Date: 2016-07-06
Type of information: Commercialisation agreement
Compound: Rizaport® (formerly RHB-103 - oral thin film formulation of rizatriptan)
Company: RedHill Biopharma (Israel) IntelGenx (Canada) Grupo JUSTE (Spain)
Therapeutic area: CNS diseases
Type agreement: commercialisation
Action mechanism: 5-HT1 receptor agonist. Rizaport® is a proprietary oral thin film formulation of rizatriptan benzoate, a 5-HT1 receptor agonist and the active drug in Merck & Co's Maxalt®. Marketing applications for Rizaport® have been filed both in the U.S. (NDA filed in March 2013) and in Europe (MAA filed in October 2014). Rizaport® is based on IntelGenx' proprietary "VersaFilm™" technology. Rizaport® dissolves rapidly and releases its active ingredient in the mouth, leading to an efficient absorption of the drug through the gastro intestinal tract. The administration method of the Rizaport® oral thin film does not require the patient to swallow a pill or consume water and presents a potentially attractive therapeutic alternative for many migraine patients, including those who suffer from migraine-related nausea estimated to be approximately 80% of the total migraine patient population.
Rizaport™ 5 mg and 10 mg were approved for marketing in Germany in October 2015 under the European Decentralized Procedure. A New Drug Application was also filed with the U.S. FDA in 2013 and a CRL was received in 2014.
Disease: acute migraines
Details: * On July 6, 2016, RedHill Biopharma and IntelGenx , a Canadian drug delivery company focused on oral drug delivery, 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. 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. * On March 29, 2016, RedHill Biopharma, together with IntelGenx, a Canadian drug delivery company focused on oral drug delivery, announced that they have entered into a binding term sheet with Grupo JUSTE granting Grupo Juste the exclusive license to commercialize Rizaport® in Spain and a right of first refusal for additional territories. Under the term sheet, subject to remaining conditions, a definitive agreement is planned to be entered into within 60 days of the execution of the term sheet. Pursuant to the signing of a definitive agreement, RedHill will grant Grupo Juste the exclusive rights to register and commercialize Rizaport® in Spain and a right of first refusal for the territories of Belize, Carribean, Chile, Colombia, Costa Rica, Dominican Republic, El Salvador, Guatemala, Honduras, Mexico, Nicaragua, Panama, Middle East and Morocco. The initial term of the definitive agreement is expected to
be for ten years from the date of first commercial sale with an automatic renewal for an additional two-year term. Commercial launch in Spain is estimated to take place in the second half of 2017.
Financial terms: Under the term sheet, RedHill and IntelGenx will receive an upfront payment and will be eligible to receive additional milestone payments upon achievement of certain predefined regulatory and commercial targets, as well as tiered royalties. Financial terms of the term sheet were not disclosed.
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