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November 27, 2001
Protein Sciences Announces Availability Of Two Patented Late Stage Influenza Vaccines
Meriden, CT, November 27, 2001 - Protein Sciences Corporation (PSC) announced today that it has reacquired all rights to two patented, late stage influenza vaccines. The vaccines are:
- Recombinant hemagglutinin (rHA) that potentially can be used as a replacement for the current egg-based influenza vaccines. rHA has completed several Phase II human clinical trials conducted by the National Institutes of Allergy and Infectious Diseases (NIAID) and academic institutions involving over 600 patients that demonstrated safety and efficacy as reported in four published studies in the Journal of Infectious Diseases. The initial target market is the elderly where the licensed vaccine is less effective than in other populations. Clinical trials of rHA have shown efficacy in the elderly population.
- Recombinant neuraminidase (rNA) that has potential for use as an efficacy-enhancing additive to influenza vaccines. rNA completed Phase II(b) clinical trials conducted by the NIAID. Clinical data demonstrated safety and, when combined with the current vaccine, a significant increase in the level of antibodies and, for vaccinated people who become ill, less viral shedding and shorter duration of illness compared to the licensed vaccine alone.
Both products are covered by issued patents in the United States and foreign counterparts. The United States Food and Drug Administration approved for compassionate use an rHA vaccine that PSC developed and manufactured to vaccinate health care workers and researchers against a potentially pandemic strain of influenza that circulated in Hong Kong in 1997.
Manon Cox, PSC's Vice President, Corporate and Process Development, commented, "We are delighted with this development. These vaccines had been licensed exclusively to Aventis Pasteur. Over the past years, several companies expressed interest in licensing these products and we are now able to actively pursue their full potential either alone or with a partner." She added, "We believe that these products are eligible for substantial Government funding. NIAID has traditionally funded clinical trials of new influenza vaccines and could fund the cost of producing clinical materials under a contract we recently signed that provides for up to $76 million of funding for production of new vaccines for infectious diseases."
rHA and rNA have also demonstrated safety and efficacy in extensive trials in chickens, swine, horses and companion animals. The rights for veterinary uses have not been licensed.
Founded in 1983, Protein Sciences Corporation (www.proteinsciences.com) is the world leader in developing genes encoding for proteins into commercial human and veterinary vaccines, therapeutics and diagnostics using its proprietary baculovirus expression vector system (BEVS) technology that includes its patented expresSF+® serum free, high yielding, scalable insect cell line. Customers access PSC's proprietary BEVS technology through its GeneXpress® program. This allows them to obtain cGMP human and animal clinical materials more reliably, rapidly and less expensively than through alternative protein expression systems.
