MOVANTIK™ (naloxegol)

Therapeutic Area Nektar
Discovered
Indication Phase Partner
CNS/Pain
MOVANTIK™ Tablets CII (naloxegol) Opioid-induced constipation in adults patients with chronic, non-cancer pain
Approved in US
AstraZeneca
MOVENTIG® (naloxegol) Opioid-induced constipation
Filed in EU
AstraZeneca
NKTR-119
(naloxegol fixed-dose combination product)
Analgesic for pain
Preclinical
AstraZeneca

About MOVANTIK™ (naloxegol) CII Tablets
For information on the recent U.S. FDA approval of MOVANTIK, please visit: http://www.astrazeneca-us.com/media/press-releases/Article/20140916-fda-approves-movantik-naloxegol-tablets-cii.

MOVENTIG® (naloxegol) has been filed for regulatory approval in the European Union. On September 26, 2014, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending approval of MOVENTIG® (naloxegol), an investigational, 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). The CHMP’s positive opinion on MOVENTIG will be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union.

About Nektar and AstraZeneca Agreement
In September 2009, AstraZeneca and Nektar Therapeutics entered into a worldwide agreement for naloxegol. Under Nektar’s agreement with AstraZeneca, AstraZeneca is responsible for development and commercialization. Nektar is eligible to receive up to $235 million in aggregate payments upon the achievement of certain regulatory and launch milestones, as well as additional tiered sales milestone payments of up to $375 million. Nektar will also be eligible to receive significant double-digit royalty payments on net worldwide sales. The agreement also covers NKTR-119, which is an early stage drug development program that is intended to combine naloxegol with selected opioids. For NKTR-119, Nektar is eligible for additional development milestone payments, tiered sales milestone payments and significant double-digit royalty payments on net sales worldwide.

MOVANTIK is a trademark and MOVENTIG is a registered trademark of the AstraZeneca group of companies.

 
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