Intellectual Property - November 18, 2016
Favorable outcome for Orexo in patent infringement litigation
Orexo announces that the United States District Court for the District of Delaware ruled in Orexo’s favor in one of the patent infringement litigations against Actavis Elizabeth LLC regarding Zubsolv in the US. Orexo commenced this patent infringement litigation in June 2014 in response to Actavis’s Abbreviated New Drug Application seeking approval to market and […]
Regulatory compliance - October 3, 2016
Orexo announce EU regulatory submission
Mundipharma and Orexo have announced the submission of a regulatory submission of a Marketing Authorisation Application (MAA) for Zubsolv (buprenorphine and naloxone) sublingual tablet to the European Medicines Agency (EMA), seeking approval for the treatment of opioid dependence. If approval is received, the buprenorphine and naloxone sublingual tablet would be the first fast dissolving buprenorphine […]
Acquisition - March 21, 2016
AZ acquires all rights to Orexo’s OX-CLI
AstraZeneca has decided to acquire all rights to Orexo’s leukotriene C4 synthase inhibitor program (OX-CLI project) for MUSD 5. AstraZeneca established a collaboration with Orexo AB for OX-CLI in 2013 and maintained an option to acquire all rights in the program. As the program has advanced into pre-clinical development with an identified development compound (candidate drug), […]
Drug Development Pharma - August 17, 2015
Orexo’s ZUBSOLV approved
Orexo has announced that the US Food and Drug Administration has approved ZUBSOLV (buprenorphine/naloxone CIII sublingual tablet) for induction of buprenorphine maintenance therapy in patients with opioid dependence. The approval expands on the current indication for ZUBSOLV, originally approved by the U.S. FDA on July 3, 2013, and is based on data from two Phase […]
Drug Development Pharma - October 13, 2014
Orexo applies for expanded label of ZUBSOLV
The Uppsala-based company has submitted an application to the U.S. Food and Drug Administration for an expanded label of ZUBSOLV. Orexo hopes to include initiation of treatment for opioid dependence. The company now anticipates a potential approval of the expanded label during the third quarter 2015. “The FDA submission constitutes an important milestone for ZUBSOLV. Today we take […]
Financing - September 1, 2014
Orexo completes private placement of SEK 346.5 million
Orexo AB has announced that its private placement of 2,493,046 Orexo shares has been completed. The placement included all Orexo shares held in treasury by the company in addition to newly issued shares. The price of SEK 139 per share was determined through a book-building procedure, resulting in total cash proceeds of approximately SEK 346.5m before […]
