Bellerophon Therapeutics Announces Notice of Intention to Grant a European Patent Supporting Its INOpulse Program

WARREN, N.J., Jan. 21, 2016 -- Bellerophon Therapeutics, Inc. (Nasdaq:BLPH), a clinical-stage biotherapeutics company, today announced that the European Patent Office has issued a Notice of Intention to Grant a European Patent that provides protection for the company’s INOpulse program.  The patent, entitled “System of Administering a Pharmaceutical Gas to a Patient,” covers the ability to provide a known amount of pharmaceutical gas to a patient regardless of the patient inspiration rate or volume and distinguishes the INOpulse® delivery system from others on the market. Upon grant by the European Patent Office, the patent can be officially validated in up to 38 European countries.

The administration of a pharmaceutical gas patent is currently issued in the United States as well as in Australia, China, Hong Kong, Japan, and Mexico.  Patent applications are pending in Brazil and Canada.  In addition, the INOpulse program is protected by issued patents in the United States covering the tri-lumen cannula and the indexed valve for the drug cartridge, with patent applications pending in multiple countries including the European Union.

Jonathan Peacock, Chairman and Chief Executive Officer of Bellerophon Therapeutics, stated, “We are pleased to announce the Intention to Grant for the System of Administration patent.  This further supports the innovative technology of the INOpulse delivery system and marks another important milestone in our continued efforts to develop and bring the INOpulse therapy to the European market.”

INOpulse Clinical Program Focus

The focus of the company’s INOpulse clinical program is the continued development of its nitric oxide therapy for patients with pulmonary hypertension (PH). The lead indication for INOpulse is Pulmonary Arterial Hypertension (PAH), for which FDA issued Special Protocol Assessment for the Phase 3 program and agreement was reached with European Medicines Agency (EMA) through their Scientific Advice Working Party (SAWP) process.  The Phase 3 program will include 2 confirmatory trials in approximately 450 patients.  The primary endpoint for each trial is Six Minute Walk Distance (6MWD), with Time to Clinical Worsening (TTCW) as a secondary endpoint, pooled across both trials. In September 2015, Bellerophon released encouraging results from the long-term extension of the company’s Phase 2 PAH clinical trial demonstrating benefit for patients on long-term oxygen therapy whose disease is progressing despite taking one or more existing PAH therapies.  Bellerophon also plans to continue with Phase 2 testing in PH associated with Chronic Obstructive Pulmonary Disease (PH-COPD) and PH associated with Idiopathic Pulmonary Fibrosis (PH-IPF) for which results are anticipated by the end of 2016.

About Bellerophon

Bellerophon Therapeutics is a clinical-stage biotherapeutics company focused on developing innovative therapies at the intersection of drugs and devices that address significant unmet medical needs in the treatment of cardiopulmonary and cardiac diseases. The company is currently developing three product candidates for patients with Pulmonary Hypertension under its INOpulse program, a proprietary pulsatile nitric oxide delivery device. For more information, please visit www.bellerophon.com.

Forward-looking Statements

Any statements in this press release about our future expectations, plans and prospects, including statements about clinical development of our product candidates and expectations regarding the sufficiency of our cash balance to fund clinical trials, operating expenses and capital expenditures, and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation of future clinical trials, availability and timing of data from ongoing and future clinical trials and the results of such trials, whether preliminary results from a clinical trial will be predictive of the final results of that trial or whether results of early clinical trials will be indicative of the results of later clinical trials, expectations for regulatory approvals, availability of funding sufficient for our foreseeable and unforeseeable operating expenses and capital expenditure requirements and other factors discussed in the “Risk Factors” section of our most recent filings with the Securities and Exchange Commission. In addition, any forward-looking statements included in this press release represent our views only as of the date of this release and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligation to update any forward-looking statements included in this press release.

Contact
At Bellerophon:
Amy Edmonds, Vice President
Head of Clinical Operations & Administration
(908) 574-4765

At Rx Communications Group:
Melody Carey
(917) 322-2571
[email protected]