DEERFIELD, Ill., February 2, 2004 – Baxter Healthcare Corporation announced today that it has signed a licensing agreement with Teva Pharmaceutical Industries Ltd. whereby Teva has been granted exclusive European rights to the development, manufacture and marketing of LEUPROMAXX leuprolide acetate, under development for the treatment of prostate cancer and other hormone-dependent diseases. LEUPROMAXX is a sustained-released formulation of the peptide hormone leuprolide acetate, which has been formulated by Baxter using its proprietary PROMAXX drug delivery technology.
Baxter´s North American licensee, SICOR, Inc., recently completed Phase II trials in the U.S. for formulations of LEUPROMAXX leuprolide acetate. Teva will assume responsibility for all required clinical trials for registration of formulations in Europe. The agreement also provides for the development of additional products between Baxter and Teva utilizing Baxter´s PROMAXX drug delivery technology. Terms of the agreement were not disclosed.
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 30 pharmaceutical companies and among the largest generic pharmaceutical companies in the world. The company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients. Close to 90% of Teva´s sales are in North America and Europe.
"We are pleased to have established this agreement with Teva for LEUPROMAXX products in Europe," said Anthony Garramone, president of Epic Therapeutics, Inc., a wholly owned subsidiary of Baxter Healthcare Corporation. "Europe is an important market for LEUPROMAXX and greatly increases the scope beyond our previously announced licensing of the technology for North America. Teva Pharmaceuticals is an ideal partner for us based upon their large and established European presence, as well as their commitment to the oncology market."
For more than 20 years, Baxter´s Drug Delivery business has partnered with pharmaceutical and biotech companies around the world to formulate medications in a variety of delivery presentations that make injectable drugs efficient and easy for clinicians to prepare and administer, while keeping them safe and effective for patients.
The business is uniquely positioned to support its pharmaceutical partners´ product life cycles from development through patent expiration. In 2001, the business introduced NANOEDGE Technologies, a "toolbox" of formulation and manufacturing technologies that incorporates insoluble drug delivery (IDD) technology to help pharmaceutical partners formulate their challenging insoluble drug molecules. In 2002, Baxter added the PROMAXX suite of controlled-release protein and pulmonary delivery formulation technologies with its acquisition of Epic Therapeutics, Inc.
"This is another example where Baxter applies its proprietary drug formulation and drug delivery technologies to develop improved formulations of known drugs," explained Joel Tune, general manager of Baxter´s Drug Delivery business. "In this case, Baxter initiated development, demonstrating "proof of concept," and then identified the best partner to take the product forward in development and marketing. This represents a win-win for both companies, leveraging strengths and investment dollars where they are most appropriate."
Baxter Healthcare Corporation is the principal domestic operating subsidiary of Baxter International Inc. (NYSE:BAX). Baxter International Inc., through its subsidiaries, assists health-care professionals and their patients with treatment of complex medical conditions, including cancer, hemophilia, immune disorders, kidney disease and trauma. The company applies its expertise in medical devices, pharmaceuticals and biotechnology to make a meaningful difference in patients´ lives.
LEUPROMAXX, NANOEDGE and PROMAXX are trademarks of Baxter International Inc., its subsidiaries and affiliates.