Full Press Release Details
Verona Pharma, Expanding its Portfolio to Include
Ohtuvayre (ensifentrine), a
First-In-Class COPD Maintenance Treatment for Adults and Expected to Drive Growth into the Next Decade
Acquisition aligns with Merck's science-led
business development strategy and expands pipeline and portfolio of treatments for cardio-pulmonary diseases
Merck to hold investor call at 8 a.m. ET today
RAHWAY, N.J., and RALEIGH, N.C., July 9, 2025 - Merck (NYSE:
MRK), known as MSD outside of the United States and Canada, and Verona Pharma plc (Nasdaq: VRNA) ("Verona Pharma"), a biopharmaceutical
company focused on respiratory diseases, today announced that the companies have entered into a definitive agreement under which Merck,
through a subsidiary, will acquire Verona Pharma for $107 per American Depository Share (ADS), each of which represents eight Verona Pharma
ordinary shares, for a total transaction value of approximately $10 billion.
Through this acquisition Merck will add Ohtuvayre (ensifentrine),
a first-in-class selective dual inhibitor of phosphodiesterase 3 and 4 (PDE3 and PDE4), to its growing cardio-pulmonary pipeline and portfolio.
The U.S. Food and Drug Administration approved Ohtuvayre in June 2024 for the maintenance treatment of chronic obstructive pulmonary disease
(COPD) in adult patients. Ohtuvayre is the first novel inhaled mechanism for the treatment of COPD in more than 20 years and combines
bronchodilator and non-steroidal anti-inflammatory effects. Ohtuvayre is also being evaluated in clinical trials for the treatment of
non-cystic fibrosis bronchiectasis.
"This acquisition of Verona Pharma reflects
the commitment we have to delivering innovative treatments to patients and our ability to execute on our science-led and value-driven
business development strategy," said Robert M. Davis, chairman and chief executive officer, Merck. "Ohtuvayre complements
and expands our pipeline and portfolio of treatments for cardio-pulmonary diseases while delivering near- and long-term growth as well
as value for shareholders. This novel, first-in-class treatment addresses an important unmet need for COPD patients persistently symptomatic
based on its unique combination of bronchodilatory and non-steroidal anti-inflammatory effects. We look forward to welcoming the talented
Verona Pharma team to Merck."
"Today's announced agreement with Merck
is the culmination of years of focus and determination by the Verona Pharma team advancing Ohtuvayre, the first novel inhaled mechanism
for the maintenance treatment of COPD in two decades," said David Zaccardelli, president and chief executive officer, Verona Pharma.
"Since launching Ohtuvayre in August 2024 we have seen rapid and accelerating uptake in the U.S. We believe Merck's commercial
footprint and industry-leading clinical capabilities will help accelerate the potential of Ohtuvayre to reach more patients living with
COPD. This agreement will enable the strong launch trajectory of this important medicine and provides value to Verona Pharma shareholders."
The transaction was unanimously approved by both
the Merck and Verona Pharma Boards of Directors and is intended to be effected by way of a scheme of arrangement under UK law. Closing
of the proposed acquisition is subject to approval under the Hart-Scott-Rodino Antitrust Improvements Act, approval of Verona Pharma shareholders,
sanction by the High Court of Justice of England and Wales and other customary conditions. The transaction is expected to close in the
fourth quarter of 2025 and will result in the capitalization of most of the purchase price as an intangible asset for Ohtuvayre (which
will be amortized as a GAAP-only charge over the life of the product).
Merck will hold an investor call today, July 9,
2025 at 8 a.m. ET to discuss the proposed transaction. Journalists who wish to ask questions are requested to contact a member of
Merck's Media Relations team at the conclusion of the call. Investors, journalists and the general public may access a live audio
webcast of the call via this weblink.
All participants may join the call by dialing (800)
369-3351 (U.S. and Canada Toll-Free) or (517) 308-9448 and using the access code 2398172.
Morgan Stanley & Co. LLC acted as financial advisors to Merck in this transaction and Freshfields LLP acted as Merck's legal
advisor. Centerview Partners LLC acted as exclusive financial advisor to Verona Pharma and Latham & Watkins LLP as Verona Pharma's
Ohtuvayre Indication and Important Safety Information
Ohtuvayre is indicated for the maintenance treatment of chronic obstructive
pulmonary disease (COPD) in adult patients.
IMPORTANT SAFETY INFORMATION
Contraindication: Ohtuvayre is contraindicated in patients with
hypersensitivity to ensifentrine or any component of this product.
