Full Press Release Details
SAN DIEGO and ALLSCHWIL, Switzerland , May 11, 2020 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX ) and Idorsia Ltd (SIX: IDIA) today announced, following Investigational New Drug (IND) application acceptance by the U.S. Food and Drug Administration (FDA), Neurocrine Biosciences has exercised its option to license the global rights of Idorsia's ACT-709478. Neurocrine Biosciences plans to initiate a Phase II study with this potent, selective, orally-active and brain penetrating T-type calcium channel blocker for the treatment of a rare pediatric epilepsy in the second half of 2020.
Martine Clozel, MD and Chief Scientific Officer of Idorsia, commented: "Our drug discovery efforts have produced a diverse pipeline of innovative compounds, addressing different diseases where treatment options are either non-existent or unsatisfactory. If the efficacy of our selective T-type calcium channel blocker seen in preclinical models is confirmed in children with rare pediatric epilepsy, it could transform the life of children with this disease. When we discover a new drug that shows promise in an indication where we have the necessary expertise, we will vigorously pursue the development ourselves. Sometimes we believe more value can be created by working with a partner. This is one such example where Neurocrine Biosciences can bring their exceptional expertise in the development of innovative drugs for neurological disorders."
About the license and collaboration agreement In 2019, Neurocrine Biosciences paid a $5 million upfront fee to Idorsia for the option rights to ACT-709478 and a preclinical research collaboration. In May 2020 , upon Investigational New Drug (IND) application acceptance by the U.S. Food and Drug Administration (FDA), Neurocrine Biosciences exercised the option to license
ACT-709478. The exercise of the option triggered an upfront payment of $45 million in cash from Neurocrine Biosciences to Idorsia. In addition, Neurocrine Biosciences will provide an incremental $7 million in funding to Idorsia as part of the research collaboration to discover, identify and develop additional novel T-type calcium channel blockers.
The agreement is subject to the following terms:
About ACT-709478 ACT-709478 is a potent, selective, orally-active and brain penetrating T-type calcium channel blocker in development for epilepsy. A Phase I clinical trial was completed in healthy adult subjects in 2019. The IND application was accepted by the FDA on April 30, 2020 . A Phase 2 study in a rare pediatric epilepsy is planned for the second half of 2020.
Idorsia has received Rare Pediatric Disease designation from the U.S. FDA for ACT-709478 for the treatment of a rare pediatric epilepsy. The FDA grants Rare Pediatric Disease designation for diseases that primarily affect children ages 18 years or younger and fewer than 200,000 persons in the U.S.
About Neurocrine Biosciences Neurocrine Biosciences is a neuroscience-focused, biopharmaceutical company with 28 years of experience discovering and developing life-changing treatments for people with serious, challenging and under-addressed neurological, endocrine and psychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson's disease and endometriosis* and clinical development programs in multiple therapeutic areas including a gene therapy for Parkinson's disease, chorea in Huntington disease, congenital adrenal hyperplasia, epilepsy, uterine fibroids* and polycystic ovary syndrome*. Headquartered in San Diego , Neurocrine Biosciences specializes in targeting and interrupting disease-causing mechanisms involving the interconnected pathways of the nervous and endocrine systems. For more information, visit neurocrine.com , and follow the company on LinkedIn . (*in collaboration with AbbVie)
About Idorsia Idorsia Ltd is reaching out for more - We have more ideas, we see more opportunities and we want to help more patients. In order to achieve this, we will develop Idorsia into one of Europe's leading biopharmaceutical companies, with a strong scientific core.
Headquartered in Switzerland - a biotech-hub of Europe - Idorsia is specialized in the discovery and development of small molecules, to transform the horizon of therapeutic options. Idorsia has a broad portfolio of innovative drugs in the pipeline, an experienced team, a fully-functional research center, and a strong balance sheet – the ideal constellation to bringing R&D efforts to business success.
Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in June 2017 and has over 800 highly qualified specialists dedicated to realizing our ambitious targets.
Idorsia Forward-Looking Statements The above information contains certain "forward-looking statements", relating to the company's business, which can be identified by the use of forward-looking terminology such as "estimates", "believes", "expects", "may", "are expected to", "will", "will continue", "should", "would be", "seeks", "pending" or "anticipates" or similar expressions, or by discussions of strategy, plans or intentions. Such statements include descriptions of the company's investment and research and development programs and anticipated expenditures in connection therewith, descriptions of new products expected to be introduced by the company and anticipated customer demand for such products and products in the company's existing portfolio. Such statements reflect the current views of the company with respect to future events and are subject to certain risks, uncertainties and assumptions. Many factors could cause the actual results, performance or achievements of the company to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking statements. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected.
SOURCE Neurocrine Biosciences, Inc.