Vacaviille's Large Scale Biology wins 'orphan drug' OK

Sacramento Business Journal - August 1,
2005link to story here

LATEST NEWS

Sacramento Business Journal - 10:08 AM PDT Monday

Large Scale Biology wins 'orphan drug' OK

The U.S. Food and Drug Administration has granted an "orphan drug" designation to an enzyme product by Vacaville-based Large Scale Biology Corp., opening the door to special treatment of the product by federal regulators.

The biotech company said Monday that it received the FDA sign-off for its recombinant

Lysosomal Acid Lipase (LAL) product within three months of submitting its application. LAL is an enzyme that the human body uses to metabolize certain fats, and some diseases are caused or worsened by a lack of the enzyme, which causes fats to build up in organs.

The orphan drug program encourages development of treatments for conditions that affect fewer than 200,000 patients in the United States or similar rates elsewhere, which because they are relatively rare may not attract attention from researchers for large pharmaceutical makers. The orphan drug program offers market protection and other incentives to researchers who target such unusual medical conditions.

In addition to the "orphan" conditions, Large Scale Biology sees promise in using the LAL product in treating the much more common problems caused by accumulations of fatty plaque inside human arteries, which would open a broader market.

Large Scale Biology is working with Cincinnati Children's Hospital Medical Center, and researchers there who identified LAL and its characteristics, on therapeutic applications for the enzyme.

Shares of Large Scale Biology (Nasdaq: LSBC) were up 6 cents, or 7.5 percent, in midday trading Monday. © 2005 American City Business Journals Inc.