Halozyme's partner granted FDA clearance for in vitro fertilization enzyme, SynVitro Cumulase

By Lisa Kerner

Erie, Pa., May 23 - Halozyme Therapeutics, Inc.'s worldwide distribution partner, MediCult A/S, has received 510(k) clearance from the Food and Drug Administration for SynVitro Cumulase for the treatment of oocytes to facilitate certain in vitro fertilization (IVF) procedures.

SynVitro Cumulase contains the active pharmaceutical ingredient found in Cumulase-10X, the only recombinant human hyaluronidase approved in the United States for cumulus removal in the IVF process, according to a company news release.

"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," president and chief executive officer Jonathan Lim said in the release.

SynVitro Cumulase, a formulation of recombinant human PH20 hyaluronidase prepared in MediCult's proprietary SynVitro media, may replace bovine and ovine extracts currently used for the preparation of oocytes.

The enzyme removes the hyaluronic acid surrounding the oocyte, an essential component during the process of intracytoplasmic sperm injection.

San Diego-based Halozyme develops and commercializes recombinant human enzymes for the drug delivery, palliative care, oncology and infertility markets.

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