Date: 2015-03-19
Type of information: Commercialisation agreement
Compound: Movantik™ (naloxegol)
Company: AstraZeneca (UK) Daiichi Sankyo (Japan)
Therapeutic area: Digestive diseases - Cancer -Oncology
Type agreement: commercialisation
Action mechanism: peripherally-acting mu-opioid receptor antagonist (PAMORA). Movantik™/Moventig®(Naloxegol) is a peripherally-acting mu-opioid receptor antagonist being investigated for the treatment of constipation (opioid-induced constipation or OIC) as a side effect of prescription opioid pain medicines. 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 (GI) tract. Naloxegol is part of the exclusive worldwide license agreement announced on 21 September 2009 between AstraZeneca and Nektar Therapeutics. It was developed using Nektar’s oral small molecule polymer conjugate technology.
Disease: opioid-induced constipation (OIC) for adult patients 18 years and older
Details: * On March 19, 2015, Daiichi Sankyo announced a co-commercialization agreement with AstraZeneca for Movantik™ (naloxegol) in the US, in line with the Daiichi Sankyo strategy to expand its US portfolio through strategic alliances, in addition to internal R&D and acquisitions. Movantik™ was approved by the FDA in September 2014 for the treatment of opioid-induced constipation (OIC) for adult patients 18 years and older, including patients with inadequate response to laxatives. 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.
Financial terms: 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.
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