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Daniel D. Adams, President and CEO, said, "Emergent's blatant disregardfor its contractual commitments is shocking. They continue to try to damagePSC with inappropriate and unauthorized contact to our customers andcollaborators and appear to have launched an effort to disrupt the approvalprocess for our BLA for FluBlok(R). Fortunately, we have loyal customers,collaborators and shareholders that remain very supportive of PSC and ourmanagement team."
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In other developments, PSC announced that the FDA's inspection of PSC'sfacility and operations in connection with its Biologics License Application(BLA) for FluBlok was completed in mid-July. Manon Cox, PSC's Chief OperatingOfficer, noted, "We were well prepared for the FDA inspection of ourmanufacturing facility and are satisfied with the nature of the preliminarycomments that we received from the FDA. We remain on track for a decision onour BLA by mid-October, 2008 under the FDA's accelerated approval pathway."PSC also announced that it reached an important milestone related to FluBlokwhen it successfully produced the vaccine necessary to combat each of thethree strains that will make up the influenza vaccine for the 2008-2009 fluseason.
PSC also announced that it submitted a proposal for federal funding for acontract to develop recombinant seasonal and pandemic influenza vaccines fromthe Department of Health and Human Services (BARDA). Negotiations over thecontract have been ongoing and a decision may be reached by BARDA within thenext few weeks. PSC has requested funding for, among other things, additionalclinical trials to support pediatric and pandemic formulations of FluBlok;purchase of equipment for large scale manufacturing; and process andmanufacturing facility validation as specified in the Request for Proposalissued by BARDA in 2007. If the contract is awarded, PSC expects that thework and funding will be spread over a five-year period.
About PSC. PSC is a privately held biotechnology company that usesproprietary recombinant DNA technology to manufacture human and animalvaccines, therapeutics and diagnostics. Our lead product is a human seasonalflu vaccine -- FluBlok(R). Our underlying technology is a viable alternativeproduction platform to the egg-based production methods that currentlydominate vaccine production and our 2007 revenues were in excess of$6,000,000, primarily from our GeneXpress and research antigen business.
SOURCE Protein Sciences Corporation
