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FDA sets back Novartis’ best chance at a COVID-19 drug

Dive Brief:

  • Novartis is reevaluating its commitment to an experimental COVID-19 treatment originally developed by fellow Swiss drug company Molecular Partners after the Food and Drug Administration indicated another study will be required. Shares of Molecular, which also lost a partnership with Amgen, dropped 37% in early trading Wednesday.


  • Novartis filed for emergency authorization of the medicine, called ensovibep, in February, after a mid-stage trial showed a single injection could dramatically reduce hospitalizations and deaths. The positive results followed a failure a few months earlier in a large, U.S.-government sponsored study looking at a variety of COVID-19 treatments for already hospitalized patients.


  • Executives are now in discussions with the FDA about what kind of late-stage research would be required, Novartis CEO Vas Narasimhan told investors Tuesday. The company will then make a “sober evaluation” as to whether such a study is doable “in light of the waning rates of COVID around the world,” he said.


Dive Insight:

Novartis originally teamed up with Molecular Partners in October 2020, when there were no vaccines and few treatment options for the new coronavirus. The picture today looks quite different, with vaccines widely available and a growing array of medications that include pills from Pfizer and Merck & Co.

Still, Novartis maintains that ensovibep offers intriguing possibilities. In discussions with the company, FDA officials were “excited about the concept” of a one-time injection for COVID-19, Narasimhan told investors. Manufacturing could be scaled up relatively quickly, according to Novartis, and the drug has also maintained its potency against all major variants of the virus, including omicron.

“Certainly, we believe in the profile of the molecule,” Narasimhan said.

Molecular Partners developed the drug using its “DARPin” technology, allowing tiny proteins to be fused together to perform multiple functions. Novartis originally secured options for two experimental protein drugs from the biotech in 2020 and then finalized a licensing agreement for ensovibep in January after the positive Phase 2 results.

The work with Novartis “validated” the DARPin technology and opened up new possibilities for drug development, SVB analyst Daina Grayboschwrote in a note to investors.

Now, the FDA’s stance on a new study likely means that, at best, Molecular will face a delay in its pursuits to win its first approval and start collecting revenue from a royalty agreement with Novartis. At worst, Novartis may decide to abandon the project.

For its part, Novartis has largely been on the sidelines of the pandemic in terms of drug development. The company jumped in to help manufacture vaccines developed by rivals, but its own attempt at repurposing a rare disease drug for COVID-19 faltered in late 2020.