TUSTIN, Calif., Oct. 20 /PRNewswire-FirstCall/ -- Peregrine Pharmaceuticals, Inc. , today announced that Avid Bioservices, Inc., Peregrine’s wholly-owned manufacturing subsidiary, has entered into an agreement to provide development services and clinical supply manufacturing of a therapeutic monoclonal antibody for a new international customer. Services specifically covered under the agreement may include technology transfer, process and test method development, and clinical supply manufacturing under current Good Manufacturing Practices (cGMP).
“This new contract for an antibody already in Phase II clinical studies gives us the opportunity to demonstrate our broad manufacturing capabilities,” said Steven King, president and CEO of Peregrine. “We intend to work with our new customer’s scientists to optimize and scale-up the bioproduction process, ensuring that the product meets regulatory requirements while also meeting our customer’s clinical trial timelines and objectives.”
Work on the project has been initiated and is expected to continue over the next nine to 12 months.
Based in Tustin, California, Avid maintains and operates a state-of-the-art current good manufacturing practice (cGMP) facility to produce monoclonal antibodies and recombinant proteins to diagnose and treat human diseases. The facility was expanded last year with the installation of a 1,000-liter mammalian cell culture bioreactor.
About Avid Bioservices, Inc.
Avid Bioservices is the wholly-owned manufacturing subsidiary of Peregrine Pharmaceuticals, Inc. Avid manufactures cGMP supplies for all phases of clinical trials and for commercial distribution for biotechnology and biopharmaceutical industries. The company’s comprehensive range of services includes:
* cGMP cell banking and cell bank storage * Media and culture optimization for production in stirred tanks * Purification development and scale-up * cGMP manufacturing utilizing 100L, 300L and 1000L bioreactors in batch, fed-batch, and perfusion capacities * Assay development, qualification and validation * Final product filling (including labeling and packaging services) * In-process Material and Final Container testing using in-house assays and qualified contractors * In-process Material and Final Container Stability programs * Process Validation * Regulatory strategy and support For more information about Avid, please visit www.avidbio.com. About Peregrine
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio of innovative product candidates in clinical trials for the treatment of cancer and viral diseases. The company is pursuing three separate clinical trials in cancer and anti-viral indications with its lead product candidates Tarvacin(TM) and Cotara(R). Peregrine also has in-house manufacturing capabilities through its wholly-owned subsidiary Avid Bioservices, Inc. (www.avidbio.com), which provides development and biomanufacturing services for both Peregrine and outside customers. Additional information about Peregrine can be found at www.peregrineinc.com.
Statements in this press release which are not purely historical, including statements regarding Peregrine Pharmaceutical’s 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, uncertainties associated with Avid Bioservices’ ability to attract new customers. It is important to note that the company’s actual results could differ materially from those in any such forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to, Avid Bioservices’ loss of current customers and inability to attract new customers. Our business could be affected by all of the foregoing and 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 April 30, 2005. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. Peregrine Pharmaceuticals, Inc. disclaims any obligation, and does not undertake, to update or revise any forward-looking statements in this press release.
Investors Media Barbara Lindheim Stephen Gendel GendeLLindheim BioCom Partners GendeLLindheim BioCom Partners (800) 987-8256 (212) 918-4650 ir@peregrineinc.com
Peregrine Pharmaceuticals, Inc.
CONTACT: investors, Barbara Lindheim, +1-800-987-8256,ir@peregrineinc.com, or media, Stephen Gendel, +1-2120918-4650, both ofGendeLLindheim BioCom Partners, for Peregrine Pharmaceuticals, Inc.
