Alkermes Inc. has entered into an exclusive agreement with Cilag GmbH International, a unit of Johnson & Johnson, to commercialize Vivitrol (naltrexone for extended-release injectable suspension) for the treatment of alcohol and opioid dependence in Russia and other countries in the Commonwealth of Independent States (CIS).

As part of the agreement, Cilag GmbH International will pay upfront and milestone payments up to $39 million as well as ongoing royalties on commercial sales of Vivitrol in this territory. The product will be commercialised by Janssen-Cilag, an affiliate company of Cilag GmbH International. Alkermes will retain exclusive development and marketing rights to Vivitrol in all markets outside the US, Russia and other countries in the CIS. In the US, Vivitrol is commercialised primarily by Cephalon, Inc.

Under the terms of the agreement, Cilag GmbH International will have primary responsibility for filing the new drug application for Vivitrol in Russia and other countries in the CIS. Alkermes will be responsible for manufacturing Vivitrol and will receive from Cilag GmbH International manufacturing revenues and a royalty based on product sales. Cilag GmbH International will make an initial payment of $5 million cash to Alkermes and up to an additional $34 million cash payments upon regulatory approvals for the product, certain agreed-upon events and levels of Vivitrol sales. Additional terms of the agreement were not disclosed.

"This agreement highlights the value of Vivitrol and provides us with the opportunity to expand the commercialisation of this product," said David Broecker, president and chief executive officer, Alkermes. "We believe Janssen-Cilag brings the commercial capabilities and infrastructure required for a successful product launch in Russia and look forward to a productive partnership."

Vivitrol is the first and only once-monthly, extended-release injectable medication for the treatment of alcohol dependence and was approved by the US FDA in April 2006. The proprietary Medisorb drug delivery technology in Vivitrol enables the medication to be gradually released into the body at a controlled rate over a one-month time period.

There are approximately 10 million people in Russia who are dependent on alcohol. Alcohol is causally related to more than 60 medical conditions, including heart disease, liver disease, infectious disease, and cancer and contributes to an estimated 30 per cent of all deaths in Russia each year. Russia is becoming the largest heroin market in Europe and it is estimated that over 2 million people in Russia regularly use opiates.

Naltrexone has the capacity to cause hepatocellular injury when given in excessive doses. Naltrexone is contraindicated in acute hepatitis or liver failure, and its use in patients with active liver disease must be carefully considered in light of its hepatotoxic effects.

Vivitrol is contraindicated in patients receiving opioid analgesics, with current physiologic dependence on opioids, in acute opioid withdrawal or who have previously exhibited hypersensitivity to naltrexone, PLG or any other components of the diluent.