Healthcare Industry News:  hyaluronidase 

Biopharmaceuticals FDA

 News Release - May 23, 2006

Halozyme Therapeutics Announces FDA 510(k) Clearance for MediCult's SynVitro Cumulase Product

SAN DIEGO, May 23 (HSMN NewsFeed) -- Halozyme Therapeutics, Inc. (Amex: HTI ), a biopharmaceutical company developing and commercializing recombinant human enzymes, today announced that its worldwide distribution partner, MediCult A/S, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for SynVitroŽ CumulaseŽ for the treatment of oocytes to facilitate certain in vitro fertilization (IVF) procedures. The media-formulated SynVitro Cumulase product contains the active pharmaceutical ingredient found in CumulaseŽ-10X, the first and only recombinant human hyaluronidase approved in the United States for cumulus removal in the IVF process.

"We are thrilled that our distribution partner MediCult has received FDA 510(k) clearance to market SynVitro Cumulase in the U.S.," said Jonathan Lim, MD, Halozyme's President and CEO. "This achievement is another key milestone for our company and provides further validation of our technology and our team's ability to develop and commercialize products based on recombinant human hyaluronidase, whether by ourselves or through our partners."

SynVitro Cumulase is a formulation of rHuPH20 (recombinant human PH20 hyaluronidase) prepared in MediCult's proprietary SynVitro media, and is ready to use in ex vivo IVF procedures. This product may replace bovine and ovine extracts currently used for the preparation of oocytes prior to IVF during the process of intracytoplasmic sperm injection (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. SynVitro Cumulase provides the IVF specialist with yet another 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-10X 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 10X product in the U.S. Together, Cumulase-10X and SynVitro Cumulase are the first and only recombinant human hyaluronidase products approved for cumulus removal in the IVF process.

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: CumulaseŽ, 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.

Safe Harbor Statement

In addition to historical information, the statements set forth above include forward-looking statements (including, without limitation, statements concerning the potential effectiveness of commercial products and the demand and potential market for these products) 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-Q and other filings with the Securities and Exchange Commission.


Source: Halozyme Therapeutics

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