Biohaven Announces Expedited Development Path for BHV-0223 Following Successful Pre-IND Interaction With FDA

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Biohaven Pharmaceutical Holding Company Ltd. (d/b/a Biohaven) announced receiving favorable and productive feedback from their Pre-Investigational New Drug Application (PIND) interaction with the Food and Drug Administration (“FDA”). Biohaven received a written response from FDA in lieu of an in-person meeting.

Company Plans for Timely Completion of Bioequivalence Study and NDA Submission

Biohaven Pharmaceutical Holding Company Ltd. (d/b/a Biohaven) announced receiving favorable and productive feedback from their Pre-Investigational New Drug Application (PIND) interaction with the Food and Drug Administration (“FDA”). Biohaven received a written response from FDA in lieu of an in-person meeting. The PIND response pertained to Biohaven’s investigative product, BHV-0223, and the intended initial registrational program for the indication of amyotrophic lateral sclerosis (“ALS”).

BHV-0223 is a unique formulation of riluzole, a glutamate modulating agent, that utilizes the Zydis® ODT fast-dissolve technology under an exclusive worldwide agreement with Catalent. Agents that modulate glutamate neurotransmission may have therapeutic potential in multiple disease states involving glutamate dysfunction, including ALS, Alzheimer’s disease, Rett syndrome, dementia, dystonia, tinnitus, anxiety disorders, and affective disorders like major depressive disorder. Biohaven is pursuing the use of glutamate modulating agents across several therapeutic indications.

The formal correspondence received from the FDA discussed clinical, nonclinical, and regulatory issues for BHV-0223, including the IND-opening clinical trial design and a proposed development plan for ALS. No issues were identified in the FDA response that would impede Biohaven’s planned bioequivalence trial in 2016. The key highlights from the PIND meeting feedback include:
¥ The FDA agreed that the 505(b)2 pathway is acceptable for BHV-0223 in ALS.
¥ The FDA agreed that no additional efficacy or toxicology studies are necessary for submission of the NDA.

Vlad Coric, M.D., CEO of Biohaven, commented, “We now have a clear regulatory path forward for BHV-0223 in ALS. The responses we received from FDA were aligned with our expectations, and no material issues were raised that would delay the timely initiation of our bioequivalence study. Our clinical program will expand upon our existing data with BHV-0223 and the goal will be to establish bioequivalence to the active pharmaceutical ingredient (riluzole) with lower doses of our new formulation. After we establish bioequivalence in the upcoming trial and demonstrate the advantages of this formulation to patients, we will be in position for a timely NDA submission. We believe that the enhanced formulation, dosage and route of administration of BHV-0223 will benefit patients with this devastating disease.”

The dosing of BHV-0223 proposed in the IND-opening clinical trial was based on the results of a successful Phase I trial (BHV223-101). This trial assessed the tolerability and unique pharmacokinetic characteristics of BHV-0223, in both single and multiple dosing in humans. Study BHV223-101 also compared the drug exposures of BHV-0223 and riluzole, the standard generic treatment for ALS.

Biohaven’s Chairman, Declan Doogan M.D., stated, “The Biohaven team continues to demonstrate their ability to develop and execute on their strategy for BHV-0223. Biohaven will next take steps to prepare for an anticipated commercialization of the investigational agent upon successful results from the planned bioequivalence study.”

About Biohaven

Biohaven is a privately-held biopharmaceutical company engaged in the identification and development of clinical stage compounds targeting the glutamatergic system. Biohaven owns a substantial amount of intellectual property and has also licensed intellectual property from Yale University and Massachusetts General Hospital. Biohaven is owned by a group of investors including Portage Biotech Inc. (OTC Market: PTGEF, Canadian Securities Exchange: PBT.U), Yale University and other private investors. Biohaven’s first drug candidate, BHV-0223, is a novel formulation of riluzole that modulates glutamate and is being developed under FDA 505(b)(2) guidelines. The FDA approved Biohaven’s BHV-0223 Investigational New Drug application (IND) in August 2015 and Biohaven has completed a PK study in humans, which findings enable the bioequivalence study start in 2016. Biohaven plans to advance other glutamatergic agents and is actively exploring licenses for additional compounds.

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Dr. Declan Doogan, Chairman
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