Vectura, a company specialized in inhaled airway products, will now be responsible for all future development costs to advance the product in the country.
Pulmatrix is best known for its patented iSPERSE technology that was used in developing PUR0200. iSPERSE is delivery platform for dry powder therapies, aiming to maximize drug concentrations in the lungs and reduce systemic side effects.
“Vectura has deep experience with inhaled drugs and innovative dry powder delivery technologies which makes them an optimal partner to advance PUR0200 as a better product for COPD patients,” Robert W. Clarke, PhD, chief executive officer of Pulmatrix, said in a press release.
PUR0200 is a once-daily, inhaled reformulation of tiotropium bromide, the active component in Spiriva HandiHaler, an approved COPD therapy by Boehringer Ingelheim. PUR0200, a “branded generic” of Spiriva, was seen in early clinical studies to almost five times more efficient in delivering treatment to the lungs than the approved therapy, Pulmatrix reports.
In a Phase 1 clinical study (NCT01921712) with 38 COPD patients divided into five groups — given one of three doses of PUR0200 (3, 6 or 9 mcg), placebo or Spiriva HandiHaler — PUR0200 was also found to be well-tolerated with mild adverse events.
PUR0200 9 mcg was shown to provide a 4.5 times higher lung dose of tiotropium than Spiriva’s 18 mcg of tiotropium. Lung function also improved significantly with all doses compared to placebo, and was similar to that attained with Spiriva.
These results were reported in a 2015 article published in The European Respiratory Journal.
Pulmatrix will provide Vectura with the necessary data for PUR0200 and assist with all necessary activities. As part of the agreement, a technology access fee of $1 million will be paid to Pulmatrix upon successful achievement of pre-agreed criteria.
Pulmatrix will also receive a percentage of revenues from the sale of PUR0200 and PUR0200-related products should it be approved for use.
“By out-licensing the program to Vectura, PUR0200 is in the hands of a partner with a demonstrated ability to develop drugs for COPD and allows Pulmatrix to focus on our product pipeline,” Clarke said.
The company reports on its website that PUR0200 is “poised to enter pivotal studies to support [its] registration.”