Vyluma and Laboratoires Théa Enter into Licensing Agreement for the Registration and Commercialization of NVK002 in Canada, Mexico, and Select South American Countries

BRIDGEWATER, N.J., June 14, 2022 (GLOBE NEWSWIRE) — Vyluma, Inc. (“Vyluma”), a biopharmaceutical company developing multiple assets in the ophthalmic space for the treatment of refractive errors, and Laboratoires Théa (“Théa”) announced that they have recently entered into an exclusive licensing agreement for the registration and commercialization of NVK002 in Canada, Mexico, and select South American Countries. This agreement represents an expansion of the previously announced exclusive licensing agreement for the commercialization of NVK002 in Europe and other select countries.

NVK002 is a proprietary, investigational, preservative-free eye drop administered nightly and intended for slowing the progression of myopia in children ages three to 17. It is currently under late-stage clinical evaluation in the CHAMP (Childhood Atropine for Myopia Progression) study, a Phase III multi-center clinical trial being carried out in the U.S. and Europe.

“We are very pleased to build upon the strong partnership we have established with Théa to include these exciting new markets,” noted Raul A. Trillo, MD, MBA, Chief Commercial Officer at Vyluma. “Théa has been an acknowledged pioneer in preservative-free eye care treatments, and by expanding the scope of the agreement signed in 2021, more patients will now have access to this important new therapeutic.”

Under the terms of the agreement, Théa will manage the approval process for the product and once approved will launch, sell, and support the product in the newly selected countries. With this latest agreement, Vyluma has the potential to receive payments exceeding $150 million upon the successful attainment of key regulatory and sales milestones across the Théa-licensed markets in Europe, Canada, and Latin America. In addition, Vyluma will be entitled to tiered royalty payments, ranging from the mid to upper teens, on net sales of NVK002 under the expanded agreement.

About Vyluma, Inc.
Vyluma is a development-stage biopharmaceutical company with a focus on pharmaceutical treatments for refractive errors of the eye. Vyluma’s pipeline of therapies is led by NVK002, an investigational, preservative-free, low-dose atropine eye drop to slow the progression of myopia in children. NVK002 is currently in late Phase III clinical development in the United States, Europe, and Asia.

Vyluma has a robust pipeline of other assets in various stages of development which address important unmet treatment needs of patients with refractive errors or eye pain.

Vyluma itself is a subsidiary of Nevakar Inc., a holding company whose subsidiaries are engaged in developing products for the ophthalmic and injectable markets. For additional information please visit www.vyluma.com.

About Nevakar Inc.
Nevakar Inc. is a fully integrated privately held, late-stage biopharmaceutical company with an extensive portfolio of products in the ophthalmic and injectable areas. Founded in 2015, and headquartered in Bridgewater, New Jersey, the Company is focused on developing and commercializing innovative products to address unmet medical needs, thereby improving patients’ quality of life and healthcare outcomes. Nevakar utilizes the 505(b)(2) regulatory pathway, along with its proven expertise in the development of novel and proprietary sterile pharmaceutical products to identify, develop, and obtain regulatory approval for its products. Additional information is available at www.nevakar.com.

About Théa
Théa is the leading independent European pharmaceutical group in ophthalmology. Based in Clermont-Ferrand, France, it has thirty-five affiliates & offices in Europe, North and South America, North Africa, and the Middle East. Today, its network includes more than 1,500 employees, and its products are available in 75 countries around the world. In 2021, Théa had global revenues of approximately $773 million. The independent and family-owned and run group, founded from a Research and Development start-up by Henri Chibret, has been chaired since 2008 by Jean-Frédéric Chibret, his nephew. To learn more about Théa, visit https://www.laboratoires-thea.com/en

Investor Contact for Nevakar and Vyluma:

Marshall Woodworth
Chief Financial Officer
T: 908.699.4940
E: mwoodworth@nevakar.com
E: mwoodworth@vyluma.com

Lisa M. Wilson
In-Site Communications, Inc.
T: (212) 452-2793
E: lwilson@insitecony.com

Contact for Théa:

Colin Francou
Business Development Manager
E: colin.francou@theapharma.com