USA-based Alkermes has entered into an exclusive agreement with Cilag GmbH International, a subsidiary of US health care major Johnson & Johnson, to commercialize Vivitrol (naltrexone for extended-release injectable suspension) for alcohol and opioid dependence in Russia and other countries in the Commonwealth of Independent States.
As part of the agreement, Cilag will make upfront and milestone payments up to $39.0 million as well as ongoing royalties on commercial sales in this territory. The product will be commercialized by Janssen-Cilag, an affiliate company of Cilag, while Alkermes will retain exclusive development and marketing rights to the agent in all markets outside the USA, Russia and other countries in the CIS. In the USA, Vivitrol is primarily commercialized by local firm Cephalon.
Under the terms of the deal, Cilag will have the main responsibility for filing the New Drug Application for Vivitrol in Russia and other countries in the CIS. Alkermes will be responsible for manufacturing the product and will receive revenues and sales-based royalties from Cilag, which will also make an initial cash payment of $5.0 million and up to $34.0 million upon regulatory approvals, certain agreed-upon events and sales levels.
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