On a January morning last year, after a blizzard had covered the city with a foot of snow, Glenn Batchelder showed up for his first day of work at an old factory complex in Chelsea.
The one-time box factory, built in 1908, had been converted into a pharmaceutical manufacturing plant, but it had been vacant since 2008 when all the employees were abruptly laid off. Martin Freed, who accompanied Batchelder into the dark, cold building on that January day, kept making references to “The Shining,’’ the horror movie set in an empty Colorado hotel.
Batchelder and Freed were there to turn the lights back on, and attempt to make a new product for people suffering from Parkinson’s disease. About 1 million people in the United States have been diagnosed with Parkinson’s, a neurological disorder that causes tremors, muscle rigidity, and difficulty moving. The story of the Chelsea company, Civitas Therapeutics, traces back to 1997, and it illustrates the incredible twists and turns that life sciences companies often take.
Like most life sciences companies around Boston, Civitas’s story begins in university labs. Professors at MIT and Penn State had worked on a new kind of particle that could carry a drug deep into the lungs, allowing it to be delivered through an inhaler. “The really appealing idea was that you could get away from the needles that patients need, sometimes several times a day,’’ Batchelder says.
A company was formed, Advanced Inhalation Research, and it raised $2.1 million from Polaris Venture Partners, a Waltham venture capital firm.
Less than two years after AIR was founded, the 30-person start-up was acquired for an astonishing $125 million by another local company, Alkermes, which viewed it as a way to diversify its products beyond drugs delivered by injection. “Delivering drugs through the pulmonary system was the rage,’’ Batchelder recalls.
As part of Alkermes, the AIR team evaluated more than 50 drugs that could be delivered via the lungs. And, as is often the case with smaller pharmaceutical companies, Alkermes sought a bigger partner to help finance the research-and-development costs, get the product approved by the Food and Drug Administration, and eventually distribute and market it. They found Eli Lilly and Co., the Indianapolis maker of Cialis and other drugs.
The two companies explored ways to deliver insulin, human growth hormone, and osteoporosis drugs with an inhaler. The insulin project moved ahead quickly, in part because of the potential. Many diabetics inject themselves with insulin several times a day, and Lilly was already in the business of selling injectable insulin, giving it a vast sales force.
The partners renovated a derelict building in Chelsea, with tax breaks from the city and state, and began preparing to make the inhalable insulin powder there.
Lilly and Alkermes used a plastic inhaler that was a bit fatter and shorter than a cigar. It didn’t need to be cleaned, and was cheap enough to be tossed after 30 days. They were close to the finish line, running Phase 3 clinical trials, when Lily suddenly decided to call it quits.
The 75 people who worked at the Chelsea plant were laid off, along with another 75 Alkermes employees working on the Lilly partnership. In the press release, Lilly’s president offered only the vaguest explanation.
“One day, they were talking about adding another hundred jobs here, and it seemed like the next day, the building was being moth-balled,’’ says Jay Ash, Chelsea’s city manager.
But executives at Alkermes were hoping to find someone to adopt the technology for the inhaler and the special drug formulations that it could deliver. “Our life would’ve been a hundred times easier if the technology just didn’t work, and we could’ve just cut off our arm and moved on,’’ says Alkermes vice president Blair Jackson.
Instead, Alkermes talked to other pharmaceutical companies, but none would commit. But Batchelder and two AIR alumni were interested, and they spent almost two years assembling a plan, with Alkermes, to spin out the technology.
As Batchelder tried to recruit others who had been involved with AIR to join the new company, Civitas Therapeutics, he thought of the Blues Brothers driving around Chicago, trying to get their old band back together. (Today, almost half of Civitas’s 20 employees are veterans of AIR or the Alkermes/Lilly project. Batchelder wasn’t one, but he knew many of the key players.)
Early last year, Civitas announced $25 million in funding from three venture capital firms, along with a grant from Michael J. Fox’s Parkinson’s research foundation. Alkermes also received a significant stake in the company and a seat on the board.
Instead of insulin, Civitas is focusing on a drug called L-dopa, which has been used by those afflicted by Parkinson’s disease for decades. It helps supply the brain with dopamine, a key neurotransmitter that controls motor functions, and is lacking in Parkinson’s patients.
The company believes the inhaler could deliver the drug more quickly than pills, helping patients who are slipping into an “off state,’’ when they become stiff or can’t move.
“When you inhale L-dopa into the lungs, the effect is immediate,’’ Batchelder says. “It’s a more direct route to the brain.’’
The company believes the inhaler has the potential to generate $1 billion in worldwide sales. It plans to win FDA approval and launch the product without a partner to bankroll clinical trials or handle marketing and distribution, a rarity in the life sciences business.
“We’re doing it in a way that allows us to control our own destiny,’’ Batchelder says.
Last month, Civitas began the first stage of clinical trials of the Parkinson’s inhaler. At the factory in Chelsea, scientists were once again buzzing around the labs. Shiny metal silos for making the L-dopa powder, and two-story-tall machines that can pack it into 100,000 capsules an hour stood ready, waiting to produce something that will finally find its way into a pharmacy.