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News
6 Jul 2016

RedHill Biopharma and IntelGenx announce definitive agreement for commercialization of Rizaport for migraines with Grupo JUSTE in Spain

Rizaport was recently approved for marketing in Germany under the European Decentralized Procedure; RedHill and IntelGenx continue to work together to secure additional commercialization partners for Rizaport in the US, Europe and other territories.

RedHill Biopharma together with IntelGenx Corp. have announced the signing of an exclusive license agreement with Grupo JUSTE, for the commercialization of Rizaport in Spain, and a right of first refusal for additional territories. Rizaport is a proprietary oral thin film formulation of rizatriptan for the treatment of acute migraines.

Grupo JUSTE is a prominent private Spanish company with over 90 years of experience in the research, development and commercialization of proprietary pharmaceutical products, including migraine and other central nervous system (CNS) drugs, in Europe, Latin America and other territories.

Under the terms of the agreement, RedHill granted Grupo JUSTE the exclusive rights to register and commercialize Rizaport in Spain and a right of first refusal for a predefined term for the territories of Belize, Carribean, Chile, Colombia, Costa Rica, Dominican Republic, El Salvador, Guatemala, Honduras, Mexico, Nicaragua, Panama, the Middle East and Morocco. RedHill and IntelGenx are entitled to receive an upfront payment and additional milestone payments upon the achievement of certain predefined regulatory and commercial targets, as well as tiered royalties. Financial terms of the agreement were not disclosed. The initial term of the agreement is for ten years from the date of the first commercial sale and shall automatically renew for an additional two-year term. Commercial launch in Spain is expected to take place in the second half of 2017.

“We are delighted to enter into this first commercialization agreement for Rizaport and look forward to building a long-term relationship with Grupo JUSTE in support of their efforts to introduce Rizaport in Spain and potentially other LATAM and Middle Eastern territories” said Adi Frish, RedHill’s Senior VP Business Development & Licensing. “We believe that, thanks to the pleasant flavouring and convenient use of the rapidly dissolving thin-film, Rizaport could potentially become a preferred therapeutic option for migraine patients worldwide. We continue working diligently together with IntelGenx to bring this unique and advantageous drug to additional markets in the near future.”

Inés Juste, President of Grupo JUSTE, added: “We are extremely satisfied to announce the planned arrival of this new formulation of a leading treatment for migraine. Our partners, IntelGenx and RedHill possess a deep knowledge in the pharmaceutical industry including strong leadership in innovative formulations that improve the compliance and the administration pattern of gold standard drugs. This agreement should allow Grupo JUSTE to bring this new effective treatment to migraine patients in Spain and potentially some Latin American and Middle East countries and to reinforce its presence in Neurology.”

The Federal Institute for Drugs and Medical Devices of Germany recently granted marketing authorization for Rizaport 5 mg and 10 mg under the European Decentralized Procedure (DCP), in which Germany served as the Reference Member State for other European Union countries. This authorization was the first national marketing approval for Rizaport.

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