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March 30, 2009 BIOTECH BUZZ

Political Fight On Biologics Heats Up

A political battle over drug costs and development is heating up at our nation’s capital. And the resolution of the debate will no doubt impact biotechnology companies in Central Massachusetts.

The fight du jour involves the development of biologic drugs, which are made from proteins manufactured in living cells. On one side are the fight are biotechnology companies who want to be able to market their compounds for as long as possible. On the other side are the developers of generic drugs that want to be able to bring their copies to the public sooner.

Bills Square Up

One of the most recent political answers is a bill that the biotechnology industry and many of its individual members favor: H.R. 1548. It was recently submitted to Congress by Reps. Anna Eshoo, D-Calif., Jay Inslee, D-Wash., and Joe Barton, R-Texas. The bill would allow companies that develop biologics to have exclusive control over their study data for a 12-year period that would follow the normal 17-year period that patents provide. The extension would prevent developers of generic copies from using that clinical trial data to support their cheaper alternatives.

Others, like U.S. Rep. Henry Waxman, D-Calif., have proposed a shorter, five-year period that would allow generic versions to reach the market more quickly. And President Barack Obama has said it is important to get generic biologics on the market sooner to help patients without insurance and to aid in health care reform.

A longer period after a patent’s time period would allow biologic developers to recoup the money they spent on research and development and FDA approvals. Hopefully, it would also give them time to earn some profits.

Not surprisingly, the Massachusetts Biotechnology Council has come down in favor of HR 1548 and its 12-year time period.

“The Massachusetts Biotechnology Council thinks that the bill is a step in the right direction...We think that it is certainly the right amount of time data exclusivity as long as safety and efficacy issues are addressed,” said John Heffernan, MBC’s vice president of policy and external affairs.

Heffernan said that if shorter times for data exclusivity are passed, it could stifle innovation because companies may decide the development costs just aren’t worth it in the long run when they can’t make back their investment before generics hit the market.

A perfect example of a local company that could benefit from additional exclusivity for their biologic is GTC Biotherapeutics in Framingham. In February, the FDA approved the company’s ATryn, which is an antithrombin, or plasma protein, which prevents blood clots and has anti-inflammatory properties.

It is the first transgenically made protein: human DNA is injected into a goat’s embryo, which is then implanted into another goat. The transgenic offspring make the antithrombin in their milk, which is purified and used by people who can’t make antithrombin, particularly before surgery or in the event of a problem during pregnancy.

“Innovators want to have some assurance that after they’re done spending all their money they’ll have something to show for it,” said Tom Newbury, GTC Therapeutics’ vice president of corporate communications and government relations.

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