- Avid Bioservices Is Manufacturing the Active Ingredients for Hylenex™, Now Approved for Marketing by the FDA -

TUSTIN, Calif., Dec. 6 /PRNewswire-FirstCall/ -- Avid Bioservices, Inc., the wholly owned manufacturing subsidiary of Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM), became a commercial stage manufacturing organization as FDA approval was announced for commercial distribution of a recombinant human enzyme Avid is manufacturing for Halozyme Therapeutics. Avid produces the active pharmaceutical ingredients (API) for the drug Hylenex™. The API produced by Avid will be further processed by Baxter Healthcare for final commercial distribution.

"This is a major milestone for Avid Bioservices, as we demonstrate our ability to move beyond clinical stage manufacturing into commercial production," said Steven W. King, chief executive officer of Avid. "This contract with Halozyme is an excellent example of the resources and potential Avid has to support companies during the inspection and approval processes. Having now added the capability for commercial stage production greatly enhances the opportunities available to both our partners and to Peregrine."

Avid maintains and operates a state-of-the-art cGMP manufacturing facility to produce monoclonal antibodies and recombinant proteins to diagnose and treat human diseases. The Tustin, California, manufacturing facility was expanded last year with the installation of a 1,000-liter mammalian cell culture bioreactor.

"The FDA's pre-approval inspection (PAI) is an important part of the drug approval process, and Avid has done a great job ensuring that their manufacturing processes and quality systems meet the standards for current good manufacturing practices (cGMP)," said Jonathan Lim, M.D., Halozyme's chairman and CEO. "Avid is a strong partner and we appreciate the relationship we have with them."

About Avid Bioservices

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™ and Cotara®. Peregrine also has in-house manufacturing capabilities through its wholly-owned subsidiary Avid Bioservices, Inc. (www.avidbio.com), which provides development and bio-manufacturing services for both Peregrine and outside customers. Additional information about Peregrine can be found at www.peregrineinc.com.

SOURCE Peregrine Pharmaceuticals, Inc.



CONTACT: Investors, Betsy Brod, or Jonathan Schaffer, both of Brod&Schaeffer, +1-800-987-8256, ir@peregrineinc.com; or Media, Stephen Gendel of GendeLLindheim BioCom Partners, +1-212-918-4650, all for Peregrine Pharmaceuticals, Inc.
/Web site: http://www.peregrineinc.com
http://www.avidbio.com