CytoDyn Inc. granted Vyera Pharmaceuticals LLC an exclusive license to market and distribute leronlimab for treating HIV in the U.S. in exchange for up to $87.5 million in upfront and milestone payments.
New York-based private pharmaceutical company Vyera also agreed to pay CytoDyn royalties of 50% on net sales of the drug. Also, Vyera will invest $4 million in CytoDyn's common shares.
Vancouver, Wash.-based CytoDyn will be responsible for the development and approval of leronlimab by the U.S. Food and Drug Administration for all HIV-related and other indications.
Leronlimab, which is being developed under the name PRO 140, was approved by the FDA in November to treat certain breast cancer patients under the regulator's expanded access program that allows patients to access unproven treatments after getting approval from an institutional review board.
The FDA granted a fast-track designation to leronlimab in combination with HAART for the treatment of HIV-infected patients and in combination with chemotherapy drug carboplatin for treating patients with CCR5-positive triple-negative breast cancer that has spread to other parts of the body. Carboplatin is marketed by Bristol-Myers Squibb Co. as Paraplatin.