Genta and Aventis Enter Worldwide Collaboration
Agreement for Innovative Apoptosis-Directed Drug for Cancer Treatment
Berkeley Heights, NJ and Frankfurt, Germany, April 29, 2002 – Genta Incorporated and Aventis announced today that they have entered into an agreement to jointly develop and commercialize GenasenseTM (G3139), Genta’s lead antisense compound. Genasense is currently in multiple Phase 3 clinical trials that test its ability to enhance the effectiveness of chemotherapy in patients with both hematologic cancers and solid tumors. By inhibiting production of a protein called Bcl-2, Genasense is the first oncology drug of its kind to directly target the biochemical pathway (known as apoptosis) whereby cancer cells are ultimately killed by chemotherapy.
In many types of cancer, Bcl-2 is believed to play a major role in mediating resistance to anticancer treatment by preventing apoptosis. By selectively knocking out the production of Bcl-2, Genasense may greatly improve the activity of different cancer therapies by unblocking this central pathway of cell death.
“This collaboration brings together world-class leadership in oncology product development,” stated Raymond P. Warrell, Jr., M.D., Chairman and CEO of Genta. “Having followed the terrific work that Aventis has conducted with its leading oncology drug (Taxotere®), we believe this new collaboration is perfectly poised to maximize the blockbuster potential of Genasense on a worldwide basis. Genta’s expertise in hematologic oncology, both in development and marketing, will be a key factor in the ultimate success of the product.”
“Developing innovative products to help patients with cancer live longer is a primary goal for Aventis, and we believe Genasense is one of the most promising late stage investigational oncology compounds currently under study,” said Richard Markham, Chief Executive Officer for Aventis Pharma. “This is a highly significant collaboration for Aventis, as Genasense is at the leading edge of innovative, targeted cancer therapy. One of our clear objectives for achieving sales growth in the coming years is the in-licensing of late-stage development compounds with significant commercial potential, and this agreement is a tangible example of that commitment.”
Under the terms of the agreement, Genta and Aventis will jointly develop and co-market Genasense in the United States, and Aventis will have exclusive development and marketing rights to the compound in all countries outside of the U.S. Genta will retain responsibility for global manufacturing and for regulatory filings within the U.S., while Aventis will assume all regulatory responsibilities outside the U.S. Joint management teams, including representatives from both partners, will oversee the Alliance.
Collectively, this agreement will provide up to $480 million in cash, equity, milestones and convertible debt to Genta. In addition, Aventis will fund 75 percent of all future NDA-directed development costs in the U.S., and 100 percent of all other development, marketing, and sales costs within the U.S. and elsewhere. Genta will also receive royalties on all worldwide sales of Genasense. Genta will receive a total of $135 million in initial and near-term payments consisting of $10 million cash as a licensing fee and $40 million cash as development fees, $10 million in convertible debt, and $75 million pursuant to an equity investment upon achievement of a near- term clinical milestone. Genta will receive an additional $280 million in cash, and $65 million in convertible notes, pursuant to achievement of clinical and regulatory milestones.
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