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Release issued 18th August 2003
(Fort Worth, TX) --- An affiliate company of DFB Pharmaceuticals, Inc. HEALTHPOINT, Ltd., a Texas-based market leader in advanced wound care, dermatology, and surgical products, has announced that it has signed an exclusive, worldwide agreement with IsoTis, S.A. (AEX and SWX: ISON) to develop and license its patented, biologic, wound-healing technology, ALLOX(tm).
ALLOX consists of growth-arrested skin cells that secrete endogenous growth factors to promote wound healing. Specifically, ALLOX is composed of a mixture of growth factor-producing fibroblasts and keratinocytes in a fibrin spray. A prescription product stored in a frozen state, ALLOX spray is expected to be available off-the-shelf and easy to use.
Having concluded Phase I clinical trials on ALLOX in 2002, IsoTis is currently conducting a multicenter Phase II clinical trial in several countries on approximately 100 patients.
Upon completion of the Phase II trial expected late this year, HEALTHPOINT and IsoTis will collaborate on a Phase III trial in 2004, targeting FDA approval and United States market launch in 2006.
Pending regulatory approval as a biologic in the United States, the initial indication for ALLOX is expected to be the treatment of chronic venous leg ulcers. Approval will also be sought for other indications and in other NAFTA and European Union countries.
Under the terms of the long-term agreement, HEALTHPOINT will fund specific developmental activities, pay certain milestones, and share a percentage of product income in exchange for the exclusive, worldwide license.
"This agreement with IsoTis underscores HEALTHPOINT's commitment to advancing wound care," said H. Paul Dorman, HEALTHPOINT Chairman and CEO. "We have developed an excellent relationship with the people at IsoTis and are thrilled to be working with such a talented group to bring ALLOX to market."
"We are very excited at the prospect of adding ALLOX to our strong product portfolio," commented Michael Steadman, HEALTHPOINT General Manager of Tissue Management. "It is a natural fit with our other products, such as ACCUZYME®, PANAFIL®, and OASIS®, adding to our continuum of wound care treatments that cover preparation through healing."
"The future of advanced wound care will include many more pharmaceutical and biologic products than are currently available," added Marc Iacobucci, Vice President, Marketing, for Tissue Management at HEALTHPOINT. "This product is right in line with that future and is expected to be a great addition to current treatments available for patients with chronic wounds."
Since its inception in 1992, HEALTHPOINT has established a U.S. presence in the research, development, and marketing of branded pharmaceuticals, over the counter drugs, and medical devices for tissue management, dermatology, and surgical. An aggressive research and development effort has brought HEALTHPOINT's unique technologies to the market, setting the pace for its highly trained field sales organization of direct sales representatives. HEALTHPOINT, with over 250 employees, is a DFB Pharmaceuticals, Inc. affiliate company. HEALTHPOINT is based in Fort Worth, Texas. Visit HEALTHPOINT's web site at www.healthpoint.com.
Also headquartered in Fort Worth, DFB provides technology- driven products, outsourcing services and licensing opportunities to the healthcare industry worldwide through its affiliate companies, contract partners, and branded marketing organizations.
IsoTis was created in late 2002 through the merger of Modex, a Swiss biotechnology company, and IsoTis, a Dutch biomedical company. The company operates from its corporate headquarters in Lausanne, Switzerland and facilities in Bilthoven, The Netherlands. In early 2003, IsoTis completed a restructuring of the company by rationalizing its product portfolio and substantially reducing its cash burn. The company currently has 100 employees, a product portfolio with several orthobiologic medical devices on the market and in development, and is traded under the symbol "ISON" on both the Official Market Segment of Euronext Amsterdam and the Main Board of the Swiss Exchange. On June 3, 2003, IsoTis announced its intention to merge with GenSci Orthobiologics to create a leading orthobiologics player with a global presence. The official announcement and other corporate information can be found on www.isotis.com or www.gensciinc.com.
If you want to find out more about the company visit DFB Pharmaceuticals, Inc. profile.
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