Bristol Myers Squibb (BMS) is set to acquire MyoKardia for $13.1bn, in an effort to bolster its pipeline with targeted cardiovascular therapies.
As part of the merger, BMS will gain 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 now 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 set to explore the potential of mavacamten in more 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.
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.
“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, 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,” he added.