HALOZYME THERAPEUTICS INCREASED FERTILIZATION WITH CUMULASE

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COPENHAGEN, DENMARK, June 22, 2005 -Halozyme Therapeutics, Inc. (AMEX: HTI), a development stage biopharmaceutical company focused on the development and commercialization of recombinant human enzymes, and Reproductive Biology Associates, one of the leading IVF centers in the U.S., announced today results from clinical trials showing increased fertilization rates in oocytes (eggs) that were treated with Cumulase™ prior to in vitro fertilization (IVF) using the intracytoplasmic sperm injection (ICSI) procedure.  The data were presented today by Z. Peter Nagy, M.D., Ph.D., Scientific and Laboratory Director of Reproductive Biology Associates in Atlanta, Georgia, at the 21st Annual Meeting of the European Society of Human Reproduction & Embryology (ESHRE) in Copenhagen.

 

Dr. Nagy presented clinical studies comparing Cumulase to a currently used slaughterhouse-derived hyaluronidase extract in the preparation of human oocytes prior to the ICSI procedure.  The study, conducted by Dr. Nagy at Reproductive Biology Associates, revealed that Cumulase treated oocytes demonstrated significantly increased fertilization rates over oocytes exposed to the standard bovine-derived hyaluronidase extract. The study involved 26 patients and 402 oocytes. The rate of fertilization following ICSI in eggs treated with Cumulase was 81.4 percent (162 fertilized eggs out of 199) vs. 71.9 percent (146 fertilized eggs out of 203) in eggs treated with the traditional bovine-derived extract, a 13 percent increase in fertilization rate.  The range of average ICSI fertility rates in U.S. fertility clinics is currently 70 to 75 percent.

 

"These data are extremely encouraging," said Dr. Nagy.  "In addition to the higher fertility rates, we found better embryo quality for transfer following treatment with Cumulase compared to the bovine-derived hyaluronidase extracts.  Increased fertilization rates along with the better quality embryos for transfer are significant findings for the IVF community." 

 

"We are very excited about the data," said Jonathan Lim, MD, Halozyme's Chairman and CEO. "In addition to providing a safer, purer and more reliable alternative to slaughterhouse-derived enzymes, the data show that the use of Cumulase may also result in higher fertility rates compared to the standard of care.  Patients are generally unaware of the use of bovine or ovine materials used in ICSI and we believe that Cumulase provides them, in addition to IVF professionals, with an attractive alternative." 

 

Cumulase is an ex vivo formulation of rHuPH20 (recombinant human PH20 hyaluronidase) that may replace bovine and ovine extracts currently used for the preparation of oocytes prior to IVF during the process of ICSI, in which the enzyme is an essential component.  The enzyme removes the hyaluronic acid that surrounds the oocyte, allowing the clinician to then perform ICSI, injecting the sperm into the oocyte.  Cumulase provides the IVF specialist with a safer, purer and more effective alternative to slaughterhouse-derived extracts. 

 

The total Cumulase market consists of an estimated 500,000 ICSI cycles worldwide in 2005, with nearly 90,000 of those performed in the U.S. Halozyme received CE Mark approval of Cumulase in December 2004 to market the product throughout the E.U.   In April 2005, Halozyme received 510(k) clearance from the FDA to market the product in the U.S.  Cumulase is the first and only recombinant human hyaluronidase product approved for cumulus removal in the IVF process.  The company has signed agreements with Cook Ob/Gyn Incorporated, MediCult A/S, and MidAtlantic Diagnostics, Inc., to distribute Cumulase worldwide. 

 

About Reproductive Biology Associates
Reproductive Biology Associates (RBA) (www.rba-online.com), established in 1982, provides emerging reproductive technology to patients who had not achieved pregnancy through conventional diagnostic and therapeutic measures.  From its inception, RBA has been a leader in the development and refinement of clinical procedures and scientific techniques, which enhance pregnancy outcomes.  RBA was the first IVF program in the world to report a baby born with the aid of a micromanipulation technique known as partial zona dissection or PZD in 1988.  In 1993, RBA became the first center in the U.S. to achieve a pregnancy and birth through intracytoplasmic sperm injection (ICSI).  Subsequently, RBA was one of the first IVF centers in the U.S. to report success with sperm retrieved through testicular sperm aspiration.  RBA was the third IVF program in the United States to achieve a pregnancy from a frozen embryo, and in 1997, was the first clinic in the Western Hemisphere to achieve a birth through oocyte cryopreservation.  In 2004, RBA developed a new process for Intrauterine Insemination utilizing Platelet Activating Factor (PAF).
 
RBA has been featured in the media extensively worldwide, including:  Time, People, Newsweek, U.S. News & World Report, The Wall Street Journal, The New York Times, Dateline NBC, 20/20, Good Morning America, The Today Show, CNN, BBC and hundreds of other print and broadcast outlets.

 

About Halozyme Therapeutics, Inc.
Halozyme is a development stage biopharmaceutical company dedicated to developing and commercializing recombinant human enzymes for the infertility, ophthalmology, and oncology communities. The company's portfolio of products under development is based on intellectual property covering the family of human enzymes known as hyaluronidases. Halozyme's recombinant human enzymes may replace current animal slaughterhouse-derived enzymes that carry potential risks of animal pathogen transmission and immunogenicity. The versatility of the first enzyme, rHuPH20, enables Halozyme to develop the product as a medical device, drug enhancement agent, and therapeutic biologic.

 

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