Meitheal Pharmaceuticals Announces Appointment of Dr. Keith Robinson as Chief Medical Officer and Expansion of Medical Affairs Operation

• Dr. Lonnie Brent appointed Senior Vice President of Medical Affairs
• Key leadership announcements reflect Meitheal’s growth trajectory – including major role of infectious disease medicines – and expanding regulatory and commercial needs
• Leaders’ extensive track record supports potential in antibiotics franchise with key milestones expected for XENLETA^® and intravenous fosfomycin

Meitheal Pharmaceuticals, Inc. (“Meitheal”), a fully integrated biopharmaceutical company based in Chicago and focused on the development and commercialization of generic injectables, fertility, biologic, and branded products, today announced the appointment of Dr. Keith Robinson as Chief Medical Officer. Additionally, Dr. Lonnie Brent has been appointed Senior Vice President of Medical Affairs and will lead Meitheal’s recently formed Medical Affairs operation.

“With a combined 38 years of experience in clinical research and development and Medical Affairs, Keith and Lonnie join Meitheal at a critical point in our evolution to become a more diversified and innovation-driven biopharmaceutical organization,” said Tom Shea, Chief Executive Officer of Meitheal. “These strategic appointments reflect not only our confidence in Meitheal’s long-term growth but also the important steps we are taking to expand our capabilities as our pipeline advances – particularly with two medicines in the antibiotics space.”

Dr. Keith Robinson is an experienced critical care and pulmonary physician with 18 years of clinical experience. Prior to joining Meitheal, Dr. Robinson most recently served as Executive Medical Director at Syneos Health, where he led initiatives in pulmonary, critical care, and general medicine. Before Syneos, Dr. Robinson served as the Associate Medical Director at IQVIA, managing pulmonary and critical care medicine projects. He holds a BS in Exercise Science from Ithaca College, an MS in Exercise Physiology from Florida State University, and an MD from Indiana University School of Medicine.

“As a former practicing physician, providing innovative and impactful medicines that meet patients’ unmet needs has always been my top priority,” said Dr. Keith Robinson, Chief Medical Officer of Meitheal. “In my new role, I am thrilled to use this passion to lead an experienced and disciplined team that is advancing critical medicines in high-impact therapeutic areas. I look forward to educating physicians on the latest scientific advancements and best practices in our core disease areas and, ultimately, ensuring patients have access to the safe and effective therapies they need.”

Dr. Lonnie Brent is a Doctor of Pharmacy by trade and will utilize more than 20 years of experience in pharmaceuticals, research and development, Medical Affairs, and deep expertise in oncology, rare diseases, and clinical practice to build and lead Meitheal’s Medical Affairs function. Prior to joining Meitheal, Dr. Brent served as Senior Vice President of Medical Affairs at TerSera Therapeutics, where he led the Medical Affairs function and served on the organization’s extended leadership team. In this role, Dr. Brent oversaw strategy across oncology, rare disease, and supportive care, played a central role in regulatory interactions, and served as interim Chief Medical Officer during key leadership transitions. He holds a Doctor of Pharmacy and a BS in Pharmacy from St. Louis College of Pharmacy.

The recently formed and now expanding Medical Affairs team will play a pivotal role in the research and development of the Company’s portfolio of 70 on-market products and growth into the anti-infective space. Infectious disease is a key therapeutic area where the Company is strategically investing to ensure Meitheal’s long-term growth. In 2024, Meitheal gained exclusive commercial licensing rights for two antibiotics, fosfomycin for injection and XENLETA^® (lefamulin). These two medicines are designed to address the unmet issue of increasing antibiotic resistance and, following regulatory approval and commercialization, could have a positive impact on individuals in both inpatient and outpatient treatment settings.

ABOUT XENLETA^® and Fosfomycin for injection

XENLETA^® (lefamulin) is a first-in-class, semi-synthetic pleuromutilin antibiotic for systemic administration in humans. It is designed to inhibit the synthesis of bacterial protein, which is required for bacteria to grow. XENLETA^®’s binding occurs with high affinity, high specificity, and at molecular sites that are different than other antibiotic classes. Two multicenter, multinational, double-blind, double-dummy, non-inferiority trials assessing a total of 1,289 patients with CABP demonstrated XENLETA^®’s efficacy. In these trials, XENLETA^® was compared with moxifloxacin, and in one trial, moxifloxacin with and without linezolid. Patients who received XENLETA^® had similar rates of efficacy as those taking moxifloxacin alone or moxifloxacin plus linezolid.

