“This collaboration provides us with access to Capsugel’s spray dry technology, scale-up capabilities, and state-of-the-art equipment to support our growing pipeline of internal and partnered development programs,” Dr. Robert Clarke, Pulmatrix’s CEO, said in a press release. The agreement provides Capsugel with exclusive rights to manufacture both clinical trial and commercial batches of iSPERSE-based inhaled therapeutic candidates being developed by Pulmatrix and its potential development partners.
iSPERSE is described as a dry powder, small, dense, and dispersible engineered particle technology that enables efficient pulmonary delivery of drugs, with dose reproducibility and flow-rate independence. Currently, there are several products in development to leverage the iSPERSE platform, such as PUR1500, an inhaled product for the treatment of idiopathic pulmonary fibrosis (IPF); PUR1900, an inhaled anti-fungal for cystic fibrosis (CF); and PUR0200, a lead clinical stage bronchodilator for chronic obstructive pulmonary disease (COPD).
“In the near term, Capsugel will fulfill manufacturing needs for our planned clinical trial activities in cystic fibrosis and, longer term will enable us to manufacture iSPERSE-based products at commercial scale. With this partnership, we can achieve these goals cost-effectively and without the risk or required capital to build and maintain these essential capabilities,” said Dr. David Hava, Pulmatrix’s CSO.
Both companies have been working on the development of spray drying as a means of overcoming the limitations of conventional lactose blending metered dose inhaler (MDI) and dry powder inhaler (DPI) technologies. According to the release, spray drying technology provides fewer formulation dependencies, has the ability to deliver either crystalline or amorphous drugs, and has tighter particle size distribution than lactose blend technology. In June 2015, Capsugel completed a two-year, over $25 million expansion of its Bend Research spray drying commercial manufacturing facility in Bend, Oregon.
“This strategic partnership with Pulmatrix puts our companies at the forefront of bringing unique inhalation products to the market to deliver better patient outcomes,” said Dan Dobry, Capsugel’s head of Alliance Strategy at Bend Research. “We look forward to working with Pulmatrix to help advance its pipeline of proprietary and partnered products utilizing our spray dry technology and infrastructure, and to jointly explore opportunities to collaborate with the broader pharmaceutical industry to develop next-generation inhalation therapies.”