MyoKardia and LianBio have entered into a strategic collaboration to develop and commercialize mavacamten in China and other Asian territories. Mavacamten is MyoKardia’s lead therapeutic candidate being developed for the treatment of patients with hypertrophic cardiomyopathy (HCM), as well as in a targeted population of patients with heart failure with preserved ejection fraction (HFpEF). The partnership will initially pursue a registration strategy for mavacamten in China for obstructive HCM, with plans for additional indications to follow, in keeping with MyoKardia’s development strategy.
LianBio was recently launched by Perceptive Advisors to partner with biopharmaceutical companies, such as MyoKardia, to accelerate the availability of medicines addressing diseases where the unmet need is significant across China.
“Hypertrophic cardiomyopathy is estimated to affect more than one million people in China alone, yet there are limited treatment options and none that target the pathophysiology of disease,” said Bing Li, LianBio’s Chief Executive Officer. “Mavacamten’s mechanism is directed to the hypercontractility that drives HCM and we have been impressed by its consistent and encouraging clinical data.”
Mavacamten will serve to anchor the portfolio for LianBio’s cardiorenal-focused subsidiary, Lian Cardiovascular. The partnership is structured to enable MyoKardia to retain certain key decision-making input over the mavacamten program in the collaboration territory as the two companies bring their respective expertise to bear to the collaboration and share learnings from each other’s respective markets . MyoKardia will receive an equity stake in Lian Cardiovascular and Tassos Gianakakos, MyoKardia’s Chief Executive Officer, will be appointed to LianBio’s Board of Directors.
“The partnership with LianBio is consistent with MyoKardia’s strategy of adding capabilities to extend our efforts to bring precision cardiovascular therapeutics to patients in need while maintaining significant influence on both our global brand and economic rights,” said Jake Bauer, MyoKardia’s Chief Business Officer. “The LianBio leadership team brings an in-depth understanding of local market dynamics and a successful track record for regional drug development, as well as a shared commitment to accelerating the availability of mavacamten in China and other territories. This combination of proven know-how and impassioned drive to bring innovative targeted treatments to patients make them an ideal partner.”
“We have structured LianBio with the intent of greatly expanding our partner’s ability to succeed as we work together to bring exciting new therapeutics to patients in need,” said Konstantin Poukalov, LianBio’s Executive Chairman and Managing Director of Perceptive Advisors. “The collaboration with MyoKardia to bring a first-in-class targeted therapeutic with the potential to be a game-changer for cardiovascular patients, such as mavacamten, to patients in China exemplifies our aim for Lian Cardiovascular.”
In addition to its equity position, under the terms of the agreement, MyoKardia will a receive a payment of $40 million at closing, with additional committed payments within the first six months of the partnership. MyoKardia may be eligible to receive regulatory and sales milestone payments of up to $147.5 million, as well as tiered double-digit royalties on the sale of mavacamten in the territories outlined as part of the collaboration. LianBio will fund all development and commercial expenses in the collaboration territory.
MyoKardia is developing mavacamten, a first-in-class, oral, allosteric modulator of cardiac myosin, for the treatment of conditions in which excessive cardiac contractility and impaired diastolic filling of the heart are the underlying cause. Mavacamten reduces cardiac muscle contractility by inhibiting excessive myosin-actin cross-bridge formation that results in hypercontractility, left ventricular hypertrophy and reduced compliance. In clinical and preclinical studies, mavacamten has consistently reduced biomarkers of cardiac wall stress, lessened excessive cardiac contractility and increased diastolic compliance.
Mavacamten is initially being developed for the treatment of hypertrophic cardiomyopathy (HCM) and has received breakthrough therapy and orphan drug designations for symptomatic, obstructive HCM. MyoKardia plans to submit a New Drug Application (NDA) for U.S. regulatory approval in this indication in the first quarter of 2021. Based on its mechanism of action and evidence of therapeutic activity, mavacamten is also being studied in the clinic for the treatment of symptomatic non-obstructive HCM, and the company plans to conduct future studies among a targeted population of patients with heart failure with preserved ejection fraction (HFpEF).