The International Council on Infertility Information Dissemination, Inc

Press Release: New Survey Reveals Most Patients Are Unaware That Slaughterhouse-Derived Animal Products Are Used in a Majority of IVF Procedures

ARLINGTON, Va., and SAN DIEGO, Oct. 26 /PRNewswire-FirstCall/ -- The International Council on Infertility Information Dissemination (INCIID) and Halozyme Therapeutics, Inc. (AMEX: HTI) , a biopharmaceutical company developing and commercializing recombinant human enzymes, today announced the results of a survey designed to determine in vitro fertilization (IVF) patients' level of awareness of lab practices surrounding intracytoplasmic sperm injection (ICSI) procedures on their eggs. While over 82 percent of the 168 survey respondents are generally aware that there are a number of procedures performed on their eggs after retrieval, only 8 percent are aware that many IVF clinics use slaughterhouse-derived animal extract products (from bovine and ovine sources) to treat eggs prior to the ICSI procedure. More than 89 percent of respondents do not know that the use of animal extract products may have a potential impact on the outcome of an IVF cycle, such as fertilization rates and quality of embryos, for example. Fifty-seven percent of IVF procedures performed in the U.S. are ICSI or include ICSI. The survey of 168 respondents was provided online to INCIID members over a two-month period.


"We were surprised by the lack of information or choice available to patients about IVF lab procedures," said Linda Davies INCIID Accounts Representative. "INCIID promotes the sharing of information about IVF and encourages patients to ask about alternative lab products that may impact their fertilization rates and resulting clinical outcome."


Halozyme recently announced the publication of clinical data in the May issue of Fertility & Sterility, the official journal of the American Society for Reproductive Medicine, showing increased fertilization rates in oocytes (eggs) that were treated with Cumulase(R) prior to IVF using the ICSI procedure. In the prospective, randomized, blinded, sibling oocyte clinical trial, the per-patient rate of fertilization following ICSI in mature eggs treated with Cumulase was 85.3% versus 70.0% for eggs treated with a traditional bovine-derived extract product, representing a 22% increase in fertilization rate (p<0.05). In addition, the data showed a trend toward higher quality embryos with Cumulase (43% of excellent quality) compared to the bovine-derived extract product (25%).


A subsequent, randomized, blinded, parallel group, multicenter trial is currently underway to further characterize the benefits of Cumulase, including an evaluation of longer-term clinical outcomes.


"Patients really do have a choice regarding what products are used on their eggs," said Jonathan Lim, MD, Halozyme's President and CEO. "INCIID's survey further demonstrates the importance of continuing to educate both patients and physicians about alternatives to animal-derived products in IVF cycles. Patients are generally unaware of the bovine or ovine nature of materials used in ICSI, but should be encouraged to ask their IVF specialists about the various options available to them. Cumulase provides an animal product free alternative for patients, and we believe that more physicians will seek to offer their patients this superior alternative. In addition to providing a safer, purer and more reliable alternative to slaughterhouse-derived enzymes, the published data show that the use of Cumulase also results in higher fertilization rates."


Additional survey results include:


  *  Over 85 percent of respondents were not offered a choice as to what
     products or media was used in their IVF cycle.

  *  60 percent of respondents believe or strongly believe that they should
     be given a choice between animal products versus a human recombinant
     product in their next IVF/ICSI cycle.

  *  Over 78 percent of respondents are comfortable or very comfortable
     suggesting product alternatives with their IVF specialists.


About Cumulase

Cumulase is an ex vivo formulation of rHuPH20 (recombinant human PH20 hyaluronidase), which may replace bovine and ovine extracts currently used for the preparation of oocytes prior to IVF during the process of ICSI. The enzyme is an essential component of ICSI and 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 European Union. 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 MediCult A/S and MidAtlantic Diagnostics, Inc. to distribute Cumulase worldwide.



The InterNational Council on Infertility Information Dissemination (INCIID -- pronounced "inside") is a nonprofit organization that helps individuals and couples explore their family-building options through information and educational programs < >. In late 2004 INCIID launched the first and only National IVF Scholarship program, From INCIID The Heart. INCIID, with sponsors OrganonUSA, Sher Institutes for Reproductive Medicine, and Baby Beat, continues to put treatment into the hands of consumers who need financial help to battle infertility.


About Halozyme Therapeutics, Inc.

Halozyme is a biopharmaceutical company developing and commercializing recombinant human enzymes for the drug delivery, palliative care, oncology, and infertility markets. The company's portfolio of products 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 extracts that carry potential risks of animal pathogen transmission and immunogenicity. The company has received FDA approval for two products: Cumulase(R), the first and only recombinant human hyaluronidase for cumulus removal in the IVF process; and Hylenex for use as an adjuvant to increase the absorption and dispersion of other injected drugs. The versatility of the first enzyme, rHuPH20, enables Halozyme to develop the product as a medical device, drug enhancement agent, and therapeutic drug. For more information visit the Company's website at


Safe Harbor Statement

In addition to historical information, the statements set forth above include forward-looking statements (including, without limitation, statements concerning pre-clinical data, clinical data, the potential effectiveness of products under development, the timing and nature of clinical trials for products under development, and the demand and potential market for these products, if approved by the FDA) 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 "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "possible," "should," "continue," and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including regulatory approval requirements and competitive conditions. These and other factors that may result in differences are discussed in greater detail in the company's reports on Forms 10-KSB, 10-QSB and other filings with the Securities and Exchange Commission.


Halozyme Contact                  
David A. Ramsay                   
Chief Financial Officer           
(858) 794-8889                         

Media Contacts 

Megan Swanland Riggs/ Joleen Schultz


(858) 455-5500, x200/ x215                              


INCIID Contact
Linda Davies
(703) 379-9178
Contact INCIID



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