The acquisition will give Bristol-Myers Squibb full rights to Cardioxyl’s lead asset CXL-1427, a novel nitroxyl (HNO) donor (prodrug) in Phase 2 clinical development as an intravenous treatment for acute decompensated heart failure (ADHF). The transaction includes upfront and near-term milestone payments of up to $300 million and potential additional consideration of up to $1.775 billion upon the achievement of certain development, regulatory and sales milestones. The transaction, which is expected to be dilutive to 2015 GAAP EPS by approximately $0.12, with minimal dilution to non-GAAP EPS in both 2015 and 2016, has been approved by the boards of directors of both companies.
CXL-1427 releases nitroxyl, a molecule that has demonstrated beneficial effects on heart muscle and vascular function. Pre-clinical and early clinical data indicate that CXL-1427 improves how the heart muscle contracts and relaxes without increasing heart rate or the demand for oxygen. Current therapies for ADHF that improve heart muscle function produce an increase in heart rate and/or oxygen consumption, and are associated with an increased risk for ischemia, arrhythmias and increased mortality.
"The acquisition of Cardioxyl strengthens Bristol-Myers Squibb’s heart failure pipeline with a Phase 2 asset that has the potential to change the course of the disease rather than simply treating the symptoms," said Francis Cuss, MB BChir, FRCP, executive vice president and chief scientific officer, Bristol-Myers Squibb. "Bristol-Myers Squibb is uniquely positioned, with our understanding of patient needs in the hospital setting and our heritage in cardiovascular diseases, to continue development of CXL-1427 as a potential new therapy to address the clinical and economic burden of heart failure."
"We are excited about the breadth of drug development capabilities and cardiovascular expertise that Bristol-Myers Squibb will bring to the nitroxyl donor program," said Christopher A. Kroeger, M.D., President and Chief Executive Officer, Cardioxyl. "Heart failure is an important and under-served therapeutic area and we believe Bristol-Myers Squibb is the optimal partner to bring new therapeutic options to the patients who need them."
Bristol-Myers Squibb and Cardioxyl anticipate the transaction will close during the fourth quarter of 2015. Closing of the transaction is subject to customary closing conditions, including clearance under the Hart-Scott-Rodino Antitrust Improvements Act.
About ADHF
Heart failure is the leading diagnosis for patients at the time of discharge from U.S. hospitals and the most common cause of hospitalization for patients over 65 years of age. ADHF is the sudden or gradual onset of symptoms, such as shortness of breath, edema, and fatigue, in patients with heart failure leading to hospitalization. Despite the prevalence and severity of the condition, the treatment options available for patients with ADHF remain limited. In the U.S., the treatment of HF has a direct cost of over $34 billion per year, most of which results from hospitalization.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
About Cardioxyl Pharmaceutical, Inc.
Cardioxyl Pharmaceuticals is focused on the discovery and development of new classes of safe and effective therapeutic agents for the treatment of cardiovascular disease. Cardioxyl has developed industry-leading expertise in the chemistry, biology and clinical applications of nitroxyl (HNO) technology. The company's core HNO platform has generated several pre-clinical and clinical candidates. Cardioxyl is a privately held company financed by life science venture investors, including New Enterprise Associates, OrbiMed, Aurora Funds and Osage University Partners.
