An affiliate company of DFB Pharmaceuticals Inc, Healthpoint Ltd has signed an exclusive, worldwide agreement with IsoTis, S.A. to develop and license its patented, biologic, wound-healing technology, Allox.
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."