that Celebrex can cause heart attacks and strokes at 200 mg daily – the most commonly prescribed dosage of the Pfizer pain medication.

The ruling follows a similar decision in November 2007 by the U.S. District Court of Northern California in the Celebrex multi-district federal litigation. In the federal court decision, the Court held there are “no randomized controlled trials or meta-analyses of such trials or meta-analyses of observational studies that find an association between Celebrex 200 mg/day and a risk of heart attack or stroke.” 

Together, the two decisions render certain expert opinions inadmissible, which Pfizer says could result in the dismissal of other Celebrex cases. The majority of the Celebrex cases are pending in the two courts that issued the decisions.

Food and Drug Administration advisory committee hearings in 2005 concluded that the benefits of non-steroidal anti-inflammatory drugs, including Celebrex, outweigh its cardiovascular risks for appropriate patients at approved doses, and thus remained on the market.

“We are pleased with Justice Kornreich’s decision which, like the federal court decision, recognizes the lack of any credible evidence linking Celebrex, at its most common dosage form, with heart attacks or strokes,” said Pfizer general counsel Allen Waxman. “We believe that these rulings will greatly limit the scope of this litigation, and we intend to continue to vigorously defend the cases against us.” 

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PHARMACY

House investigates possibly misleading Lipitor advertisement

BY Drew Buono

WASHINGTON Democrats in the House of Representatives are investigating as to whether or not consumers are being misled by advertisements for Lipitor featuring Dr. Robert Jarvik, the inventor of the artificial heart, the Associated Press reported.

Michigan Reps. John Dingell and Bart Stupak sent a letter to the drug’s manufacturer Pfizer on Monday, questioning the credibility of Jarvik, whom they believe is not certified to practice or prescribe medicine because he might not have taken the necessary tests or performed an internship.

Pfizer spokesman Chris Loder said Jarvik’s presence in the advertisements is meant to educate consumers on the importance heart health. “Dr. Jarvik is a respected health care professional and heart expert who knows how imperative it is for patients to do everything they can to keep their heart working well,” Loder said in a statement.

The representatives have requested that Pfizer turn over all of its information concerning Jarvik including its contract with him and any information about his professional qualifications.

Lipitor is the most prescribed drug in the U.S., with sales of $13.6 billion in 2006.

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King ends five-year Skelaxin patent suit against CorePharma

BY Drew Buono

BRISTOL, Tenn. & MIDDLESEX, N.J. King Pharmaceuticals has ended is patent lawsuit with CorePharma regarding its muscle relaxant drug Skelaxin and has signed an agreement with CorePharma related to the drug, according to Forbes.

On Jan. 2, the two companies signed an agreement under which, CorePharma will gain certain exclusive rights to Skelaxin 800 mg to market a generic version, called metaxalone and have also gained a non-exclusive license to produce and market a 400 mg version of the drug. This license will come into effect on Jan. 1, 2012.

Back in 2003, CorePharma was one of several biopharmaceutical companies to file with the Food and Drug Administration seeking permission to produce a generic. King countered by suing CorePharma and later Eon Labs and Mutual Pharmaceuticals, who also sought permission to produce a generic.

As of now, CorePharma is the only company that King Pharmaceuticals has an agreement with concerning Skelaxin. The drug is estimated to account for about $400 million in sales in 2008, according to Morgan Stanley.

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