IntelGenx, RedHill Biopharma sign deal with Grupo Juste for commercialization of RIZAPORT

All commercial manufacturing of RIZAPORT will take place at IntelGenx’ new state-of-the-art manufacturing facility in Canada. Full details of the financial terms of the agreement were not disclosed.

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.

According to the definitive agreement, Grupo Juste has obtained exclusive rights to register, promote and distribute RIZAPORT in Spain. In exchange, IntelGenx and RedHill will receive upfront and milestone payments, together with a share of the net sales of RIZAPORT.

Commercial launch in Spain is estimated to take place in the second half of 2017. The initial term of the definitive agreement shall be for ten years from the date of first commercial sale of the product and shall automatically renew for one additional two-year term.

The agreement will give Grupo Juste the right to market the product in the territory of Spain, with the right of first refusal for a predefined term for certain Latin American and Middle East countries.

"We are most excited to be partnering with Grupo Juste as we believe it will bring patients in Spain and additional potential countries suffering with migraines an innovative solution using our VersaFilm™ technology," said Dr. Horst G. Zerbe, President and CEO of IntelGenx.

"We view this as a significant achievement for IntelGenx and RedHill as this is the first commercial agreement of what we expect to be many opportunities in the future for RIZAPORT™. This will be the first commercial product manufactured in our new state-of-the-art manufacturing facility. IntelGenx and RedHill are actively pursuing several opportunities to bring RIZAPORT™ to new markets."

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 for commercialization 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."

About RIZAPORT :

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®. RIZAPORT 5mg and 10mg was approved for marketing in Germany in October 2015, under the European Decentralized Procedure. A New Drug Application for RIZAPORT was also filed with the U.S. FDA in 2013 and a CRL was received in 2014. Rizatriptan is considered one of the most effective oral triptans, a class of molecules that constricts blood vessels in the brain to relieve swelling and other migraine symptoms.

The worldwide annual sales of triptans were estimated to have exceeded $870 million in 20141. RIZAPORT is based on IntelGenx’s proprietary "VersaFilm™" technology. It dissolves rapidly and releases its active ingredient in the mouth, leading to efficient absorption of the drug through the gastrointestinal tract.

The administration method of the RIZAPORT oral thin film, which does not require the patient to swallow a pill or consume water, along with its pleasant flavor, 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.