Avid Bioservices Executive Explains How to Select the Right CMO to Achieve Biosimilar Success

TUSTIN, Calif. and ATLANTA, GA, May 19, 2009 -- Avid Bioservices, Inc., a leading provider of cGMP contract manufacturing of biologics and other key services, today announced that senior vice president Richard Richieri will give a presentation at the 2009 BIO International Convention highlighting the key role contract manufacturing organizations (CMOs) can play in achieving market exclusivity for biosimilar products.  In his talk, Mr. Richieri will describe the many important parameters developers of biosimilars must consider in selecting a CMO and provide specific guidance on how to evaluate their suitability.  The talk, “The Importance of CMO Partnership for Bio-Similar Production: Market Exclusivity,” will be presented at the GEN Theater, Booth #5807, May 20 at 4:30 pm EDT.

Under proposed federal legislation promoting the development of biosimilar versions of marketed protein drugs, manufacturing will play a critical role in determining whether and when biosimilar candidates will obtain regulatory approval.  Timing is particularly important since the proposed legislation awards a period of market exclusivity only to the first company to demonstrate product interchangeability with the marketed product. 

Mr. Richieri notes, “My talk will illustrate how an experienced, quality-focused CMO can be critical to achieving timely approval and will help biosimilar developers unravel the many factors they must assess to ensure their CMO partner helps maximize their chances for success.” 

Mr. Richieri will focus on how to evaluate critical CMO capabilities, including:

• Facility suitability and capability—does the CMO have experience with similar products?
• Is the requisite capacity in place and available?  Are there flexible options?
• What is the status of quality systems and in-house testing capabilities?
• How good are process and assay validation procedures and what is their record of success?
• Is there a robust regulatory and inspection history?
• Are personnel at all levels experienced?  What is the status of training requirements?
• Are there options throughout to ensure reasonable process and production costs?
• Does the corporate culture promote excellence and a collaborative spirit?

Mr. Richieri added, “Biosimilar developers should understand that CMO relationships can impact their success in fundamental ways.  It is therefore well worth the effort to become educated on how to optimize the selection of a CMO partner, and I look forward to sharing our insights as an innovative contract manufacturer and process developer with successful experience serving a growing roster of clients and products.”

A copy of Mr. Richieri’s presentation will be available on the Avid website beginning May 21, 2009 at www.avidbio.com.  Avid Bioservices is a wholly owned subsidiary of Peregrine Pharmaceuticals Inc. (Nasdaq: PPHM).

Avid is exhibiting at Booth #5801 and hosting an open reception on May 19 beginning at 5:00 pm EDT.

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.  The company has over 10 years of manufacturing experience producing monoclonal antibodies and recombinant proteins in batch, fed-batch and perfusion modes.  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 clinical programs in cancer and hepatitis C virus infection with its lead product candidates bavituximab and Cotara®.  Peregrine also has in-house manufacturing capabilities through its wholly owned subsidiary Avid Bioservices, Inc. that provides development and biomanufacturing services for both Peregrine and outside customers.  Additional information about Peregrine can be found at www.peregrineinc.com.