AstraZeneca today announced a co-commercialisation agreement with Daiichi Sankyo, Inc. for MOVANTIK™ (naloxegol) in the US, in line with the Company's strategy of delivering value through its own development and commercial capabilities as well as through external collaboration. MOVANTIK is a first-in-class once-daily oral peripherally-acting mu-opioid receptor antagonist (PAMORA) for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain.
MOVANTIK was approved by the US Food and Drug Administration in September 2014. It was descheduled by the US Drug Enforcement Administration in January 2015 and is no longer labelled as a controlled substance. The launch of MOVANTIK in the US is planned for early April 2015.
Under the terms of the agreement, Daiichi Sankyo Inc. will pay a $200 million up-front fee and subsequent sales-related payments of up to $625 million. AstraZeneca will be responsible for manufacturing, will book all sales and will make sales-related commission payments to Daiichi Sankyo, Inc. Both companies will be jointly responsible for commercial activities. AstraZeneca's 2015 financial guidance, provided on 6 March 2015, is unaffected by today's announcement.
Paul Hudson, President, AstraZeneca US and Executive Vice President, North America, said: "We are delighted to collaborate with Daiichi Sankyo to expand our commercialisation efforts in the US in order to get this important medicine to the large number of patients suffering with opioid-induced constipation. Our agreement reflects our evolving business model by creating value from our portfolio through externalisation activity. Together, we will grow the potential of this important treatment, while we retain our significant interest in the long-term commercial success of MOVANTIK in our largest market."
Ken Keller, President, US Commercial, Daiichi Sankyo, Inc., said: "We are proud to bring our proven primary care and specialty expertise to this collaboration with AstraZeneca. MOVANTIK represents an opportunity to help patients manage one of the most common conditions arising from widely used pain medications, as well as an opportunity to continue to build the Daiichi Sankyo US portfolio of medicines in this therapeutic area."
The agreement is in line with AstraZeneca's business model, which includes value creation from the strong science underpinning its pipeline and portfolio through externalisation activity. This approach aims to benefit patients by collaborating with subject matter experts that can help us to bring important treatments to market while delivering revenue.
NOTES TO EDITORS
About MOVANTIK™ (naloxegol) tablets
MOVANTIK (naloxegol) tablets is the first FDA approved once-daily oral PAMORA specifically designed for the treatment of OIC in adult patients with chronic non-cancer pain. In the Phase III clinical studies, MOVANTIK 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 tract.
MOVENTIG® (naloxegol) also received Marketing Authorisation from the European Commission in December 2014 for the treatment of OIC in adult patients who have had an inadequate response to laxative(s).
MOVANTIK/MOVENTIG is part of the exclusive worldwide license agreement announced in 2009 between AstraZeneca and Nektar Therapeutics. It was developed using Nektar's oral small-molecule polymer conjugate technology.
OIC is a condition caused by prescription opioid pain medicines. Millions of patients are treated with opioids each year. Opioids play an important role in chronic pain relief and work by binding to mu-receptors in the central nervous system, but they can also bind to mu-receptors in the bowel, which can result in patients suffering from OIC. The incidence of OIC in patients with chronic pain varies and has been suggested to be as high as 81%.
About Daiichi Sankyo, Inc.
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical products to address the diversified, unmet medical needs of patients in both mature and emerging markets. While maintaining its portfolio of marketed pharmaceuticals for hypertension, dyslipidemia and bacterial infections used by patients around the world, the Group has also launched treatments for thrombotic disorders and is building new product franchises. Furthermore, Daiichi Sankyo research and development is focused on bringing forth novel therapies in oncology and cardiovascular-metabolic diseases, including biologics. The Daiichi Sankyo Group has created a 'Hybrid Business Model' to respond to market and customer diversity and optimize growth opportunities across the value chain. For more information, please visit: www.daiichisankyo.com. Daiichi Sankyo, Inc., headquartered in Parsippany, New Jersey, is a member of the Daiichi Sankyo Group. For more information on Daiichi Sankyo, Inc., please visit www.dsi.com.
About AstraZeneca in Neuroscience
A significant unmet medical need remains in the areas of cognitive disorders, chronic pain, and other central nervous system disorders. With a rich heritage and a research and development focus on specific aspects of neurodegenerative diseases, analgesia and psychiatry, AstraZeneca continues to push the boundaries of science in neuroscience in collaboration with others across industry and academia. Notably, in September 2014, AstraZeneca announced an alliance with Eli Lilly for the joint development of AZD3293/LY3314814, an oral beta secretase cleaving enzyme (BACE) inhibitor as a potential treatment for Alzheimer's disease, which is currently being studied in a pivotal Phase II/III trial.
AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. 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.