Rehovot, Israel – February 18, 2020 – Pharma Two B Ltd., a privately held company developing innovative therapeutics based on previously approved drugs for Parkinson disease, announced today the appointment of David S. Tierney M.D. as Chief Executive Officer, effective immediately as well as the establishment of a fully owned U.S. subsidiary to serve as the marketing base of the Company’s activities.
Pharma Two B’s main product, P2B001, is targeting patients with early stage Parkinson’s Disease. According to the Michael J. Fox Foundation for Parkinson’s Research (MJFF), Parkinson’s disease is estimated to affect nearly 1 million people in the United States and more than 6 million people worldwide. The Company estimates that approximately 15%-20% of these patients could be defined as early stage patients.
“We are excited to have David, a highly accomplished pharmaceutical executive with proven business development, medical and financial acumen, join Pharma Two B as CEO,” said Ehud Marom, Chairman of Pharma Two B’s Board of Directors. “David has a successful track record in drug approvals, developing and executing plans of commercial organizations as well as raising equity capital raising from both private and VC investors, and the public markets, including the completion of an IPO.”
Dr. Tierney stated, “I am delighted to lead Pharma Two B at this pivotal time and believe there are substantial opportunities to create significant value by registering P2B001 and building the commercial infrastructure to launch the product in the U.S. in 2021. This plan will include securing the needed financial resources for a successful launch through quality financings with high quality investors that will prepare the Company for an IPO and or strategic combination.”
P2B001 is a low dose, sustained release combination of pramipexole and resagiline. The drug is orally dosed once daily with no titration. P2B001 is near the end of the Phase 3 pivotal study and the Company is preparing for an NDA submission next year via the 505(b)(2) regulatory pathway. Dr. Tierney added, “I look forward to working with our team and board members, completing the ongoing Phase 3 study and building the infrastructure to support a successful launch, including marketing and collaboration with potential partners.”
About David S. Tierney, M.D.
Prior to David’s appointment as CEO of Pharma Two B, he was President and CEO of BioPharmX Corp (NYSE American: BPMX) and of Icon Bioscience, Inc., where he led a team that in 2018 received U.S. FDA approval of its New Drug Application (NDA) for DEXYCU™ (dexamethasone intraocular suspension), a dropless, long-acting therapeutic for treating inflammation associated with cataract surgery. Icon was merged with EyePoint Pharmaceutical, Inc (NASDAQ: EYPT) in March 2018.
Dr. Tierney served as President and COO of Oceana Therapeutics, Inc., a specialty therapeutic company he co-founded in 2008. Oceana quickly established a global commercial network and by 2011 was acquired by Salix Pharmaceuticals. In 2000, David was appointed President & CEO of Hydro Med Sciences (HMS), a research firm with a promising drug delivery platform. Under his leadership, HMS emerged as Valera Pharmaceuticals, a fully integrated, commercial, specialty pharma company that successfully completed an initial public offering in 2005. Valera has since been merged into Endo Pharmaceuticals (NASDAQ: ENDP). In total, Dr. Tierney has over 30 years of experience in executive and management positions in the pharmaceutical industry. Dr. Tierney received his medical degree from Royal College of Surgeons in Ireland.
David Tierney is the recipient of two Ernst & Young Entrepreneur of the Year® awards, first in 2005 and again in 2011, respectively, reflecting his accomplishments at Valera and Oceana. He was also featured in the inaugural 2010 Irish Life Science 50, an honor presented by the President of Ireland in conjunction the Irish Voice and Irish America Magazine. Additionally, in 2005, 2006, and 2011, PharmaVOICE 100 named David one of the most inspiring people in health sciences.
About Pharma Two B
Pharma Two B is a clinical-stage pharmaceutical company that is developing differentiated and value-added products, based on previously approved drugs. The Company’s aim is to improve efficacy, safety and delivery profiles with the goal of increasing clinical value and decreasing the timeline to regulatory approval via the US FDA 505(b)(2) regulatory pathway. The Company’s lead product P2B001 is being investigated as treatment for early stage Parkinson’s disease (PD). P2B001 has shown remarkable results in a Phase II clinical trial. Currently P2B001 is being investigated in a Phase III clinical trial. Pharma Two B is led by highly experienced team, supported by prominent scientific and clinical key opinion leaders, and backed by a dedicated group of investors. For more information, please visit: www.pharma2b.com
Irit Zalayet –
Chief Financial Officer