NEW YORK, Sept. 29, 2020 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, announced today the appointment of William K. White as senior vice president, head of market access and pricing. Mr. White has more than 25 years' experience in leading successful product commercialization and securing market access for innovative new medicines.
"Bill has an extensive track record working with public and private payers to help secure patient access to innovative therapies, and brings an important skill set to BrainStorm. His appointment is part of a strategic initiative to build a senior team with proven commercial capabilities," commented Chaim Lebovits, BrainStorm's Chief Executive Officer. "Bill's experience will help us develop market access, patient services and distribution strategies that will be vital to the timely and efficient market entry of NurOwn® for ALS, assuming its approval by the FDA."
William White commented, "The life-changing potential of the investigational NurOwn technology platform, which is nearing completion of its Phase 3 pivotal trial in amyotrophic lateral sclerosis, makes this an opportune time to join BrainStorm. I look forward to leading a team that will help ensure, if approved by the FDA, that NurOwn is covered by insurers and is readily accessible to patients in need. I am proud to join a company with such visionary leadership and enormous growth potential, and I am excited about helping BrainStorm to deliver on its promise of bringing autologous cellular therapies to patients with debilitating neurodegenerative diseases."
Mr. White was most recently Vice President of Patient and Market Access at Avexis, now Novartis Gene Therapies. While at Avexis, he led a large team responsible for securing reimbursement and developing patient support services with national and regional insurers and state Medicaid payers. His work in developing and implementing the market access strategy for AVXS-101/Zolgensma® helped to expedite delivery of a novel new treatment to an underserved patient population and helped the company transition to the commercial stage. Mr. White has also held leadership positions in managed care and patient access at Insys Therapeutics and Lundbeck (formerly Ovation Pharmaceuticals).
In addition to his specialization in market access, reimbursement and distribution design and implementation, Mr. White has expertise in rare/orphan diseases, gene therapy, neuromuscular disease, managed care, and leadership development. He holds a B.S. in Business Administration from Rider University.
About NurOwn® The NurOwn technology platform (autologous MSC-NTF cells) represents a promising investigational cellular therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented culture conditions that induce the cells to secrete high levels of neurotrophic factors (NTFs). Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression.
About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has fully enrolled and dosed a phase 3 pivotal trial in ALS (NCT03280056); this trial is investigating repeat-intrathecal administration of autologous MSC-NTF cells at six U.S. sites supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a BLA filing for FDA approval of autologous MSC-NTF cells in ALS. BrainStorm is also conducting an FDA-approved phase 2 open-label multicenter trial in progressive multiple sclerosis (MS) that is now fully enrolled (NCT03799718).
Safe-Harbor Statement Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm's need to raise additional capital, BrainStorm's ability to continue as a going concern, regulatory approval of BrainStorm's NurOwn® treatment candidate, the success of BrainStorm's product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm's NurOwn® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm's ability to manufacture and commercialize the NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm's ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation, and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.