May 5 (Reuters) - -Jaguar Health Inc's recent price hikes on its anti-diarrheal drug, Mytesi, were not tied to the COVID-19 pandemic, and it is not currently in talks with the National Institute of Allergy and Infectious Diseases about potential uses of the drug in patients with the novel coronavirus, the drugmaker said in a statement issued late Monday night.
The statement responded to a letter released Monday by Representative Carolyn Maloney, the chair of a House of Representatives committee, and a fellow Democratic committee member Representative Jackie Speier, who urged Jaguar to reverse recent price hikes of its drug and asked that Jaguar provide information on the price increases.
“We are concerned that the nearly three-fold price increase your company imposed ... may prevent Americans from accessing Mytesi if it is approved for use during the current coronavirus outbreak,” the letter said.
They asked Jaguar to provide all communications pertaining to the price increases to the Committee on Oversight and Reform by May 18.
Mytesi is currently approved for use in treating diarrhea and other gastrointestinal symptoms in patients being treated for HIV or AIDS with antiretroviral drugs. Jaguar Health in March applied for Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration for Mytesi to treat similar symptoms in coronavirus patients. The FDA denied the application last month without explanation.
In the letter, the congresswomen said that Jaguar has reportedly been in ongoing talks with the NIAID about the effectiveness of Mytesi for coronavirus patients, but Jaguar said that it is not currently conducting any such talks.
Jaguar said that the decision to raise price hikes was made in December prior to the coronavirus outbreak hitting the United States, and that the price hikes were implemented only after the FDA declined to approve Mytesi for emergency use in patients with COVID-19. The company is not currently profitable, and said that this factored into its decision to raise prices.
"If we had received emergency use authorization, we would have deferred the price adjustment until after the emergency use period ended," Jaguar said.
Editing by Cynthia Osterman