Monday, October 27, 2008 8:32:13 AM
“Avid Bioservices to Serve as Contract Manufacturer for Catalyst Biosciences' Novel Human Coagulation Factor Clinical Candidate”
http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=343156
TUSTIN, Oct. 27 2008: Avid Bioservices, Inc. today announced it has signed a manufacturing supply agreement with Catalyst Biosciences, Inc. to produce clinical-grade material in support of their clinical candidate, CB 813, an improved version of factor VIIa for the treatment of acute bleeding in hemophilia patients.
[ http://www.catalystbiosciences.com ]
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 Steven W. King, president of Avid. "We are delighted to be working with the talented Catalyst Biosciences team and their promising engineered protease technology. We view this agreement as further recognition of Avid's proven ability to produce clinical and commercial grade drug product."
"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 Nassim Usman, Ph.D., CEO of Catalyst Biosciences.
Avid Bioservices is a wholly owned subsidiary of Peregrine Pharmaceuticals Inc. (Nasdaq: PPHM - News).
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® production system [ http://tinyurl.com/4geqxw ]. For more information about Avid, visit http://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 3 separate Phase II clinical programs in cancer and hepatitis C virus (HCV) infection with its lead product candidates bavituximab and Cotara®. 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 http://www.peregrineinc.com.
Safe Harbor *snip*
CONTACTS:
• Avid Bioservices: Candice Fliedner, 714-508-6188
• Media: Barbara Lindheim, GendeLLindheim BioCom Partners, 212-918-4650
= = = = = = =
AVID BIOSERVICES, Inc. (Peregrine's Mfg. Subsidiary): http://www.avidbio.com
10-27-08: Avid is CMO for Catalyst Biosciences’ CB813 protease candidate. http://tinyurl.com/5fg7zg
6-25-08: Avid Selected as 1st U.S. CMO for DSM/Crucell’s PER.C6 Cell Line http://tinyurl.com/4geqxw
…9-30-08 Crucell gets $40mm NIAID/BARDA award for Ebola-Marburg Vaccine: http://tinyurl.com/4wc2of
8-8-08: Avid is Halozyme's 'Sole Contract Mfg'er' for ENHANZE: http://tinyurl.com/5nnbfp
...8-21-08 Cook Pharmica chosen as HALO's 2nd CMO: http://tinyurl.com/5hdk2l
7-14-08: Avid is CMO for Arius Research’s lead drug, “AR001 Targeting CD44”: http://tinyurl.com/6hrwrt
...7-23-08 Roche buys Arius for $190mm : http://tinyurl.com/5fg6jd
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