New deal may include up to 20 cGMP runs per year.

Avid Bioservices extended its commercial manufacturing supply agreement with Halozyme Therapeutics related to two of Halozyme’s marketed products. Under the terms of the contract amendment, Avid could manufacture up to 20 runs per year over the next five years of a recombinant human enzyme that is the active ingredient in Hylenex™ and Cumulase®.

Hylenex recombinant (hyaluronidase human injection) is indicated for use as an adjuvant agent to increase the absorption and dispersion of other injected drugs, for hypodermoclysis. It is also used as an adjunct in subcutaneous urography for improving resorption of radiopaque agents. Cumulase™ is an ex vivo formulation of rHuPH20 to replace the bovine enzyme currently used for the preparation of oocytes prior to in vitro fertilization during the process of intracytoplasmic sperm injection, in which the enzyme is an essential component.

Previous articleLCT Approved to Manufacture Xeno Products for Human Use
Next articleWyeth’s Renal Cell Carcinoma Drug Gets NDA Priority Review Status