May 29, 2024 6:45 AM ET
The acquisition includes Restoret™, a new late-stage candidate for diabetic macular edema and neovascular age-related macular degeneration, as well as a preclinical pipeline targeting retinal diseases
Restoret is expected to enter a pivotal trial for diabetic macular edema in the second half of 2024
Merck to acquire EyeBio for $1.3 billion upfront and up to $1.7 billion in future milestones for a potential value of $3 billion
RAHWAY, NJ & NEW YORK–(BUSINESS WIRE)–
Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Eyebiotech Limited (EyeBio), a privately held ophthalmology biotechnology company, today announced that the companies have entered into a definitive agreement under which Merck, through a subsidiary, will acquire EyeBio.
“We continue to execute on our science-based business development strategy to expand and diversify our pipeline,” said Dr. Dean Y. Li, president of Merck Research Laboratories. “The EyeBio team led by Dr. David Guyer and Dr. Tony Adamis has a long history of developing pioneering ophthalmic therapies. By combining our strengths, we aim to consistently advance and accelerate the development of their promising pipeline of retinal disease candidates.”
Under the terms of the agreement, Merck, through a subsidiary, will acquire all of EyeBio’s outstanding shares for up to $3 billion, including an upfront payment of $1.3 billion in cash and a potential additional $1.7 billion in development, regulatory and commercial milestone payments. The acquisition was unanimously approved by EyeBio’s board of directors.
EyeBio is developing a number of clinical and preclinical candidates for the prevention and treatment of vision loss associated with retinal vascular leakage, a known risk factor for retinal disease. The company’s lead candidate, Restoret™ (EYE103), is a tested, potentially first-in-class tetravalent, trispecific antibody that acts as an agonist of the Wingless-related integration site (Wnt) signaling pathway. Based on positive results from the open-label phase 1b/2a study of AMARONE in patients with diabetic macular edema (DME) and neovascular age-related macular degeneration (NVAMD), Restoret is expected to advance to a pivotal phase 2b/3 study investigating the treatment of DME patients in the second half of 2024.
“The EyeBio team has successfully assembled a number of novel candidates with the potential to provide new treatment options for patients with retinal disease,” said Dr. David R. Guyer, CEO and President of EyeBio. “As a subsidiary of Merck, EyeBio will be in a position to leverage the resources and infrastructure needed to support the clinical, regulatory and commercial development of these candidates and help bring them to patients around the world.”
In addition to expanding Merck’s pipeline, the acquisition significantly expands the company’s presence in ophthalmology. The EyeBio team and management including founders Dr. David Guyer and Dr. Tony Adamis will leverage his experience and world-class expertise as part of Merck to continue his pioneering work to advance the clinical development of Restoret and other ongoing development programs.
“Less than three years ago, EyeBio was hatched to turn Dr. David Guyer’s idea for a potential new therapy for retinal disease into reality,” said Kate Bingham, EyeBio Chairman and Managing Partner, SV Health Investors. “This agreement reflects the hard work of EyeBio’s talented team, led by Dr. Guyer, who has placed Restoret on a defined development path to patients through this agreement.”
Closing of the proposed acquisition is subject to approval under the Hart-Scott-Rodino Antitrust Improvement Act and other customary conditions. The transaction is expected to close in the third quarter of 2024 and will be accounted for as an asset acquisition. Merck expects to record a charge of approximately $1.3 billion, or approximately $0.50 per share, which will be included in non-GAAP results in the quarter when the transaction closes.
advisors
Citi acted as financial advisor to Merck in this transaction and Gibson, Dunn & Crutcher LLP acted as its legal counsel. Centerview Partners LLC acted as financial advisor to EyeBio and Skadden, Arps, Slate, Meagher & Flom LLP acted as legal counsel to the company.
On the blood-retinal barrier and retinal vascular leakage
Some retinal conditions are characterized by both inflammation and breakdown of the inner hematoretinal barrier (iBRB), resulting in vascular permeability and leakage into the adjacent retinal tissue. Vascular leakage is a known risk factor for retinal diseases including diabetic macular edema (DME) and neovascular age-related macular degeneration (NVAMD).
About Restore
Restoret is an investigational, potentially first-in-class, tetravalent, trispecific Wnt antibody designed to address unmet medical needs in patients with retinal diseases, including diabetic macular edema (DME) and neovascular age-related macular degeneration (NVAMD). Restoret is administered as an intravitreal injection that seeks to eliminate leakage in retinal vascular disease by agonizing the Wnt pathway to restore and maintain the hematoretinal barrier. Preclinical evidence suggests that agonizing the Wnt pathway in the retina can reduce vascular leakage.
