TABUK LAUNCHES VIBATIV® FDA-APPROVED ANTIBIOTIC WITH LIFE-SAVING POTENTIAL IN SAUDI ARABIA

Rhea-AI Summary

Cumberland Pharmaceuticals (NASDAQ:CPIX) and Tabuk Pharmaceutical Manufacturing Company have launched Vibativ® (telavancin) injection in Saudi Arabia. This FDA-approved antibiotic is designed to treat hospital-acquired and ventilator-associated pneumonia, including infections from flu and COVID-19, as well as serious skin infections.

The drug specifically targets drug-resistant bacteria, including Methicillin-resistant Staphylococcus aureus (MRSA) and Methicillin-sensitive Staphylococcus aureus (MSSA). Vibativ maintains its potency against difficult-to-treat bacteria even after 10 years since introduction, featuring a unique molecular design that combines lipophilic and hydrophilic components to enhance cell wall penetration and tissue reach.

The launch follows an exclusive agreement granting Tabuk rights to register and promote Vibativ in Saudi Arabia and other Middle Eastern countries.

Positive

• Vibativ maintains full potency against resistant bacteria after 10 years of use
• Drug demonstrates significantly higher cure rates compared to vancomycin in specific infections
• Once-daily dosing without therapeutic drug monitoring requirement reduces healthcare staff exposure
• Geographic expansion into Saudi Arabia and Middle East markets through established partner
• Addresses urgent global health crisis of antimicrobial resistance (AMR)

Negative

• Complex administration method requiring intravenous delivery
• Limited to hospital and clinical settings due to administration requirements

Insights

Pharmaceutical Industry Expert

Cumberland's Vibativ launch in Saudi Arabia via Tabuk partnership expands their market reach in battling dangerous antimicrobial-resistant infections.

This partnership between Cumberland Pharmaceuticals and Tabuk Pharmaceutical represents a significant market expansion for Vibativ (telavancin), addressing a critical global health challenge. The timing is particularly strategic given the World Health Organization's recent warning about antimicrobial resistance (AMR) as an urgent global crisis.

What makes Vibativ particularly valuable in today's treatment landscape is its unique molecular design. Unlike many antibiotics that quickly lose effectiveness against resistant bacteria, Vibativ was specifically engineered with dual mechanisms: a lipophilic component that enhances cell wall penetration and inhibits new cell wall formation (the primary bacterial resistance mechanism), and a hydrophilic component that improves tissue penetration to reach infections inaccessible to other antibiotics.

The clinical significance cannot be overstated - Vibativ has maintained its potency against multidrug-resistant pathogens for over 10 years, demonstrating remarkable durability in an era where antibiotic resistance is rapidly growing. Clinical studies showed significantly higher cure rates compared to vancomycin for hospital-acquired and ventilator-associated bacterial pneumonia caused by Staphylococcus aureus strains with elevated vancomycin MICs.

For Cumberland, this agreement provides access to Saudi Arabia plus additional Middle Eastern markets through Tabuk's established regional distribution network spanning 17 countries. The once-daily dosing without therapeutic drug monitoring requirements offers practical advantages for healthcare providers while reducing their exposure to potentially infected patients - a notable benefit in hospital settings dealing with serious infections.

Vibativ ^®  treats patients with pneumonia and serious skin infections

NASHVILLE, Tenn. and RIYADH, Saudi Arabia, Sept. 29, 2025 /PRNewswire/ -- Specialty pharmaceutical companies Tabuk Pharmaceutical Manufacturing Company a fully owned subsidiary of Astra Industrial Group and a leading pharmaceutical company in the Middle East and Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX), a specialty pharmaceutical company, today announced the launch of Cumberland's Vibativ^® (telavancin) injection in Saudi Arabia.

The announcement follows an agreement between the companies providing Tabuk with the exclusive rights to register and promote the product for patients in Saudi Arabia and other countries in the Middle East.

