• E-mail
• Print
• Comment
• Font Size
• Digg
• del.icio.us
• Discuss article

Biotechnology Firms Race for FDA Approval on Rival Growth-Stimulating Drugs

Posted on: Tuesday, 16 August 2005, 09:01 CDT

Aug. 16--It's a race to the finish for two biotechnology companies that have developed a drug to help short people.

One is in Henrico County. The other is in Brisbane, Calif. Both are seeking approval from the U.S. Food and Drug Administration for a drug that will stimulate growth.

Insmed Inc., the local company, has filed a "citizen petition" to block approval of its competitor's drug. It asks the U.S. Food and Drug Administration to deny approval of Increlex, made by Tercica Inc.

John A. Scarlett, president and CEO of Tercica, said in a statement released yesterday that he did not have access to the citizen petition.

However, "we believe it was important to disclose this development [to shareholders]."

The content of the petition is expected to be made public this week.

No one at Insmed could be reached for comment yesterday.

Insmed expects to hear from the FDA by Oct. 3 whether its drug, SomatoKine, is approved. Tercica is looking at an Aug. 31 decision.

SomatoKine treats growth-hormone insensitivity syndrome, a rare childhood disease that results in short stature.

Insmed is researching other uses for the drug that include treatments for muscle and nerve degeneration, extreme insulin resistance and an abnormal buildup or loss of fat related to the AIDS virus.

Both companies are dealing with a possible "orphan drug exclusivity" designation.

The label -- granted to products for diseases that affect fewer than 200,000 people -- gives companies the right to exclusively market drugs for seven years.

If Insmed wins approval, SomatoKine would be the company's first and only drug on the market.

Tercica is dealing with a similar situation. Increlex, developed to treat short stature and associated metabolic disorders, would be its first product.

-----

To see more of the Richmond Times-Dispatch, or to subscribe to the newspaper, go to http://www.timesdispatch.com.

Copyright (c) 2005, Richmond Times-Dispatch, Va.

Distributed by Knight Ridder/Tribune Business News.

For information on republishing this content, contact us at (800) 661-2511 (U.S.), (213) 237-4914 (worldwide), fax (213) 237-6515, or e-mail reprints@krtinfo.com.

INSM, TRCA,

Source: Richmond Times-Dispatch

More News in this Category