Serono S.A. and Ivax Corporation announced a worldwide agreement to develop and commercialize Ivax' product, cladribine, as potentially the first orally effective treatment of multiple sclerosis.
"We are very pleased to enter into this agreement with Serono, a leading innovator in the development of drugs to treat multiple sclerosis," remarked Phillip Frost, Chairman and Chief Executive Officer of Ivax Corporation. "This agreement brings together our combined expertise in the development of CNS therapeutics, Ivax' capabilities for manufacturing proprietary oral pharmaceutical products and Serono's global experience in the marketing and sales of Rebif, an important treatment for multiple sclerosis."
Ernesto Bertarelli, Chief Executive Officer of Serono, commented, "This agreement is part of our long-term strategy for developing novel therapies in neurology. With cladribine we plan to offer patients an oral therapy which complements Rebif, our leading treatment for multiple sclerosis."
Based upon clinical and Magnetic Resonance Imaging (MRI) data from phase II trials suggesting that intravenous cladribine may be effective in certain MS patients, Serono and Ivax plan to establish the optimal oral formulation of cladribine and then initiate further clinical trials.
Under terms of the agreement, Ivax will receive a series of undisclosed milestone payments and will also receive royalties on sales of the product, once marketed. The current worldwide market for multiple sclerosis treatments is more than $2.5 billion.