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Capsugel and Pulmatrix Enter Collaboration

February 16, 2016

Will develop and manufacture novel inhaled therapeutics

Capsugel and Pulmatrix have formed a collaboration to develop novel inhaled therapeutics to treat serious pulmonary diseases. The agreement provides Capsugel exclusive rights to manufacture clinical trial and commercial batches of iSPERSE-based inhaled therapeutic candidates being developed by Pulmatrix and its potential development partners. Capsugel will combine its spray drying process development, scale-up expertise and commercial manufacturing capabilities at its Bend Research facility in Bend, Or with Pulmatrix's iSPERSE (inhaled small particles easily respirable and emitted) technology.

"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, head of alliance strategy at Bend Research, a division of Capsugel Dosage Form Solutions. "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."

Pulmatrix's iSPERSE dry powder technology is a small, dense and dispersible engineered particle technology that enables pulmonary delivery of drugs with high delivery efficiency, dose reproducibility and flow-rate independence. Several products leveraging the iSPERSE platform are in development, including a lead clinical stage bronchodilator (PUR0200) for chronic obstructive pulmonary disease (COPD), an inhaled anti-fungal (PUR1900) for cystic fibrosis (CF) and a pipeline of products for use in the treatment of rare pulmonary diseases, CF and idiopathic pulmonary fibrosis.

"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," said Robert Clarke, chief executive officer, Pulmatrix.

Pulmatrix's chief scientific officer, David Hava, said, "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."

Capsugel and Pulmatrix have played leadership roles in the development of spray drying as an enabling technology to address the limitations of conventional lactose blending dry powder inhaler (DPI) and metered dose inhaler (MDI) technologies. Spray drying technology provides fewer formulation dependencies, the ability to deliver either crystalline or amorphous drugs, and tighter particle size distribution than that provided by lactose blend technology. This engineered particle approach and expertise applied to the iSPERSE technology translates into improved delivery efficiency, flow-rate independence and drug dosing for patients.

Capsugel continues to make significant investments to maintain and build its premier spray drying capabilities and capacity. In June 2015, Capsugel completed a two-year, more than $25 million investment to expand Bend Research's spray drying commercial manufacturing facility, providing the company with the largest integrated pharmaceutical spray drying technology capability in North America. Capsugel is also investing to expand its late-stage inhalation offering to include full cGMP analytical services and large-scale encapsulation for DPI applications.

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