Organon/Medarex Expand UltiMab Antibody Agreement To Focus On Novel Target

Firms will codevelop Medarex-identified target, interim CEO Lerner tells “The Pink Sheet” DAILY.

Medarex and Organon have signed a 50/50 deal for development and commercialization of human monoclonal antibody therapeutics for the treatment of cancer and autoimmune disorders, the companies announced May 16. Organon originally licensed Medarex's UltiMab technology in February 2006 to generate therapeutic mAbs for its own targets.

"They found a target that we were working on to be interesting ... and came in to talk to us about developing a different kind of partnership, what we call our 50/50 kind of partnership. In this case, we put up the target and our platform technology, the UltiMab human [mAb] technology, and we will proceed together to develop that product," Medarex's interim Chief Executive Officer Irwin Lerner said in an interview with "The Pink Sheet" DAILY.

"Our strategy has been for some time to engage in a variety of different ... partnerships both with big pharma companies and with other biotech companies, whereby ... we put up our technology, the other company generally puts up a target, we meld the two, codevelop the products to commercialization and then either have the opportunity to opt in on a copromotion basis or to sit back and collect royalties and milestone payments," Lerner explained.

Under the deal announced May 16, Medarex and Organon plan to share equally in development and commercialization responsibilities on any antibody-based therapeutics resulting from their collaboration and to share revenues generated from the sales of products. Financial terms were not disclosed.

Princeton, N.J.-based Medarex is developing its lead compound, MDX-010 (ipilimumab), in collaboration with Bristol-Myers Squibb (¹ (Also see "Medarex Studying Ipilimumab As First-Line Treatment For Metastatic Melanoma" - Pink Sheet, 19 Jun, 2006.)). The product is in Phase III trials in metastatic melanoma, and the partners aim to file a BLA by year-end or in early 2008, Lerner said.

Medarex currently is studying its copromotion options with Bristol. "We have the opportunity to put up a certain amount of money for the marketing costs, in return receiving a certain amount of the net profits," Lerner said.

Also on May 16, Medarex announced that Howard Pien would succeed Lerner, who has served in the interim position since November. Lerner will continue in his role as chairman of the board of Medarex. Pien was president and CEO of Chiron until April 2006, when the company was acquired by Novartis.

Based in Oss, Netherlands, Organon has a U.S. research center in Cambridge, Mass., that is focused on identifying mAb therapies for immunology, oncology and other therapeutic areas.

"We have recently increased our efforts in Cambridge ... to identify novel biologicals which will be effective treatments for autoimmune and oncological disorders. This additional collaboration with Medarex represents a further step toward becoming a very effective biological drug hunting company," Organon Executive VP-R&D David Nicholson said in a statement.

In March, Schering-Plough announced plans to acquire Organon, the pharmaceutical and animal health care business of Dutch chemical company Akzo Nobel, (² (Also see "Schering-Plough Makes Its Move, Snapping Up Organon For $14.4 Billion" - Pink Sheet, 12 Mar, 2007.)).

Medarex has several collaborations with firms focused on discovering novel targets. A similar deal, with Israel's Compugen, was announced in January (³ (Also see "Medarex Strikes Partnership With Compugen For Oncology and Autoimmune Drug Targets" - Pink Sheet, 24 Jan, 2007.)).

- Shirley Haley ([email protected])

[Editor's note: In a recent ⁴ (Also see "Schering-Plough CEO Fred Hassan: An Interview With “The Pink Sheet” DAILY (Part 1 of 3)" - Pink Sheet, 27 Apr, 2007.) with "The Pink Sheet" DAILY, Schering-Plough CEO Fred Hassan talked about the Organon acquisition and his company's development plans in the area of novel biologics.]