1 March 2016
AstraZeneca today announced that it 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.
NOTES TO EDITORS
About MOVENTIG (naloxegol)
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 21 September 2009 between AstraZeneca and Nektar Therapeutics (NASDAQ:NKTR). 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.
ProStrakan Group is a rapidly growing specialty pharmaceutical company engaged in the development and commercialisation of prescription medicines for the treatment of unmet therapeutic needs in major markets. ProStrakan is a subsidiary of Kyowa Hakko Kirin Co., Ltd., the Japan-based global specialty pharmaceutical company. ProStrakan's head office is located in Galashiels in Scotland. Sales and marketing of ProStrakan's portfolio of products are handled by commercial subsidiaries in the UK, US, France, Germany, Spain, Italy and other EU countries. You can learn more about the business at: www.prostrakan.com.
About Kyowa Hakko Kirin
Kyowa Hakko Kirin is a research-based life sciences company with special strengths in biotechnologies. In the core therapeutic areas of oncology, nephrology and immunology/ allergy, Kyowa Hakko Kirin leverages leading-edge biotechnologies centered on antibody technologies, to continually discover innovative new drugs and to develop and market those drugs world-wide. In this way, we are working to realise our vision of becoming a Japan-based global specialty pharmaceutical company that contributes to the health and comfort of people around the world. More information can be found at www.kyowa-kirin.com.
AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three main therapy areas - respiratory, inflammation, autoimmune disease (RIA), cardiovascular and metabolic disease (CVMD) and oncology – as well as in infection and neuroscience. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com.
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Key: RIA - Respiratory, Inflammation and Autoimmunity, CVMD - Cardiovascular and Metabolic Disease, ING - Infection, Neuroscience and Gastrointestinal