Pharma Two B announced 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.”
“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,” Dr. Tierney said.
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.
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Prior to Dr. Tierney’s appointment as CEO of Pharma Two B, he was President and CEO of BioPharmX and of Icon Bioscience, 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 in March 2018.
Dr. Tierney served as President and COO of Oceana Therapeutics, 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, Dr. Tierney 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. 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.