Biohaven Announces Positive Results From Bioequivalence Study With Sublingual Rimegepant Zydis® Orally Dissolving Tablet

NEW HAVEN, Conn., March 1, 2018 /PRNewswire/ -- Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) ("Biohaven" or the "Company") announced positive results today from its bioequivalence study with rimegepant Zydis^® orally dissolving tablets (ODT). Rimegepant is a small molecule, oral, calcitonin gene-related peptide ("CGRP") receptor antagonist currently in two pivotal Phase 3 trials for the acute treatment of migraine using a tablet formulation.  Biohaven has been working with Catalent U.K. Swindon Zydis Limited, a subsidiary of Catalent, Inc. (NYSE: CTLT) ("Catalent") to develop a new ODT formulation of rimegepant which dissolves on the tongue without the need for fluid intake.

The purpose of the bioequivalence study was to demonstrate pharmacokinetic equivalence of the rimegepant Zydis^® ODT formulation compared to the rimegepant tablet formulation used in the Phase 3 program. Topline results demonstrate that the rimegepant Zydis^® ODT achieves bioequivalent exposures relative to the current Phase 3 tablet fomulation. In the study, 34 healthy volunteers were administered rimegepant 75mg Zydis^® ODT and the current rimegepant 75mg tablet. In the pre-specified primary analysis, rimegepant Zydis^® ODT achieved area-under-the-curve and peak exposures of approximately 97% and 105%, respectively, compared to those generated by rimegepant tablet. The 90% confidence intervals were within the 80% to 125% range that is commonly used to define bioequivalence.

Vlad Coric, M.D., Chief Executive Officer of Biohaven, commented, "We are very excited about the favorable results from the study establishing the bioequivalence of our innovative rimegepant Zydis^® ODT with the tablet formulation used in the Phase 3 trials. The fast-dissolving Zydis^® rimegepant formulation is designed to enable patients with migraine to start their acute treatment promptly, without a need for swallowing liquids. The characteristics of this formulation are particularly advantageous for the acute treatment of migraine because many individuals with migraine often experience concurrent nausea or vomiting. Our rimegepant Zydis^® ODT is a convenient formulation that can be taken wherever and whenever a migraine occurs. We are progressing multiple formulations across our small molecule CGRP receptor antagonist platform in an effort to meet patient needs across the spectrum of migraine treatment."

Based upon these bioequivalence results, Biohaven is planning to initiate a Phase 3 trial with rimegepant Zydis^® ODT in the first quarter of 2018 to assess onset of action and patient satisfaction with the Zydis^® ODT formulation. Biohaven's development program enables the potential to bring rimegepant to market with this new formulation while staying on track with its original rimegepant development timeline. Biohaven expects to receive topline results from its two pivotal Phase 3 trials examining the efficacy of rimegepant 75mg oral tablet versus placebo in the acute treatment of migraine by the end of the first quarter of 2018.

Robert Croop, M.D., Chief Development Officer – Neurology, added, "We are pleased with the topline results from the bioequivalence study and look forward to introducing the rimegepant Zydis^® ODT into our Phase 3 clinical program. Our upcoming Phase 3 trial with the rimegepant Zydis^® ODT will enable the determination of the speed of onset of rimegepant for the acute treatment of migraine using this unique formulation.  Because the Zydis^® formulation disperses almost instantly in the mouth, there is no need to take it with water, potentially allowing for pre-gastric absorption and rapid onset of action."

Biohaven has an exclusive worldwide license agreement with Catalent to provide Catalent's Zydis^® ODT fast-dissolving technology for the development of Biohaven's lead CGRP receptor antagonist product candidate, rimegepant. The agreement also provides exclusive rights for developing additional small molecule CGRP receptor antagonists with the Zydis^® ODT technology. Catalent's proprietary Zydis^® technology creates a unique, freeze-dried, oral solid dosage form that disperses almost instantly in the mouth, without the need for water. With more than 20 products launched in 50 countries and a dispersion speed of three seconds or less, Zydis^® ODT is the world's fastest and best-in-class orally dissolving tablet.

About Biohaven

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, Rutgers, 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.

About Catalent

More products. Better treatments. Reliably supplied.™

Catalent is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With over 80 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. Catalent employs approximately 10,000 people, including over 1,400 scientists, at more than 30 facilities across five continents, and in fiscal 2017 generated more than $2 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information, visit www.catalent.com. 

Forward-Looking Statements

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, including the Company's expected timing of the receipt of data from the ongoing Phase 3 clinical trials of rimegepant tablet and the initiation of the Phase 3 clinical trial of rimegepant Zydis^® ODT, the overall development timeline for rimegepant, and the expected benefits of the Zydis ODT formulation of rimegepant in the acute treatment of migraine, are forward-looking statements. The use of certain words, including the "believe", "could", "expect" 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, including uncertainties relating to the timing of the receipt and statistical analysis of clinical trial data from the rimegepant trials and the initiation of the Phase 3 clinical trial of rimegepant Zydis^® ODT and the ability of the Zydis ODT formulation of rimegepant to demonstrate efficacy in clinical trials. 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 November 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.

For further information, contact Dr. Vlad Coric, the Chief Executive

Officer, at Vlad.Coric@biohavenpharma.com.

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SOURCE Biohaven Pharmaceutical Holding Company Ltd.