PHARMACY

Takeda submits FDA application for once-a-day diabetes pill

BY Drew Buono

OSAKA, Japan Takeda Pharmaceuticals is seeking approval from the Food and Drug Administration to sell its new drug alogliptin, a diabetes pill that is taken once daily as a treatment for Type 2 diabetes, according to Bloomberg.com.

The company is hoping this drug will help its sales after its other diabetes medication Actos loses patent protection in 2011. “Takeda needs a new source of revenue,” said Kumi Miyauchi, an equities analyst at Daiwa Research Institute, in a telephone interview with Bloomberg. If approved, Takeda may be able to start selling the drug in early 2009, generating as much as $2 billion per year, said Miyauchi.

Takeda’s filing was supported by data from six final-stage trials involving more than 2,000 patients conducted in 220 centers worldwide, Takeda said. Results of second and third stages of clinical studies on alogliptin will be published this year, Takeda spokesman Seizo Masuda said. Patients taking the medicine weren’t inclined to gain weight, a potential side effect with Actos, he said.

Also, Takeda and Abbott Laboratories have filed for FDA approval for their drug TAK-390MR, proton pump inhibitor that will treat diseases caused by stomach acid.

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FDA approves Depomed’s 1,000 mg Glumetza

BY Drew Buono

MENLO PARK, Calif. Depomed has received approval from the Food and Drug Administration for a 1,000 mg strength of Glumetza tablets. Glumetza is used as an adjunct to diet and exercise to improve glycemic control in adult patients with Type 2 diabetes.

“This approval is good news for patients with Type 2 diabetes who are on metformin therapy and prefer to take fewer tablets per day,” stated Carl Pelzel, president and chief executive officer of Depomed. “The American Diabetes Association guidelines recommend that metformin therapy be titrated to its maximally effective dose, generally regarded as 2,000 mg/day as tolerated. We believe this 1,000 mg dosage form is a great addition to the Glumetza franchise, as we now have two ways for patients to achieve 24-hour glycemic control: the original Glumetza 500 mg tablets, which start out as small, easy-to-swallow tablets that expand once in the stomach, and the new 1,000 mg tablets, which require fewer tablets to hit the target dose. We are working very closely with our commercial supplier, Biovail, to make these tablets commercially available in the United States in the near future.”

Depomed acquired exclusive U.S. rights to the 1,000 mg formulation of Glumetza in December 2005 from Biovail, and has a supply agreement with Biovail related to the formulation. Glumetza had sales of $3.8 million in the third quarter of 2007.

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Ivans launches LIME Medicare Internet solution

BY Drew Buono

STAMFORD, Conn. Ivans, a technology company that provides Medicare connectivity solutions and services has unveiled its new product, an Internet solution for healthcare providers that processes Medicare transactions, called LIME.

The goal of the program will be to save providers time and money through its elimination of manual searches and by streamlining the claims process so claims are paid faster and more accurately. The program is approved by the Centers for Medicare and Medicaid Services and is compliant with the Health Insurance Portability and Accountability Act.

Using LIME, providers are able to process Medicare claims 10 times faster than dial-up modems. Providers indicated that while it used to take one hour to process three claims, by using the new program 30 claims can be processed during that same time period. Because this is a multi-user solution that can be used for other Medicare transactions such as eligibility and claims remittance, the time and money saved in a one-year period is equivalent to three staff members working full-time.

Currently, more than 100,000 part A and part B healthcare providers are supported by Ivans solutions.

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