Neurocrine Biosciences Announces Regulatory Approval of Dysval® (valbenazine) for the Treatment of Tardive Dyskinesia in Japan
Neurocrine Biosciences (Nasdaq: NBIX) announced on March 28, 2022, that its collaboration partner, Mitsubishi Tanabe Pharma Corporation, received regulatory approval from the Japanese Ministry of Health for DYSVAL® (valbenazine) capsules 40 mg, aimed at treating tardive dyskinesia (TD). This approval signifies a key milestone in their partnership established in March 2015, under which MTPC covers all costs related to development and commercialization in Japan and select Asian markets. Neurocrine will earn tiered royalties on future sales, bolstering its financial outlook.
- Regulatory approval of DYSVAL (valbenazine) for tardive dyskinesia enhances market presence in Japan.
- Royalties from MTPC's future sales of valbenazine could provide a significant revenue stream for Neurocrine.
- None.
SAN DIEGO, March 28, 2022 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced that its collaboration partner, Mitsubishi Tanabe Pharma Corporation (MTPC), obtained regulatory approval of DYSVAL® capsules 40 mg (valbenazine) for the treatment of tardive dyskinesia from the Japanese Ministry of Health, Labour and Welfare on March 28, 2022.
MTPC made a public announcement, which is available here: MTPC Announcement
Neurocrine Biosciences and MTPC Collaboration Details
In March 2015, Neurocrine Biosciences entered into a collaboration and license agreement with MTPC for the development and commercialization of valbenazine capsules for movement disorders in Japan and other select Asian markets. Under the terms of the agreement, MTPC is responsible for all development, manufacturing and commercialization costs of valbenazine in such markets. Neurocrine Biosciences would be entitled to receive royalties at tiered percentage rates on MTPC's future net sales of valbenazine in Japan and other select Asian markets for the longer of ten years or the life of the related patent rights.
About Tardive Dyskinesia (TD)
Tardive dyskinesia (TD) is a movement disorder that is characterized by uncontrollable, abnormal and repetitive movements of the face, torso and/or other body parts, which may be disruptive and negatively impact patients. The condition is associated with taking certain kinds of mental health medicines (like antipsychotics) that help control dopamine receptors in the brain. Antipsychotics commonly prescribed to treat mental illnesses such as depression, bipolar disorder, schizophrenia and schizoaffective disorder, and certain medications to treat upset stomach, nausea and vomiting may also cause TD. In patients with TD, these treatments are thought to result in irregular dopamine signaling in a region of the brain that controls movement. The symptoms of TD can be severe and are often persistent and irreversible. TD is estimated to affect approximately 600,000 people in the U.S.
About Neurocrine Biosciences
Neurocrine Biosciences is a neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs, but few options. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson's disease, endometriosis* and uterine fibroids*, as well as over a dozen mid-to-late-stage clinical programs in multiple therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn. (*in collaboration with AbbVie)
About Mitsubishi Tanabe Pharma Corporation
Mitsubishi Tanabe Pharma Corporation (MTPC), founded in 1678, is one of the oldest pharmaceutical companies in the world. Focused on ethical pharmaceuticals, MTPC is headquartered in Doshomachi, Osaka, the birthplace of Japan's pharmaceutical industry. In light of the anticipated changes in healthcare needs in the future, MTPC is advancing business activities under MISSION of "Creating hope for all facing illness," and has set the corporate vision for 2030 (VISION 30) to "Be a healthcare company that delivers optimal therapy to each individual." As part of the vision for 2030, MTPC is prioritizing work on "precision medicine" to provide drugs with high treatment satisfaction by identifying patient populations with high potential for efficacy and safety, focusing on the disease areas of central nervous system and immuno-inflammation. In addition, MTPC is working to develop "around the pill solutions" to address specific patient concerns based on therapeutic medicine, including prevention of diseases, pre-symptomatic disease care, prevention of aggravation and prognosis. MTPC is a member of Mitsubishi Chemical Holdings Group. For more information, go to https://www.mt-pharma.co.jp/e/
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SOURCE Neurocrine Biosciences, Inc.
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