| MADISON, N.J., and STRASBOURG, France, February 4, 1998 — Schering-Plough Corporation (NYSE:SGP) and TRANSGENE today anounced a research collaboration and licensing agreement covering the use of TRANSGENE's adenoviral gene delivery systems in conjunction with Schering-Plough's p53 tumor suppressor gene and several other Schering-Plough proprietary genes to develop gene therapy products. |   |
Under the terms of the agreement, Schering-Plough receives rights to existing and future adenoviral gene technology developed by TRANSGENE in conjunction with the p53 gene. In addition, Schering-Plough has the option the license TRANSGENE's adenoviral gene delivery systems for up to five additional Schering-Plough genes.
Under this agreement, Schering-Plough has agreed to pay to TRANSGENE $ 8 million in initial licensing fees. If Schering-Plough exercises it option to utilise TRANSGENE's adenoviral delivery systems for all six genes over the next five years, total revenue to TRANSGENE could exceed $ 88 million in additional licensing fees, research funding and milestone payments. The agreement also provides for royalties on future product sales.
"This collaboration with Schering-Plough confirms the quality of TRANSGENE's research and the potential of its technology platform in the field of gene therapy" said Bernard Gilly, President and Chief Executive Officer of TRANSGENE. "In addition, it also demonstrates TRANSGENE's ability to leverage its gene delivery technologies for developing products based upon the proprietary genes of pharmaceutical companies."
Successful development of gene therapy is dependent on two key elements: the identification of key cellular genes that provide a missing biological function associated with a specific disease, and an effective way to deliver these genes to specific target cells. TRANSGENE believes that its improved adenoviral vectors may be particularly efficient in delivering genes to tumors, and therefore may be a more effective gene delivery system for gene such as the p53 gene that need to be expressed within tumor cells.
Schering-Plough initiated a clinical development program for its recombinant adenovirus encoding human p53 (rAd/p53) gene therapy in a Phase I non-small-cell lung cancer trial in 1996. Early Phase trials are ongoing to investigate intratumoral administration of rAd/p53 in head and neck cancer, and intraperitoneal administration of rAd/p53 in patients with liver malignancies. In this trial, evidence of gene expression in tumors by this systemic route has been seen despite pre-existing antibodies to the adenovirus.
Schering-Plough's p53 gene therapy program began in 1994 as a research collaboration with Canji, Inc., a leading developer of gene-related therapeutic products. Canji was acquired by Schering-Plough in February 1996 and now is Scring-Plough's Research Institute's center for gene therapy discovery.
TRANSGENE, based in Strasbourg, France, is an integrated biotechnology company dedicated to the discovery and development of gene therapy technologies and products for the treatment of acquired or inherited diseases for which there is no cure or adequate therapy at present. Its proprietary technology platform includes adenoviral, vaccinia viral, retroviral, cellular and a range of synthetic vectors for gene delivery. Three of these vector families are currently in clinical development for several disease applications. TRANSGENE expects its programs against melanoma and breast cancer to begin Phase II clinical trials in the first quarter of 1998. Additional disease targets for TRANSGENE's gene therapy delivery systems include cystic fibrosis (Phase I completed), muscular dystrophy and cardiovascular diseases.
Schering-Plough Research Institute is the pharmaceutical research and development arm of Schering-Plough, a research-based company engaged in the discovery, development, manufacturing and marketing of pharmaceutical and health care products worldwide.
Source: Transgène
