LEXINGTON, Mass. -- Indevus Pharmaceuticals, Inc. (NASDAQ: IDEV) today announced a licensing agreement between Grupo Ferrer and IVAX Corporation for citicoline, an oral neuroprotective therapy for the treatment of stroke. Under the terms of this agreement, IVAX will be responsible for fulfilling the requirements for FDA approval of citicoline for acute stroke and for commercializing citicoline in the United States. The financial terms were not disclosed. Under an agreement between Indevus and Grupo Ferrer signed earlier this year, Indevus will receive a portion of milestone payments made to Ferrer by a third party in connection with the development of citicoline, as well as royalties on net sales of the product. In exchange, Indevus granted Ferrer exclusive rights to its patents and know-how related to citicoline.
"We are pleased that Ferrer and IVAX have entered into their agreement for the final development of citicoline," said Glenn L. Cooper, M.D., chairman, president and chief executive officer of Indevus. "We have always considered citicoline to be a potentially important therapeutic agent for the treatment of acute stroke. Our agreement with Ferrer provides Indevus with a significant participation in the economic potential of citicoline in the U.S. marketplace. Importantly, it has allowed us to allocate resources for the clinical development of other products in our portfolio that are more consistent with our primary therapeutic areas of interest - urology, gynecology and infectious diseases."
Citicoline is an oral neuroprotective agent with a 24-hour therapeutic window that is marketed by Ferrer in Europe and by Takeda Chemical Industries in Japan as a treatment for stroke. Two meta-analyses of clinical trials conducted by Indevus and other companies were presented at the 27th International Stroke Conference. These meta-analyses and a published analysis of data pooled from various control trials support the results of individual studies showing that treatment with citicoline may reduce infarct growth after stroke and reduce rates of death or disability over the long term.
Indevus Pharmaceuticals is a biopharmaceutical company engaged in the development and commercialization of a diversified portfolio of pharmaceutical product candidates, including multiple compounds in development: SANCTURA(TM), SANCTURA XR(TM) (once-a-day SANCTURA), pagoclone for panic and generalized anxiety disorders, IP 751 for pain and inflammatory disorders, PRO 2000 for the prevention of infection by HIV and other sexually transmitted pathogens and aminocandin for systemic fungal infections.
Except for the descriptions of historical facts contained herein, this press release contains forward-looking statements that involve risks and uncertainties that could cause the Company's actual results and financial condition to differ materially from those anticipated by the forward-looking statements. These risks and uncertainties are set forth in the Company's filings under the Securities Act of 1933 and the Securities Exchange Act of 1934 under "Risk Factors" and elsewhere, and include, but are not limited to: dependence on the success of SANCTURA(TM) and SANCTURA XR(TM); the early stage of products under development; uncertainties relating to clinical trials, regulatory approval and commercialization of our products, particularly SANCTURA and SANCTURA XR; risks associated with contractual agreements, particularly for the manufacture and co-promotion of SANCTURA and SANCTURA XR; dependence on third parties for manufacturing and marketing; competition; need for additional funds and corporate partners, including for the development of our products; failure to acquire and develop additional product candidates; history of operating losses and expectation of future losses; product liability and insurance uncertainties; risks relating to the Redux-related litigation; limited patent and proprietary rights; dependence on market exclusivity; valuation of our Common Stock; risks related to repayment of debts; risks related to increased leverage; and other risks.
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