BioWorld International Correspondent

PARIS Immuno-Designed Molecules SA, a Paris-based company specialized in the development of cellular immunotherapies for cancer, signed a co-development agreement with the French pharmaceutical company Sanofi-Synthélabo SA covering the whole range of IDM’s “cell drugs” for cancer.

The deal could be worth as much as EUR616 million (US$545 million) to IDM if Sanofi-Synthélabo, also of Paris, develops and commercializes the maximum number of products covered in the deal. And that does not include the revenues IDM could earn from manufacturing products.

The agreement gives Sanofi-Synthélabo first right of refusal on up to 20 cell drugs from IDM’s portfolio of cellular immunotherapies and therapeutic vaccines for cancer. It can select a maximum of 10 new IDM products during the first five years, and then two more each year for a further five years (no minimum number is specified). During the first two months of the agreement, to the end of February, Sanofi-Synthélabo can make an initial selection from among IDM’s existing products, namely four cellular immunotherapies and two therapeutic vaccines that already are in clinical development.

At a conference in Paris to announce the signing of the agreement, IDM Chief Operating Officer Bernard Brigonnet made it clear that he expected Sanofi-Synthélabo to announce the selection of at least one of these products before the deadline expires.

Sanofi-Synthélabo will pay IDM milestones of between EUR17 million and EUR32 million on each product it develops. If it selects an existing product, it will make an immediate lump-sum payment to IDM equivalent to the cumulative milestones it would have had to pay under the terms of the agreement. IDM will bear the preclinical development costs of the products concerned, while Sanofi-Synthélabo will finance their clinical development, up to and including regulatory filings. Sanofi-Synthélabo will have exclusive worldwide rights to commercialize the selected cell drugs for which it obtains regulatory approval.

The agreement also provides for Sanofi-Synthélabo to make an equity investment of about EUR30 million in IDM within the next 12 months, within the framework either of an initial public offering or a private placement. Sanofi-Synthélabo, with which IDM entered into an initial research collaboration covering therapeutic vaccines in May 1999, already holds a 3 percent stake in the company, and this operation is designed to increase that to about 10 percent.

IDM will manufacture the products at all stages, not only the initial batches for clinical trials, but also the industrial-scale volumes for commercial sales. Brigonnet explained that it would receive revenues and profits on the supply of those products to Sanofi-Synthélabo, but no royalties. The only royalties payable under the agreement would be by IDM to Sanofi-Synthélabo on the use of products for other applications, and the rate of royalty would be 1.5 percent, Brigonnet said.

IDM also is permitted to continue developing both existing and new products not selected by Sanofi-Synthélabo, as well as any product that is not a cell drug, and can collaborate with other companies on those. IDM has entered into several industrial partnerships, the main ones being with Medarex Inc., of Princeton, N.J., with which it concluded an agreement in October 2000 for the right to use certain therapeutic products developed by Medarex in exchange for an equity stake (Medarex currently owns 29 percent of IDM); Oxford BioMedica plc, of Oxford, UK, for the supply of antigens; and Paris-based Stedim SA, for the supply of sterile medical devices.

The six IDM products already in clinical development consist of four antibody-based cell drugs and two therapeutic vaccines. The four cell drugs are IDM-1, for ovarian cancer (in Phase III); IDM-2, for bladder cancer (Phase II); IDM-3, for chronic lymphocyte leukemia (Phase II); and IDM-4, for metastatic cancers (Phase I). The vaccines IDD-1 and IDD-3 are for the treatment of prostate cancer and melanoma, respectively, and both are in Phase II trials.

In addition, the company has 10 products in what Brigonnet described as “advanced preclinical development, meaning they will enter clinical development this year.” In that regard, the company’s CEO, Jean-Loup Romet-Lemonne, stressed the value of the injection of funds IDM would be receiving from Sanofi-Synthélabo. “The additional financial resources will enable us to speed up our drug development. We have 10 products in preclinical development now; by the year end we could have 20.”

IDM has hitherto raised a total of EUR67 million in successive funding rounds, the last of which was completed in November 2000 and netted EUR48.9 million from investors in Israel, the United States and Europe.

“IDM ended 2001 with EUR30 million in the bank, so we have two and a half years of cash. Sanofi-Synthélabo’s EUR30 million will come on top of that,” said Brigonnet, adding: “That doesn’t rule out the possibility of another funding round in 2002, which could take the form of an IPO, for which we’ve been ready since last year, or a private placement.” He said one of the uses of the additional funds might be the acquisition of new technology, especially in the U.S.

IDM, which currently employs 90 people, has manufacturing facilities in Paris, including a cell processor production plant certified ISO 9002 and ISO 9001, and is developing a new plant in Brussels to full GMP standards.