Australia's Starpharma Holdings Ltd. granted the U.S. marketing rights to its patented antibacterial gel VivaGel BV to ITF Pharma.

VivaGel BV, meant to treat bacterial vaginosis, is being reviewed by the U.S. Food and Drug Administration. The water-based vaginal gel is already approved in Australia and the EU.

Under the licensing agreement, Starpharma can receive up to A$142 million in regulatory approval and commercialization milestone payments, along with escalating double-digit sales royalties.

ITF Pharma will source VivaGel BV from Starpharma, but its parent, privately held European specialty pharmaceutical company Italfarmaco SpA, may apply for FDA approval of its own manufacturing facility.

Starpharma said the U.S. license it granted is valid until the later of 10 years or VivaGel BV's patent expiration, set in 2030 at the earliest.

VivaGel BV will be ITF Pharma's lead women's health product upon launch, according to Starpharma.