Fosfomycin for injection belongs to a different class of antibiotics, called phosphonics, which has a unique target in bacterial cell wall synthesis, making it bactericidal against most contemporary multidrug-resistant (MDR) strains, such as extended-spectrum beta-lactamase (ESBL)-producing Enterobacterales. The medicine has been approved for several indications by other regulatory authorities and has been utilized for over 45 years outside the U.S. to treat serious bacterial infections. Meitheal has submitted a New Drug Application (NDA) to the U.S. Food & Drug Administration (FDA) for fosfomycin for injection. The company’s NDA is currently under FDA review, with a target action date (PDUFA date) of October 29, 2025. If approved, it would be the first therapy of its kind indicated for the treatment of complicated urinary tract infections (cUTI), including acute pyelonephritis.

XENLETA^® IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

XENLETA^® is contraindicated in patients with known hypersensitivity to lefamulin, pleuromutilin class drugs, or any of the components of XENLETA^®. Concomitant use of XENLETA^® tablets with CYP3A substrates that prolong the QT interval is contraindicated.

WARNINGS AND PRECAUTIONS

QT Prolongation: Avoid use in patients with known QT prolongation, ventricular arrhythmias including torsades de pointes, and patients receiving drugs that prolong the QT interval such as antiarrhythmic agents. Embryo-Fetal Toxicity: May cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to use effective contraception. Clostridioides difficile-associated Diarrhea: Evaluate patients who develop diarrhea.

ADVERSE REACTIONS

The most common adverse reactions associated with XENLETA^® Injection include administration site reactions, hepatic enzyme elevation, nausea, hypokalemia, insomnia, and headache. The most common adverse reactions associated with XENLETA^® Tablets include diarrhea, nausea, vomiting, and hepatic enzyme elevation.

Please see Full Prescribing Information for more information.

ABOUT MEITHEAL PHARMACEUTICALS, INC.

Founded in 2017 and based in Chicago, Meitheal is focused on the development and commercialization of generic injectable medications and, as of 2022, has expanded its focus to include fertility, biologic, and branded products. Meitheal currently markets over 70 U.S. FDA-approved products across numerous therapeutic areas including anti-infectives, oncolytics, intensive care, and fertility. As of July 2025, Meitheal, directly or through its partners, has 29 products in the research and development phase, 10 additional products planned for launch in 2025, 4 products in clinical trial phases, and 22 products under review by the FDA. Meitheal’s mission is to provide easy access to fairly priced products through robust manufacturing, consistent supply, and rapid response to our customers’ needs. Ranked the past three years on Crain’s Fast 50 in Chicago and regularly rated as a top 100 on Crain’s Best Places to Work in Chicago, Meitheal emulates the traditional Irish guiding principle we are named for—working together toward a common goal, for the greater good.

Learn more about who we are and what we do at www.meithealpharma.com.

ABOUT HONG KONG KING-FRIEND INDUSTRIAL COMPANY (HKF)

Hong Kong King-Friend Industrial Company is a wholly owned subsidiary of NKF, founded in 2010.

ABOUT NANJING KING-FRIEND BIOPHARMACEUTICAL COMPANY (NKF)

Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. (NKF) is a China-based company principally engaged in the research and development, production and sales of Active Pharmaceutical Ingredients (API) and Finished Dosage Form (FDF). Established in 1986 as one of the world leading manufacturers of heparin related APIs, NKF has grown into a fully integrated API and FDF manufacturer in multiple therapeutic areas including critical care and oncology. With three U.S. FDA approved manufacturing sites in China and more than 500 employees, including more than 100 dedicated research and development experts, NKF strives to meet patient needs globally with market presence in the U.S., China, EU and across the world. The Company is publicly listed on Shanghai Stock Exchange with a market capitalization over U.S. $3.0 billion.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250731498961/en/