-Strengthens team as CVT-301 Phase 2b trial completes patient enrollment -
CHELSEA, Mass. – January 8, 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 Timothy S. Nelson as Chairman of the Board of Directors. Civitas also announced today that it has completed enrollment in its ongoing Phase 2b clinical study for its lead compound CVT-301, with data expected by the end of the first quarter of this year. CVT-301 is being developed as an adjunct, as needed (PRN) therapy to potentially provide rapid and reliable relief from intermittent debilitating motor fluctuations (OFF episodes) that affect many Parkinson’s disease patients.
“Tim brings an exceptional track record of transformative leadership and company building across a broad range of therapeutic and medical device domains. His recent experience leading MAP Pharmaceuticals, initially as a privately-held platform company and ultimately as a publicly-traded late stage development company will be particularly relevant in helping to guide Civitas’ continued growth,” said Glenn Batchelder, Chief Executive Officer and Co-Founder of Civitas. “With our shared focus on improving patients’ lives and his proven talent for building shareholder value, we are pleased to welcome Tim as Chairman of the Board.”
“Civitas has a highly-validated drug inhalation platform, a potentially transformative Parkinson’s therapy with important upcoming clinical data and a management team with an exceptional record of execution. This unique combination provides a strong foundation to build a company with a robust portfolio of differentiated therapies," said Mr. Nelson. “I am delighted to be joining the Civitas Board and look forward to supporting the team as they deliver on the company’s remarkable promise.”
Mr. Nelson has more than 20 years of experience with drug delivery, medical devices and drug device combinations. Most recently he was Chief Executive Officer of MAP Pharmaceuticals, where he led the company through its initial public offering and developed LEVADEX, inhaled dihydoergotamine for migraine, through NDA filing (Allergan acquired MAP in March 2013). Prior to MAP, he served as Senior Vice President of Business and Commercial Development of Durect Corporation and previously held various positions at Medtronic including Business Director of Neurological Division for Europe, Middle East and Africa, and Manager of Drug Delivery Ventures and Business Development where he implemented growth initiatives for innovative therapies treating a variety of medical disorders. Mr. Nelson holds a bachelor’s degree in chemical engineering from the University of Minnesota and a master of management degree with distinction from the J.L. Kellogg Graduate School of Management, Northwestern University.
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 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 is currently conducting a Phase 2b study to evaluate the efficacy and safety of CVT-301 in treating emergent OFF episodes during one month of continued use. 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