Key Developments: Acura Pharmaceuticals Inc (ACUR.O)
6 Dec 2013
Latest Key Developments (Source: Significant Developments)
Acura Pharmaceuticals Inc Announces Settlement of Oxecta Patent Litigation With Par Pharmaceutical and Impax Laboratories Inc
Acura Pharmaceuticals Inc announced that it has entered into distinct Settlement Agreements with each of Par Pharmaceutical and Impax Laboratories Inc, to settle Acura's patent infringement action pending against them in the United States District Court for the District of Delaware. In the suit, Acura alleges that a generic Oxecta product for which each of Par and Impax is separately seeking approval to market in the United States pursuant to an Abbreviated New Drug Application (ANDA) filing with the U.S. Food and Drug Administration (FDA) infringes a U.S. patent owned by Acura. Par is the first filer of an ANDA for a generic Oxecta product and is entitled to the 180-day first filer exclusivity under applicable law and FDA regulations. Under the terms of the Settlement Agreement with Par, Par may launch its generic Oxecta product in the U.S., through the grant of a non-exclusive, royalty-bearing license from Acura to Par that would trigger on January 1, 2022. Par is required to pay Acura royalties in the range of 10% to 15% of Par's net profits from the sale of its generic Oxecta product. Under the Settlement Agreement, Impax may launch its generic Oxecta product in the U.S., through the grant of a non-exclusive, royalty-free license from Acura to Impax that would trigger 180 days following the first sale of a generic Oxecta product in the U.S. by an entity that is entitled to the 180 day first-filer exclusivity under applicable law and FDA regulations. Full Article
Acura Pharmaceuticals Inc announced that Investigational New Drug application (IND) has been filed with the U.S. Food and Drug Administration (FDA) to allow clinical testing of Acura's hydrocodone bitartrate with acetaminophen formulated with Aversion Technology. Clinical testing can commence under the IND 30 days following the IND filing unless questions are raised by the FDA. An open IND is required for Acura to initiate intranasal abuse liability testing in recreational drug users of the crushed drug product. Full Article
Reuters reported that Pfizer Inc will return three products it was developing using Acura Pharmaceuticals Inc's abuse resistant technology, Acura said on July 27, 2012. The license termination, which concerns three clinical stage products using Acura's Aversion technology, will be effective a year from Thursday, when Pfizer notified Acura. The Pfizer will retain rights to Oxecta and return all assets and regulatory and clinical responsibility related to the three drugs, MacKay Jimeson, a spokesman for Pfizer, told Reuters via email. Acura had received an aggregate of $78.5 million in payments from Pfizer as of March 31, under their 2007 license agreement. It was eligible to receive tiered royalties of 5% to 25% on combined annual net sales of all products marketed under the agreement. Full Article
- Acura Pharmaceuticals Inc said a painkiller made with its abuse-deterrent technology did not show statistically significant results in reducing likability among abusers, sending its shares down as much as 34 percent in extended trading.