Experience Developing, Seeking Regulatory Approval of and Commercializing Multi-Billion Dollar Neurology Therapies
NEW YORK, May 27, 2020 /PRNewswire/ — BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, announced today that Stacy R. Lindborg, Ph.D. has been appointed Executive Vice President Head of Global Clinical Research effective June 1, 2020. Dr. Lindborg is an experienced healthcare professional and globally recognized medical statistician with over 24 years of multinational experience in R&D, regulatory, strategy development, analytics and big data.
Prior to her appointment at BrainStorm, Dr. Lindborg spent 8 years at Biogen Inc. the global biotech that discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases. She held several senior leadership positions, most recently Vice President, Analytics and Data Science, where she built a world class Analytics and Data Sciences team, responsible for global data as well as statistical and epidemiological support for R&D and marketed products. She served on R&D governance during a time of significant growth for Biogen, and was active in guiding the firm’s long-term vision for growth through analytics and by stimulating innovative development platforms to increase productivity. As the portfolio grew to tackle a diverse set of neurological diseases, Dr. Lindborg motivated novel analytic and development approaches, shaving time off novel drug approvals to globally address chronic diseases. Her accomplishments at Biogen included a leadership role in seeking, receiving and maintaining global marketing approvals for Zinbryta®, Plegridy® and Spinraza®, all of which included novel data analytical elements. The Phase 3 Spinraza program was recognized with the prestigious 2017 Prix Galien Award Winner for Best Biotechnology Product (the biomedical industry’s highest accolade). She also played a key role in the Phase 3 development program for Aducanumab in Alzheimer’s Disease.
“The investigational NurOwn® technology platform currently in Phase 3 and Phase 2 for ALS and progressive MS, respectively, have life changing potential. This has been the most significant factor in my decision to join Brainstorm,” said Dr. Stacy R Lindborg. “I have been impressed by the leadership, depth of talent and aspiration of goals at BrainStorm. I look forward to seeing NurOwn and the Company’s pipeline advance across all stages of clinical development.”
Chaim Lebovits, Chief Executive Officer of BrainStorm, commented, “Stacy’s experience in launching and commercializing highly visible top selling neuroscience- based pharmaceutical products and her expertise in product launches from NDA to post-approval marketing studies make her exceptionally well qualified to join the BrainStorm leadership team at this pivotal time in the Company’s history. She has played leadership roles in clinical trial design and regulatory interactions for development stage and marketed products in neuroscience, immunology and orphan diseases. Her experience includes global organization design and development at two of the world’s leading neurology companies, including substantial corporate builds. Without question Dr. Lindborg, will significantly enhance our global commercialization and regulatory strategy, as we work to bring better treatment options to patients afflicted with neurodegenerative diseases. We look forward to the strategic contributions and insights she will being to BrainStorm.”
Prior to her roles in Biogen, from 1996 to 2012, Dr. Lindborg held positions of increasing responsibility at Eli Lilly and Company. As Head of R&D strategy, she was responsible for characterizing the productivity of the portfolio and driving key R&D strategy projects including the annual R&D Long-Range Plan. In this role, she created seminal insights into R&D productivity by connecting individual drug program-based development decisions to portfolio risk practices, driving fundamental R&D decisions to increase number of drug launches. Additionally, she was Leader of Zyprexa Product Management in which she was responsible for R&D, Commercial and Manufacturing plans. She was accountable for driving market share through product differentiation, global registration and launching of an injectable form of Zyprexa, working through regulatory manufacturing inspections and 483 citations. Zyprexa had peak sales of $4.7 billion.
Dr. Lindborg holds a Ph.D. in statistics from Baylor University. She has been active in professional organizations across her career, holding numerous positions within the American Statistical Association and International Biometric Society, having been elected Fellow of the association in 2008. She serves on the Scientific Advisory Board of biotechnology and technology companies and on the board of directors of the Massachusetts Down Syndrome Congress. She was a Board Member to the Strategic Initiative: Women in Statistics. Dr. Lindborg was also profiled in the book “STEM Gems” (2017) as the only women from the pharmaceutical industry highlighted as a leader in science, technology, engineering and mathematics.
NurOwn® (autologous MSC-NTF) cells represent a promising investigational 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 conditions that induce the cells to secrete high levels of neurotrophic factors. 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. BrainStorm has fully enrolled a Phase 3 pivotal trial of autologous MSC-NTF cells for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm also recently received U.S. FDA acceptance to initiate a Phase 2 open-label multicenter trial in progressive MS and enrollment began in March 2019.
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 (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm has fully enrolled a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-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 filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm also recently received U.S. FDA clearance to initiate a Phase 2 open-label multicenter trial in progressive Multiple Sclerosis. The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) started enrollment in March 2019. For more information, visit the company’s website at www.brainstorm-cell.com
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.