PHARMACY

Teva settles patent dispute with Amgen

BY Allison Cerra

THOUSAND OAKS, Calif. — Generic drug maker Teva recently admitted that one of its drugs infringes two of Amgen’s patents.

The U.S. District Court in Pennsylvania has barred Teva from selling its human G-CSF (human granulocyte colony-stimulating factor) product Neutroval in the United States until Nov. 10, 2013. What’s more, the court’s injunction extends to Teva’s other human G-CSF product, Neugranin. Teva will not sell Neugranin until Nov. 10, 2013, unless it first obtains a final court decision that Amgen’s patents are not infringed by Neugranin.

The two patents at issue in the litigation, U.S. Patent Nos. 5,580,755 and 5,582,823, expire in early December 2013.

"We are very pleased with this outcome, as it reaffirms the validity of these important patents," Amgen SVP general counsel and secretary David Scott said. "This closes this matter and allows Amgen to continue to focus on bringing innovative therapies to patients with grievous illnesses."

Human G-CSF is a hormone designed to stimulate the bone marrow to produce granulocytes and stem cells.

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PHARMACY

Affordable Medicines Utilization Act of 2011 encourages use of generic drugs

BY Allison Cerra

WASHINGTON — New bipartisan legislation introduced to the Senate last week seeks to offer states incentives to use generic drugs by allowing states to temporarily keep a portion of the savings.

Senators Scott Brown, R-Mass.; Ron Wyden, D-Ore.; and John McCain, R-Ariz., introduced the Affordable Medicines Utilization Act of 2011, saying that the bill would encourage states to take advantage of cost-saving generic drugs.

“With our nation in a financial crisis and as federal and state healthcare expenditures continue to rise, we must ensure that our healthcare programs are efficiently managed,” McCain said. “A recent study found that the federal/state Medicaid program potentially overspends by more than $300 million per year on brand-name drugs when a cheaper generic drug equivalent is available. This bipartisan proposal incentivizes state Medicaid programs to substitute generics for more expensive brand-name drugs, introducing real competition for reimbursement dollars and saving taxpayers’ hard-earned money.”

The bipartisan legislation has received endorsement from the National Association of Chain Drug Stores, stating in a letter that, “The Affordable Medicines Utilization Act of 2011 will provide incentives that will encourage state programs to efficiently use their healthcare dollars through increased use of more cost-efficient generic drugs while at the same time generating savings for not only the state but for the patient as well,” NACDS wrote.

NACDS did, however, caution against "evaluating spending on prescription drugs in a vacuum."

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Investigational antidepressant garners positive results in late-stage clinical trial

BY Alaric DeArment

NEW YORK — Patients taking an investigative antidepressant undergoing late-stage clinical development showed “significant” improvement, according to study results released Monday.

Forest Labs and Pierre Fabre Medicament announced results of a phase-3 trial of levomilnacipran in adults with major depressive disorder. Results showed a statistically significant improvement in patients treated with the drug, compared with those taking placebo.

“Depressed patients often struggle to find the right antidepressant, and the need for new medications is high,” Forest Research Institute SVP research and development Marco Taglietti said. “These positive phase-3 results are very encouraging and support the continued research of levomilnacipran in adult patients with major depressive disorder.”

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