Vibativ is a patented, FDA-approved injectable anti-infective that can serve as a potentially life-saving treatment in patients with hospital-acquired and ventilator-associated pneumonia resulting from infections, including the flu and COVID-19. It is intravenously administered with once-daily dosing and does not require therapeutic drug monitoring, decreasing health care professionals' exposure to the patient. It is designed to treat serious infections due to Staphylococcus aureus (S. aureus) and other Gram-positive bacteria, including Methicillin-resistant Staphylococcus aureus (MRSA) and Methicillin-sensitive Staphylococcus aureus (MSSA). Vibativ addresses a range of Gram-positive bacterial pathogens, including those that are considered difficult-to-treat and multidrug-resistant.

"Given the global concern about multidrug-resistant organisms, Vibativ is an important addition to our anti-infective portfolio and supports our mission to deliver unique health solutions and save the lives of people throughout the Middle Eastern countries we operate in," said Ismail Shehadah, CEO of Tabuk. "We believe Vibativ will provide our physicians with a powerful new tool to battle multidrug-resistant infections and we are excited to launch the product in Saudi Arabia."

According to a recent report from the World Health Organization, antimicrobial resistance (AMR) is an urgent global health and socioeconomic crisis. Further, the global rise in antibiotic resistance poses a significant threat, diminishing the efficacy of many common antibiotics against widespread bacterial infections.

Unlike many recently introduced antibiotics that are quickly losing the battle to fight the bacteria they were designed to kill because those bacteria have become drug-resistant, Vibativ was specifically designed to kill drug-resistant bacteria. The molecule of an existing antibiotic to which bacteria had developed a resistance, vancomycin, was altered by adding a lipophilic (fat-loving) component and a hydrophilic (water-loving) component. The lipophilic addition increases Vibativ's ability to penetrate the cell wall and inhibits the formation of new cell walls (the development of new and/or additional cell walls is the most common way that bacteria become resistant to drugs). The hydrophilic addition increases Vibativ's penetration into tissue, and is able to attack infections that are not reachable by other antibiotics.

Studies show that Vibativ is just as potent today against difficult-to-treat and multidrug-resistant bacteria as it was when it was introduced over 10 years ago.

"We are very pleased to expand the reach of Vibativ – an important and potentially life-saving drug – through this partnership with Tabuk," said A.J. Kazimi, CEO of Cumberland Pharmaceuticals. "We are confident that Tabuk has the resources and experience to ensure Vibativ reaches as many patients in Saudi Arabia as possible."

About Vibativ^®

Vibativ^® (telavancin) injection was discovered in a research program dedicated to finding new antibiotics for serious infections due to Staphylococcus aureus (S. aureus) and other Gram-positive bacteria, including MRSA and MSSA. Vibativ is a once-daily, injectable lipoglycopeptide antibiotic with in vitro potency, bactericidal activity within six hours and penetration into target infection sites. The drug is approved in the U.S. and Saudi Arabia for the treatment of adult patients with hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of S. aureus when alternative treatments are not suitable.

In addition, Vibativ is approved in the U.S. and Saudi Arabia for the treatment of adult patients with complicated skin and skin structure infections (cSSSI) caused by susceptible isolates of Gram-positive bacteria, including S. aureus, both methicillin-susceptible (MSSA) and methicillin-resistant (MRSA) strains. The product labeling also describes the use of Vibativ in treating patients whose pneumonia or skin infection is complicated by concurrent bacteremia. The product's proven efficacy against difficult-to-treat Gram-positive infections has been demonstrated in several large, multinational registrational studies, which involved one of the largest cohorts of patients with S. aureus infections studied to date. Importantly, these studies demonstrated significantly higher cure rates for Vibativ as compared to vancomycin in HABP/VABP due to any single Gram-positive pathogen or S. aureus with vancomycin MIC ≥1 µg/mL. Additionally, there is extensive and well-documented evidence of the drug's in vitro potency and in vivo activity against a broad collection of Gram-positive bacterial pathogens, including those that are considered difficult-to-treat and multidrug-resistant.

For full prescribing information, including important safety information, visit www.vibativ.com.

About Tabuk Pharmaceutical Manufacturing Co.

