PHARMACY

Aricept patent is still intact after lawsuit, says Eisai

BY Adam Kraemer

NEW YORK Even after a decision by a U.S. court related to Japanese Eisai’s Alzheimer’s disease drug, Aricept, the company still insists that its patent is valid.

The U.S. District Court of New Jersey on Dec. 20 dismissed a suit filed by Eisai against Philadelphia-based Mutual Pharmaceutical Co. over the latter’s move to seek Food and Drug Administration approval for marketing a generic version of Aricept. The patent expires in three years.

Eisai Thursday said the ruling was issued on procedural grounds and doesn’t affect the validity of its Aricept patent, which the company believes remains valid through Nov. 25, 2010. Mutual Pharmaceutical still can’t sell a generic version of the drug, Eisai said.

The dismissal, Eisai stated, stemmed from the court’s decision that “there is no case or controversy between the parties, because Mutual did not make a certification challenging the Aricept patent and does not yet have U.S. Food and Drug Administration approval to market its product,” the Wall Street Journal reported.

The Japanese company also said that the U.S. company will give 45 days’ notice of any introduction of a generic version of Aricept.

Eisai this month agreed to pay $3.9 billion to buy MGI Pharma to boost its growth prospects, giving it more reach in the U.S., where Eisai also is building a research-and-development facility.

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Congress passes bill giving $1.73 billion to FDA

BY Adam Kraemer

WASHINGTON Congress last week passed a consolidated appropriations bill, giving, among other things, nearly $1.73 billion to the Food and Drug Administration, more than $79 million over the president’s budget request.

In addition, the bill also gives the Center for Drug Evaluation and Research more than $682 million, of which $41.9 million is available for the Office of Generic Drugs, while the Center for Biologics Evaluation and Research would receive more than $236 million.

On Dec. 17, the House passed H.R. 2764 by a vote of 214–189, and the following day, the Senate passed a revised version by a vote of 76–17, The House agreed to send the revised version to the president, increasing 2007’s FDA funding by $145 million.

In addition, the committees encouraged the FDA to limit “to the greatest extent possible” granting financial conflict-of-interest waivers to advisory committee members, which has been a hot topic recently. While the committees were encouraged by the FDA’s announcement earlier this year that it would limit the number of waivers, they said the agency should do more.

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Cubist acquires Illumigen in potential $341.5 million deal

BY Adam Kraemer

SEATTLE and LEXINGTON, Mass. Cubist Pharmaceuticals may pay up to $341.5 million to buy Illumigen Biosciences, adding an experimental treatment for hepatitis C, a blood-borne virus that can damage the liver, to its pipeline.

Lexington, Massachusetts-based Cubist, the maker of the skin-infection drug Cubicin, will pay $9 million to acquire Seattle-based Illumigen, plus a potential $332.50 million in regulatory and drug development payments, the companies said today in a statement.

The purchase of Illumigen will add an experimental HCV treatment, called IB657, to Cubist’s portfolio of infection-fighting medicines. The HCV market, the companies said in a statement, was $2.2 billion in 2005 and is expected to reach $4.4 billion in 2010.

Cubist will make payments during the development of IB657 for hepatitis of up to $75.5 million and an additional $117 million if Cubist develops Illumigen products for other viruses, the companies said. The company will pay up to $140 million in milestone payments once products reach the market.

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