Xbrane Biopharma and STADA have entered into an exclusive licensing agreement with US biosimilars specialist Valorum Biologics for their ranibizumab biosimilar candidate.
Valorum will pay a license fee of up to USD 45 million, plus royalties on net product sales. This fee, plus royalties paid by Valorum on net sales of the product, will be shared equally by STADA and Xbrane. Under a separate agreement, Xbrane will supply the product to Valorum at a double-digit mark-up over cost of goods sold (CoGS).
“We believe Valorum is the ideal partner for us to commercialize ranibizumab in the US. We share the same entrepreneurial spirit and mindset,” says Martin Åmark, CEO of Xbrane Biopharma. “Success of this launch will be as important and defining for Valorum as for us, and hence we are convinced the product will get the full attention it requires. Further, we are convinced that Valorum with its unparalleled team with vast experience and network across the US will be able to commercialize biosimilars, including Lucamzi, highly effectively.”
Xbrane and STADA are responsible for completing the regulatory approval process for the ranibizumab candidate, which was developed under the Xlucane name. Xbrane is responsible for commercial manufacturing and supply. Valorum will be responsible for sales, marketing and all other commercialization efforts in the United States following regulatory approval of the product, which is expected to be marketed under the Lucamzi brand name.
Ranibizumab
Ranibizumab is an anti-VEGF (vascular endothelial growth factor) drug for treating retinal vascular disorders, which are a leading cause of blindness globally. Estimated direct healthcare costs of visual impairment due to AMD in the US, Canada, and Cuba (WHO subregion AMR-A) are approximately USD 98 billion, while direct healthcare costs globally linked to AMD total USD 255 billion, according to the companies.
Photo of Martin Åmark: Xbrane
