May 12 2011
Halozyme Therapeutics, Inc. (Nasdaq: HALO) and ViroPharma Incorporated (Nasdaq: VPHM), today announced the signing of a worldwide exclusive licensing agreement for the use of rHuPH20 (recombinant human hyaluronidase) in the development of a subcutaneous formulation of Cinryze (C1 esterase inhibitor [human]). Under terms of the agreement, Halozyme may receive up to $83 million, commencing with an upfront payment of $9 million and total potential future milestone payments of $74 million dependent upon the achievement of clinical and regulatory targets, plus a 10% royalty on future sales of the combination of Cinryze with rHuPH20. The license provides ViroPharma with exclusivity to C1 esterase inhibition and to the hereditary angioedema (HAE) indication, along with three additional orphan indications. ViroPharma will fund all development and commercialization expenses for the program. Additional terms of the transaction have not been disclosed.
Cinryze has received FDA approval for intravenous administration for routine prophylaxis against angioedema attacks in adolescent and adult patients with hereditary angioedema. A combination formulation of Cinryze with rHuPH20 for subcutaneous, or under the skin, administration is expected to enter clinical trials by the end of the year. The initial focus of the collaboration will be on the development of a novel subcutaneous formulation of Cinryze for routine prophylaxis against attacks of HAE.
"Halozyme's rHuPH20 enzyme may facilitate the subcutaneous administration and absorption of a broad range of pharmaceuticals and biologics, including plasma-derived proteins such as Cinryze," stated Gregory I. Frost, Ph.D., Halozyme's president and CEO. "The commercial success of Cinryze is notable, and we look forward to working with ViroPharma to simplify the self-administration of this important biologic that may ultimately provide a more convenient product for as many people as possible with HAE worldwide."
"This collaboration is consistent with our goals of continually providing innovative product enhancements, advancing long term solutions to meet the needs of our patients, and helping to maintain and build Cinryze brand loyalty for years to come," commented Colin Broom, M.D., ViroPharma's chief scientific officer. "The goal of our broad subcutaneous Cinryze program is to enable more patients with hereditary angioedema to benefit from access to convenient formulations of Cinryze to prevent their HAE attacks."
SOURCE Halozyme Therapeutics, Inc.