Pleco Therapeutics Announces Expansion with the Incorporation of a U.S. Subsidiary and the Appointme
Nijmegen, Netherlands and Newark, N.J., July 26, 2022 (PRNewswire) — Pleco Therapeutics BV, a specialty biopharmaceutical company developing novel treatments designed to detoxify the cancer promoting cellular micro-environment, today announces its expansion, with the incorporation if a U.S. subsidiary, Pleco Therapeutics USA, Inc., alongside the appointment of Michael Stalhamer as its President and first employee. Mr Stalhamer also serves on the global leadership team as Vice President (VP) Product Development and Regulatory Affairs.
Incorporated in Delaware, Pleco Therapeutics USA, Inc., will operate from New Jersey. The formation of a U.S. subsidiary reflects Pleco’s corporate development as it advances its Plecoid™ product, PTX-061 and readies for commercialisation, with the aim of improving the effectiveness of chemotherapy in patients with Acute Myeloid Leukaemia (AML).
Mr. Stalhamer joins from STI Pharma where he has been VP Regulatory Affairs & Product Development for the past 13 years. He brings over 25 years’ experience in pharmaceutical /biotechnology and medical device research, operations, engineering, facility and equipment design, regulatory affairs, quality assurance and marketing gained in the US, India and Europe. Prior to STI Pharma, his experience included roles at Heritage Pharmaceuticals, Artes Medical, Amylin Pharmaceuticals, GlaxoSmithKline and Novartis. During that time, he managed facility upgrades, progressing products from Phase II/III through to commercialization of sterile and non-sterile pharmaceutical products as well as medical devices. He has worked closely with the FDA in putting together IND/NDA/ANDA and PMA submissions and gaining timely approval of a number of pharmaceutical and medical device products in a variety of therapeutic areas. He also has experience in negotiating and managing development contracts for the launch and manufacturing of generic as well as branded products. He received his MS in Chemical Engineering from New Jersey Institute of Technology (NJIT) and his BS from Rutgers University, College of Engineering.
Ivo Timmermans, Chief Executive Officer of Pleco Therapeutics BV, said: “We are delighted to welcome Michael to head up our new US operations. He will be a valuable addition to our leadership team as he has exactly the experience we need to manage the development, registration and commercialization of our first Plecoid™ product.
“The USA is a critical market and getting our products to patients will deliver on our goal of improving the effectiveness of existing chemotherapy and changing the outcome for patients with relapsed cancers.”
Plecoid™ agents are patented, innovative treatments that include chelating agents with specific characteristics, that change the balance of toxic metals in the cell as a novel approach to treating cancer.
Michael Stalhamer newly appointed President of Pleco Therapeutics USA, Inc., said: “This is an exciting time to be joining the Pleco team, as it is at a pivotal point in its product development. Whilst there are always hurdles ahead, the potential of our Plecoid™ products looks very promising in various cancer models and other therapeutic areas.”
In the coming months, Pleco anticipates securing additional finance and further expanding its team.