By Debbie Strickland

Schering-Plough Corp. has the cargo many cancer patients need — the p53 tumor-suppressor gene — and now the pharmaceutical giant is looking to biotech firms to provide delivery systems that will escort the DNA to a variety of tumor-cell destinations.

In its second major gene delivery collaboration in as many months, Schering-Plough agreed to pay more than $88 million to the French firm Transgene SA. Schering-Plough gains rights to existing and future Transgene adenoviral systems for use with the p53 gene, and has the option to license the technology for up to five additional undisclosed genes.

In a span of six weeks, Schering-Plough has put $168 million on the table for gene delivery, including at least $15 million guaranteed for 1998. The first $80 million agreement went to Genzyme Molecular Oncology (GMO), of Framingham, Mass., for rights to its lipid delivery system for p53 and five other genes. GMO is a division of Genzyme Corp., of Cambridge, Mass. (See BioWorld Today, Jan. 6, 1998, p. 1.)

"The idea is that depending on the target cancer, there may be a need for a number of different delivery systems," said Robert Consalvo, vice president for corporate communications at Schering-Plough, referring to the p53 deals. "It's not necessarily the case that one or the other will be the answer."

The company is already using a recombinant adenoviral-based delivery system to test the gene clinically in Phase I and Phase II trials.

In the latest delivery deal involving p53, privately held Transgene will receive $8 million in initial licensing fees, a sizable boost for its coffers, which had $30 million in cash at the midpoint of fiscal 1997.

If Schering-Plough exercises its option to license Trangene's technology for the other five genes, the French firm's total revenue from the deal could exceed $88 million over five years.

First Gene Therapy Deal For Transgene

The agreement marks the first corporate collaboration for Strasbourg, France-based Transgene since the former contract research firm remade itself into a gene therapy company in 1992.

"The deal is consistent with our business strategy of leveraging our technological platform," said Bernard Davitian, Transgene's executive vice president and chief financial officer. "It's important to us because it's a validation of the quality of our science and technology platform for a pharmaceutical company that is a big name in genomics and gene therapy to collaborate with us."

The company's adenoviral vectors offer a number of improvements over earlier generations of the technology, he said, including elimination of self-replication; a reduction of adenoviral protein synthesis in target cells, thereby reducing the risk of activating the immune system; and the capacity to carry larger DNA segments.

Transgene also has developed vaccinia viral, retroviral, cellular and a range of synthetic vectors for gene delivery.

Internal research and development programs center on cancer, cystic fibrosis, muscular dystrophy and cardiovascular diseases, with several products now at or past the Phase I stage of clinical testing in Europe.

In the field of cancer, Transgene uses vero cell and vaccinia virus vectors to deliver interleukin-2 to tumors. Melanoma and breast cancer therapies are poised to enter Phase II trials this quarter.

The cystic fibrosis gene therapy, which has completed Phase I testing, employs an aerosol-delivered adenovirus vector to replace patients' defective cystic fibrosis transmembrane regulatory protein gene.

Transgene, whose U.S. headquarters is in Rockland, Mass., is aiming to bring its technology to this side of the Atlantic with the expected 1998 launch of a clinical trial for a prostate cancer therapy. That agent is the subject of the 19-year-old company's first investigational new drug application, filed with the FDA this week.

Transgene plans to commercialize its gene delivery platforms through both collaborations and independent development.

The company raised $48 million in a 1994 private placement. As for an initial public offering, "We are considering the possibility," said Davitian, "but we have no plans to go public." *

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