Biohaven Pharmaceuticals And Weill Cornell Medicine Collaborate To Initiate Proof Of Concept Trial With CGRP Receptor Antagonist In Plaque Psoriasis

• Weill Cornell Medicine’s Dr. Richard Granstein, M.D., Chairman of Dermatology, will collaborate with Biohaven to study a Calcitonin Gene-Related Peptide (CGRP) receptor-antagonist in plaque psoriasis
• Psoriasis is a chronic and painful autoimmune disease characterized by red patches of dry, cracked skin that may bleed, itch, and burn that affects 7- 8 million people in the U.S.
• CGRP is a neuropeptide believed to play an important role in the pathogenesis of inflammatory skin diseases such as psoriasis

NEW HAVEN, Conn., Nov. 16, 2020 /PRNewswire/ -- Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN), a commercial-stage biopharmaceutical company with a portfolio of innovative, late-stage product candidates, today announced that Dr. Richard Granstein, M.D., Chairman of Dermatology at Weill Cornell Medicine in New York City, will initiate an investigator-led clinical trial with a Biohaven CGRP-receptor antagonist for the treatment of plaque psoriasis.

Vlad Coric M.D., Chief Executive Officer of Biohaven commented, “Biohaven’s neuroinnovation portfolio is powered by a combination of strong science and patient need. Dr. Granstein is a foremost expert in the CGRP-related biology of dermatological conditions, which has been a focus of his research for nearly two decades. We are committed to following the science of CGRP-receptor antagonism across disease states and Dr. Granstein’s pioneering work affirms that neuropeptide CGRP may play a critical role in plaque psoriasis. This scientific foundation, together with a recognized need for more safe and effective treatment options for people suffering with psoriasis, has inspired our meaningful collaboration.”

The investigator-led clinical trial will explore whether treatment with one of Biohaven’s CGRP-receptor antagonists will reduce the severity of disease and percentage of area affected as measured by patients’ Psoriasis Activity Severity Index (PASI) score after 16 weeks of treatment as compared to placebo. In addition, the study will assess the potential impact on itch and patient quality-of-life measures.

Dr. Granstein commented, “The animal models and clinical reports of CGRP in psoriasis suggest that CGRP receptor antagonism could alleviate the severity of disease. This clinical study will enable us to evaluate this therapeutic candidate’s efficacy, the findings of which will be the first step in bringing this novel, translational idea to patients. Pathways by which the nervous system exerts regulatory effects on immunity may prove to provide important druggable targets for a range of inflammatory disorders.”

Biohaven’s CGRP-receptor antagonist platform includes Nurtec™ ODT (rimegepant) and zavegepant. Nurtec ODT™ was approved by the FDA in February 2020 for the acute treatment of migraine. Biohaven filed a supplemental New Drug Application (sNDA) for Nurtec™ ODT (rimegepant) for the preventive treatment of migraine earlier this year which was accepted for review in October 2020. The Prescription Drug User Fee Act (PDUFA) goal date for completion of the FDA review of the preventive sNDA is set for 2Q2021.

Zavegepant is a third generation, high affinity, selective and unique, small molecule CGRP receptor antagonist that is structurally distinct from rimegepant. Zavegepant may be suitable for multiple routes of delivery including nasal, subcutaneous, inhalation or oral administration. Positive results were announced in late 2019 from a Phase 2/3 study of intranasal zavegepant in the acute treatment of migraine, and the company plans to initiate an additional Phase 3 study before the end of 2020. Biohaven also initiated a Phase 2 trial with intranasal zavegepant in April 2020 in collaboration with Thomas Jefferson University in Philadelphia, PA, to study the potential benefits of CGRP receptor-blockade in mitigating an excessive immune response in pulmonary function which in some cases can be fatal in COVID-19 patients.

About Plaque Psoriasis

Psoriasis is a serious and chronic autoimmune skin disease that causes cells to develop rapidly on the skin, which affects 7-8 million people in the US alone. This overgrowth leads to formation of thick, scaly, often painful plaques that can bleed and itch. Psoriasis affects both men and women and can appear at any age. Psoriasis has a serious negative impact on patients’ lives, often leading to lost productivity, work absenteeism and significant modification of daily activities. While the exact cause of psoriasis is unknown, several different mechanisms may play a role, as well as genetic and environmental factors. Recent research suggests that the neuropeptide and vasodilator, CGRP, also contributes to the regulation of immune and inflammatory processes within the skin.

About Biohaven

Biohaven is a commercial-stage biopharmaceutical company with a portfolio of innovative, best-in-class therapies to improve the lives of patients with debilitating neurological and neuropsychiatric diseases, including rare disorders. Biohaven’s neuroinnovation portfolio includes FDA-approved NURTEC™ ODT (rimegepant) for the acute treatment of migraine and a broad pipeline of late-stage product candidates across three distinct mechanistic platforms: CGRP receptor antagonism for the acute and preventive treatment of migraine; glutamate modulation for obsessive-compulsive disorder, Alzheimer’s disease, and spinocerebellar ataxia; and myeloperoxidase (MPO) inhibition for multiple system atrophy and amyotrophic lateral sclerosis. More information about Biohaven is available at www.biohavenpharma.com.

Forward-Looking Statements
This release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The use of certain words, including “believe”, “continue”, “may”, “will” and similar expressions, are intended to identify forward-looking statements. These forward-looking statements involve substantial risks and uncertainties, including statements that are based on the current expectations and assumptions of Biohaven’s management about the potential use of Biohaven’s CGRP receptor antagonists as a treatment for patients with plaque psoriasis. Factors that could affect these forward-looking statements include those related to: Biohaven’s ability to effectively develop a CGRP receptor antagonist for the treatment of plaque psoriasis, complying with applicable U.S. regulatory requirements, the expected timing, commencement and outcomes of Biohaven’s planned and ongoing clinical trials, the timing of planned interactions and filings with the FDA, the timing and outcome of expected regulatory filings, the potential commercialization of Biohaven’s product candidates, the potential for Biohaven’s product candidates to be first in class or best in class therapies and the effectiveness and safety of Biohaven’s product candidates. 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 Biohaven’s Annual Report on Form 10-K for the year ended December 31, 2019, filed with the Securities and Exchange Commission on February 26, 2020 and Biohaven’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2020 filed with the Securities and Exchange Commission on November 9, 2020. The forward-looking statements are made as of this date and Biohaven 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.

Biohaven Contact
Dr. Vlad Coric
Chief Executive Officer
Vlad.Coric@biohavenpharma.com

NURTEC is a trademark of Biohaven Pharmaceutical Ireland DAC.

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