VIVITROL is the first and only monthly injectable drug for the treatment of alcohol dependence and was approved by the U.S. FDA in April 2006. The proprietary medisorb (R) drug distribution technology in VIVITROL allows the drug to be gradually released at a controlled rate over a period of one month in the body. CAMBRIDGE, Mass., 07.01.2008 (BUSINESS WIRE) — Alkermes, Inc. (NASDAQ: ALKS) announced today that it has entered into an exclusive agreement with Cilag GmbH International, a subsidiary of Johnson and Johnson, for the marketing of VIVITROL (R) (Naltrexon for extended injectable suspension) for the treatment of alcohol and opioid dependence in Russia and other countries of the Commonwealth of Independent States (CIS). As part of the agreement, Cilag GmbH International will pay milestone advances and payments of up to $39 million, as well as current royalties for the commercial sale of VIVITROL in the region. The product is marketed by Janssen-Cilag, a subsidiary of Cilag GmbH International. Alkermes retains exclusive rights to develop and market VIVITROL in all markets outside the United States, Russia and other CIS countries. In the United States, VIVITROL is primarily marketed by Cephalon, Inc. For full information on the prescription, please www.vivitrol.com or call 1-800-896-5855. “This agreement underscores the value of VIVITROL and gives us the opportunity to expand the commercialization of this product,” said David Broecker, President and Chief Executive Officer of Alkermes. “We believe that Janssen-Cilag provides the business skills and infrastructure needed to successfully launch products in Russia, and look forward to a productive partnership.” Click CONTINUE to access an external website or CANCEL to return to vivitrol.com. Certain statements made above may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not only, statements regarding: the successful registration, introduction and marketing of VIVITROL in Russia and other CIS countries; successful manufacturing of VIVITROL for sale in Russia and other CIS countries; Obtaining certain administrative approvals, other agreed events and, if applicable, future sales of VIVITROL; and the expected benefits of the agreement for Alkermes, in particular that Janssen-Cilag has the commercial capabilities and infrastructure necessary for a successful introduction of VIVITROL in Russia and other CIS countries.
While Alkermes believes that such statements are based on reasonable assumptions as part of its knowledge, forward-looking statements are neither promises nor guarantees, and Alkermes` operations are subject to considerable risks and uncertainties. It is therefore not possible to guarantee that Alkermes` actual results will not differ materially from its expectations. These risks and uncertainties include, among other things, the delay or denial of VIVITROL`s administrative authorization in Russia and other CIS countries, including the requirement to conduct additional clinical trials; If approved, the inability to successfully start, increase or maintain VIVITROL`s revenue; inability to produce VIVITROL successfully and effectively. Further information on the factors that could lead to the company`s actual results differing materially from expectations regarding the company`s reports to the Securities and Exchange Commission, as amended by the Securities Exchange Act of 1934.