-- Company prepares for late stage development and commercialization of CVT-301--
CHELSEA, Mass. – January 29, 2014 – Civitas Therapeutics, Inc., a biopharmaceutical company with a lead program in Parkinson’s disease that utilizes the proprietary ARCUS(TM) respiratory delivery platform, today announced the appointment of Mark Iwicki as President and Chief Executive Officer. Mr. Iwicki is
an accomplished pharmaceutical executive with a successful track record leading fully integrated organizations, developing therapeutics across all stages and launching multiple successful products. Mr. Iwicki has also been elected to the Board of Directors. Mr. Iwicki succeeds Glenn Batchelder, co- founder and CEO from the company’s inception, who will remain an active member of the Board of Directors.
“Having successfully launched numerous products in the pulmonary and central nervous system (CNS) therapeutic areas, Mark is uniquely qualified to direct the advancement of Civitas’ lead program CVT- 301, for Parkinson’s disease, into late stage clinical development,” said Tim Nelson, Chairman of the Board of Directors. “Mark’s proven ability to lead high performance teams from early development through commercialization will help achieve the Civitas mission to build a robust and sustainable pipeline around the ARCUS(TM) platform. The Board would like to thank Glenn Batchelder for his leadership and contributions to Civitas’ remarkable success to date.”
Mr. Iwicki has more than 24 years of experience as a pharmaceutical industry leader across multiple therapeutic areas. He has extensive experience building brands and has been instrumental in the success of a number of drugs, including Prilosec®, Diovan®, Zelnorm®, Lunesta®, and Latuda®. Prior to joining Civitas, Mr. Iwicki was CEO of Blend Therapeutics and CEO of Sunovion Pharmaceuticals, which was created after the acquisition of Sepracor by Dainippon Sumitomo Pharmaceuticals. At Sepracor, Mr. Iwicki served as Chief Commercial Officer for the company, launching three products and managing all aspects of the company’s portfolio. Prior to joining Sepracor in 2007, he was the senior vice president and head of the cardiovascular business unit at Novartis Pharmaceuticals. He began his career with management positions of increasing responsibility at Astra Merck and Merck.
“It is a great privilege to join the Civitas team during this pivotal period and fully capitalize on the unique capabilities of the ARCUS(TM) technology," said Mr. Iwicki. “Civitas unites a highly differentiated and clinically validated platform, a fully-operational commercial manufacturing facility, a lead program addressing a significant unmet need for Parkinson’s patients and an opportunity to produce transformative therapies.”
"Mark shares the Civitas commitment to make a difference in patients' lives," said Mr. Batchelder. "He is dedicated to helping Civitas become a leading biopharmaceutical company and is the ideal candidate to direct the company during this next phase of success."
About Civitas Therapeutics
Civitas Therapeutics is a privately-held biopharmaceutical company focused on developing a robust pipeline of inhaled therapeutics with the clinically-proven ARCUS(TM) dry powder pulmonary delivery platform. The company’s lead program, CVT-301, is being developed as adjunctive, on-demand (PRN) therapy to provide Parkinson’s disease patients with rapid and reliable relief from intermittent debilitating motor fluctuations (OFF episodes). OFF episodes result from the unreliability of current medications -- a problem impacting about half of all Parkinson’s disease patients. In April 2013, Civitas announced positive results for CVT-301 in a Phase 2 dose-ranging study. The company has completed enrollment of a Phase 2b study to evaluate the efficacy and safety of CVT-301 in treating emergent OFF episodes during one month of continued use, with data expected by the end of the first quarter of this year. The Company’s pipeline also includes products for respiratory disease, central nervous system disorders and infectious disease.
The ARCUS(TM) platform is a proprietary dry powder and device combination with a unique ability to deliver a large, precise dose independent of inspiratory flow rate from a simple, breath actuated device and is protected by a large intellectual property estate. The technology has successfully delivered more than one million doses to patients and the manufacturing technology has been scaled to accommodate a significant commercial launch. The Company is financed by leading investors including Alkermes plc, Bay City Capital, Canaan Partners, Fountain Healthcare Partners, Longitude Capital and RA Capital.
For further information on Civitas, please visit www.civitastherapeutics.com.
For additional information contact:
Stephanie Gillis Maureen L. Suda (Media)
Civitas Therapeutics Suda Communications LLC