Wednesday, October 25, 2023
A biotechnology company focused on delivering innovative medicines to patients in China and other significant Asian markets has recently announced a major agreement with Bristol-Myers Squibb (BMS). This agreement grants BMS exclusive rights to develop and commercialize mavacamten in various markets, including mainland China, Hong Kong, Macau, Taiwan, Singapore, and Thailand. The exclusive license agreement, originally signed by Liantuo with MyoKardia (now a wholly-owned subsidiary of BMS) in August 2020 to secure these rights, will also be terminated simultaneously.
Under the terms of this agreement, Liantuo Biotech will receive a one-time payment of US$350 million. Furthermore, the remaining milestone payment obligation of US$127.5 million to be paid to MyoKardia, as per the previously established license agreement with Liantuo, will be waived.
In April 2023, China's National Medical Products Administration (NMPA) accepted the New Drug Application (NDA) for mavacamten, specifically for the treatment of adult patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM), designating it as a Priority Review. During the same period, mavacamten also received approval in Macau SAR, China, and Singapore for treating adult patients with symptomatic oHCM.
Liantuo Biotech, expressed, "For the past three years, we have been working closely with BMS to bring mavacamten to patients in Asia. The Liantuo team has executed the clinical trials of mavacamten extremely well in the licensed regions, developing a robust registration strategy, and is fully prepared for the drug's launch. We anticipate that mavacamten will receive marketing approval in China next year. With BMS holding global rights to this product, they are well-positioned to promote mavacamten effectively in the Chinese market through Liantuo, enhancing accessibility to this innovative drug for patients in these regions."
Bristol-Myers Squibb, emphasized the importance of expanding their presence in China and bringing innovative medicines to patients suffering from conditions like oHCM. Lenkowsky stated, "oHCM significantly impacts the lives of patients, so we are excited to build on the solid foundation laid by Liantuo Biotech to make mavacamten available to more patients worldwide."
As part of this agreement, BMS plans to offer employment opportunities to certain Liantuo Biotech employees responsible for the development and commercialization of mavacamten.
The transaction also coincides with Liantuo Biotech's board of directors initiating a comprehensive strategic assessment of the company's business. The results of this strategic review are expected to be announced in the first half of 2024.
Mavacamten, marketed as Camzyos®, is the first and currently the only cardiac myosin inhibitor approved by the U.S. FDA for treating symptomatic adult patients with New York Heart Association (NYHA) functional class II-III obstructive hypertrophic cardiomyopathy (oHCM). It has also obtained approval in the EU for treating symptomatic adult patients with oHCM in NYHA cardiac function class II-III. Regulatory approvals for marketing have been granted in Australia, Brazil, Canada, the United Kingdom, the Macau Special Administrative Region of China, Singapore, South Korea, and Switzerland. Camzyos operates as a selective, allosterically reversible inhibitor of cardiac myosin, reducing the likelihood of force generation (systole) and residual (diastole) cross-bridge formation. This addresses mechanistic features of HCM, reducing dynamic left ventricular outflow tract (LVOT) obstruction and improving cardiac filling pressures in HCM patients.
Hypertrophic cardiomyopathy is a chronic, progressive disease characterized by excessive contraction of the heart muscle, leading to left ventricular blood filling obstruction, debilitating symptoms, and heart dysfunction. It's estimated that approximately 1 in 500 people globally suffers from hypertrophic cardiomyopathy. The condition is often linked to mutations in cardiac sarcomeric proteins. Patients with hypertrophic cardiomyopathy, whether obstructive or non-obstructive, may experience fatigue or dyspnea during strenuous physical activity, affecting their daily lives. The condition is also associated with an increased risk of atrial fibrillation, stroke, heart failure, and sudden cardiac death. In China, there are approximately 1.1 to 2.8 million patients with hypertrophic cardiomyopathy.
Source: globenewswire.com
