Bellerophon Therapeutics Expands License Agreement With INO Therapeutics to Develop INOpulse(R) for Three Additional Cardiopulmonary Diseases

License Doubles Potential INOpulse Indications in Product Pipeline


HAMPTON, N.J., July 29, 2015 (GLOBE NEWSWIRE) -- Bellerophon Therapeutics, Inc. (Nasdaq:BLPH), a clinical-stage biotherapeutics company, today announced that it has expanded its license agreement with INO Therapeutics LLC, a division of Mallinckrodt plc (NYSE:MNK), allowing Bellerophon to develop INOpulse® for the treatment of three additional cardiopulmonary diseases, including chronic thromboembolic pulmonary hypertension (CTEPH), pulmonary hypertension associated with sarcoidosis and pulmonary hypertension associated with pulmonary edema from high altitude sickness. Bellerophon's existing exclusive, worldwide, royalty-free license with INO Therapeutics covers the development of INOpulse to treat patients with pulmonary arterial hypertension (PAH), pulmonary hypertension associated with COPD (PH-COPD) and pulmonary hypertension associated with idiopathic pulmonary fibrosis (PH-IPF). Terms of the expanded license agreement include a 5% royalty on net sales for the three additional indications.

Jonathan Peacock, Chairman and Chief Executive Officer of Bellerophon Therapeutics, noted, "We are pleased to expand our agreement with INO Therapeutics. While nitric oxide is currently approved for use in the hospital setting to treat pulmonary hypertension in neonates, we believe that INOpulse, our portable nitric oxide delivery system, is well suited for use in a wide range of additional chronic conditions. This expanded license gives us the ability to broaden our targeted population of patients suffering from pulmonary hypertension. The three new indications will complement our ongoing clinical activities of INOpulse in PAH, which is entering Phase 3 with patient recruitment expected to start later this year, and in PH-COPD, which has completed a Phase 2a trial."

About INOpulse

Bellerophon's INOpulse is a drug-device combination system that is targeted to reducing pulmonary hypertension in patients with this condition, including patients with PAH and PH-COPD. The INOpulse system is designed to deliver pulsed doses of pharmaceutical-grade nitric oxide, a molecule naturally produced in the endothelial lining of blood vessels that plays a significant role in vasodilation, or opening of the arteries, including arteries in the lung. INOpulse is also designed to be portable for chronic at-home use and is programmed to automatically adjust based on patients' breathing patterns to deliver consistent dosing. The device has approximately the same dimensions as a paperback book and weighs about 2.5 pounds. It incorporates a simple, intuitive user interface and has an estimated battery life of 24 hours when recharged.

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. For more information, visit www.bellerophon.com.

Forward-looking Statements

Any statements in this press release about Bellerophon's future expectations, plans and prospects, including statements about the clinical development of Bellerophon's current and future product candidates, constitute forward-looking statements for purposes of the safe harbor provisions under 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 clinical trials, availability and timing of data from ongoing and future clinical trials and the results of such trials, availability of funding sufficient for Bellerophon's foreseeable and unforeseeable operating expenses and capital expenditure requirements and other factors discussed in the "Risk Factors" section of Bellerophon's most recently filed Annual Report on Form 10-K and Quarterly Report on Form 10-Q and in other filings that Bellerophon makes with the Securities and Exchange Commission. Any forward-looking statements represent Bellerophon's views only as of the date of this press release. Bellerophon anticipates that subsequent events and developments will cause its views to change. While Bellerophon may elect to update these forward-looking statements at some point in the future, Bellerophon specifically disclaims any obligation to do so.



            

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