AstraZeneca, a global, innovation-driven biopharmaceutical business, has entered into an agreement with ProStrakan Group, a subsidiary of Kyowa Hakko Kirin Co. Ltd., for the rights to Moventig (naloxegol) in the European Union (EU), Iceland, Norway, Switzerland and Liechtenstein. Moventig is the first once-daily, oral peripherally-acting mu-opioid receptor antagonist (PAMORA) approved in Europe for the treatment of opioid-induced constipation (OIC) in adult patients who have had an inadequate response to laxative(s).
Under the terms of the agreement, ProStrakan will make an upfront payment to AstraZeneca of $70 million, to acquire the rights to sell and develop Moventig in the EU, Iceland, Norway, Switzerland and Liechtenstein. ProStrakan will make additional payments contingent on market access decisions in certain European markets, and will pay AstraZeneca tiered double-digit royalties on sales as well as sales milestones. In line with AstraZeneca’s ongoing interest in Moventig globally, certain strategic decisions will be made jointly between AstraZeneca and ProStrakan in the European territory. The transaction does not include the transfer of any AstraZeneca employees or facilities. Moventig is currently available in the UK, Ireland, Germany, the Nordics, Austria and Switzerland.
Luke Miels, executive vice president, global product and portfolio strategy, AstraZeneca, said, “This agreement is in line with our strategy to focus our resources within our three main therapy areas while unlocking value from the important medicines in our portfolio. ProStrakan’s significant expertise in the area of pain medication will ensure patients across Europe benefit from a first-in-class treatment. It complements our commitment along with Daiichi Sankyo to build the market and co-commercialise this important medicine in the US.”
Tom Stratford, chief executive of ProStrakan, said, “Moventig is an excellent fit for our oncology and pain-focused sales teams across Europe and opens up broader opportunities to serve both cancer and non-cancer chronic pain patients with this innovative, first-in-class therapy. This important medicine will complement our existing breakthrough cancer pain products, Abstral and PecFent, and, through our existing contact with oncology and pain specialists across the continent as well as other planned physician groups, I am confident that we can make Moventig available as an option to a broad range of patients who suffer opioid-induced constipation.”
Revenue from the agreement will be reported as Externalisation Revenue in AstraZeneca’s financial statements. In addition to the upfront and recurring milestone payments outlined above, the externalisation of Moventig will provide recurring Externalisation Revenue through tiered double-digit royalty payments on Product Sales. The agreement does not impact the financial guidance for 2016.
Moventig is a peripherally-acting mu-opioid receptor antagonist (PAMORA) for the treatment of opioid-induced constipation (OIC) in adult patients who have had an inadequate response to laxative(s). It is the first once-daily oral peripherally-acting mu-opioid receptor antagonist (PAMORA) to be approved in the EU. In phase III clinical studies, Moventig was administered as a once-daily tablet and was designed to block the binding of opioids to opioid receptors in tissues such as the gastrointestinal (GI) tract.
The KODIAC clinical programme was comprised of four studies: KODIAC-4, -5, -7 and -8. KODIAC-4 and -5 were identically designed, placebo controlled, double-blind, 12 week studies assessing safety and efficacy, while KODIAC-7 was a 12 week safety extension to KODIAC-4, and KODIAC-8 was a 52 week long-term safety study.
Moventig is part of the exclusive worldwide licence agreement announced on September 21, 2009 between AstraZeneca and Nektar Therapeutics. Moventig was developed using Nektar’s oral small molecule polymer conjugate technology.
Moventig was granted Marketing Authorisation by the European Medicines Agency in December 2014. Outside the EU, it was launched in the US in March 2015 and in Canada in October 2015 under the brand name Movantik.
In March 2015, AstraZeneca entered into an agreement with Daiichi Sankyo, Inc., for the co-commercialisation of Movantik in the US.