SAN DIEGO, April 12 /PRNewswire-FirstCall/ -- Halozyme Therapeutics, Inc. (BULLETIN BOARD: HZYM) , a therapeutically driven biopharmaceutical company focused on the development and commercialization of recombinant human enzymes, today announced it has signed a manufacturing agreement with Avid Bioservices, Inc., a wholly-owned subsidiary of Peregrine Pharmaceuticals, Inc. . Avid will manufacture under cGMP Halozyme’s first recombinant human enzyme, which will be used in the development of Cumulase(TM) and Enhanze SC(TM), Halozyme’s first two product candidates. Cumulase(TM) and Enhanze SC(TM) will offer synthetic alternatives to impure slaughterhouse-derived enzymes currently used in the infertility and ophthalmology markets.
“We are pleased to contract with Avid for production of our first enzyme,” said Jonathan Lim, M.D., Halozyme’s Chairman and CEO. “Avid will handle the complete process from cell bank production to delivery of cGMP-manufactured bulk material. We are now well positioned to rapidly advance our near-term products to the market.”
Halozyme’s recombinant human enzyme technology replaces current animal slaughterhouse-derived enzymes that carry risks of animal pathogen contamination and immunogenicity. The versatility of the first enzyme, rHuPH20, will enable Halozyme to simultaneously market the product as a medical device, drug enhancement agent, and therapeutic biologic.
“We are pleased with the confidence Halozyme has shown in Avid by selecting us, and we look forward to the scale-up and manufacturing of this important product,” added Jay Treat, Ph.D., Avid’s Chief Operations Officer.
About Avid Bioservices, Inc.
Avid Bioservices provides a full range of cGMP manufacturing services for the biotechnology and biopharmaceutical industries. Avid operates a state-of-the-art cGMP biologics contract manufacturing facility and production laboratories in Tustin, California. The company’s comprehensive package of services includes mammalian cell culture, process development, analytical method development and regulatory support in addition to cGMP manufacturing, purification and bulk packaging. Avid has 10 years of antibody manufacturing experience producing monoclonal antibodies to support clinical trials ranging from Phase I to Phase III. Avid personnel have experience manufacturing monoclonal antibodies and recombinant proteins in batch, fed-batch and perfusion modes. For more information about Avid, please visit http://www.avidbio.com/. Information on Peregrine Pharmaceuticals, Inc. may be found at http://www.peregrineinc.com/.
About Halozyme Therapeutics, Inc.
Halozyme is a therapeutically driven biopharmaceutical company dedicated to the development and commercialization of recombinant human enzymes for the infertility, ophthalmology, and oncology communities. The company’s broad product portfolio is based on intellectual property covering the family of human enzymes known as hyaluronidases. The company’s lead products offer a safe and pure alternative to existing slaughterhouse-derived extracts that carry risks of animal pathogen contamination and immunogenicity. The commercialization of Halozyme’s highly versatile enzyme technology within proven markets will enable the company to significantly impact the quality of medicine.
Safe Harbor Statement
In addition to historical information, the statements set forth above include forward-looking statements (including, without limitation, statements concerning the marketing and distribution methods Halozyme intends to employ with respect to its first enzyme) that involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are also identified through use of the words “believes,” “enable,” and other words of similar meaning. Factors that may result in differences are discussed in greater detail in Halozyme Therapeutics’ Annual Report on Form 10-K and other filings with the Securities and Exchange Commission.
Halozyme Therapeutics, Inc.
CONTACT: David A. Ramsay, Chief Financial Officer of Halozyme,+1-858-794-8889, dramsay@hyalozyme.com; or Investor Relations, Ina McGuinness,imcguinness@lhai.com, or Bruce Voss, both of Lippert/Heilshorn & Associates,+1-310-691-7100, for Halozyme; or Media Inquiries, Kathy Sweeney, ext. 212,kwitz@mentus.com, or Megan Riggs, ext. 215, megan@mentus.com, both of Mentus,+1-858-455-5500, for Halozyme
Web site: http://www.hyalozyme.com/
Web site: http://www.avidbio.com/
