PHARMACY

U.S. Patent Office accepts Pfizer application for correction of Lipitor patent

BY Alaric DeArment

NEW YORK The United States Patent and Trademark Office has accepted an application from Pfizer to correct its patent for the cholesterol drug Lipitor.

The New York-based drug maker announced last week that it had submitted a correction of a technical defect for the E995 enantiomer patent for atorvastatin calcium, the salt form of Lipitor. It said certain formalities must be completed before the office grants the reissue patent.

The reissue patent will have the same force, effect and expiration date as the original, expiring in June 2011 and including six months in which Pfizer will retain exclusive rights to market Lipitor for use in children.

“This is a very positive development, not just for Pfizer but for all those who believe that defending intellectual property is vital to supporting the enormous investments required to develop life-saving new medicines,” Pfizer VP for worldwide communications Raymond Kerins said in a statement. “We have said all along that we had strong arguments for securing the reissue of the patent, and after a vigorous examination, the Patent Office agreed with this conclusion.”

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FDA approves Forest Labs’, Cypress Bioscience’s Savella for fibromyalgia treatment

BY Alaric DeArment

NEW YORK The Food and Drug Administration has approved a new drug for treating the chronic pain diseases fibromyalgia.

Forest Labs and Cypress Bioscience announced Wednesday that the FDA had approved Savella (milnacipran hydrochloride), a drug belonging to the class known as selective serotonin and norepinephrine dual reuptake inhibitors.

“Savella is the product of a unique clinical development program, one that considered a patient to be a responder to therapy only if they demonstrated concurrent clinically significant changes in multiple aspects of their fibromyalgia, including pain, patient global assessment and physical function,” Cypress Bioscience chairman and CEO Jay Kranzler said in a statement.

Fibromyalgia causes widespread pain and decreased physical function. It affects up to 6 million people in the United States.

“Fibromyalgia is a chronic and often debilitating condition, with a significant need for new therapies,” Forest chairman and CEO Howard Solomon said in a statement.

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Eli Lilly to pay $1.415B to resolve allegations of unapproved use of antipsychotic drug Zyprexa

BY Alaric DeArment

WASHINGTON Drug maker Eli Lilly & Co. has agreed to pay $1.415 billion to resolve allegations that it promoted the antipsychotic drug Zyprexa for unapproved uses.

The Department of Justice announced Thursday that the Indianapolis-based company would pay a $515 million criminal fine – the largest ever in a healthcare case and the largest criminal fine ever imposed on an individual corporation – and up to $800 million in a civil settlement with the federal government and the states. It also will forfeit assets of $100 million.

The settlement will resolve criminal and civil allegations that Lilly promoted Zyprexa (olanzapine) for uses not approved by the Food and Drug Administration, including treatment of dementia in elderly people.

In a plea agreement, the company has admitted its guilt to a misdemeanor charge. It also signed a civil settlement to resolve claims that by marketing the drug for off-label uses, it caused the submission of false payment claims to federal health insurance plans such as Medicaid, TRICARE and the Federal Employee Health Benefits Program.

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