SAN DIEGO, Dec. 8 /PRNewswire-FirstCall/ -- Halozyme Therapeutics, Inc. , a biopharmaceutical company developing and commercializing products targeting the extracellular matrix, today announced that Roche has dosed the first patient in a Phase 1 pharmacokinetic clinical trial with a subcutaneous formulation using Enhanze Technology of a biologic directed to a Roche exclusive target. This has triggered a milestone payment under the agreement.
Roche has also selected an additional exclusive target under the existing license and collaboration agreement. Under the terms of the agreement, Roche will pay Halozyme for exclusive, global rights for the application of its hyaluronidase enzyme, rHuPH20, to a fourth biologic target selected by Roche.
“Roche and Halozyme have successfully completed the necessary drug product formulation and preclinical studies required to initiate a clinical trial. Entering the clinic is a significant achievement and demonstrates Roche’s strong commitment to a successful partnership,” said Jonathan Lim, M.D., Halozyme’s President and CEO. “We are very pleased with the progress that is being made through our collaboration. Roche is a global leader in the development of biologics and we are excited that they have selected a fourth exclusive target, in addition to the three already under development, further validating Halozyme’s core technology.”
Roche has also maintained its rights to other targets covered in the license and collaboration agreement. An aggregate payment of $10.25 million will be made to Halozyme for commencing a Phase 1 clinical trial, exercising exclusive global rights to a fourth biologic target and for annual maintenance fees.
Halozyme also announced that it has entered into a supply agreement with Roche to provide rHuPH20 for use in formulations with biologics directed against Roche targets covered under the licensing and collaboration agreement. Halozyme continues to scale up its manufacturing processes to enhance yields and efficiencies in order to produce multi-kilogram quantities of enzyme. As specified in the agreement, Halozyme will supply rHuPH20 to Roche to fulfill all of its clinical development and commercialization requirements.
Halozyme Roche Collaboration
In December 2006, Halozyme entered into an agreement with Roche to apply Halozyme’s proprietary Enhanze(TM) Technology to Roche’s biological therapeutic compounds. Under the terms of the agreement, Roche paid Halozyme an initial payment for the application of its recombinant human enzyme, rHuPH20, to three pre-defined Roche biologic targets. Roche has now selected a fourth biologic target and has the option to exclusively develop and commercialize rHuPH20 with an additional nine targets. Pending the successful achievement of a series of clinical, regulatory, and sales events, Roche may pay Halozyme additional milestones as well as royalties on potential future product sales. Under the collaboration, Roche has access to Halozyme’s expertise in developing and applying rHuPH20 to Roche targets. Roche obtained a worldwide, exclusive license to develop and commercialize product combinations of rHuPH20 and Roche target compounds resulting from the collaboration.
About Halozyme Therapeutics, Inc.
Halozyme is a biopharmaceutical company developing and commercializing products targeting the extracellular matrix for the endocrinology, oncology, dermatology and drug delivery markets. The company’s portfolio of products and product candidates is based on intellectual property covering the family of human enzymes known as hyaluronidases. The company’s Enhanze(TM) Technology is a novel drug delivery platform designed to increase the absorption and dispersion of biologics. Its key partnerships are with Roche to apply Enhanze Technology to Roche’s biological therapeutic compounds for up to 13 targets and with Baxter to apply Enhanze Technology to Baxter’s biological therapeutic product, GAMMAGARD LIQUID 10%. In addition, the company has received FDA approval for two products: Cumulase(R), for use in in-vitro fertilization, and HYLENEX, for use as an adjuvant to increase the absorption and dispersion of other injected drugs and fluids. HYLENEX is partnered with Baxter International Inc. Halozyme also has a number of different enzymes in its portfolio that target significant areas of unmet medical need. For more information visit http://www.halozyme.com.
Safe Harbor Statement
In addition to historical information, the statements set forth above include forward-looking statements (including, without limitation, statements concerning Roche’s progress under the collaboration) 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-K, 10-Q, and other filings with the Securities and Exchange Commission.
CONTACT: Robert H. Uhl, Senior Director, Investor Relations of Halozyme
Therapeutics, Inc., +1-858-704-8264, ruhl@halozyme.com; or Karen Sparks,
+1-858-455-5500, ext. 275, karen@mentus.com, or Joleen Schultz,
+1-858-455-5500, ext. 215, jschultz@mentus.com, both of Mentus for Halozyme
Therapeutics, Inc.
Web site: http://www.halozyme.com/
