SAN DIEGO, Dec. 8 Halozyme Therapeutics, Inc.(Nasdaq: HALO), a biopharmaceutical company developing and commercializingproducts targeting the extracellular matrix, today announced that Roche hasdosed the first patient in a Phase 1 pharmacokinetic clinical trial with asubcutaneous formulation using Enhanze Technology of a biologic directed to aRoche exclusive target. This has triggered a milestone payment under theagreement.
Roche has also selected an additional exclusive target under the existinglicense and collaboration agreement. Under the terms of the agreement, Rochewill pay Halozyme for exclusive, global rights for the application of itshyaluronidase enzyme, rHuPH20, to a fourth biologic target selected by Roche.
"Roche and Halozyme have successfully completed the necessary drug productformulation and preclinical studies required to initiate a clinical trial.Entering the clinic is a significant achievement and demonstrates Roche'sstrong commitment to a successful partnership," said Jonathan Lim, M.D.,Halozyme's President and CEO. "We are very pleased with the progress that isbeing made through our collaboration. Roche is a global leader in thedevelopment of biologics and we are excited that they have selected a fourthexclusive target, in addition to the three already under development, furthervalidating Halozyme's core technology."
Roche has also maintained its rights to other targets covered in thelicense and collaboration agreement. An aggregate payment of $10.25 millionwill be made to Halozyme for commencing a Phase 1 clinical trial, exercisingexclusive global rights to a fourth biologic target and for annual maintenancefees.
Halozyme also announced that it has entered into a supply agreement withRoche to provide rHuPH20 for use in formulations with biologics directedagainst Roche targets covered under the licensing and collaboration agreement.Halozyme continues to scale up its manufacturing processes to enhance yieldsand efficiencies in order to produce multi-kilogram quantities of enzyme. Asspecified in the agreement, Halozyme will supply rHuPH20 to Roche to fulfillall of its clinical development and commercialization requirements.
Halozyme Roche Collaboration
In December 2006, Halozyme entered into an agreement with Roche to applyHalozyme's proprietary Enhanze(TM) Technology to Roche's biologicaltherapeutic compounds. Under the terms of the agreement, Roche paid Halozymean initial payment for the application of its recombinant human enzyme,rHuPH20, to three pre-defined Roche biologic targets. Roche has now selected afourth biologic target and has the option to exclusively develop andcommercialize rHuPH20 with an additional nine targets. Pending the successfulachievement of a series of clinical, regulatory, and sales events, Roche maypay Halozyme additional milestones as well as royalties on potential futureproduct sales. Under the collaboration, Roche has access to Halozyme'sexpertise in developing and applying rHuPH20 to Roche targets. Roche obtaineda worldwide, exclusive license to develop and commercialize productcombinations of rHuPH20 and Roche target compounds resulting from thecollaboration.
About Halozyme Therapeutics, Inc.
Halozyme is a biopharmaceutical company developing and commercializingproducts targeting the extracellular matrix for the endocrinology, oncology,dermatology and drug delivery markets. The company's portfolio of products andproduct candidates is based on intellectual property covering the family ofhuman enzymes known as hyaluronidases. The company's Enhanze(TM) Technology isa novel drug delivery platform designed to increase the absorption anddispersion of biologics. Its key partnerships are with Roche to apply EnhanzeTechnology to Roche's biological therapeutic compounds for up to 13 targetsand with Baxter to apply Enhanze Technology to Baxter's biological therapeuticproduct, GAMMAGARD LIQUID 10%. In addition, the company has received FDAapproval for two products: Cumulase(R), for use in in-vitro fertilization, andHYLENEX, for use as an adjuvant to increase the absorption and dispersion ofother injected drugs and fluids. HYLENEX is partnered with BaxterInternational Inc. Halozyme also has a number of different enzymes in itsportfolio that target significant areas of unmet medical need. For moreinformation visit http://www.halozyme.com.
Safe Harbor Statement
In addition to historical information, the statements set forth aboveinclude forward-looking statements (including, without limitation, statementsconcerning Roche's progress under the collaboration) that involve risk anduncertainties that could cause actual results to differ materially from thosein the forward-looking statements. The forward-looking statements are alsoidentified through use of the words "believe," "enable," "may," "will,""could," "intends," "estimate," "anticipate," "plan," "predict," "probable,""potential," "possible," "should," "continue," and other words of similarmeaning. Actual results could differ materially from the expectationscontained in forward-looking statements as a result of several factors,including regulatory approval requirements and competitive conditions. Theseand other factors that may result in differences are discussed in greaterdetail in the company's reports on Forms 10-K, 10-Q, and other filings withthe Securities and Exchange Commission.Halozyme Contact Media Contacts Robert H. Uhl Karen Sparks / Joleen Schultz Senior Director, Investor Relations Mentus (858) 704-8264 (858) 455-5500, x275/x215 firstname.lastname@example.org email@example.com firstname.lastname@example.org
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