Ocumension Therapeutics Submits a New Drug Application for Zerviate in China
Nicox SA announced that its exclusive Chinese partner, Ocumension Therapeutics, has submitted a new drug application (NDA) for approval to commercialize Zerviate (cetirizine ophthalmic solution), 0.24%, in China, for ocular itching associated with allergic conjunctivitis. The approval process is expected to take around 12 months, leading to a potential launch of Zerviate in China in 2024. Ocumension plans to manufacture Zerviate in their new state-of-the-art purpose-built manufacturing facility located in Suzhou, China.
“Ocumension is a strong partner for Nicox, and we are pleased to see the submission of this new drug application, following the completion of an additional Chinese phase 3 trial carried out by Ocumension. Alongside a broad portfolio of ophthalmology assets in development, Ocumension has also built a commercial operation in China, which will be able to add Zerviate directly into their detailing activities upon approval,” Gavin Spencer, Chief Business Officer of Nicox, said in a company news release. “The approval and launch of Zerviate in 2024 would add another royalty revenue stream to Nicox, onpotential annual net sales which Ocumension forecasts will be over $100 million within 7 years in China. We look forward to Ocumension also expanding the availability of Zerviate to the other Southeast Asian markets they have rights to.”
Zerviate is the first and only eye drop formulation of the antihistamine cetirizine, the active ingredient in Zyrtec, and is currently commercialized in the U.S. for ocular itching associated with allergic conjunctivitis. The prescription market for allergic conjunctivitis products in China is expected to grow to almost $500 million by 2030, according to Nicox.
The Zerviate NDA in China is supported by the data package licensed by Nicox to Ocumension and an additional Chinese phase 3 clinical trial of Zerviate run by Ocumension. Zerviate was compared to emedastine difumarate ophthalmic solution, 0.05%, an antihistamine marketed under the brand name Emadine. Zerviate was found to be noninferior to emedastine difumarate in the primary efficacy endpoint of change from baseline in the itching score in the 24 hours prior to the Day 14 visit. Zerviate was safe and well-tolerated with no difference in the proportion of patients with adverse events compared to emedastine difumarate.
Zerviate is exclusively licensed to Ocumension Therapeutics for development and commercialization in the Chinese and the majority of the Southeast Asian markets. All costs of commercialization are borne by Ocumension and Nicox may potentially receive sales milestones of up to US $17.2 million together with royalties of between 5% and 9% of net sales of Zerviate by Ocumension.