Navigation Links
Halozyme Therapeutics Announces Roche Begins Phase 1 Clinical Trial and Selects Fourth Exclusive Biologic Target

SAN DIEGO, Dec. 8 /PRNewswire-FirstCall/ -- Halozyme Therapeutics, Inc. (Nasdaq: HALO), 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

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.

     Halozyme Contact                        Media Contacts
     Robert H. Uhl                           Karen Sparks / Joleen Schultz
     Senior Director, Investor Relations     Mentus
     (858) 704-8264                          (858) 455-5500, x275/x215             

SOURCE Halozyme Therapeutics, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Halozyme Therapeutics Announces Positive Findings With Pegylated Enzyme in Prostate Cancer Models
2. Halozyme Therapeutics Announces That Chemophase Meets Primary Endpoint in Phase I/IIa Clinical Trial
3. Halozyme Therapeutics Announces Phase I Clinical Trial Results Demonstrating that the Combination of Recombinant Human Hyaluronidase (rHuPH20) With Humulin R(R) and with Humalog(R) Yields Faster, More Physiologic Insulin Kinetics and Better Predictability
4. Halozyme Therapeutics Presents Findings on Combinations of rHuPH20 Enzyme With Bisphosphonates at the American Association for Cancer Research Conference
5. Halozyme Therapeutics Presents Pre-Clinical Studies of Systemic Delivery of Pegylated rHuPH20 Enyzme in Prostate Cancer Models at American Association for Cancer Research Conference
6. Halozyme Therapeutics Announces Peer-Reviewed Publications of the INFUSE-LR Clinical Trial Results and Clinical Practice Experience With Hylenex
7. Halozyme Therapeutics Completes Enrollment in Chemophase Phase I/IIa Clinical Trial for Superficial Bladder Cancer
8. Orexigen(R) Therapeutics Announces Changes to Its Clinical Programs and Management Team
9. TorreyPines Therapeutics Muscarinic Agonist NGX267 Meets Primary Endpoint in a Phase II Clinical Trial in Patients with Xerostomia
10. Horizon Therapeutics Announces Two Pivotal HZT-501 Phase 3 Trials Meet Primary Endpoints
11. Duska Therapeutics Applies for Phase 3 Special Protocol Assessment
Post Your Comments:
(Date:6/24/2016)... , June 24, 2016 ... Markets has announced the addition of the " ... offering. This ... and provides an updated review, including its applications in ... the total market, which includes three main industries: pharmaceutical ...
(Date:6/24/2016)... June 24, 2016 The Academy of Managed ... recommendations that would allow biopharmaceutical companies to more ... that make formulary and coverage decisions, a move that ... new medicines. The recommendations address restrictions in ... on the drug label, a prohibition that hinders decision ...
(Date:6/24/2016)... SAN CLEMENTE, Calif. , June 24, 2016  American ... function testing company, is now able to perform sophisticated lung assessments ... ndd Medical Technologies , Inc. Patients are no ...  Thanks to ndd,s EasyOne PRO ® , ARL patients like Jeanne ... needed testing done in the comfort of her own home. ...
Breaking Medicine Technology:
(Date:6/26/2016)... , ... June 26, 2016 , ... Pixel Film Studios ... X. , "Film editors can give their videos a whole new perspective by using ... - CEO of Pixel Film Studios. , ProSlice Levels contains over 30 Different ...
(Date:6/25/2016)... TX (PRWEB) , ... June 25, 2016 , ... Austin ... of the American College of Mohs Surgery and to Dr. Russell Peckham for medical ... and highly effective treatment for skin cancer. The selective fellowship in Mohs Micrographic Surgery ...
(Date:6/25/2016)... ... 25, 2016 , ... Dr. Calvin Johnson has dedicated his ... implemented orthobiologic procedures as a method for treating his patients. The procedure is ... to perform the treatment. Orthobiologics are substances that orthopaedic surgeons use to help ...
(Date:6/24/2016)... ... June 24, 2016 , ... June 19, 2016 is World Sickle Cell ... pain and the benefits of holistic treatments, Serenity Recovery Center of Marne, ... Cell Disease. , Sickle Cell Disease (SCD) is a disorder of the red blood ...
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... Comfort Keepers® ... American Cancer Society and the Road To Recovery® program to drive cancer patients to ... and other adults to ensure the highest quality of life and ongoing independence. ...
Breaking Medicine News(10 mins):