Bristol Myers Squibb (BMS) has completed its $13.1bn acquisition of MyoKardia, bolstering its pipeline with targeted cardiovascular clinical and pre-clinical therapies.
As part of the merger, BMS has now gained the rights to MyoKardia’s investigational treatment mavacamten, which is currently in development for obstructive hypertrophic cardiomyopathy (HCM).
In the EXPLORER-HCM study, mavacamten met the primary endpoint of a composite functional score, designed to assess symptoms and cardiac function. When compared to placebo, patients on mavacamten had greater reductions in post-exercise LVOT gradient as well as improved symptom scores.
Following the positive results, BMS is planning to submit a new drug application to the US Food and Drug Administration (FDA) in the first quarter of 2021. In addition to HCM, BMS is also set to explore the potential of mavacamten in additional indications, including non-obstructive HCM.
As well as mavacamten, BMS will develop MyoKardia’s pipeline of novel compounds, which comprises two clinical-stage therapeutics, danicamtiv and MYK-224, as well as two pre-clinical assets, ACT-1 and LUS-1.
The addition of MyoKardia’s pipeline cardiovascular candidates builds on BMS’ established presence in this therapy area. This includes the company’s oral anticoagulant Eliquis (apixaban), BMS’ second biggest product after cancer immunotherapy Opdivo (nivolumab).
However, BMS is facing competition from generic rivals of Eliquis – in December 2019, the FDA approved the first two generics of the anticoagulant drug from Micro Labs and Mylan.
Although BMS maintained at the time that the patent for composition of matter covering apixaban in the US expires in February 2023 and subsequent awards have extended until 2031, this is being challenged in the courts.
The generic competition highlights the need for BMS to move beyond its established products and line up potential therapies to offset any loss over the coming years as a result of newly-emerging rivals.
“We are excited to welcome MyoKardia colleagues to Bristol Myers Squibb. The MyoKardia team has revolutionised cardiovascular treatments to address significant unmet medical needs, and we look forward to helping more patients together,” said Giovanni Caforio, board chair and chief executive Officer of BMS.
“With MyoKardia, we are bolstering our leading cardiovascular franchise and adding exceptional scientific capabilities, a potentially transformative new medicine with significant commercial potential and a promising pipeline of candidates. Cardiovascular remains an important therapeutic area for Bristol Myers Squibb with a strong legacy and a promising future,” he added.