PHARMACY

Isis grants Excaliard license for development of antisense drugs

BY Drew Buono

CARLSBAD and ENCINITAS, Calif. Isis and Excaliard Pharmaceuticals have entered into an agreement to discover and develop antisense drugs for the local treatment of fibrotic diseases, including scarring. Isis has granted Excaliard an exclusive worldwide license for the development and commercialization of certain antisense drugs.

Under the agreement, Excaliard made an upfront payment in the form of equity and paid $1 million cash to Isis for the licensing of a particular gene target. Isis will also be eligible to receive development milestones and royalties on antisense drugs developed by Excaliard.

“Isis has made superb progress in the development of second-generation antisense drugs over the last few years, as evidenced by its clinical pipeline and current collaborations with companies such as Bristol-Myers Squibb, Eli Lilly and Ortho-McNeil, among others,” said Excaliard co-founder J. Gordon Foulkes, acting chief executive officer for Excaliard and managing director of RiverVest Venture Partners. “Having access to Isis’ antisense technology and expertise provides a great opportunity for Excaliard.”

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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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