About EyeBio (Eyebiotech Limited) and its investors
Eyebiotech Limited (EyeBio) is a private, clinical-stage ophthalmic biotechnology company dedicated to developing and delivering next-generation therapies to protect, restore and improve vision in patients with sight-threatening eye diseases. Founded in August 2021 by David Guyer, MD, and Tony Adamis, MD, and SV Health Investors, EyeBio has a leadership team with a superior track record in ophthalmology drug development. With operations in the United States and the United Kingdom, EyeBio is building and expanding a range of eye therapies that combine scientifically robust targets with innovative translational approaches. To date, EyeBio has raised $130 million. SV Health Investors (Kate Bingham, DBE and Mike Ross, Ph.D.) founded and incorporated the company in August 2021 and were joined in February 2022 by co-principals Samsara BioCapital (Srini Akkaraju, MD, Ph.D.), Jeito Capital ( Andreas Wallnoefer, Ph.D.) in raising a $65 million Series A funding round, with funding from MRL Ventures Fund (Olga Danilchanka, Ph.D.), the corporate arm of Merck. In November 2023, the Series A round was expanded to $130 million with the addition of new investors Bain Capital Life Sciences (Leonard Feiner (MD, Ph.D. and Amir Zamani, MD), Omega Funds (Bernard Davitian) and Vertex Ventures HC (Christine Brennan, Ph.D. More information can be found at www.eyebiotech.com).
About Merck
At Merck, known as MSD outside the United States and Canada, we are united around our goal: Using the power of cutting-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We strive to be the world’s leading research-intensive biopharmaceutical company – and today we are at the forefront of research that delivers innovative healthcare solutions that advance the prevention and treatment of disease in humans and animals. We support a diverse and inclusive global workforce and work responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and contact us at X (formerly Twitter)Facebook, Instagram, YouTube and LinkedIn.
Forward-looking statement by Merck & Co., Inc., Rahway, NJ, USA
This press release from Merck & Co., Inc., Rahway, NJ, USA, contains statements that are not statements of historical fact or “forward-looking statements,” including statements about the proposed acquisition of Eyebiotech Limited (EyeBio) by Merck, and readers are cautioned that not to place too much reliance on such statements. Such forward-looking statements include, but are not limited to, Merck’s and EyeBio’s ability to complete the transactions contemplated by the definitive agreement, including the parties’ ability to satisfy the conditions to consummate the acquisition contemplated by this agreement, statements regarding the expected timeline for completion of the transaction, Merck’s and EyeBio’s beliefs and expectations, and statements of benefits , to be achieved in Merck’s proposed acquisition of EyeBio, the potential effects of the acquisition on both Merck and EyeBio, the possibility of any termination of the definitive agreement, as well as the expected benefits and success of EyeBio’s product candidates. These statements are based on the current beliefs and expectations of Merck management and are subject to significant risks and uncertainties. There can be no assurance that the conditions to the closing of the proposed transaction will be satisfied on the anticipated schedule or at all, or that any product candidate will receive the necessary regulatory approvals or prove commercially successful. If underlying assumptions prove to be inaccurate or risks or uncertainties materialize, actual results may differ materially from those expressed in the forward-looking statements.
Risks and uncertainties include, but are not limited to, uncertainties regarding the timing of the acquisition; the possibility that various conditions to the completion of the acquisition contained in the definitive agreement may not be satisfied or waived; the effects of the disruption of the transactions contemplated by the definitive agreement and the impact of the notice and pending transactions on EyeBio’s business; general industry conditions and competition; general economic factors, including fluctuations in interest rates and exchange rates; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends towards containment of health care costs; technological advances, new products and patents achieved by competitors; challenges associated with new product development, including obtaining regulatory approval; Merck’s ability to accurately predict future market conditions; production difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Merck’s patents and other protections for innovative products; and exposure to litigation, including patent litigation, and/or regulatory action.
Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise, except to the extent required by law. Other factors that could cause results to differ materially from those described in forward-looking statements can be found in Merck’s 2023 Annual Report on Form 10-K and in Merck’s other filings with the Securities and Exchange Commission ( SEC), which are available on the SEC website. (www.sec.gov).
Source: Merck & Co., Inc.