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Novaliq and Senju Pharmaceutical close on license agreement for NOV03 in Japan

Article

The agreement includes rights to develop, manufacture and commercialize NOV03 in Japan for the treatment of dry eye disease.

Stock image of a business agreement, with one person signing a contract and another person sitting across the table from them. (Adobe Stock / Wasan)

NOV03 is a water-free, preservative-free treatment for dry eye disease (DED). According to Novaliq, NOV03 has a “unique mode of action [that] directly targets tear evaporation by forming a monolayer at the air-liquid interface of the tear film.” (Adobe Stock / Wasan)

Senju Pharmaceutical and Novaliq GmbH announced the closing of a licensing agreement allowing the Japan-based Senju Pharmaceutical rights to Novaliq’s NOV03 (perfluorohexyloctane ophthalmic solution) in Japan.

According to a joint press release from the companies,1 the agreement includes Japan rights to develop, manufacture, and commercialize NOV03. Novaliq is eligible to receive upfront and milestone payments contingent upon the achievement of regulatory and sales milestones as well as royalties on net sales of NOV03 in Japan according to the agreement.

NOV03 is a water-free, preservative-free treatment for dry eye disease (DED). According to Novaliq, NOV03 has a “unique mode of action [that] directly targets tear evaporation by forming a monolayer at the air-liquid interface of the tear film.”

Related: FDA approves Novaliq's cyclosporine ophthalmic solution for treatment of signs and symptoms of dry eye disease

Shuhei Yoshida, president of Senju Pharmaceutical touched on the partnership in the joint press release.

“We are thrilled to collaborate with Novaliq as a pioneer for cutting edge water-free eye drop technology. On the basis of very unique features and unparalleled clinical data of NOV03, we strongly believe that it will provide huge clinical benefits to Japanese patients”, said Yoshida.

In Japan, more than 5 million patients are diagnosed with DED and treatments addressing evaporative DED or DED associated with clinical signs on Meibomian gland dysfunction are limited.2

Christian Roesky, PhD, CEO of Novaliq, also gave some insight into the agreement in the joint press release.

“We are proud to partner with Senju Pharmaceutical, a leading ophthalmic company in Japan, to bring NOV03 to patients in Japan,” said Roesky. “NOV03 offers a new and unique mode of action and is clinically validated. Its safety and efficacy has been demonstrated in numerous studies in Europe, United States and China. With approximately 10,000 million units sold in Europe and Australia since its launch in 2015, our water-free EyeSol® technology is proven to be safe and well accepted”.

References:
1. Senju Pharmaceutical and Novaliq Enter Into License Agreement For NOV03 (Perfluorohexyloctane Ophthalmic Solution) For the Treatment of Dry Eye Disease in Japan. Press Release. Senju Pharmaceutical/Novaliq; June 13, 2023. Accessed June 13, 2023. https://www.wvnews.com/business/senju-pharmaceutical-and-novaliq-enter-into-license-agreement-for-nov03-perfluorohexyloctane-ophthalmic-solution-for-the/article_a50462b1-2dc3-54d8-bca5-1d637ac47a3b.html
2. Global Data. Dry Eye Syndrome: Seven-Market Drug Forecast and Market Analysis Update | December 2022
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