Pharma industry briefing: FDA rejects oral heart failure drug, the race for the RSV market, and new blood for Pfizer's cancer portfolio

Republished with permission from Pharmascan

FDA denies approval
A setback for heart failure drug

The US FDA rejected approval of Cytokinetics' oral heart failure drug Omecamtiv mecarbil, citing insufficient data to demonstrate its effectiveness.

An external expert panel had earlier recommended against the drug on safety grounds. The FDA is now requiring an additional trial to establish the drug's effectiveness in patients with low ejection fraction.

Cytokinetics will shift its focus to another drug, Aficamten. Trial results for the drug in hypertrophic cardiomyopathy are due this year, and analysts expect a higher likelihood of FDA approval.

Heating up
The race for the RSV vaccine market

A US FDA advisory committee unanimously backed GSK's respiratory syncytial virus (RSV) vaccine for preventing RSV-related lower respiratory tract disease in adults aged 60 and older, and voted 10 to 2 in favor on safety.

One FDA panel member noted that the subjects in GSK's study better represented the population actually likely to fall ill. Earlier the same week, Pfizer's RSV vaccine was also recommended by an FDA expert panel.

If approved, GSK's RSV vaccine could reach peak global sales of US$2.8 billion. Analysts currently estimate the market at more than US$5 billion, potentially exceeding US$10 billion by 2030.

A deal in the making?
Targeting cancer drugs

Foreign media report that Pfizer is negotiating acquisition terms with Seagen in a deal expected to exceed US$30 billion. If completed, the transaction would inject new blood into Pfizer's oncology portfolio. Seagen's core research is in antibody-drug conjugates (ADCs), a therapy that uses antibodies to home in on cancer cells and deliver chemotherapy agents.

Seagen had previously negotiated with Merck over a deal reportedly worth up to US$37 billion, but talks stalled at the end of August 2022. Merck had shortly before acquired Imago BioSciences, another ADC-focused company, for US$1.35 billion.

Observers see the approach as no coincidence: beyond the patent cliffs Pfizer faces in the coming years, investors have been pressing the company to actively deploy the cash earned during the pandemic. Pfizer has so far declined to comment on the reports.

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References

Cytokinetics (2023,Mar 1).Cytokinetics Receives Complete Response Letter From Fda For New Drug Application For Omecamtiv Mecarbil. Retrieved from https://ir.cytokinetics.com/news-releases/news-release-details/cytokinetics-receives-complete-response-letter-fda-new-drug (2023,Mar 8)

GSK(2023,March 1).US FDA Advisory Committee votes to support effectiveness and safety of GSK’s respiratory syncytial virus older adult vaccine candidate. Retrieved from https://www.gsk.com/en-gb/media/press-releases/us-fda-advisry-committee-votes-to-support-effectiveness-and-safety-of-gsk-s-rsv-older-adult-vaccine-candidate/ (2023,Mar 8)

Lisa Jarvis(2023, Feb 28).Seagen Could Be the Deal Pfizer Investors Have Been Craving. Retrieved from https://www.bloomberg.com/opinion/articles/2023-02-27/pfizer-seagen-m-a-could-be-the-deal-investors-have-been-craving?leadSource=uverify%20wall (2023,Mar 8)