Xbrane Biopharma and its co-development partner STADA have entered into an exclusive licensing agreement with Bausch + Lomb to commercialize Xlucane, a Lucentis (ranibizumab) biosimilar candidate, in the United States and Canada.
The companies aim to obtain regulatory approval of all currently approved indications for Lucentis in both the United States and Canada.
Developing Xlucane for North American markets
STADA and Xbrane will be jointly responsible for finalizing development in the United States and Canada. Xbrane will also provide commercial supply. Bausch + Lomb will be responsible for the sales, marketing and all other commercialization efforts for the biosimilar candidate in the United States and Canada following regulatory approval.
“We continue to make good progress in developing Xlucane for North American markets. Bausch + Lomb has a very strong brand recognition and reputation amongst ophthalmologists and an existing sales infrastructure to leverage. We are excited to finalize the final steps towards marketing approval and together with our partners, bring the product to patients with severe eye diseases in dire need for cost efficient VEGFa inhibitors in the United States and Canada,” says Martin Åmark, CEO of Xbrane Biopharma.
Under the terms of the licensing agreement, Bausch + Lomb will make a mid-single digit million USD up-front payment and will pay further milestone payments subject to approval and launch of the product in the United States. Xbrane and STADA will also be entitled to a share of gross profits from sales of the product by Bausch + Lomb. Xbrane and STADA will share equally in the proceeds they receive from Bausch + Lomb.
Photo of Martin Åmark: Xbrane