At MIT and Penn State University, initial large porous particles for respiratory drug delivery are invented and described in a seminal paper published in the journal Science. Advanced Inhalation Research (AIR®) is founded by Dr. Robert Langer and Dr. David Edwards to develop pharmaceuticals for treating respiratory diseases as well as advancing systemic delivery of complex macromolecules via the lung. The company was financed by Polaris Ventures with Civitas co-founder, Dr. Rick Batycky, as one of AIR's founding employees. 1999
AIR® is acquired by Alkermes Inc.
Alkermes initiates several collaborations around the AIR® platform, including an exclusive agreement with Eli Lilly in 2001 to develop AIR® formulations of insulin and other diabetes products. 1999-2010
Alkermes develops several proprietary programs using the AIR® platform that entered clinical development such as AIR-Epinephrine and ALKS27. 2001
Technology that enables pulmonary delivery of unprecedented doses with high efficiency is invented.
Construction completed at Chelsea, MA Brickyard laboratory and commercial manufacturing facility, which was a finalist for Facility of the Year Award, sponsored by ISPE, the leading international society for pharmaceutical manufacturing. The facility was specially designed for manufacturing, filling and final packaging of large porous particle based products with a modular infrastructure capable of supporting multiple products and over 50 million commercial doses per year. 2004
Current breath actuated inhaler is invented. It has since been validated through Phase 3 including rigorous in-use and misuse testing. Eli Lilly and Alkermes broaden relationship, naming Alkemes the exclusive worldwide commercial manufacturer of AIR® Insulin, which was in Phase 3 testing at the time.
Pfizer ceases marketing its inhaled insulin product, Exubera, developed in collaboration with Nektar due to disappointing sales. 2008
Eli Lilly terminates the AIR® Insulin development program based on a commercial analysis following the removal of Exubera from the market. In its press release, Lilly noted that this decision was not a result of observations relating to the safety of the product, but rather a business decision.
Civitas Therapeutics is founded by Jim Wright, Rick Batycky, Glenn Batchelder, Martin Freed, Jennifer Fujii, and Jeff Elton. The founding insight was that the capability to deliver large precise doses with a simple breath actuated device, perfected by Alkermes for systemic delivery of proteins, had transformative therapeutic potential when applied to established small molecules agents. 2010
Alkermes spins-out their pulmonary delivery business to Civitas including the overall technology, 15 pipeline assets, 130 issued patents, and the 90,000 square foot development laboratories and commercial manufacturing facility with equipment.
Civitas closes a $25M Series A financing co-led by Longitude Capital and Canaan Partners. Civitas becomes operational based out of the Chelsea, MA facility with a lead program, CVT-301, for treating Parkinson's disease. Civitas' mission is to leverage the inhaled technology from Alkermes, along with the breadth and depth of the team's vast experience, to improve the lives of patients with breakthrough therapies. To highlight the unique attributes of the technology, Civitas renamed all the AIR platform ARCUS™ to reflect the platform's precision of an arrow combined with the effortless transport of a cloud. Civitas' mission is to leverage the ARCUS™ technology along with this deep reservoir of assets and resources to improve the lives of patients with breakthrough therapies.
|Michael J. Fox Foundation for Parkinson's Research recognizes the therapeutic promise of CVT-301 for Parkinson's patients and awards a grant supporting the product's clinical development.|