Treatment of breakthrough pain in cancer patients

Abstral treats breakthrough cancer pain in patients already being treated with opioids. The product contains the pain-relieving substance fentanyl. Abstral allows doses to be customized according to individual requirements, which is essential for achieving optimal pain relief.

Abstral is a rapidly disintegrating tablet that is placed under the tongue. The advantage is that the active ingredient is absorbed into the body through the mucous membrane. The effect is thereby fast and predictable. The tablet is easy to dose, store and handle.

The product was approved in 2008 for sales in Europe. Since then it has been launched in most countries in the EU. In January 2011, Abstral was approved by the U.S. Food and Drug Administration, FDA, and was subsequently launched in the USA in April 2011 by Orexo’s partner ProStrakan. In February 2011 Abstral was also approved in Canada.

In November 2012, Orexo’s Japanese partner Kyowa Hakko Kirin submitted a New Drug Application for KW-2246 (Abstral®) in Japan.

During the second quarter of 2012, Orexo entered into a new agreement with ProStrakan regarding Abstral, whereby Orexo takes over the product rights for Abstral in the USA during the first half of 2013. Orexo assesses that Abstral has good chances of achieving similar success in the USA to that in Europe and currently Orexo is evaluating the best commercial partnership structure in the USA. At the same time ProStrakan acquired the rights in the EU and the rest of the world, except for Japan.
Orexo will, in addition to fixed royalty payments, continue to receive royalties on these sales over and above certain predetermined levels.

In the EU Abstral continues to grow rapidly and gain market share. During 2012 sales in the EU amounted to approximately MSEK 350, an increase of 40 percent compared with the previous year.

During 2012, royalty revenues from Abstral’s EU sales amounted to MSEK 175.2 (70.5).