BMS Bets Big on Cardiovascular Pipeline with $13.1B MyoKardia Acquisition: Can Mavacamten Fill the O药 Revenue Gap?

Bullish on a promising drug candidate, industry giants are now directly acquiring the companies behind them.

On October 6, Bristol-Myers Squibb (BMS) and MyoKardia announced that BMS would acquire MyoKardia for $13.1 billion. On the same day, its stock price surged more than 50% to $221.25 per share, having nearly doubled since the beginning of the year. The acquisition has been approved by the boards of directors of both companies and is expected to be completed in the fourth quarter of this year.

This marks another major acquisition by BMS, which last year acquired Celgene for $74 billion, setting a record for the largest deal in pharmaceutical history.

Bristol-Myers Squibb’s globally first PD-1 inhibitor, “O drug” (Opdivo, a PD-1 inhibitor), has long dominated its revenue stream. Currently, Celgene’s flagship product Revlimid (with anti-angiogenic and antitumor properties) has become BMS’s new sales “champion,” further intensifying its revenue dependence on anticancer drugs.

This acquisition is expected to alleviate this situation, helping BMS supplement its cardiovascular drug portfolio and expand its product layout.“By acquiring mavacamten, an investigational drug from MyoKardia, we will further strengthen our cardiovascular franchise,” said Giovanni Caforio, CEO of Bristol-Myers Squibb.

MyoKardia is a clinical-stage biopharmaceutical company dedicated to the discovery and development of targeted therapies for serious cardiovascular diseases. Under the acquisition agreement, Bristol-Myers Squibb (BMS) will gain access to mavacamten, a potential “first-in-class” cardiovascular drug primarily indicated for the treatment of obstructive hypertrophic cardiomyopathy (obstructive HCM).

Supplementing the Cardiovascular Drug Pipeline with “High-Quality Ammo”?

In May this year, MyoKardia announced the data from the Phase III clinical trial EXPLORER-HCM for mavacamten. The data showed that mavacamten met the primary endpoint and all secondary endpoints, reducing blood flow obstruction in the heart and significantly improving symptoms, functional status, and quality of life in patients with obstructive HCM.

Hypertrophic Cardiomyopathy is a chronic, progressive disease in which excessive myocardial contraction impairs left ventricular filling, thereby compromising overall cardiac function; the most common cause is mutations in sarcomeric myocardial proteins.

According to statistics from Bristol-Myers Squibb (BMS), there are approximately 160,000 patients with hypertrophic cardiomyopathy (HCM) in the United States and Europe. Currently, there are no FDA-approved treatments available. The small-molecule drug mavacamten works by blocking the interaction between myosin and another protein, actin, during muscle contraction; however, it specifically targets cardiac muscle without affecting other types of muscles in the body.

Based on the clinical trial data from EXPLORER-HCM, the FDA granted mavacamten Breakthrough Therapy Designation in July of this year, and it is expected that a New Drug Application (NDA) for mavacamten will be submitted to the FDA in the first quarter of 2021.

BMS stated that it will continue to develop additional indications for mavacamten, including non-obstructive HCM. Furthermore, the company plans to advance several innovative pipeline drugs from MyoKardia that are already in clinical stages: danicamtiv (formerly known as MYK-491) and MYK-224. Danicamtiv is a next-generation myosin inhibitor indicated for dilated cardiomyopathy (DCM), while MYK-224 is being developed for the treatment of HCM.

Notably, last year Sanofi terminated its four-year collaboration with MyoKardia on the aforementioned three drugs. Reports indicated that MyoKardia was unwilling to extend the commercial rights associated with this partnership. Industry analysts further suggested that Sanofi was then repositioning its business strategy, with plans to prioritize its focus on the oncology sector.

Opdivo’s Sense of Crisis: Cardiovascular Drugs Step Up to Take the Baton

In the past few years, BMS's50+ Drug PipelinesIt shows that its drug R&D is mainly focused on hematologic cancers and solid tumors. Opdivo, the former blockbuster sales driver of Bristol-Myers Squibb (BMS), has fallen from the top spot to third place. According to the latest financial report: in the first half of 2020, Revlimid's sales reached $5.799 billion (accounting for approximately 28% of total revenue), Eliquis generated $4.804 billion in revenue, a year-on-year increase of 21%, while Opdivo achieved $3.419 billion in revenue, a year-on-year decrease of 6%.

In the PD-1 inhibitor arena, Opdivo (O drug) is invariably compared with Merck’s Keytruda (K drug). According to Merck’s financial report for the first half of 2020, Keytruda generated revenue of $6.672 billion, a year-on-year increase of 36%, accounting for 33% of the company’s pharmaceutical sales. Data from Evaluate Pharma shows that in 2019, Keytruda’s sales revenue exceeded that of Opdivo by approximately $3 billion.

In fact, the downward trend in Opdivo’s growth emerged in 2018. Starting from the second quarter of 2018, Keytruda ($1.667 billion) surpassed Opdivo ($1.627 billion), and its revenue doubled to $3.388 billion by the second quarter of 2020. In contrast, Opdivo’s revenue for the second quarter of this year was $1.653 billion, showing a decline rather than an increase.

To address the predicament of being continuously overtaken, BMS is actively expanding into cardiovascular drug development while broadening the indications for Opdivo and establishing a presence in hematologic cancers. The acquisition of mavacamten through MyoKardia is expected to generate significant commercial value for the company in the near future.Wedbush analyst David Nierengarten estimates that annual revenue for mavacamten will reach at least $2.6 billion by 2026.

In fact, Bristol-Myers Squibb (BMS) has assembled multiple pipelines in the cardiovascular field. Marketed drugs include Eliquis (apixaban), an oral factor Xa inhibitor co-developed with Pfizer, and Plavix (clopidogrel), developed in collaboration with Sanofi. Additionally, there is cimlanod, currently in Phase II trials for heart failure, and BMS-986177, a factor XIa inhibitor targeting thrombosis, developed in partnership with Johnson & Johnson.

Currently, Eliquis is an anticoagulant approved to reduce the risk of stroke and blood clots, and its sales have experienced rapid growth in recent years. In 2019, the drug generated $4.22 billion in revenue for Pfizer, a year-on-year increase of 26%, while contributing $7.929 billion in sales for Bristol-Myers Squibb (BMS), a year-on-year increase of 23%. As a result, Eliquis became one of the top ten best-selling drugs globally in 2019 and was the second best-selling drug for BMS.

A forecast report released by GlobalData in November 2019 showed that,In 2025, global sales of Eliquis will reach $18.7 billion, making it the second best-selling drug worldwide, after Merck’s Keytruda (a PD-1 inhibitor).

With the FDA’s approval of two generic versions of Eliquis for market launch, BMS and Pfizer will face challenges from 25 generic drug manufacturers in the future., but due to their active filing of lawsuits and signing of multiple settlement agreements, this “generic drug competition battlefield” has been delayed until 2026.

This article is sourced from EqualOcean, an original piece by author Mi Congcong. For reprint or collaboration inquiries, please click hereReprint Notice, Unauthorized reproduction will be subject to legal action.