PHARMACY

Healthcare organizations rally to expand diabetes care in Indiana

BY Alaric DeArment

INDIANAPOLIS Seven healthcare organizations have joined together to help fill the gaps in diabetes care in Indiana.

Drug maker Eli Lilly and Co., health insurer Anthem Blue Cross and Blue Shield – which are spearheading the effort – and five others have formed the Healthy Hoosiers Alliance, which will address healthcare quality, safety, access and affordability in the state, they said.

“The Healthy Hoosiers Alliance was conceived with the recognition that by combining our expertise and resources as never before, we can have a greater, more coordinated impact on the health of our community,” Lilly VP account-based markets Jack Bailey stated.

Other participants of the alliance, conceived in spring 2007, include the Indiana Health Information Exchange, the Juvenile Diabetes Research Foundation, the American Diabetes Association, the Indiana State Department of Health and Gov. Mitch Daniels’ INShape Indiana.

According to the Indiana State Department of Health, as much as 8.1% of Indiana’s adult population is diagnosed with diabetes, compared to 7.8% nationally.

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Two new diabetes drugs to be reviewed by FDA next week

BY Alaric DeArment

NEW YORK The Food and Drug Administration’s Endocrinologic and Metabolic Drugs Advisory Committee will review two new diabetes drugs next week, and this has left investors nervous, according to published reports.

On April 1, the committee will review Onglyza (saxagliptin), by AstraZeneca and Bristol-Myers Squibb, and review Victoza (liraglutide) the next day. According to Reuters, however, an FDA rejection earlier this month of Takeda Pharmaceutical’s alogliptin calling for additional clinical data, caused the company’s stock to fall.

According to the news agency, an analyst said that the FDA might be slow to approve drugs similar to those on the market. Onglyza is a DPP-4 inhibitor, belonging to the same class as alogliptin; Merck & Co.’s DPP-4 inhibitor Januvia (sitagliptin) is already on the market.

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Mylan confirms first-to-file challenges

BY Alaric DeArment

PITTSBURGH Mylan could get exclusive rights to four generic drugs.

The generic drug maker confirmed Thursday that six drug companies and two research centers had sued it in connection with four “first-to-file” regulatory approval applications containing Paragraph IV certifications.

  • Sepracor sued Mylan and Alphapharm in the U.S. District Court of New Jersey over an application for eszopiclone tablets in the 1 mg, 2 mg and 3 mg strengths. The tablets are a generic version of the insomnia drug Lunesta, which had sales of $796 million in 2008, according to IMS Health.
  • Shire sued Mylan and subsidiary Matrix Labs in the U.S. District Court for the Southern District of New York over an application for lanthanum carbonate chewable tablets in the 500 mg, 750 mg and 1 g strengths. The tablets, used to treat kidney disease, are a generic version of Fosrenol, which had sales of $108 million in 2008, according to IMS Health.
  • OSI Pharmaceuticals, Pfizer and Genentech sued Mylan in the U.S. District Court in Delaware over an application for erlotinib hydrochloride tablets in the 25 mg, 100 mg and 150 mg strengths. The tablets, used to treat lung cancer, are a generic version of Tarceva, which had sales of $492 million in 2008, according to IMS Health.
  • Galderma Labs, New York University and the Research Foundation of the State University of New York sued Mylan in the U.S. District Court of Delaware over an application for doxycycline delayed-release capsules in the 40 mg strength. The capsules are a generic version of Galderma’s adult rosacea treatment Oracea, which had sales of $82 million in 2008, according to IMS Health.

Under the Hatch-Waxman Act of 1984, the first company to seek approval for a generic version of a drug gets six months of market exclusivity once the generic drug gets final approval from the Food and Drug Administration. A Paragraph IV certification asserts that a branded company’s patent on a drug is invalid, unenforceable or won’t be infringed by a generic version.

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