All About Multiple Sclerosis

More MS news articles for May 2003

FDA program boosts Virogenomics drug

http://portland.bizjournals.com/portland/stories/2003/05/12/daily16.html

May 13, 2003
Portland Business Journal

The U.S. Food and Drug Administration has granted investigational drug VG1000 "orphan drug" status for the treatment of multiple sclerosis.

Portland-based Virogenomics Inc. holds an exclusive license to commercialize the drug, which was discovered by researchers at Oregon Health & Science University.

The FDA's orphan drug program is intended to encourage research, development and regulatory approval of products for diseases that affect fewer than 200,000 patients in the United States. In addition to potential market exclusivity, orphan drug status provides tax incentives for up to 50 percent of a company's investment in U.S. clinical research, partial funding to support clinical trials, study design assistance and waivers from FDA user fees.

"Orphan drug status is a significant step in the commercialization of a discovery made by OHSU scientists," said Todd Sherer, director of OHSU Technology and Research Collaborations, which spun off the drug technology to Virogenomics. "This will help bring VG1000 to market."

MS usually strikes young adults aged 20 to 40. Women are twice as likely to be affected than men. The progress, severity and specific symptoms of the disease cannot be predicted; symptoms may range from tingling and numbness to paralysis and blindness.

Virogenomics spun out of OHSU in 2001. Under the license agreement, OHSU is a shareholder of Virogenomics and also receives funding from Virogenomics to support the research. The university is entitled to royalties and a share of sublicense fees on any products commercialized by Virogenomics as a result of the technologies.

© 2003 American City Business Journals Inc.



FDA grants investigational multiple sclerosis treatment orphan drug status

http://www.datamonitor.com/~bb8da74b9fb144499a6cc19d814a4aff~/all/news/product.asp?pid=3BA16F9D-22F2-44E7-9C95-E30A1D9F118F

14 May 2003

The FDA has granted the investigational compound VG1000 orphan drug status for the treatment of multiple sclerosis. The Portland-based drug discovery company Virogenomics, holds an exclusive license to commercialize the drug, which was discovered by researchers at the Oregon Health & Science University.

The FDA's orphan drug program is intended to encourage research, development and regulatory approval of products for diseases that affect fewer than 200,000 patients in the US. In addition to potential market exclusivity, orphan drug status provides tax incentives for up to 50% of a company's investment in US clinical research, partial funding to support clinical trials, study design assistance and waivers from FDA user fees.

"Orphan drug status is a significant step in the commercialization of a discovery made by Oregon Health & Science University (OHSU) researchers," said Dr Todd Sherer, director of OHSU Technology and Research Collaborations, which spun off the drug technology to Virogenomics. "This will help bring VG1000 to market."

Multiple sclerosis (MS) is caused when T cells that normally lead the attack against foreign invaders of the body instead target nerves in the spinal cord and brain, creating lesions in myelin, the protective sheath around nerve cells.

In animal models of MS, treatment with VG1000 restored normal neurological function. The drug targets and inactivates the T cells that cause inflammation and myelin damage in the brain and spinal cord. At present, preclinical animal studies are being completed in anticipation of submitting an Investigational New Drug application to the FDA.
 

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