NEW HAVEN, C.T. – February 21, 2018 — Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) (“Biohaven” or the “Company”) announced today that it has entered into an exclusive worldwide license agreement with Catalent U.K. Swindon Zydis Limited, a subsidiary of Catalent, Inc. (NYSE: CTLT) (“Catalent”) to provide Catalent’s Zydis® ODT (orally disintegrating tablet) fast-dissolving formulation for the development of Biohaven’s lead calcitonin-gene related peptide (CGRP) antagonist product candidate, rimegepant. The agreement also provides exclusive rights for developing small molecule CGRP receptor antagonists with the Zydis ODT technology. Catalent’s proprietary Zydis technology is 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.
Vlad Coric, M.D., Chief Executive Officer of Biohaven, commented, “This exclusive agreement with Catalent now adds the world’s leading ODT formulation to our CGRP antagonist platform. Fast-dissolve formulations are particularly well suited for people with migraine. Migraine patients need to take acute treatments promptly, whenever and wherever an attack hits. People with migraine often have accompanying nausea and have an aversion to consuming food or liquids during an attack. The Zydis ODT formulation uniquely addresses this issue by allowing such patients to take a fast-dissolving tablet without water.”
Biohaven is progressing multiple formulations across its small molecule CGRP platform in an effort to meet patient needs across the spectrum of acute treatment and prevention of migraine. Biohaven has completed enrollment in two pivotal Phase 3 trials testing rimegepant, with over 2,800 total patients enrolled, and topline data is expected to be received before the end of the first quarter of 2018. A long-term safety trial that allows up to daily dosing of rimegepant began in August 2017 and currently has over 1,000 patients enrolled and eligible to receive rimegepant for up to one year. Biohaven’s third-generation small molecule CGRP antagonist, BHV3500, is scheduled to begin a Phase 1 study in the first half of 2018. Biohaven also continues making progress across glutamate modulation technology platforms for neurodegenerative diseases with high unmet need.
Elyse Stock, M.D., Biohaven’s Chief of Portfolio Strategy and Development added, “The Zydis ODT disperses almost instantly in the mouth – no water required, potentially allowing for pre-gastric absorption and rapid onset of action. We are on schedule to initiate an adequate and well-controlled pivotal trial with the rimegepant Zydis ODT in the first quarter of 2018 to allow for the potential to come to market with this preferred formulation without any delay to our timelines.”
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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
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 over $2 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information, visit www.catalent.com
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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 [top-line] data from the ongoing Phase 3 clinical trials of rimegepant and the initiation of the Phase 1 study of BHV-3500, as well as 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 1 trial of BHV-3500 and the ability of the Zydis ODT formulation of rimegepant to demonstrate efficacy and a favorable pharmacokinetic profile 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