Nicox Announces Vyzulta Now Commercialized in 7 Territories and Approved in Further 9 Countries
Nicox provided an update on the approvals and launches of Vyzulta (latanoprostene bunod ophthalmic solution) 0.024%, exclusively licensed worldwide by Nicox to Bausch + Lomb.
“Vyzulta is the first product based on our nitric oxide-donating research platform which has been commercialized, and we are pleased to see the continued rollout of approvals and launches, maximizing the data that were generated for the US NDA. The recent decision by the United States Patent and Trademark Office concerning the eligibility of latanoprostene bunod patents for patent term extension could ensure recurrent revenue from Vyzulta up to 2030 in the United States. In other countries, the revenue stream may go beyond that date,” said Gavin Spencer, Chief Business Officer of Nicox.
As of December 31, 2021, Vyzulta was commercialized in 7 territories: United States (2017), Canada (2019), Argentina (2020), Mexico (2020), Hong Kong (2020), Taiwan (2021) and Ukraine (2021). Vyzulta is also approved in 9 other countries, namely Brazil, Colombia, Jordan, Qatar, Singapore, South Korea, Thailand, Turkey and United Arab Emirates. Vyzulta is indicated for the reduction of IOP in patients with open-angle glaucoma or ocular hypertension in the United States. Bausch + Lomb will continue seeking approvals in territories where the clinical data package, part of the U.S. New Drug Application, can be used for approval by the regulatory authorities.
Latanoprostene bunod, the active pharmaceutical ingredient in Vyzulta, was invented and patented by Nicox and was licensed to Bausch + Lomb in 2010. Under the terms of the exclusive global license agreement with Bausch + Lomb, Nicox receives increasing tiered royalties of 6% to 12% on net global sales of Vyzulta and is entitled to receive a $20 million milestone payment1 upon Vyzulta net sales reaching $100 million.
Nicox maintains the patents for latanoprostene bunod, and the US Patent and Trademark Office recently determined that three U.S. composition of matter patents covering latanoprostene bunod are eligible for patent term extension, potentially through to 2030.