Santen and Aerie to accelerate global deployment of Rhopressa/Rhokiinsa and Rocklatan/Roclanda Expanding the area of exclusive licensing, including Europe and China
2021-12-07 · Santen Gmbh · original santen.com ↗
Santen and Aerie to accelerate global deployment of Rhopressa®/Rhokiinsa® and Rocklatan®/Roclanda® Expanding the area of exclusive licensing, including Europe and China December 7th, 2021 - Santen Pharmaceutical Co., Ltd. ( Head Office: Osaka; hereinafter “Santen”) announced a global expansion of its exclusive development and commercialization agreement with Aerie Pharmaceuticals (Head Office: Durham, North Carolina; hereinafter “Aerie”) for Rhopressa® / Rhokiinsa®(netarsudil ophthalmic solution) and Rocklatan® / Roclanda®(netarsudil and latanoprost ophthalmic solution) by concluding a new agreement to target additional territories, including Europe, China and several other regions. The two produ cts are marketed by Aerie in the U.S. for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. In October 2020, Santen and Aerie signed an exclusive development and marketing agreement for the products for Japan and other Asian countries. With this new agreement, Santen will deploy the benefits of ROCK inhibitors to other regions globally, further strengthening its global glaucoma portfolio. Aerie is an ophthalmic pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of patients with primary open-angle glaucoma, ocular surface diseases and retinal diseases. Rhopressa® 0.02% and Rocklatan® 0.02%/0.005% are approved and being sold in the United States by Aerie. Aerie has also received market authorization for the products in the EU and the UK, as Rhokiinsa® and Roclanda,® respectively. In Japan, the phase III clinical trial for Rhopressa® began in November 2020. In the primary endpoint of intraocular pressure (IOP) at week 4, taking netarsudil 0.02% once daily was shown to be superior to ripasudil 0.4% twice daily.i “As a specialized company dedicated to ophthalmology, we aim to reduce the social and economic opportunity losses of people around the world caused by eye diseases and defects,” says Shigeo Taniuchi, President and CEO of Santen. “We are delighted to add ROCK inhibitors to our global glaucoma portfolio with this expansion in Europe where the products have already been approved, and in China where future growth is expected. Adding the ROCK inhibitors to our global glaucoma portfolio will broaden patients’ treatment options to suit their conditions thereby fulfilling unmet medical needs for glaucoma treatment.” Glaucoma is a disease that causes damage to the optic nerve, leading to visual field loss and is a major cause of visual impairment including decreased vision and blindness in many countries. Since the disease is generally progressive and irreversible, early detection and treatment to control the progression of suc h damage and visual field defects are crucial in treatment, and lowering intraocular pressure is the most effective means of avoiding glaucomatous damage. The estimated number of patients globally in 2020 is 76 million, and it is expected to increase to 95 million by 2030.ii Under the terms of the new agreement, Aerie will receive an upfront payment of $88 million and is entitled to receive milestones and royalty payments. About Santen As a specialized company dedicated to ophthalmology, Santen carries out research, development, marketing, and sales of pharmaceuticals, over-the-counter products, and medical devices, and its products now reach patients in over 60 countries. Toward realizing “WORLD VISION” (Happiness with Vision), the world Santen ultimately aspires to achieve, and as a “Social Innovator”, we aim to reduce the social and economic opportunity loss of people around the world caused by eye diseases and defects by orchestrating and mobilizing key technologies and players around the world. With scientific knowledge and organizational capabilities nurtured over a 130-year history, Santen provides products and services to contribute to the well- being of patients, their loved ones and consequently to society. For more information, please visit Santen’s website (www.santen.com). About Aerie Aerie is an ophthalmic pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of patients with open-angle glaucoma, ocular surface diseases and retinal diseases. Aerie's first product, Rhopressa ® (netarsudil ophthalmic solution) 0.02%, a once-daily eye drop approved by the U.S. Food and Drug Administration (FDA) for the reduction of elevated intraocular pressure (IOP) in patients with open -angle glaucoma or ocular hypertension, was launched in the United Stat es in April 2018. In clinical trials of Rhopressa ®, the most common adverse reactions were conjunctival hyperemia, corneal verticillata, instillation site pain, and conjunctival hemorrhage. More information about Rhopressa ®, including the product label, is available at https://rhopressa.com/. Aerie’s second product for the reduction of elevated IOP in patients with open -angle glaucoma or ocular hypertension, Rocklatan® (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%, the first and only fixed- dose combination of Rhopressa® and the widely-prescribed PGA (prostaglandin analog) latanoprost, was approved by the FDA and was launched in the United States in the second quarter of 2019. In clinical trials of Rocklatan ®, the most common adverse reactions were conjunctival hyperemia, corneal verticillata, instillation site pain, and conjunctival hemorrhage. More information about Rocklatan®, including the product label, is available at www.rocklatan.com . Aerie continues to focus on global expansion and the development of additional product candidates and technologies in ophthalmology, including for the treatment of dry eye, wet age -related macular degeneration and diabetic macular ed ema. More information is available at www.aeriepharma.com. Contact Corporate Communications Group Santen Pharmaceutical Co., Ltd. E-mail: [email protected] i Aerie Investors. News Releases. Available here: https://investors.aeriepharma.com/news-releases/news-release- details/aerie-pharmaceuticals-announces-positive-phase-3-topline-results (Last accessed: November 2021) ii World report on vision - WHO | World Health Organization
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