The pharmaceutical giant has high hopes for its new Covid drug.
(Photo: AP)
Frankfurt. The Covid-19 drug candidate from Novartis and the Swiss biotech company Molecular Partners has shown positive results in a clinical study and achieved its main goal.
The active ingredient developed by Molecular Partners led to a significant reduction in viral load in the phase 2 study, which was accompanied by Novartis, with 301 patients. The risk of worsening the disease with hospitalization or death as a result fell by 78 percent, Novartis announced.
Drug candidates usually have to successfully complete three phases of clinical trials in order to be able to submit an application for approval. Novartis now intends to in-license Ensovibep and assume responsibility for development, manufacture, sales and marketing. In return, Molecular Partners will receive 150 million Swiss francs.
Both companies have stated that they are in close contact with the approval authorities in order to accelerate the testing and approval of Ensovibep.
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Novartis does not currently have any of its own Covid-19 vaccines or drugs on the market. However, the pharmaceutical company provides production capacities for the Covid-19 vaccine from the Mainz-based company Biontech at its location in Stein, Switzerland.
As part of the agreement, the Zurich-based company Molecular Partners had already received an advance payment of 60 million Swiss francs including equity from Novartis. In the event of approval, the biotech company will then receive significant license fees on sales in the future.
Molecular Partners has agreed to waive license fees in poorer countries and, in line with Novartis, intends to offer the drug at an affordable price based on the countries’ needs and economic capabilities.
Corona drug Ensovibep also works against Omikron
The antiviral agent Ensovibep was tested in a global study that included a total of 407 infected but not hospitalized Covid-19 patients. 99 of them were given a dummy drug (placebo).
The active ingredient was administered in three different doses. The result was a statistically significant reduction in viral load over eight days compared to placebo for all three dosing arms. Compared to the placebo group, patients who received the active ingredient had a 78 percent lower risk of becoming so seriously ill that they had to be hospitalized or even died.
If approved, Ensovibep will be the first multi-specific antiviral molecule for the treatment of Covid-19, according to Novartis. The remedy is a protein-based therapy that docks at three points of the Sars-CoV-2 virus and is supposed to neutralize it so strongly.
Treatment with Ensovibep, which is now to be further researched in the lowest dose, offers protection against the dangerous virus variants identified so far, including Omikron, according to Novartis. However, it should take a few more months for approval.
Various special Covid-19 drugs are currently available in Germany. These include the Ronapreve infusion solution, which was jointly developed by the Swiss Roche Group and the US company Regeneron. The genetically engineered active ingredient consists of antibodies that bind to Sars-CoV-2 and thus prevent the virus from multiplying.
In December, the antibody drug sotrovimab was approved in Europe by Glaxo-Smithkline and the biotech company Vir. As early as July 2021, GSK and Vir had agreed with the European Commission to deliver up to 220,000 cans.
With the marketing authorization in the EU, member states can now source sotrovimab to support their pandemic fight. In addition, at the end of December, the new federal government ordered one million packs of the drug Paxlovid from the US company Pfizer to treat severe Covid courses. The drug has an emergency approval in the United States. The approval process in the EU is ongoing.
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