November 19, 2014
By Mark Terry, BioSpace.com Breaking News Staff
Montreal, Quebec-based Knight Therapeutics Inc. announced today it has auctioned off its Neglected Tropical Disease Priority Review Voucher (“PRV”) to Foster City, Calif.-based Gilead Sciences, Inc. for $125 million in cash.
In 2007 the U.S. Food and Drug Administration (FDA) created the PRV as an incentive for companies to study and develop drugs and vaccines for neglected tropical diseases. The PRV, which is transferrable, entitles the holder to an FDA priority review for a drug of its choice. Once the FDA accepts the application for a standard New Drug Application (NDA) review or a Biologic License Application (BLA), the FDA expedites the PRV from a typical 10 months to six months.
Knight received the PRV in March 2014 with the approval of Impavido (miltefosine), a compound to treat visceral, mucosal and cutaneous leishmaniasis. Leishmaniasis is one of the 16 neglected tropical diseases under the PRV. The FDA defines Neglected Tropical Diseases (NTD) as “infectious diseases that generally are rare or absent in developed countries, but are often widespread in the developing world. Some of the NTDs, such as tuberculosis, affect populations globally, including U.S. populations. Other NTDs, such as African trypanosomiasis, are more geographically confined.”
On March 19, 2014, Knight announced the FDA had approved Impavido (miltefosine), and also received the PRV. At that time Jonathan Ross Goodman, president and chief executive of the company said in a statement, “We are thrilled to get Impavido approved for patients and to be the fourth company in the world to receive a Priority Review Voucher, and we would like to thank the many team members at Paladin Labs Inc. for all their hard work. Our plan is to commercialize Impavido in the United States and to monetize the voucher for maximum value, which may take time to materialize.”
Leishmaniasis is a parasitic disease caused by an intracellular protozoan, which is transmitted to mammalian hosts through the bite of the female phlebotomine sandfly. In the U.S., leishmaniasis is seen in travelers returning from countries and regions where the disease is endemic, and in American soldiers returning from Iraq, Afghanistan or South America. According to the World Health Organization (WHO), there are about 400,000 new cases of visceral leishmaniasis diagnosis annually worldwide. Anywhere from 7,000 to 1.2 million cutaneous leishmaniasis cases occur annually across the globe.
“We are thrilled to successfully transfer our priority review voucher in expectation that this will encourage others to invest in R&D for neglected tropical diseases for the benefit of humanity,” said Goodman in today’s statement.
