Specialty pharmaceuticals firm, Espero Pharmaceuticals and cardiovascular drugs company, Armetheon announced plans to merge to form Espero BioPharma, which will focus on developing drugs for unmet cardiovascular indications. The new entity will be headed by Quang Pham, founder, chairman, and CEO of Espero Pharmaceuticals. The merger is expected to complete during Q2 2017. Financial details were not disclosed.
“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,” Pham stated. “Espero is committed to bringing new treatment options to patients in this underinvested therapeutic category, while also delivering significant benefits to all our stakeholders.”
“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,” added Peter Milner, M.D., Armetheon’s co-founder and executive chairman.
The new firm will inherit a combined portfolio and pipeline of FDA-approved, pivotal-stage and Phase II candidates for treating cardiovascular disorders. Espero Pharmaceutials’ GONITRO™ (nitroglycerin) sublingual powder for the acute relief of an attack or prophylaxis of acute angina, was approved by the FDA in June 2016.
Armetheon’s lead product, Tecarfarin, is an oral vitamin K-antagonist anticoagulant that isn’t metabolized by the CYP450 system, and so may offer an alternative to warfarin in patients who are CYP2C9 deficient (30% of the population) and in patients who are on drugs that inhibit CYP2C9 (30% of the population), the firm claims. Armetheon says the drug may also allow greater INR stability than therapy with warfarin, and have utility in patients with mechanical and prosthetic heart valves, and patients with renal dysfunction.
Last month, Armetheon reported reaching an agreement with the FDA that a single, 1000-patient, final, pivotal tecarfarin trial (Tecarfarin for AntiCoagulation Trial; TACT) will be sufficient to support a future NDA filing, which the firm said is projected for 2019. The agency also confirmed that Armetheon could amend an existing Special Protocol Assessment for the TACT study. The pivotal trial will evaluate tecarfarin in patients requiring anticoagulation for any indication, including those with prosthetic heart valves. Also last month, Armetheon reported that the European Medicines Agency’s (EMA) Scientific Advice Working Group (SAWG) had separately advised that a single, 1000-patient pivotal study would support an MAA for tecarfarin in Europe.
Armetheon’s second clinical candidate, the oral antiarrhythmic drug candidate, budiodarone, is in Phase II development for treating refractory atrial fibrillation, and is also in development for suppressing ventricular arrhythmias and device firing in patients with implantable cardioverter defibrillators (ICDs).