A new licensing and supply deal has been made between Mitsubishi Tanabe Pharma America Inc. (MTPA) and Aquestive Therapeutics concerning the commercialization of riluzole in the United States. Riluzole, being marketed as EXSERVAN, is an oral film that was developed for the treatment of amyotrophic lateral sclerosis (ALS). Now that the deal has been made, patients can expect this treatment to become available by the middle of this year.
Amyotrophic lateral sclerosis (ALS) is a progressive, neurological disease in which nerve cells in the brain stem, brain, and spinal cord deteriorate. Due to this deterioration, muscles weaken and people lose control of them and their voluntary movement. In the late stages of ALS, the muscles necessary for breathing weaken, resulting in death. There are two forms of this disease: sporadic and familial. The former is the most common, with 90-95% of cases falling into this category. In the familial form of the disease, it is known that a mutated gene is inherited from parents, but it is still not fully understood and only accounts for 5-10% of cases. Otherwise, the cause of ALS is unknown. Researchers believe that there is a connection between frontotemporal dementia and ALS. Another theory is that exposure to certain substances or toxins leads to the development of ALS.
Symptoms of ALS vary between individuals. They also worsen as the disease progresses. Symptoms begin with difficulty with small movements and everyday things like walking. At the onset of the disease, people may trip and feel weakness in their arms, hands, and legs. As it progresses, people experience difficulties with speaking and swallowing, slowed and slurred speech, twitches and cramps in the muscles, and difficulty holding good posture. In the later stages people will be unable to move their muscles gradually, which affects the entire body. This inability affects movements like blinking. While people with ALS experience loss of muscle function, they do not lose any of their cognitive abilities.
About the Deal
MTPA and Aquestive Therapeutics have both agreed to a licensing and supply deal; it states that MTPA has the right to commercialize EXSERVAN in the US, while Aquestive attains the right to be the exclusive, sole supplier and manufacturer. The agreement also states that Aquestive will obtain milestone payments, upfront consideration, revenue, and royalties on net sales.
The deal is what is best for patients, according to the president of MTPA, Atsushi Fujimoto. As many ALS patients face difficulty swallowing, this new medication will greatly improve their quality of life; it dissolves on the tongue. Both MTPA and Aquestive are excited to make EXSERVAN available in the United States by the middle of 2021.
Read more about the deal here.