Protein Sciences Announces Licensing of FluBlOk(TM) to UMN Pharma for the Japan Market

Aug 29, 2006, 01:00 ET from Protein Sciences Corporation

    MERIDEN, Conn., Aug. 29 /PRNewswire/ -- Protein Sciences Corporation
 (PSC) announced today that it signed an agreement with UMN Pharma Inc., an
 entrepreneurial Japanese company (UMN), licensing FluBlOk, PSC's patented
 recombinant influenza vaccine, for the Japan market. PSC will transfer
 technology to UMN which will be responsible for the registration,
 manufacture, marketing and sale of FluBlOk in Japan. Applications include
 annual and pandemic use of FluBlOk. After registration is achieved, UMN
 will buy commercial quantities of FluBlOk from PSC until a commercial
 manufacturing facility is available in Japan. The license terms include a
 multimillion dollar up front payment and double digit royalties.
     FluBlOk has received "accelerated approval" status from the United
 States Food and Drug Administration (FDA). PSC is completing the final
 requirements needed for licensure in preparation for filing a Biologics
 License Application with the FDA in early 2007.
     Daniel D. Adams, President and CEO of PSC, said, "We are delighted to
 be working with UMN, which represents exactly the kind of energetic,
 entrepreneurial company that we want to be our partner in bringing our
 novel influenza vaccine to market in various countries. We believe that UMN
 has the skill sets and innovative style needed to invigorate the Japanese
 vaccine market." He added, "We are discussing licensing arrangements with
 similar companies that we believe can be effective partners in other
 countries and groups of countries."
     Yasunari Kashihara, President and CEO of UMN, said, "We are excited
 about the opportunity to work with PSC on the development and
 commercialization of FluBlOk in Japan. This recombinant influenza vaccine
 will provide Japanese people with a new option for the prevention of
 influenza. UMN believes that PSC's excellent clinical data reflect a
 significant breakthrough in the development of both annual and pandemic
 influenza vaccines with great promise for the health of the Japanese
     Protein Sciences, a biotechnology company based in Meriden,
 Connecticut, USA, is utilizing recombinant DNA technology to develop and
 manufacture modern protein-based vaccines, diagnostics and therapeutics. A
 recently completed Phase II/III field trial of FluBlOk achieved 100%
 protection against both circulating and drifted strains of influenza and a
 more than 54% reduction in influenza-like illness (as defined by the U.S.
 Centers for Disease Control; CDC) compared to placebo. FluBlOk also has
 shown in clinical studies that it can induce protective antibody levels in
 humans against avian (potentially pandemic) influenza and that it provides
 100% protection of animals challenged with a lethal avian influenza virus.
 PSC has a broad portfolio of patented products in development including a
 second patented influenza vaccine, recombinant neuraminidase, that has
 completed Phase II(b) human clinical trials, a SARS vaccine that is
 scheduled to enter the clinic shortly, a novel adjuvant and several
 vaccines and therapeutics being developed with customers.
     UMN Pharma, a pharmaceutical company based in Akita, Japan, is
 dedicated to developing innovative disease preventives and therapeutics to
 satisfy unmet medical needs. UMN' leverages extensive pharmaceutical
 industry experience to generate time-efficient, focused development plans
 followed by rapid preclinical and clinical development to meet both
 Japanese and international regulatory specifications. In addition to its
 focus on vaccines, UMN has a diverse pipeline of novel small molecule and
 protein drug candidates targeted to cancer, diabetes and other major
 therapeutic markets. Four products, including FluBlOk are currently in
 preclinical development with the first clinical study scheduled for late
 2006. UMN anticipates that four products will be in the clinic within a
 two-year timeframe.

SOURCE Protein Sciences Corporation