Swiss drugmaker Novartis AG (NVS) announced on Monday that it reached an agreement with U.S. regulators to conduct a randomized Phase 3 trial of its generic malaria drug hydroxychloroquine for the potential treatment against COVID-19 disease.
The malaria drug, which received emergency use authorization for coronavirus disease by the U.S. Food and Drug Administration (FDA) will be tested in 440 hospitalised patients, Novartis said in a statement. The clinical trial drug supply will be provided by Sandoz, the generics and biosimilars division of Novartis. Shares advanced 0.6% to $89.69 in early U.S. trading.
“We recognize the importance of answering the scientific question of whether hydroxychloroquine will be beneficial for patients with COVID-19 disease,” said John Tsai, Head of Global Drug Development and Chief Medical Officer at Novartis. “We mobilized quickly to address this question in a randomized, double-blind, placebo-controlled study.”
Novartis will donate up to 130 million tablets of hydroxychloroquine to supply global clinical research efforts should the medicine prove to be beneficial for the treatment of COVID-19 disease. The drugmaker has already provided 30 million tablets to the US Department of Health and Human Services and is dispatching additional shipments to countries based on requests from governments around the world.
Wall Street analysts are bullish on Novartis stock. TipRanks data shows that all three analysts covering the company in the past three months have a Buy rating adding up to a Strong Buy consensus. The $112 average price target implies a 25% upside potential in the next 12 months (See Novartis stock analysis on TipRanks).