Espero Pharmaceuticals, a privately held, commercial-stage cardiovascular pharmaceutical company, and Armetheon, a privately held, late-clinical stage pharmaceutical company developing novel drugs addressing major unmet needs in cardiovascular diseases, today announced their plans to merge. Upon completion of the merger, which is expected to occur in the second quarter of 2017, the combined company will be named Espero BioPharma, Inc.

The merger will create a premier cardiovascular biopharmaceutical company with a portfolio of recent FDA-approved products, a robust late-stage pipeline, and a growth plan focused on developing innovative products, acquisitions and the commercialization of portfolio products in the U.S. and with partners worldwide. Armetheon recently announced it has reached agreement with the FDA for a single 1,000 patient final pivotal trial for its leading drug candidate, tecarfarin (Tecarfarin for AntiCoagulation Trial or TACT) prior to filing a New Drug Application (NDA), which is currently projected to occur in 2019.

Tecarfarin is positioned to potentially be, if approved, the oral anticoagulant (OAC) therapy of choice for patients who require anticoagulation with a Vitamin K antagonist (VKA), such as warfarin. There are at least 15 conditions requiring OAC therapy where a VKA such as warfarin is predominantly used because of a need for a strong anticoagulant, contraindications, or recommended by professional medical societies. These conditions represent at least 1.7 million patients in the U.S. alone, with 91% of these patients taking at least one cytochrome P450 (CYP) interacting drug.

“Armetheon’s promising late stage pipeline and Espero’s leadership and commercialization expertise will result in a biopharmaceutical company solely focused on commercializing standard of care medicines as well as developing and approving late stage candidates treating cardiovascular diseases,” said Peter Milner, co-founder and executive chairman, Armetheon.

Espero’s currently marketed products include GoNitro (nitroglycerin) sublingual powder for the acute relief and prophylaxis of angina pectoris, which recently was awarded recognition by the Journal of Emergency Medical Services. Leveraging its existing and scalable commercial platform, Espero has the ability to commercialize tecarfarin and potential new product acquisitions.

“Cardiovascular diseases are the number one cause of death in the U.S. and worldwide, yet less than 10% of the new chemical entities approved by FDA in the last six years are for the treatment of cardiovascular diseases,” said Quang Pham, founder, chairman and chief executive officer, Espero. “Espero is committed to bringing new treatment options to patients in this underinvested therapeutic category, while also delivering significant benefits to all our stakeholders.”

Mr. Pham was selected by both boards of directors to lead the new company.