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Flex Pharma, Inc. (NASDAQ:FLKS), a clinical-stage biotechnology company that is developing innovative and proprietary treatments for cramps and spasticity associated with severe neurological diseases including multiple sclerosis (MS), Charcot-Marie-Tooth (CMT) and amyotrophic lateral sclerosis (ALS) under FDA Fast Track designation, today announced that the Board of Directors has appointed William McVicar, Ph.D., as President and Chief Executive Officer of Flex Pharma.
Dr. McVicar joined Flex Pharma in April 2017 as President of Research & Development. In June 2017, Dr. McVicar was appointed interim President and CEO with Christoph Westphal, M.D., Ph.D. continuing to serve as Chairman of the Board of Flex Pharma.
“On behalf of the Board of Directors, I am excited to announce Bill as the permanent President and CEO of Flex Pharma,” said Dr. Westphal. “As a company, we have made important strides in recent months across our therapeutic portfolio, most notably with the recent Fast Track designation granted by the FDA for the development of FLX-787 for the treatment of severe muscle cramps in patients with ALS. I believe that Bill and the entire senior management team will succeed in executing on our business strategy while optimizing shareholder value over the long-term.”
“At Flex Pharma, we are dedicated to developing and delivering novel treatments for neuromuscular disorders to patients in need,” said Dr. McVicar. “It is an honor to be named as President and CEO of a company focused on alleviating severe cramping and spasticity prevalent among incurable neurological diseases, such as ALS, CMT and MS. We are encouraged by the Fast Track designation received for FLX-787, one of the most advanced, novel compounds for severe neurological diseases, and look forward to continued collaboration with the FDA in this phase of accelerated clinical development. We are on track to initiate Phase 2 clinical trials of FLX-787 in both ALS and CMT this quarter in the US. These studies will yield important data readouts in 2018.”
“Following a thorough search process, Bill emerged as the best leader for the company as it enters this important phase of clinical execution,” said Dr. Rod MacKinnon, Nobel laureate and Flex Pharma Scientific Co-Founder, Board Member, and Scientific Advisory Board Co-Chair. “Flex Pharma is well positioned for clinical and operational success. I have full confidence in Bill to lead the continued advancement of our potentially life-altering therapies through the necessary regulatory pathways and ultimately deliver to the patients who currently have no safe and effective options.”
Dr. McVicar has a track record of clinical development and operational success with nearly 30 years of experience, most recently serving as Chief Scientific Officer at Inotek. During his tenure at Inotek, he also served as Executive Vice President of Pharmaceutical Development, Chief Scientific Officer, and President. Prior to Inotek, he served as Vice President of Development Operations at Sepracor, where he oversaw the development, FDA review, and approval of multiple NDAs and SNDAs, including BROVANA®, XOPENEX MDI®, and XOPENEX’s pediatric approval, which were each approved in a single 10-month review cycle. Dr. McVicar and Flex Chief Medical Officer Thomas Wessel, M.D., Ph.D. worked together at Sepracor through the U.S. approval of LUNESTA®. Prior to Sepracor, Dr. McVicar held various positions of increasing responsibility at Sandoz, Novartis and Rhone Poulenc Rorer.
About Flex Pharma
Flex Pharma, Inc. is a clinical-stage biotechnology company that is developing innovative and proprietary treatments for cramps and spasticity associated with the severe neurological diseases including ALS, MS and Charcot-Marie-Tooth (CMT). The Company’s lead candidate, FLX-787, is being developed under Fast Track designation for the treatment of severe muscle cramps associated with ALS. Flex Pharma was founded by National Academy of Science members Rod MacKinnon, M.D. (2003 Nobel Laureate), and Bruce Bean, Ph.D., recognized leaders in the fields of ion channels and neurobiology, along with Chair Christoph Westphal, M.D., Ph.D.
Forward-Looking Statements
This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, the design and timing of ongoing and anticipated clinical trials, including the timing for results of our clinical trials. These forward-looking statements are based on management's expectations and assumptions as of the date of this press release and are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation: the status, timing, costs, results and interpretation of our clinical studies; the uncertainties inherent in conducting clinical studies; our ability to enroll patients in each of clinical studies on a timely basis; expectations of our ability to make regulatory filings and obtain and maintain regulatory approvals; availability of funding sufficient for our foreseeable and unforeseeable operating expenses and capital expenditure requirements; the inherent uncertainties associated with intellectual property; and other factors discussed in greater detail under the heading "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2016 and subsequent filings with the Securities and Exchange Commission (SEC). You are encouraged to read our filings with the SEC, available at www.sec.gov, for a discussion of these and other risks and uncertainties. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.