New Haven, Connecticut (NYSE: BHVN) November 6, 2017 – Biohaven Pharmaceutical Holding Company Ltd. (“Biohaven” or the “Company”) and its wholly owned subsidiary, Biohaven Pharmaceuticals, Inc., today announced that the first subject was dosed in its bioequivalence study designed to demonstrate the pharmacokinetic equivalence of sublingual BHV-0223 compared to Rilutek (riluzole).
Biohaven is developing BHV-0223, a sublingual formulation of riluzole, as a potential treatment for patients with Amyotrophic Lateral Sclerosis (ALS). Previously, the Company reported that the FDA had concluded its review of the investigational new drug (IND) application and notified Biohaven that it may proceed with its clinical program. Biohaven previously received regulatory feedback from the FDA that the Section 505(b)(2) pathway is acceptable for BHV-0223 in ALS, and that no additional efficacy or toxicology studies are necessary for submission of a new drug application (NDA) for this indication.
BHV-0223 is an innovative sublingually administered and orally dissolving tablet (ODT) formulation of riluzole, a glutamate modulating agent, which is designed to advance beyond the current limitations of riluzole tablets. While riluzole tablets are FDA-approved for ALS, they may be difficult to administer in ALS patients, who often have dysphagia or trouble swallowing. The riluzole tablets also have certain pharmacokinetic (PK) and pharmaceutic limitations, including being associated with a negative food effect that can result in uncertain PK performance (low bioavailability) due to patients not fasting one hour before or two hours after taking the tablets. BHV-0223 is unique in that it utilizes the Zydis® ODT fast-dissolve, dosing technology developed under an exclusive worldwide agreement with Catalent. In a Phase 1 clinical trial, 35 mg BHV-0223 was associated with less PK variability than 50 mg Rilutek tablets.
Vlad Coric, M.D., Chief Executive Officer of Biohaven, commented, “We are excited to advance the unique BHV-0223 Zydis® orally dissolving tablet (ODT) formulation into the clinic. If positive, the current study will establish the bioequivalence of sublingually administered BHV-0223 and thereby offer patients an optimized formulation with enhanced pharmaceutic properties.”
Beyond its planned bioequivalence study in ALS, Biohaven is making progress across its oral, small molecule calcitonin gene receptor peptide (CGRP) antagonist and glutamate modulation technology platforms.
Biohaven is a clinical-stage biopharmaceutical company with a portfolio of innovative, late-stage product candidates targeting neurological diseases, including rare disorders. Biohaven has combined internal development and research with intellectual property licensed from companies and institutions including Bristol-Myers Squibb Company, AstraZeneca AB, Yale University, Catalent, ALS Biopharma LLC and Massachusetts General Hospital. Currently, Biohaven’s lead development programs include multiple compounds across its CGRP receptor antagonist and glutamate modulation platforms. The company’s common shares are listed on the New York Stock Exchange and traded under the ticker symbol BHVN. More information about Biohaven is available at www.biohavenpharma.com.
This news release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements involve substantial risks and uncertainties, including statements that are based on the current expectations and assumptions of the Company’s management. All statements, other than statements of historical facts, included in this press release regarding the Company’s business and product candidate plans and objectives are forward-looking statements. Forward-looking statements include those related to: the expected timing, commencement and outcomes of the Company’s planned and ongoing clinical trials, the expected pharmacokinetic and pharmaceutic properties of BHV-0223, the expected advantage of BHV-0223 over riluzole tablets, and the timing and outcome of expected regulatory filings. The use of certain words, including “believe”, “may”, “expects” and “will” and similar expressions, are intended to identify forward-looking statements. The Company may not actually achieve the plans and objectives disclosed in the forward-looking statements and you should not place undue reliance on the Company’s forward-looking statements. Various important factors could cause actual results or events to differ materially from those that may be expressed or implied by our forward-looking statements. Additional important factors to be considered in connection with forward-looking statements are described in the “Risk Factors” section of the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 14, 2017. The forward-looking statements are made as of this date and the Company does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
Dr. Vlad Coric
Chief Executive Officer
Biohaven Pharmaceutical Holding Company Ltd.
Phone: (203) 404-0410