PHARMACY

Lilly places new focus on old diabetes business

BY Diana Alickaj

INDIANAPOLIS Indianapolis-based Eli Lilly has decided to invest millions of dollars back into its diabetes business, as a strategy to offset its losses in other areas.

According to published reports, the company has decided to take action based on the expiration of its patents for its top-selling products: Zyprexia, an antipsychotic, Humalog, an insulin drug, and Cymbalta, an antidepressant. The expiration process is set to start in the year 2011, and these drugs are said to make up more than half of Lilly’s revenue.

As a result, Lilly has begun a fast-acting campaign to delve into its diabetes division, searching for better treatments based on the increased number of diabetics throughout the years. According to the Centers for Disease Control and Prevention, the diagnosis of diabetes has doubled in the last 15 years, making 14.6 million people that had diabetes in 2005, and is expected to double by 2050.

Lilly has launched five new injection pens, according to published reports, as well as donating more than $30 million in grants to hospitals and areas where diabetes research is conducted. More signs of involvement include its purchase for the rights to a molecule for the treatment of Type 1 diabetes, as well as testing its own products for the treatments of Type 2 diabetes.

Although Lilly faces tough competition with international drug makers Sanofi-Aventis and Novo Nordisk, Lilly is moving fast to revive its company’s oldest franchise. Analysis from Credit Suisse states that Lilly’s new focus will raise its sales from $3.2 billion in diabetes products to about 4.4 billion making it 22 percent of its total revenue.

David Moller, Lilly’s vice president of endocrine and cardiovascular research and clinical investigation, said of the company’s attention to the diabetes market, “There’s a resurgence of interest in diabetes going on. I would hate to promise that a cure is right around the corner, but that is the long-term goal we have.”

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FDA to review ulcer gel, HIV medications

BY Drew Buono

WASHINGTON The Food and Drug Administration is conducting two safety reviews of the drugs Regranex gel, used for leg and foot ulcers and the HIV medications Ziagen and Videx.

Diabetic patients using Johnson & Johnson’s Regranex face an increased risk of cancer from using the gel.

Data analyses from another study indicate a higher risk of heart attack in patients infected with HIV-1 who were taking GlaxoSmithKline’s Ziagen or Bristol-Myers Squibb’s Videx as part of their drug therapy.

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FDA OKs Dendreon’s phase III Provenge trial

BY Drew Buono

SEATTLE The Food and Drug Administration has agreed to allow Dendreon to get the final results from its phase III trial for its prostate cancer drug Provenge.

Last May, the FDA requested additional clinical data from Dendreon to support its effectiveness claim for Provenge despite a vote by the Cellular, Tissues and Gene Therapies Advisory Committee in favor of approving the drug. The committee voted 13 to 4 that the product was effective and 17 to 0 that it was safe.

That request led three congressmen: Reps. Mike Michaud, D-Maine, Dan Burton, R-Ind., and Tim Ryan, D-Ohio, to point accusations that conflicts of interest on the advisory committee might have led some of its members to send written requests to the FDA asking that the drug not be approved. One of the members of the committee is a lead investigator for a competing cancer drug made by Novacea.

According to the company, interim results from the IMPACT study of Provenge still are expected later this year, but final results are now expected in the second half of next year rather than the second half of 2010.

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