NEW HAVEN, Connecticut, March 6, 2018 /PRNewswire/ — Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) announced today that it has enrolled the first patient in a Phase 3 clinical trial of the Zydis® orally dissolving tablet (“ODT”) formulation of rimegepant for the acute treatment of migraine. Rimegepant is a potent, orally available small molecule calcitonin gene-related peptide (“CGRP”) receptor antagonist in late stage development for the treatment of migraine.
The Phase 3 clinical trial will assess the onset of action, patient satisfaction, efficacy and safety of the fast-dissolve Zydis® ODT formulation of rimegepant. Biohaven has been working with Catalent U.K. Swindon Zydis Limited, a subsidiary of Catalent, Inc. (NYSE: CTLT) (“Catalent”) to develop this new ODT formulation of rimegepant and extend additional delivery formulations across its CGRP platform. Biohaven has entered into an exclusive agreement with Catalent for the use of the Zydis® ODT formulation technology in the development of small molecule CGRP receptor antagonists. The trial will randomize approximately 850 patients across two treatment arms, rimegepant 75 mg ODT versus placebo.
Vlad Coric, M.D., Chief Executive Officer at Biohaven, commented, “Biohaven is committed to bringing the most differentiated oral, small molecule CGRP receptor antagonist to patients suffering from migraine. The fast-dissolving Zydis® ODT rimegepant formulation is designed to conveniently enable people experiencing a migraine attack to promptly initiate their acute treatment without the need for taking with liquids. We believe that rimegepant Zydis® ODT has the potential to be a best-in-class therapy option for the acute treatment of migraine.”
Robert Croop, M.D., Chief Development Officer – Neurology, at Biohaven, added, “This clinical trial with the new fast-dissolve Zydis® ODT formulation complements our ongoing work with rimegepant. We are very pleased to incorporate the trial into our ongoing Phase 3 clinical program. We believe that the rimegepant Zydis® ODT will be a desirable new approach for the acute treatment of migraine.”
Biohaven continues to expect topline results from its two pivotal Phase 3 trials examining the efficacy of rimegepant 75 mg oral tablet versus placebo by the end of the first quarter of 2018, and expects topline results from the Phase 3 trial with rimegepant Zydis® ODT in the fourth quarter of 2018.
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.
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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.
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 the Phase 3 clinical trial of rimegepant Zydis® ODT 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 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.