PHARMACY

IMPAX announces limited resumption of sales of oxycodone

BY Drew Buono

STAMFORD, Conn. IMPAX Laboratories and its distributor DAVA Pharmaceuticals will resume sales of its oxycodone hydrochloride extended-release tablets in a limited capacity starting today.

This is in response to an agreement the companies signed with Purdue Pharma, who manufactures the brand version, Oxycontin, which is used for the management of moderate to severe pain when a continuous around-the-clock analgesic is needed for an extended period of time. The agreement said that IMPAX acknowledged that Purdue’s patents for Oxycontin were valid, enforceable and infringed on by their generic version. Purdue in return, allowed the companies to continue selling the product on the market until June 14, and to resume the distribution at a future date for a limited period of time.

The sales of the generic are expected to continue until around Jan. 28, 2008, or until the company’s sales quota under the license agreement with Purdue has been reached.

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PHARMACY

Orphan drug application process to ease in U.S., Europe

BY Drew Buono

WASHINGTON & LONDON The Food and Drug Administration, European Commission and European Medicines Agency have decided to ease the application process for orphan drugs, drugs that are necessary but would be expensive and unprofitable to develop, in a move aimed at increasing the development of treatments for rare diseases, according to Reuters.

The agencies have adopted a common application, which would allow drug companies to apply to both regions at the same time with one application.

Rare diseases are defined as those affecting fewer than five in 10,000 people in the European Union and fewer than 200,000 people in the United States. About 30 million people in the European Union and about 25 million Americans suffer from more than 6,000 rare diseases.

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India’s drug makers move beyond generics

BY Drew Buono

NEW DELHI, India

India’s big pharmaceutical companies are moving from generic drug manufacturing to introducing their own originally researched drug molecules, which are expected to hit the market by 2010-11, according to published reports.

Among the companies involved in research and development of the new molecules are Ranbaxy, Glenmark and Dr. Reddy’s. Altogether about 10 to 12 companies have molecules under various stages of development.

Research and development investments now account for as much as 7 percent to 9 percent of sales. For example, Ranbaxy invested $80 million in research and development in 2006-07; this year that number has gone up to $100 million.

The key for these companies will be to partner with more experienced pharmaceutical manufacturers to help conduct more original research and development on new drugs.

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