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Merck to acquire Eyebiotech in deal worth up to $3B

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Merck & Co. announced it will acquire Eyebiotech Limited (EyeBio) as part of a billion-dollar definitive agreement—a major expansion into the ophthalmic industry for the pharmaceutical giant.

Let’s start with these players.

The U.S. branch of Merck was founded in 1891—following the 1668 founding of the Germany-based Merck Group—and is currently headquartered in Rahway, New Jersey.

As one of the largest multinational pharmaceutical companies in the world, it specializes in delivering health solutions via prescription medicines, vaccines, biologic therapies, and animal health products.

Most notably: Merck manufactured the first smallpox vaccine for commercial use in the U.S. and is the maker of Keytruda (pembrolizumab; for various cancers) and Gardasil (a human papillomavirus [HPV] vaccine).

And Eyebiotech?

Founded in 2021, the United Kingdom-based EyeBio is a privately held ophthalmology biotechnology company focused on developing advanced therapies for eye diseases.

Its lead investigational candidate—Restoret (EYE103)—is currently in clinical development to treat retinal diseases characterized by vascular leakage via intravitreal injection.

Gotcha. Now about some details on the purchase?

Through a subsidiary, Merck reported that it will be acquiring “all outstanding shares of EyeBio for up to $3 billion, including an upfront payment of $1.3 billion in cash plus the potential for $1.7 billion in developmental, regulatory, and commercial milestone payments.”

Note: The company noted that the acquisition has also been “unanimously approved” by the EyeBio Board of Directors.

Wow … this is pretty major. So why EyeBio?

To put it plainly: Merck is looking to advance EyeBio’s investigational pipeline targeting retinal diseases (not to mention gain a large foothold in the ophthalmic industry).

“As a subsidiary of Merck, EyeBio will be positioned to tap into the resources and infrastructure needed to support the clinical, regulatory and commercial development of these candidates,” stated EyeBio CEO and President David R. Guyer, MD, a co-founder of the company.

Tell me more about this retinal pipeline.

Let’s talk about Restoret.

What it is: The tetravalent, tri-specific antibody operates as an agonist of the Wingless-related integration site (Wnt) signaling pathway, which is part of a group of signal transduction pathways beginning with proteins that pass signals into a cell through cell surface receptors.

Why this is key: Wnt genes code for proteins that are responsible for the normal development and maintenance of the blood-retinal barrier (BRB).

  • Plus: The signaling of Wnt is known to have a key role in vascular integrity maintenance and vascular retinal leakage (due to defects).

And Restoret’s mechanism of action?

Delivered via IV injection, the antibody works to remove leakage in retinal vascular diseases by forcing the Wnt pathway to restore and maintain the BRB—currently an unmet medical need for patients with such diseases.

Which diseases are these?

EyeBio’s current focus:

  • Wet age-related macular degeneration (AMD)
  • Diabetic macular edema (DME)
  • Familial exudative vitreoretinopathy (FEVR)

How far into the clinical process is it?

The company released 12-week data in February 2024 from the phase 1b/2, multicenter, open-label, Anti-permeability Mechanism and Age-Related Ocular Neovascularization Evaluation (AMARONE) trial (NCT05919693) currently evaluating the use of Restoret for both wet AMD and DME.

How is it designed?

A total of 90 participants (aged 50+) were enrolled, with each receiving a 12-week regimen of Restoret. The two-part study included:

  • Part 1: Multiple-ascending dose (MAD) safety study
    • n = 12; divided into four cohorts of three each
      • Low, low-mid, mid-high, and high
  • Part 2: Dose-finding, single-masked comparative safety and preliminary efficacy study (n = 80)
    • Naïve DME monotherapy: medium and high doses
    • Naïve DME combination therapy (Restoret + aflibercept 2 mg): medium and high doses
    • Experienced wet AMD combination therapy (Restoret + aflibercept 2 mg): medium and high doses

And those 12-week findings?

With adverse events (AEs) and best-corrected visual acuity (BCVA) as the primary and secondary outcome measures, respectively, the EyeBio reported that:

Restoret was well-tolerated, with no reports of drug-related AEs or serious AEs, as well as intraocular inflammation (IOI).

Let’s get into specifics.

For DME patients (n = 26) receiving Restoret monotherapy, a BCVA mean improvement of +11.2 letters was demonstrated along with a mean reduction in retinal thickness of -143 microns (measured via optical coherence tomography [OCT]).

And for wet AMD patients (n = 5) receiving Restoret in combination with aflibercept, similar outcomes were demonstrated, according to the company.

What’s the significance of the data?

When reporting the results, Dr. Guyer noted that the AMARONE study—a first-in-human (FIH) trial—represented the first-ever “clinical use of a Wnt pathway agonist to address retinal disease, and we are encouraged by the preliminary safety and efficacy data we’ve seen thus far.”

Nice! So what’s next for this candidate?

The AMARONE study is expected to conclude in December 2024 … so we’ll be standing by for updated data on that.

In the meantime, EyeBio is also planning to advance Restoret into a pivotal phase 2b/3 trial (for DME, exclusively) in H2 2024.

And circling back to this acquisition: When will it close?

Subject to such customary conditions as the Hart-Scott-Rodino Antitrust Improvements Act—which requires companies to notify the Federal Trade Commission (FTC) and Department of Justice (DOJ) of certain mergers and acquisitions beforehand—the deal is expected to close in Q3 2024.

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