NEW HAVEN, Conn., April 3, 2019 /PRNewswire/ -- (NYSE: BHVN) - Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN), today announced the appointment of William "BJ" Jones as Chief Commercial Officer, Migraine and Common Diseases. Mr. Jones will have oversight of the commercial development of the company's calcitonin gene-related peptide (CGRP) receptor antagonist platform portfolio and glutamate portfolio in Alzheimer's Disease (AD), obsessive compulsive disorder (OCD), and generalized anxiety disorder (GAD). Mr. Jones will report directly to Vlad Coric M.D., Chief Executive Officer.
Mr. Jones is a seasoned pharmaceutical executive with two decades of commercial and neuroscience expertise in large pharmaceutical companies and small biotech firms. His commercial experience includes mass market product launches for notable brands like Excedrin Migraine®, Farxiga®, Pradaxa®, BiDil®, and Abilify®. He joins Biohaven from Takeda Pharmaceuticals, Inc., where he served as Vice President, Sales and Commercial Operations. In the ten years prior to joining Takeda, he held leadership roles in marketing, operations and business development at AstraZeneca, Bristol-Myers Squibb, Boehringer-Ingelheim and NitroMed. He has led large diverse teams and has significant neuroscience (schizophrenia, bipolar, depression) and migraine experience in large primary care markets.
Mr. Jones is a graduate of the U.S. Air Force Academy and attained the rank of Major through his active duty to reserve service. He has a Master of Business Administration from Stanford Graduate School of Business and a Master of Science degree in Industrial Engineering from Texas A&M University.
Vlad Coric, M.D., CEO of Biohaven, stated, "We are enthusiastic to announce the addition of BJ to our senior leadership team and fortunate to have a leader with his deep commercial experience at Biohaven. We continue to expand our commercial talent and expertise as we rapidly progress the late stage drug candidates in our portfolio towards potential regulatory approval. BJ's appointment supports our evolution as a company, allowing us to establish two separate, strong commercial teams dedicated to harnessing the distinct market opportunities for the CGRP and Glutamate/myeloperoxidase inhibition (MPO) platform candidates."
Mr. Jones commented, "I am excited to join Biohaven at this important time as we look to advance a novel therapy to patients for the acute treatment of migraine. The prevalence of migraine is high, affecting roughly 1 out of every 7 Americans with healthcare and lost productivity costs estimated to be $36 billion annually. Migraine is the third most common disease in the world, disproportionately impacting women 3:1. Rimegepant Zydis®, with its proprietary technology, has the potential to be a best-in-class CGRP receptor antagonist with its rapid and durable treatment effect."
Also joining Biohaven to help build out the Company's market access and payer relationships is Mr. Paul Sbrilli, BPharm. Paul will serve as Vice-President of Market Access, Reimbursement and Payer Relations at Biohaven Pharmaceuticals. He joins Biohaven from Biogen where he was Senior Director of Market Access & Reimbursement. Prior to Biogen, Paul held leadership positions in managed markets and sales at Bausch and Lomb, AstraZeneca, Pfizer, Wyeth and Lederle Laboratories.
Biohaven Commercial Focus – From Rare to Common Diseases
Biohaven is advancing a portfolio of innovative, clinical-stage product candidates for the treatment of neurodegenerative, neurologic and neuropsychiatric diseases, including migraine, amyotrophic lateral sclerosis (ALS), AD, spinocerebellar ataxia (SCA), multiple system atrophy (MSA) and other neurological conditions that currently lack adequate treatment options. With the possibility of its first commercial launches of Nurtec (ALS) and rimegepant (migraine) on the horizon, Biohaven is preparing to transition to a commercial-stage company.
The appointment of BJ Jones follows the recent evolution of Biohaven's commercial team to provide expert focus on Rare and Orphan Diseases as well as Migraine and Common Diseases through two dedicated groups. Under this new structure, John Tilton will continue to lead commercial strategy as Chief Commercial Officer, Rare and Orphan Diseases, focusing on our Glutamate and MPO technology platforms in these disease areas. John was an early commercial leader at Alexion where he helped to develop the launch strategy in rare disease indications.
"We continue to be driven with a sense of urgency to fill the unmet needs of patients with orphan diseases like ALS and SCA that cause great suffering," said John Tilton. "We have made so much progress towards our planned NDA submission of Nurtec, which is anticipated to be our first approved product, and we believe this option could be transformational for people living with ALS."
About Nurtec (BHV-0223)
Nurtec (BHV-0223) is a sublingually administered, orally disintegrating tablet (ODT) form of riluzole that makes use of the unique Zydis® ODT fast-dissolve technology. It is being developed under an exclusive worldwide agreement with Catalent. While riluzole is FDA-approved for ALS, existing formulations consist only of an oral tablet taken with water or an oral suspension (thickened liquid). Nurtec is designed to be placed under the tongue where it dissolves in seconds and is absorbed by the vasculature, thereby eliminating the need for swallowing.
Rimegepant is Biohaven's orally-dosed CGRP receptor antagonist, which the Company is developing as a treatment for migraine. Rimegepant represents a novel mechanism that targets the underlying pathophysiology of migraine without causing vasoconstriction. Rimegepant has met the primary efficacy endpoints in three completed Phase 3 trials, with a favorable safety profile. The co-primary endpoints achieved in the three Phase 3 trials are consistent with regulatory guidance from the FDA and provide the basis for a planned submission of an NDA to the FDA in the second quarter of 2019.
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, glutamate modulation and myeloperoxidase inhibition platforms. More information about Biohaven is available at www.biohavenpharma.com.
Biohaven has 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®ODT 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.
Catalent is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With over 85 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 over 11,000 people, including over 1,800 scientists, at more than 30 facilities across five continents, and in fiscal year 2018 generated approximately $2.5 billion in annual revenue. Zydis® is a registered trademark of Catalent. 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 statements about the potential safety, efficacy and attractive mode of administration of the Company's drug candidates, the ability of the Company to build a successful commercial infrastructure and ability to transition to a commercial-stage company and the Company's expected timelines for submissions to regulatory authorities, are forward-looking statements. The use of certain words, including "believe," "potential" and "will" and similar expressions, is 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 those described in the "Risk Factors" section of the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 28, 2019 and other filings Biohaven makes with the U.S. Securities and Exchange Commission from time to time. 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, Chief Executive Officer, Biohaven at Vlad.Coric@biohavenpharma.com
SOURCE Biohaven Pharmaceutical Holding Company Ltd.