Arctic Vision Announces Exclusive Licensing Agreement with Clearside Biomedical for XIPERE™ in Greater China and South Korea
Arctic Vison
Ophthalmic New Drug Developer
Clearside Biomedical
Biopharmaceutical Manufacturer
- Arctic Vison to Lead Development of Novel Therapies for Uveitic Macular Edema in Asia
- Enhancing Global Awareness of Innovative Suprachoroidal Injection Technology
- Clearside will be entitled to receive an upfront payment, milestone payments, and royalties on product sales.
Shanghai, China and Alpharetta, Georgia, USA, March 11, 2020 – Arctic Vison Hong Kong Biotech Limited (referred to as "Arctic Vison"), a biopharmaceutical company focused on innovative ophthalmic therapies, announced today that it has obtained exclusive licensing rights for the development and commercialization of Clearside Biomedical, Inc.'s (NASDAQ: CLSD) core product, XIPERE™ (triamcinolone acetonide suprachoroidal injection suspension), in the Greater China region (including mainland China, Hong Kong, Macau, and Taiwan) and South Korea.
XIPERE™ is a patented triamcinolone acetonide suspension formulation for suprachoroidal administration, delivered via the Clearside proprietary Suprachoroidal Space (SCS) Microinjector™, and is currently being investigated for the targeted treatment of uveitic macular edema.
“This license agreement enables Clearside to further expand the commercial opportunities for XIPERE™ in high-potential markets,” said Dr. George Lasezkay, President and Chief Executive Officer of Clearside Biomedical. “We look forward to collaborating with Arctic Vison’s team of ophthalmology industry veterans, whose members bring extensive global experience from leading ophthalmic companies such as Allergan, as well as a proven track record of successfully launching ophthalmic products in China (such as OZURDEX®, dexamethasone intravitreal implant). With the resources and financial support from top global biotechnology venture capital firm Dingfeng Life Sciences Capital, we believe that once XIPERE™ is approved in these key markets, Arctic Vison will become the best strategic partner to drive the development of XIPERE™.”
“We are delighted to establish this partnership with Clearside and look forward to working together to bring this innovative therapy to patients and healthcare providers in Greater China and South Korea as soon as possible,” said Dr. Eddy Wu, Founder and CEO of Arctic Vison. “Due to the lack of ideal treatments that balance efficacy and safety, there is an urgent need for innovative therapeutic options among uveitis patients in China. Leveraging Clearside’s proprietary advanced SCS drug delivery technology, XIPERE™ holds promise for delivering significant clinical benefits to these patients. As Arctic Vison strives to become a leader in the Chinese ophthalmology market, we regard this product as a key asset in our growing portfolio of breakthrough therapies.”
Under the terms of the agreement, Clearside is eligible to receive up to a total of USD 35.5 million in development and sales milestone payments. This amount includes a USD 4 million upfront payment, as well as milestone payments for the U.S. approval of XIPERE™ and related preliminary activities. Clearside will also receive tiered royalties ranging from 10% to 12% based on the annual net sales of XIPERE™ in the Greater China region and South Korea. Subject to authorization by Clearside, Arctic Vison will be responsible for the development and commercialization of XIPERE™ for additional ophthalmic indications in the Greater China region and South Korea.
About XIPERE™ (Triamcinolone Acetonide Suprachoroidal Injection Suspension)
XIPERE™ (triamcinolone acetonide suprachoroidal injection suspension, formerly known as CLS-TA) is a patented triamcinolone acetonide corticosteroid suspension intended for posterior segment administration to treat uveitic macular edema. Clearside’s proprietary technology is designed to deliver drugs into the suprachoroidal space, located between the choroid and the outer protective layer of the eye (the sclera). Suprachoroidal injection enables rapid and extensive distribution of the drug throughout the posterior segment, thereby potentially prolonging therapeutic effects while minimizing adverse impacts on normal intraocular tissues. Bausch + Lomb, a premier global eye health company affiliated with Bausch Health Companies Inc., holds the exclusive license for the commercialization and development of XIPERE™ in the United States and Canada. Arctic Vison holds the exclusive license for the commercialization and development of XIPERE™ in Greater China and South Korea.
About Clearside Biomedical
Clearside Biomedical, Inc. is a biopharmaceutical company dedicated to developing and providing treatments for patients with serious posterior segment eye diseases. Its SCS Microinjector™ is a patented technology that delivers drugs directly to common sites of severe ocular diseases, such as the macula, retina, and choroid, via unique suprachoroidal space (SCS®) injections. Clearside’s SCS injection technology platform is a flexible, in-office, non-surgical procedure designed to provide targeted, direct-to-site drug delivery to affected areas. It can be used with existing or novel drugs, as well as future innovative therapies (such as gene therapy). In addition to its application with XIPERE™, Clearside has entered into global licensing agreements with REGENXBIO Inc. (NASDAQ: RGNX) and Aura Biosciences to collaborate on research into the use of the SCS Microinjector™ for specific gene therapies. For more information, please visitwww.clearsidebio.com。
About Arctic Vison
Arctic Vison is a specialized ophthalmology company based in China, with a portfolio of breakthrough therapies and technologies for ocular diseases. The company is led by a team of industry veterans with proven experience in the successful R&D and commercialization of innovative ophthalmic products globally and in China. Previously, these leaders held executive positions at the headquarters, Asia-Pacific, and China divisions of top-tier global eye care companies. Arctic Vison is backed by leading global biotechnology venture capital firms, which bring extensive networks, deep professional insights, and a strong track record in company incubation across the Chinese, U.S., and European ophthalmology markets. For more information, please visitwww.arcticvision.com。
Cautionary Statement Regarding Forward-Looking Statements
Any statements in this press release that are not descriptions of historical facts may constitute forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995. These statements, based on Clearside’s current judgments and expectations, can be identified by words such as “believe,” “expect,” “may,” “plan,” “potential,” “intend,” and similar expressions. Such forward-looking statements include those regarding the commercial potential of XIPERE and Arctic Vison’s ability to successfully launch XIPERE in the Greater China region (Mainland China, Hong Kong, Macau, and Taiwan) and South Korea. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. These risks and uncertainties include: the inherent uncertainties associated with ongoing clinical trials; Clearside’s reliance on third parties over whom it may not always have full control; and other risks and uncertainties detailed in Clearside’s Annual Report on Form 10-K for the year ended December 31, 2018, filed with the U.S. Securities and Exchange Commission (SEC) on March 15, 2019; its Quarterly Report on Form 10-Q for the quarter ended September 30, 2019, filed with the SEC on November 6, 2019; and other periodic reports filed by Clearside with the SEC. Any forward-looking statements speak only as of the date of this press release and are based on information available to Clearside as of the date hereof. Clearside disclaims any obligation or intent to update any forward-looking information or statements, whether as a result of new information, future events, or otherwise.
ClearsideInvestor and Media Contact:
Jenny Kobin
Remy Bernarda
(678) 430-8206
Arctic Vison Media Contact:
Li Wenxin
021-6850-3275