CURACLE and Théa Announce Licensing and Collaboration Agreement for the Development and Commercialization of Orally Administered Treatment for Diabetic Macular Edema and Wet-AMD

CURACLE , a Korea-based biopharmaceutical company, today announced that it has entered into an exclusive license and collaboration agreement with Théa Open Innovation, the sister company of Théa, Europe’s number one independent ophthalmic company with a 150-year history, for the development and commercialization of CURACLE’s CU06-RE, that has the potential to become the first orally administered treatment for diabetic macular edema and wet age-related macular degeneration (wet-AMD).

Under the terms of the agreement, CURACLE will receive an upfront payment of $6 million and could receive up to an additional $157.5 million in potential development, regulatory and sales milestones, as well as royalties on sales if CU06-RE is successfully developed, which will entitle CURACLE to receive up to $2 billion in total payments. Théa and CURACLE will closely collaborate on the clinical development of this novel oral drug. CURACLE will be responsible for the Phase I and II clinical studies with TOI providing both financial and infrastructure support. Further, under the terms of the agreement, CURACLE will retain the marketing rights in all Asia countries while Théa will have the marketing rights in all other countries around the world.

According to Dr. Young Guen Kwon, the founder of CURACLE, “CU06-RE is expected to be the world’s first `orally administered' treatment for diabetic macular edema and wet-AMD, and because of its high efficacy and convenience as an oral treatment, CU06-RE promises to establish the standard for treatment that reduces the number of intraocular injection (IVT) administration made possible through co-administration with anti-VEGF.” Dr. Kwon added that “As the world’s first vascular endothelial dysfunction blocker developed with CURACLE’s SOLVADYS platform technology, CU06-RE can be applied to patients whose symptoms have worsened due to resistance to anti-VEGF injections, providing great hope for patients who currently do not have a suitable treatment option.”

”Through this strategic and collaborative alliance with Théa, a leading global ophthalmic company, we have been able to accelerate the development of CU06-RE as the world’s first oral treatment and the world’s first vascular endothelial dysfunction blocker,” said Jae Hyeon Ryu, the CEO of CURACLE. "We look forward to providing innovative treatments faster to the millions of patients with diabetic macular edema and wet-AMD around the world who are suffering without an appropriate treatment option,” added Mr. Ryu.

“We are excited about partnering with CURACLE, a truly innovative biotechnology company with a game changing technology platform,” remarked Mr. Jean-Frédéric Chibret, president of Théa. Mr. Chibret further commented that “through this licensing collaboration, Théa and CURACLE will provide a new first-in-class treatment with an alternative and non-invasive route of administration and most importantly, convenience for patients. This agreement is in line with the other partnerships that we have set up over the last two years and further illustrates our will to build a strong and diversified retina pipeline.”

About CURACLE

CURACLE (KOSDAQ) is a Korea-based clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of innovative therapeutics for the treatment of aged-related vascular and intractable metabolic diseases and cancers.

Founded in 2016, CURACLE has developed the disease-expressive screening system, SOLVADYS Platform, which screens substances that directly convert the pathological characteristics of the capillary vessels such as leakage, inflammatory activation, and apoptosis using human organ-specific primary endothelial cells. The SOLVADYS Platform dramatically improves the efficacy and ease of administration for acute and chronic conditions that are accompanied by vascular leakage, inflammation and loss of endothelial cells.

For more information visit: https://www.curacle.com

About Théa and Théa Open Innovation

Théa is a leading independent European pharmaceutical company specialized in the research, development, and commercialization of eye-care products.

Based in Clermont-Ferrand, France, this family-owned company has continued to expand by opening more than 30 affiliates and offices in Europe, Russia, North Africa, North and South America. Its products are available in 75 countries.

Théa Open Innovation (TOI) is a sister company of Théa. TOI's mission is to set up partnerships with companies and universities to help bring the most innovative products in ophthalmology to the market.

For more information visit: https://www.laboratoires-thea.com/en

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Contact information

Jeonghan Kim
CURACLE Co. Ltd
jeonghan.kim@curacle.com