Warnings and Precautions:
Acute Episodes of Bronchospasm Ohtuvayre should not be used
for the relief of acute symptoms, i.e., as rescue therapy for the treatment of acute episodes of bronchospasm. Acute symptoms should be
treated with an inhaled, short-acting bronchodilator.
Paradoxical Bronchospasm As with other inhaled medicines, Ohtuvayre
may produce paradoxical bronchospasm, which may be life threatening. If paradoxical bronchospasm occurs following dosing with Ohtuvayre,
it should be treated immediately with an inhaled, short-acting bronchodilator. Ohtuvayre should be discontinued immediately and alternative
therapy should be instituted.
Psychiatric Events Including Suicidality Before initiating treatment
with Ohtuvayre, healthcare providers should carefully weigh the risk and benefits of treatment with Ohtuvayre in patients with a history
of depression and/or suicidal thoughts or behavior. Patients, their caregivers, and families should be advised of the need to be alert
for the emergence or worsening of insomnia, anxiety, depression, suicidal thoughts, or other mood changes, and if such changes occur to
contact their healthcare provider. Healthcare providers should carefully evaluate the risks and benefits of continuing treatment with
Ohtuvayre if such events occur.
Treatment with Ohtuvayre is associated with an increase in psychiatric
adverse reactions. Psychiatric events including suicide-related adverse reactions were reported in clinical studies in patients who received
Ohtuvayre (1 suicide attempt and 1 suicide). Additionally, the most commonly reported psychiatric adverse reactions in the pooled 24-week
safety population were insomnia (6 patients [0.6%] Ohtuvayre 3 mg; 2 patients [0.3%] placebo), and anxiety (2 patients [0.2%] Ohtuvayre
3 mg; 1 patient [0.2%] placebo). Depression-related reactions including depression, major depression, and adjustment disorder with depressed
mood occurred in 4 patients [0.4%] receiving Ohtuvayre and no patients receiving placebo.
Adverse Reactions: The most common adverse reactions 1%
in Ohtuvayre and greater than placebo in the pooled population were back pain 1.8%, hypertension 1.7%, urinary tract infection 1.3%, and
These are not all of the possible risks associated with Ohtuvayre.
Please see Prescribing Information for Ohtuvayre (ensifentrine)
at: https://ohtuvayrehcp.com/wp-content/uploads/sites/2/2024/11/Ohtuvayre-US-Prescribing-Information.pdf, Patient Information
About Chronic Obstructive
Pulmonary Disease (COPD)
pulmonary disease (COPD) is a progressive respiratory condition that causes restricted airflow and breathing problems. Emphysema and chronic
bronchitis are the two most common types of COPD. Common symptoms of COPD include shortness of breath an ongoing cough or a cough
that produces a lot of mucus, wheezing, chest tightness or heaviness and fatigue. Smoking and air pollution are the most common causes
of COPD. An estimated 390 million people suffer from COPD worldwide as of 2019 and COPD is the fourth leading cause of death worldwide.
There is no cure for COPD.
About Ohtuvayre (ensifentrine)
Ohtuvayre is the first inhaled therapy for the
maintenance treatment of adults with COPD that combines bronchodilator and non-steroidal anti-inflammatory activities in one molecule.
Verona has evaluated nebulized Ohtuvayre in its Phase 3 clinical program ENHANCE ("Ensifentrine as a Novel inHAled Nebulized COPD
thErapy") for COPD maintenance treatment. Ohtuvayre met the primary endpoint in both ENHANCE-1 and ENHANCE-2, demonstrating statistically
significant and clinically meaningful improvements in lung function. A fixed-dose combination of ensifentrine and glycopyrrolate, a LAMA,
is currently under development for the maintenance treatment of COPD.
Verona Pharma is a biopharmaceutical company focused
on developing and commercializing innovative therapies for the treatment of chronic respiratory diseases with significant unmet medical
needs. Ohtuvayre (ensifentrine) is the company's first commercial product and the first inhaled therapy for the
maintenance treatment of COPD that combines bronchodilator and non-steroidal anti-inflammatory activities in one molecule. Ensifentrine
has potential in other respiratory diseases such as non-cystic fibrosis bronchiectasis. For more information, please visit www.veronapharma.com.
At Merck, known as MSD outside of the United States
and Canada, we are unified around our purpose: We use the power of leading-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 aspire to be the
premier research-intensive biopharmaceutical company in the world - and today, we are at the forefront of research to deliver innovative
health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global