Pulmatrix, Mylan Reach Ex-U.S. Development Agreement For PUR0200 - Quick Facts

(RTTNews) - Pulmatrix Inc. (PULM) announced that it has entered into an ex-U.S. development agreement with Mylan N.V. (MYL). The agreement is for PUR0200, a clinical stage bronchodilator therapy being studied for chronic obstructive pulmonary disease (COPD) and the first small molecule formulation from the company's novel iSPERSE inhaled dry powder technology.

PUR0200 is under development as a once-daily therapy in a capsule-based dry powder inhaler (DPI).

PUR0200 contains a long-acting muscarinic agent (LAMA) being studied for the treatment of COPD and current clinical development is focused on pharmacokinetic bioequivalence in Europe.

According to IMS Health, global sales of LAMA monotherapies for COPD are approximately $5 billion for the 12 months ending Dec. 31, 2014 with $1.5 billion in sales outside the U.S. Continued development work under the agreement will initiate in 2015.

As per the terms of the agreement, Pulmatrix will lead the development work and pharmacokinetic clinical study with collaborative support from Mylan. Mylan has retained an option for PUR0200 ex-U.S. based on successful completion of the clinical study. Financial terms of the agreement are confidential.

In a separate press release, Pulmatrix announced a new drug candidate, PUR1900, an inhaled anti-infective to treat fungal infections associated with cystic fibrosis (CF). PUR1900 is the lead product candidate in the Company's proprietary pipeline that is strategically focused on developing innovative, first-in-class inhaled therapies for rare pulmonary diseases.

PUR1900 is a dry powder formulation of a large, complex anti-fungal compound that can be administered at high therapeutic dose to the lung while minimizing systemic side effects; in contrast, oral anti-fungal medicines that have limitations in patients with CF due to long treatment regimen and serious systemic side effects.

In addition to patients with CF, PUR1900 also has potential applications in other immunocompromised patients who have fungal infections associated with their diseases. Pulmatrix plans to present further details about the structure and composition of PUR1900, as well as pre-clinical data, at a scientific meeting later this year.

Separately, Pulmatrix, Inc., previously known as Ruthigen, Inc., announced the completion of its previously announced merger, effective June 15, 2015, and the closing of a private placement generating aggregate gross proceeds of $10.0 million.

Participants in the private placement included pre-merger investors in Pulmatrix such as funds affiliated with 5AM Ventures, ARCH Venture Partners and Polaris Partners, as well as funds affiliated with Altitude Life Science Ventures. Trading in Pulmatrix's common stock will commence today on NASDAQ on a post-reverse-stock-split basis.

In addition, the combined company expects to receive approximately $7.0 million in the form a secured credit facility from Hercules Technology Growth Capital, Inc. Pulmatrix is expected to issue a warrant to purchase 25,150 shares of its common stock at an exercise price of $8.35 per share.