Cytokinetics is following in the footsteps of Bristol Myers Squibb as it prepares to try to wrest control of a heart disease market away from the Big Pharma.
About a year after BMS backed the launch of an American Heart Association (AHA) initiative, Cytokinetics has stepped up to support the expansion of the program.
BMS is the founding sponsor of the AHA’s three-year plan to standardize how patients with the heart disease hypertrophic cardiomyopathy (HCM) are identified, assessed, referred and treated. The HCM treatment pathway currently leads to Camzyos, a cardiac myosin inhibitor that BMS acquired in its $13.1 billion takeover of MyoKardia.
Cytokinetics could win FDA approval for a rival drug this year. Weeks away from its PDUFA date, the company has provided the AHA with financial support to expand the project that began on BMS’ dime.
The AHA said in a Monday announcement that it will use Cytokinetics’ funding, which reportedly matches that of BMS, to add more sites to an HCM registry, expand certification opportunities for referring centers and introduce patient support services at some facilities. It’s also planning to set up a future pilot program implementing its HCM detection algorithm.
“Too many patients living with HCM face a lack of awareness about their condition, delayed diagnoses, and limited access to specialty care,” Cytokinetics CEO Robert Blum said in the release. “We are proud to support the American Heart Association to advance a more standardized and comprehensive system of care.”
The support comes as Cytokinetics prepares to launch aficamten, a cardiac myosin inhibitor that could compete with Camzyos for the HCM market. The FDA delayed a decision on the molecule earlier this year. Having since worked through the issues, Cytokinetics executives sounded upbeat on an earnings call early this month.
“Our interactions with the FDA to date have reinforced our expectations for a differentiated risk mitigation profile anchored in [Risk Evaluation and Mitigation Strategies] and label, and we have confirmed our go-to-market plans and promotional campaign,” Andrew Callos, chief commercial officer at Cytokinetics, told investors. “Following anticipated approval in December, our launch process will begin immediately.”
Cytokinetics plans to activate its website, patient navigators and patient support services within days of the approval, which is due by Dec. 26. Cardiovascular sales and medical teams will be in the field from early January, Callos said, as Cytokinetics works to call on most or all of its 650 target prescribers in the first few weeks of launch.
Cytokinetics has also created a campaign targeting healthcare professionals to support the sales reps, the commercial chief shared during the call.
“We've developed a distinct and compelling promotional HCP campaign that highlights the differentiating characters of aficamten and key attributes of our REMS program,” Callos said. “We believe this campaign will clearly communicate the clinical value of aficamten and support broad awareness among cardiologists.”
Aficamten will be up against Camzyos, sales of which grew (PDF) 88% over the first nine months of the year to hit $714 million. Adam Lenkowsky, chief commercialization officer at BMS, discussed aficamten on an earnings call in July, telling analysts that he didn’t see any meaningful clinical differentiation versus Camzyos, though Cytokinetics has since shared more data since Lenkowsky’s comments.