10/05/2020 

米BMS、バイオ医薬を買収

米製薬大手Bristol Myers Squibb(BMS)は5日、米バイオ医薬のマイオカルディア(MyoKardia)を131億ドル(約1兆4000億円)で買収すると発表した。マイオカルディアが開発する心臓病の治療薬を取り込み、心血管疾患の領域を強化する狙い。

BMSは1株あたり225ドルを現金で支払う。前週末の2日終値(139.6ドル)から6割高い水準だ。

 

Bristol Myers Squibb to Acquire MyoKardia for $13.1 Billion in Cash

Mavacamten Is a Potential First-in-Class Medicine with Compelling Data in the Treatment of Patients with Symptomatic Obstructive Hypertrophic Cardiomyopathy

Mavacamten Will Be a Medium- and Long-Term Growth Driver Presenting a Significant Commercial Opportunity upon Approval

Promising Portfolio of Pipeline Candidates Strengthens and Extends Bristol Myers Squibb’s Leading Cardiovascular Franchise

Expected to be Accretive to Non-GAAP Earnings Starting in 2023

Bristol Myers Squibb and MyoKardia, Inc. today announced a definitive merger agreement under which Bristol Myers Squibb will acquire MyoKardia for $13.1 billion, or $225.00 per share in cash. The transaction was unanimously approved by both the Bristol Myers Squibb and MyoKardia Boards of Directors and is anticipated to close during the fourth quarter of 2020.

MyoKardia is a clinical-stage biopharmaceutical company discovering and developing targeted therapies for the treatment of serious cardiovascular 心臓血管diseases. Through the transaction, Bristol Myers Squibb gains mavacamten, a potential first-in-class cardiovascular medicine for the treatment of obstructive hypertrophic cardiomyopathy 閉塞性肥大型心筋症 (“HCM”), a chronic heart disease with high morbidity and patient impact. A New Drug Application (“NDA”) for mavacamten for the treatment of symptomatic obstructive HCM – based on data from the EXPLORER-HCM study – is expected to be submitted to the U.S. Food and Drug Administration (“FDA”) in the first quarter of 2021. Bristol Myers Squibb expects to explore the full potential of mavacamten in additional indications, including non-obstructive HCM, as well as develop MyoKardia’s promising pipeline of novel compounds, including two clinical-stage therapeutics: danicamtiv (formerly MYK-491) and MYK-224.

“The acquisition of MyoKardia further strengthens our portfolio, pipeline and scientific capabilities, and is expected to add a meaningful medium- and long-term growth driver,” said Giovanni Caforio, M.D., Board Chair and Chief Executive Officer of Bristol Myers Squibb. “We are further strengthening our outstanding cardiovascular franchise through the addition of mavacamten, a promising medicine with the potential to address a significant unmet medical need in patients with cardiovascular disease. Our companies share a commitment to innovation and bold science, and our respective strengths will help us realize the value inherent in this portfolio. We have long admired MyoKardia and what they have done to revolutionize cardiovascular treatments through a precision medicine approach. We look forward to welcoming their talented team to our company.”

“MyoKardia was formed eight years ago with the aim of changing the world for people with serious cardiovascular diseases through bold and innovative science. Since then, MyoKardia’s dedicated employees have established an unparalleled pipeline of targeted therapeutics designed to change the course of disease and return the heart to normal function,” said Tassos Gianakakos, Chief Executive Officer of MyoKardia. “Bristol Myers Squibb shares our vision for transforming the treatment of cardiovascular disease. They value our team and the potential of our platform and, most importantly, share our unwavering commitment to placing patients at the center of everything we do. Together, our complementary strengths and expanded resources and reach will further accelerate the pace at which we can discover, develop and commercialize our novel medicines for the benefit of people suffering from cardiovascular disease around the world.”

