On December 20, 2021 Cytokinetics, Incorporated (Nasdaq: CYTK) and Ji Xing Pharmaceuticals Limited (JI XING), a biopharmaceutical company based in Shanghai and backed by RTW Investments, LP (RTW), reported an expansion of their collaboration by entering into an exclusive license and collaboration agreement to develop and commercialize omecamtiv mecarbil for the proposed treatment of heart failure with reduced ejection fraction (HFrEF) in Greater China (Press release, Cytokinetics, DEC 20, 2021, View Source [SID1234597480]). In addition to the license and collaboration agreement with JI XING, Cytokinetics has also entered into Common Stock Purchase Agreements that provide for the sale and issuance to entities affiliated with RTW of 511,182 of shares of Cytokinetics common stock at a price per share of $39.125.
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Pursuant to these transactions, Cytokinetics will receive committed capital of $70 million, comprised of $50 million from JI XING of upfront and near-term payments under the collaboration agreement and $20 million from RTW as proceeds for the sale of common stock. In addition, Cytokinetics will be eligible to receive up to $330 million from JI XING in additional milestone payments plus tiered royalties on the net sales of omecamtiv mecarbil in Greater China, subject to certain reductions.
"We are pleased to expand our current relationship with JI XING to now include omecamtiv mecarbil, and believe that their expertise in drug development and commercialization in China can help bring omecamtiv mecarbil to substantially more patients in an important cardiovascular market," said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. "JI XING shares our strategic vision of building a business franchise by leveraging investments in science, people and infrastructure as can benefit the potential commercialization of both omecamtiv mecarbil as well as aficamten which was the subject of our initial collaboration. Together, we believe more patients in China may benefit from both drug candidates."
"We have been impressed by our productive partnership to date focused on aficamten and are pleased to expand our collaboration to now include omecamtiv mecarbil," said Joseph Romanelli, CEO of JI XING. "Despite the advancement of heart failure treatments in China, patients continue to need novel therapies to reduce the risk of disease. With the addition of omecamtiv mecarbil to our growing cardiovascular pipeline, we have the opportunity to potentially bring a much needed, novel heart failure medicine to patients in Greater China."
"The expansion of this collaboration further brings together the expertise from both companies to support the global commercialization of omecamtiv mecarbil and represents a tremendous opportunity to create a larger footprint to impact more people with heart failure," said Roderick Wong, M.D., Chairman of JI XING and Managing Partner, RTW Investments, LP. "The two companies have demonstrated how well they work together, and we are pleased to lend further support in the interests of better cardiovascular health."
Conference Call and Webcast Information
Members of Cytokinetics’ senior management team will host a conference call and webcast today, December 20, at 8:30 AM Eastern Time. The webcast can be accessed through the Investors & Media section of the Cytokinetics website at www.cytokinetics.com. The live audio of the conference call can also be accessed by telephone by dialing either (866) 999-CYTK (2985) (United States and Canada) or (706) 679-3078 (international) and typing in the passcode 8997061.
An archived replay of the webcast will be available via Cytokinetics’ website until January 3, 2022. The replay will also be available via telephone by dialing (855) 859-2056 (United States and Canada) or (404) 537-3406 (international) and typing in the passcode 8997061 from December 20, 2021 at 11:30 AM Eastern Time until January 3, 2022.
About Omecamtiv Mecarbil
Omecamtiv mecarbil is an investigational, selective, small molecule cardiac myosin activator, the first of a novel class of myotropes1 designed to directly target the contractile mechanisms of the heart, binding to and recruiting more cardiac myosin heads to interact with actin during systole. Omecamtiv mecarbil is designed to increase the number of active actin-myosin cross bridges during each cardiac cycle and consequently augment the impaired contractility that is associated with heart failure with reduced ejection fraction (HFrEF). Preclinical research has shown that omecamtiv mecarbil increases cardiac contractility without increasing intracellular myocyte calcium concentrations or myocardial oxygen consumption.2-4
The development program for omecamtiv mecarbil is assessing its potential for the treatment of HFrEF and includes GALACTIC-HF and METEORIC-HF, a Phase 3 clinical trial designed to evaluate the effect of treatment with omecamtiv mecarbil compared to placebo on exercise capacity.
About Heart Failure
Heart failure is a grievous condition that affects more than 64 million people worldwide5 (and well over 10 million in China6) about half of whom have reduced left ventricular function.7,8 It is the leading cause of hospitalization and readmission in people age 65 and older.9, 10 Despite broad use of standard treatments and advances in care, the prognosis for patients with heart failure is poor.11 An estimated one in five people over the age of 40 are at risk of developing heart failure, and approximately 50 percent of people diagnosed with heart failure die within five years of initial hospitalization.12,13 More than 2 million people in the U.S. are estimated to have an ejection fraction <30%, indicating they may have severe heart failure.14