Armed with advanced delivery technology, pipeline assets and a manufacturing facility all spun out of Alkermes, the up-start Civitas Therapeutics is announcing today that it has garnered $20 million in Series A cash from two venture groups. And it has an experienced biotech executive, Glenn Batchelder (pictured), at the helm with a battle plan to quickly ramp up a staff to execute a pair of clinical studies designed to produce proof-of-concept data on an inhaled Parkinson's therapy in 2012.
Alkermes--perhaps best known for providing the injectable* delivery technology for the troubled Bydureon (exenatide extended-release) program--is taking assets it developed for the now extinct program for inhaled insulin once pushed by Eli Lilly and rededicating it to Civitas. The venture money, provided by founding investor Longitude Capital and Canaan Partners, should be enough to get its lead program for Parkinson's disease through a mid-stage study.
Two years from now, says the CEO, Civitas should have a solid set of Phase I and II data in hand. And by picking up the manufacturing facility in Chelsea with the deal, he adds, the biotech will be positioned to swiftly enlist a 30 to 50 person sales force to launch a new product, provided they can go on and gain an approval.
"The core of this is this technology that has the ability to deliver a very large and precise dose independent of how patients breathe in," says Batchelder, who got to know Alkermes CEO Richard Pops back when he helmed Acceleron Pharma a few years ago.
Batchelder most recently headed Bind Biosciences, a 2008 Fierce 15 company dedicated to nanotherapeutic delivery now run by Scott Minick. Jim Write, a co-founder and current chief scientific officer at Bind, is head of the new biotech's scientific advisory board. Richard Batycky, another co-founder and the former CSO at Pulmatrix, is the chief scientific officer of the startup.
Alkermes "had already done preclinical data on Parkinson's disease," explains Batchelder. After some special tweaking, he says, he and the company backers felt they can deliver a transformative and unique therapy for Parkinson's patients.
These days, most Parkinson's treatments are oral drugs that address the dopamine shortage in the brain that triggers the most severe symptoms. "The problem that patients have is that there are response fluctuations," says the CEO. "You get varying levels from dose to dose." Oral drugs can take time to kick in. And in a crisis, a patient freezes up, unable to move very well.
Civitas' approach is to reactivate the dopamine receptor with an inhaled drug that can work on the spot, theoretically giving patients better overall control of their symptoms while also offering an intervention for a crisis.
"What attracted me to this and is really unique," says Batchelder, "is that it's not often you have a technology that's so well validated, coupled with the fact that it is state of the art. Those two pieces together is a rare find."
Right now, he says, Civitas has three full-time employees. But the plan is to grow the employee roster quickly. By the end of this year he expects the staff will hit 20 as it prepares to cross the threshold into two relatively quick clinical studies. After that, he says, Civitas will be positioned to review its options.
- here's Civitas' release
*Editor's note: This article originally stated that Bydureon is an inhalable product rather than an injectable drug.