Compelling Benefits

Bristol Myers Squibb expects the transaction, when complete, to:

  • Further strengthen the company’s outlook with the addition of mavacamten, which has significant commercial potential in the lead indication, obstructive HCM, and upside in additional future indications, including non-obstructive HCM .
    With the high unmet medical need in obstructive HCM, mavacamten can be a significant medium- and long-term growth driver. Mavacamten demonstrated clinically meaningful results in the pivotal Phase 3 EXPLORER-HCM trial, meeting the primary and all secondary endpoints, and showed meaningful improvements in symptoms, functional status and quality of life by reducing the obstruction of blood flow from the heart. This potential first-in-class medicine, for which an NDA is expected to be submitted to the FDA in the first quarter of 2021, may help to change the course of the disease.
  • Accelerate the expansion of Bristol Myers Squibb’s cardiovascular portfolio.
    Bristol Myers Squibb has established Eliquis® (apixaban) as the #1 oral anticoagulant globally with a best-in-class profile, driven by leading commercial execution.Mavacamten will be a fully owned asset that fits well into Bristol Myers Squibb’s existing portfolio, given the company’s broad expertise in cardiovascular disease. Through this acquisition, Bristol Myers Squibb gains MyoKardia’s critical talent and capabilities on the U.S. West Coast, which will support fully realizing the opportunity in obstructive HCM and exploring the full potential of mavacamten in additional indications. Bristol Myers Squibb will also be well positioned to advance the global development of MyoKardia’s portfolio of clinical- and early-stage pipeline candidates, while continuing to advance its existing Factor XIa inhibitor program.
  • Deliver significant financial benefits.
    The transaction is expected to add a significant growth driver during the medium- to long-term. It is expected to be minimally dilutive to Bristol Myers Squibb’s non-GAAP earnings per share (EPS) in 2021 and 2022 and accretive beginning in 2023. Bristol Myers Squibb reaffirms its existing 2021 non-GAAP EPS guidance range. There is no reliable estimable comparable GAAP measure as described below.

Transaction Terms and Financing

Under the terms of the merger agreement, a subsidiary of Bristol Myers Squibb will promptly commence a tender offer to acquire all of the outstanding shares of MyoKardia’s common stock for $225.00 per share in cash. MyoKardia’s Board of Directors unanimously recommends that MyoKardia shareholders tender their shares in the tender offer.

The transaction is subject to customary closing conditions, including the tender of a majority of the outstanding shares of MyoKardia’s common stock and the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. Following the successful closing of the tender offer, Bristol Myers Squibb will acquire all remaining shares of MyoKardia that are not tendered into the tender offer through a second-step merger at the same price of $225.00 per share.

Bristol Myers Squibb expects to finance the acquisition with a combination of cash and debt.

About Hypertrophic Cardiomyopathy

Hypertrophic cardiomyopathy, or HCM, is a chronic, progressive disease in which excessive contraction of the heart muscle and reduced ability of the left ventricle to fill can lead to the development of debilitating symptoms and cardiac dysfunction. HCM is estimated to affect one in every 500 people.

The most frequent cause of HCM is mutations in the heart muscle proteins of the sarcomere. In approximately two-thirds of HCM patients, the path followed by blood exiting the heart, known as the left ventricular outflow tract (LVOT), becomes obstructed by the enlarged and diseased muscle, restricting the flow of blood from the heart to the rest of the body (obstructive HCM). In other patients, the thickened heart muscle does not block the LVOT, and their disease is driven by diastolic impairment due to the enlarged and stiffened heart muscle (non-obstructive HCM). In either obstructive or non-obstructive HCM patients, exertion can result in fatigue or shortness of breath, interfering with a patient’s ability to participate in activities of daily living. HCM has also been associated with increased risks of atrial fibrillation, stroke, heart failure and sudden cardiac death.

There are currently approximately 160,000 to 200,000 people diagnosed with symptomatic obstructive HCM across the U.S. and EU, with no existing effective treatment options beyond limited symptomatic relief.Patients are typically diagnosed in their 40s or 50s and the treatment is expected to be chronic. It is estimated that only approximately 25 percent of individuals with obstructive HCM and only approximately 10 percent of individuals with non-obstructive HCM have received a diagnosis.