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From the Wires
Avid Bioservices to Serve as Contract Manufacturer for Catalyst Biosciences' Novel Human Coagulation Factor Clinical Candidate
By: PR Newswire
Oct. 27, 2008 08:01 AM
Under the terms of the agreement, Avid Bioservices will begin manufacturing drug supply under current good manufacturing practice (cGMP) regulations and provide cell bank preparation, process development, and preparation of the manufacturing portion of the FDA Investigational New Drug Application. Further terms of the agreement were not disclosed. "This agreement with Catalyst Biosciences for their lead clinical
candidate is the most recent example of the traction we are gaining as a
trusted provider of cGMP manufacturing services, as well as our broad
capabilities as a provider of valuable ancillary services," said "Avid's expertise in the scale-up and manufacture of clinical-grade
biotechnology therapeutics and their strong customer orientation made them a
good choice for Catalyst," said Avid Bioservices is a wholly owned subsidiary of Peregrine Pharmaceuticals Inc. (Nasdaq: PPHM). About Avid Bioservices Avid Bioservices provides a comprehensive range of cGMP manufacturing services for the biotechnology and biopharmaceutical industries. Avid manufactures cGMP commercial product, as well as clinical supplies for all phases of clinical trials. The company's comprehensive range of cGMP services includes cell banking, stability testing, clinical product manufacturing and purification, bulk packaging, final product filling and regulatory support. Avid also provides a variety of process development activities, including cell line optimization, analytical method development and product characterization. Avid has over 10 years of antibody manufacturing experience producing monoclonal antibodies and recombinant proteins in batch, fed-batch and perfusion modes. Avid was recently named the first pre-approved U.S. contract manufacturer of the DSM/Crucell PERC.C6(R) production system. For more information about Avid, visit www.avidbio.com. About Peregrine Pharmaceuticals Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio of innovative monoclonal antibodies in clinical trials for the treatment of cancer and serious viral infections. The company is pursuing three separate Phase II clinical programs in cancer and hepatitis C virus (HCV) infection with its lead product candidates bavituximab and Cotara(R). Peregrine also has in-house manufacturing capabilities through its wholly owned subsidiary Avid Bioservices, Inc., which provides development and bio-manufacturing services for both Peregrine and outside customers. Additional information about Peregrine can be found at www.peregrineinc.com. Safe Harbor Statement: Statements in this press release which are not
purely historical, including statements regarding Peregrine Pharmaceuticals'
intentions, hopes, beliefs, expectations, representations, projections, plans
or predictions of the future are forward-looking statements within the meaning
of the Private Securities Litigation Reform Act of 1995. The forward-looking
statements involve risks and uncertainties including, but not limited to, the
risk that Avid is unable to procure sufficient materials to process all runs
requested by Catalyst, or that Catalyst terminates the agreement prior to its
expiration because it decides to end the program or because Avid is unable to
fulfill it's drug delivery obligations. Our business could be affected by a
number of other factors, including the risk factors listed from time to time
in the Company's SEC reports including, but not limited to, the annual report
on Form 10-K for the year ended
Contacts:
Avid Bioservices Media
Candice Fliedner GendeLLindheim BioCom Partners
(714) 508-6188 Barbara Lindheim
(212) 918-4650
SOURCE Peregrine Pharmaceuticals, Inc.
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