- Amgen on Monday said it will hand back rights to two cardiovascular drugs to their owner, Cytokinetics, including a heart failure medicine that delivered disappointing late-stage data six weeks ago. Cytokinetics will discuss a regulatory submission with the Food and Drug Administration based on the finding that the drug prevented heart failure complications.
- The decision brings to an end a collaboration that has lasted more than a decade as the partners tried to advance a new generation of heart failure medications. Amgen's sublicense to Servier covering Europe and the Commonwealth of Independent States will transfer to Cytokinetics, giving it a marketing partner outside the U.S.
- The disappointment of Cytokinetics' heart failure pill and partnership termination is another blow for developers of heart drugs, which have struggled to make headway as investors and potential big pharma partners have gravitated toward disease areas like cancer. Wall Street analysts blame a lengthy and expensive development process for cardiovascular drugs discouraging further investment.
As often happens when biotechs lose a bigger partner, Cytokinetics vowed to soldier on with its lead project, called omecamtiv mecarbil. A share sale and a royalty monetization deal added a total of more than $400 million to the cash pile at the California-based biotech, and its executives estimated it will end 2020 with $500 million cash, enough to fund it for two to three years.
Omecamtiv mecarbil's outlook, however, is uncertain at best. The GALACTIC-HF trial was intended to provide evidence to the FDA and other regulators that the twice-daily pill, which aims to help cardiac muscles pump blood better, can keep heart failure patients from dying or having complications. The trial focused on the set of patients whose hearts are so weak they can only pump out less than 40% of the blood volume with each beat.
GALACTIC-HF met success as defined by its clinical team, reducing the risk of cardiovascular events and death by 8% when compared to a placebo. However, Amgen executives had set a bar at 15% risk reduction as being clinically meaningful. Moreover, a secondary analysis of the trial showed that omecamtiv mecarbil did not reduce the risk of cardiovascular death.
"This weak effect made it rather clear that omecamtiv mecarbil was unlikely to be a commercially viable product, which leaves us unsurprised by Amgen's decision to walk away for this collaboration," Baird analyst Brian Skorney wrote in a Nov. 23 note to clients.
Amgen waited to leave the partnership until after Cytokinetics presented GALACTIC-HF data at a virtual session of the American Heart Association scientific meeting on Nov. 13, which was accompanied by publication of data in the New England Journal of Medicine.
The presentation identified a 16% risk reduction in patients whose hearts are able to pump out 28% or less of the blood volume, a finding that Cantor Fitzgerald analyst Charles Duncan took heart in.
"With the additional data, we see the emerging clinical profile as more than competitive," Duncan wrote in a Nov. 15 note to clients.
Should Cytokinetics try to win approval to treat this particular patient group, FDA reviewers might ask for additional clinical study, which would add several years to the omecamtiv mecarbil development plan.
Amgen is also handing back rights to a second drug that was part of the collaboration, called AMG 594.