AVI Files for Orphan Designation for Its SARS Coronavirus Antisense Drug
PORTLAND, Ore. - Aug. 14, 2003 - AVI BioPharma, Inc. (Nasdaq: AVII, AVIIW, AVIIZ), today announced that, based on positive preclinical data, it has filed an application with the U.S. Food and Drug Administration (FDA) to obtain orphan designation for its NeuGene® antisense drug, AVI-4179, targeting the coronavirus implicated in Severe Acute Respiratory Syndrome (SARS).
The FDA grants orphan designation to drugs developed for rare diseases, which are defined as having a prevalence of less than 200,000 cases annually. The SARS virus epidemic falls well within the parameters for orphan drug designation. The achievement of orphan designation provides for seven years of marketing exclusivity, effectively preventing a similar drug from being registered and sold for that indication.
According to the World Health Organization (WHO), there have been approximately 8,437 cases of SARS reported worldwide. WHO declared recently that the SARS virus has been contained around the world, but warned that the virus could pose a seasonal threat and may emerge again in coming months.
"Orphan drug designation is an important tool for companies like AVI that are developing drugs for rare and emerging diseases," said David H. Mason Jr., M.D., AVI's senior vice president for Clinical Development and Regulatory Affairs. "Marketing exclusivity provides an important incentive for the rapid development of drugs to address important public health issues like SARS."
AVI designed and produced AVI-4179 10 days after the genetic sequence of the SARS coronavirus was made publicly available. Thus far, AVI has accumulated sufficient efficacy data from both internal in vitro analysis and outside collaborative laboratories to support an orphan drug application. The next stage of AVI's program is to complete supportive preclinical trials required for regulatory filings over the next several months. The company's objective is to have the drug ready for manufacturing under good manufacturing practices (GMP) for clinical studies as soon as possible.
"This aggressive drug development schedule is patterned after our West Nile antisense program where we finished preclinical work, completed GMP manufacturing, and filed an investigational new drug (IND) application for initiation of clinic trials in nine months, in time for the West Nile Virus season," said Denis R. Burger, CEO of AVI. "We plan to be ready with our antiviral drug for SARS in time for the potential re-emergence of this virus next winter in China and anywhere else the virus may spread."
About AVI BioPharma
AVI BioPharma develops therapeutic products for the treatment of life-threatening diseases using two technology platforms: third-generation NeuGene antisense drugs and cancer immunotherapy. AVI's lead NeuGene antisense compound is designed to target cardiovascular restenosis, cancer, polycystic kidney disease and other cell proliferation disorders. In addition to targeting specific genes in the body, AVI's antiviral program uses NeuGene antisense compounds to target single-stranded RNA viruses, including West Nile virus, SARS coronavirus, calicivirus and hepatitis C. AVI's second technology, Avicine®, is a therapeutic cancer vaccine with late-stage trials planned for the treatment of pancreatic and colorectal cancer. More information about AVI is available on the company's Web site at http://www.avibio.com/.
"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995: The statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties, including, but not limited to, the results of research and development efforts, the results of preclinical and clinical testing, the effect of regulation by the FDA and other agencies, the impact of competitive products, product development, commercialization and technological difficulties, and other risks detailed in the Company's Securities and Exchange Commission filings.