Biosyn, Inc. Obtains Exclusive Rights to Novel HIV Microbicide Candidate from National Institutes of Health

HUNTINGDON VALLEY, Penn. -- Biosyn, Inc. announced today that the company has acquired exclusive, worldwide rights from the National Institutes of Health (NIH) for the development and commercialization of the novel protein, cyanovirin-N, as an HIV microbicide. Cyanovirin-N (CV-N) has shown remarkably potent anti-HIV activity in laboratory studies and in animal models. Based on these data, Biosyn foresees significant potential in the development of CV-N as a microbicide to prevent the sexual transmission of HIV.

CV-N is a novel protein isolated from the cyanobacterium, Nostoc ellipsosporum (blue-green algae). Promising results of NIH research into the protein's use in preventing HIV included a primate model in which CV-N was shown to prevent transmission of simian-human immunodeficiency virus (SHIV), an HIV-like virus that infects monkeys. "CV-N is a member of an exciting new class of HIV drugs termed fusion inhibitors," stated Dr. Richard Bax, vice president and chief scientific officer of Biosyn. "By preventing HIV entry into and fusion with target cells, CV-N effectively inhibits the virus' mode of infection. As an intravaginal gel applied prior to intercourse, CV-N could help to avert the sexual transmission of HIV."

Under the NIH license, Biosyn receives exclusive, worldwide rights to the development and commercialization of CV-N as a microbicide, in exchange for certain milestone and royalty payments to be made to the NIH. "This agreement with NIH greatly expands our portfolio of products in the area of HIV and sexually transmitted disease, an area in which Biosyn commands a leadership position," stated Anne-Marie Corner, president and CEO of Biosyn. As announced in November 2002, the NIH awarded the company a $10 million grant for the development of CV-N as a microbicide. These funds support an ongoing development program for CV-N at Biosyn and will continue to be utilized to progress the drug into clinical trials.

Microbicides are a novel group of products that, with non-systemic application, have the potential to prevent the spread of sexually transmitted disease (STD) pathogens including HIV, chlamydia, herpes simplex virus, gonorrhea, etc. Microbicides can be produced in several forms including intravaginal gels, creams and delivery systems that release the active product over time.

Biosyn is a specialty pharmaceutical company focused on the development and commercialization of novel drugs in the areas of infectious disease and reproductive health. Biosyn's product portfolio offers significant competitive advantages in areas where there is a critical need for new or alternative therapies. The company is developing several products for the prevention of STDs including HIV, chlamydia, gonorrhea and genital herpes. Biosyn's lead product candidate, 1.0 percent C31G vaginal gel (Savvy) is entering Phase III clinical trials in 2003 for contraception and the prevention of transmission of STDs. In addition, Biosyn is developing products in other key market segments including oral infections associated with immune-suppression and skin and soft tissue infections (SSTIs).

Source: Biosyn, Inc.

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