Protein Sciences Announces Termination of Deal to Sell to Emergent BioSolutions
- PSC terminates sale due to Emergent's breaches
- PSC BLA for FluBlok remains on track with the FDA
- PSC awaiting decision on BARDA contract award
MERIDEN, Conn., July 29 /PRNewswire/ -- Protein Sciences Corporation
("PSC") announced today that the sale of its business under an Asset
Purchase Agreement between PSC and Emergent BioSolutions, Inc. (NYSE: EBS)
and its affiliate (collectively "Emergent") has been terminated by PSC due
to breaches by Emergent. PSC cited multiple breaches by Emergent including
disclosure and mischaracterization of PSC's material confidential
information obtained from PSC during due diligence and Emergent's failure
to fulfill its obligation to provide adequate funding to PSC.
Daniel D. Adams, President and CEO, said, "Emergent's blatant disregard
for its contractual commitments is shocking. They continue to try to damage
PSC with inappropriate and unauthorized contact to our customers and
collaborators and appear to have launched an effort to disrupt the approval
process for our BLA for FluBlok(R). Fortunately, we have loyal customers,
collaborators and shareholders that remain very supportive of PSC and our
management team."
In other developments, PSC announced that the FDA's inspection of PSC's
facility and operations in connection with its Biologics License
Application (BLA) for FluBlok was completed in mid-July. Manon Cox, PSC's
Chief Operating Officer, noted, "We were well prepared for the FDA
inspection of our manufacturing facility and are satisfied with the nature
of the preliminary comments that we received from the FDA. We remain on
track for a decision on our BLA by mid-October, 2008 under the FDA's
accelerated approval pathway." PSC also announced that it reached an
important milestone related to FluBlok when it successfully produced the
vaccine necessary to combat each of the three strains that will make up the
influenza vaccine for the 2008-2009 flu season.
PSC also announced that it submitted a proposal for federal funding for
a contract to develop recombinant seasonal and pandemic influenza vaccines
from the Department of Health and Human Services (BARDA). Negotiations over
the contract have been ongoing and a decision may be reached by BARDA
within the next few weeks. PSC has requested funding for, among other
things, additional clinical trials to support pediatric and pandemic
formulations of FluBlok; purchase of equipment for large scale
manufacturing; and process and manufacturing facility validation as
specified in the Request for Proposal issued by BARDA in 2007. If the
contract is awarded, PSC expects that the work and funding will be spread
over a five-year period.
About PSC. PSC is a privately held biotechnology company that uses
proprietary recombinant DNA technology to manufacture human and animal
vaccines, therapeutics and diagnostics. Our lead product is a human
seasonal flu vaccine -- FluBlok(R). Our underlying technology is a viable
alternative production platform to the egg-based production methods that
currently dominate 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
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