PHARMACY

Amgen, Array BioPharma enter development agreement for Type 2 diabetes drugs

BY Alaric DeArment

THOUSAND OAKS, Calif. Amgen has obtained exclusive rights to a program for investigational Type 2 diabetes drugs, the biotech company announced.

Amgen will pay Array BioPharma $60 million upfront plus milestone payments for the program, which covers a class of pharmaceutical drugs called glucokinase activators and includes ARRY-403, currently in phase 1 clinical trials.

Array will be responsible for completing the ARRY-403 trial and will have the option to co-promote the drug in the United States, while Amgen will be responsible for future clinical development and commercialization for the drug.

“Type 2 diabetes affects over 20 million Americans, and its incidence is increasing at an alarming rate,” Amgen EVP research and development Roger Perlmutter said. “We are pleased to be collaborating with Array BioPharma in this arena and are excited about the potential of this glucokinase activator.”

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Ranbaxy will not merge with Nippon Chemiphar

BY Alaric DeArment

GURGAON, India Indian generic drug maker Ranbaxy Labs has dissolved its joint venture with Japan’s Nippon Chemiphar. The dissolution gives Nippon Chemiphar full ownership of the venture, Nihon Pharmaceutical Industry Co.

The two companies had decided that it would serve their respective interests to develop their generic businesses independently, though Ranbaxy will continue to manufacture generic drugs for Nippon Chemiphar at its plants in India.

Japan is the world’s second largest pharmaceutical market and has been gradually opening up to generic drugs. In October, Sandoz launched Japan’s first biosimilar, a follow-on of Pfizer’s human growth hormone Genotropin (somatropin) already marketed in the United States, the European Union and Australia under the name Omnitrope.

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FDA approves generic treatment of Alzheimer’s disease

BY Alaric DeArment

ROCKVILLE, Md. The Food and Drug Administration has approved the first generic version of a drug used to treat dementia related to Alzheimer’s disease, the agency announced Tuesday.

The FDA approved Philadelphia-based Mutual Pharmaceutical’s donepezil hydrochloride orally disintegrating tablets in the 5-mg and 10-mg strengths, a generic version of Eisai’s Aricept. While generic versions of Aricept already are available, the newly approved generic is a version that dissolves on the tongue, designed for patients who have difficulty swallowing.

“Generics offer greater access to health care for all Americans,” FDA Office of Generic Drugs director Gary Buehler said. “Healthcare professionals and consumers can be assured that FDA-approved generic drugs have met the same rigorous standards as the brand-name drug and are the same as the branded in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use.”

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