Tabuk Pharmaceutical Manufacturing Company is a leading Saudi pharmaceutical company with a regional presence in the Middle East and North Africa. Tabuk Pharmaceuticals develops, manufactures, markets and distributes various pharmaceutical products, in addition to manufacturing pharmaceutical products for renowned international partners at its manufacturing sites in Saudi Arabia, as part of its continuous efforts to cover the needs of patients by providing high quality medicines. Tabuk Pharmaceuticals is a major player in the pharmaceutical sector not only in the Kingdom of Saudi Arabia, but also throughout the Middle East and North Africa, thanks to its four state-of-art manufacturing sites located in Tabuk and Dammam in the Kingdom, as well as in Sudan and Algeria, and orchestrated by a team of more than 2,400 employees. Tabuk Pharmaceuticals reaches patients in 17 countries in the Middle East and Africa, in addition to futuristic plans to expand its presence in the region.

About Cumberland Pharmaceuticals

Cumberland Pharmaceuticals Inc. is the largest biopharmaceutical company founded and headquartered in Tennessee and is focused on providing unique products that improve the quality of patient care. The company develops, acquires, and commercializes products for the hospital acute care, gastroenterology and oncology market segments. The company's portfolio comprises six FDA-approved brands. The company also has a series of Phase II clinical programs underway evaluating its ifetroban product candidate in patients with cardiomyopathy associated with Duchenne Muscular Dystrophy, Systemic Sclerosis and Idiopathic Pulmonary Fibrosis.

For more information, visit www.cumberlandpharma.com.

Forward-Looking Statements

This press release contains forward-looking statements, which are subject to certain risks and reflect Cumberland's current views on future events based on what it believes are reasonable assumptions. No assurance can be given that these events will occur. Forward-looking statements include, among other things, statements regarding the company's intent, belief or expectations, and can be identified by the use of terminology such as "may," "will," "expect," "believe," "intend," "plan," "estimate," "should," "seek," "anticipate," "look forward" and other comparable terms or the negative thereof. As with any business, all phases of Cumberland's operations are subject to factors outside of its control, and any one or combination of these factors could materially affect Cumberland's operation results. These factors include macroeconomic conditions, including rising interest rates and inflation, competition, an inability of manufacturers to produce Cumberland's products on a timely basis, failure of manufacturers to comply with regulations applicable to pharmaceutical manufacturers, natural disasters, public health epidemics, maintaining an effective sales and marketing infrastructure, and other events beyond the company's control as more fully discussed in its most recent annual report on Form 10-K as filed with the U.S. Securities and Exchange Commission (SEC), as well as the company's other filings with the SEC from time to time.

There can be no assurance that results anticipated by the company will be realized or that they will have the expected effects. Readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date hereof. The company does not undertake any obligation to publicly revise these statements to reflect events after the date hereof.

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SOURCE Cumberland Pharmaceuticals Inc.

FAQ

What is Vibativ and what does Cumberland Pharmaceuticals' CPIX drug treat?

Vibativ (telavancin) is an FDA-approved injectable antibiotic that treats hospital-acquired pneumonia, ventilator-associated pneumonia, and serious skin infections caused by Gram-positive bacteria, including MRSA and MSSA.

How effective is Vibativ against drug-resistant bacteria?

Vibativ has maintained its full potency against difficult-to-treat and multidrug-resistant bacteria for over 10 years, showing significantly higher cure rates compared to vancomycin in specific infections.

What makes Cumberland's Vibativ different from other antibiotics?

Vibativ features a unique molecular design with both lipophilic and hydrophilic components, allowing it to better penetrate cell walls and reach infections that other antibiotics cannot, while maintaining effectiveness against drug-resistant bacteria.

Where is CPIX's Vibativ now available in the Middle East?

Through a partnership with Tabuk Pharmaceutical, Vibativ is now available in Saudi Arabia, with plans to expand to other Middle Eastern countries under the exclusive agreement.

How is Vibativ administered to patients?

Vibativ is administered intravenously once daily and does not require therapeutic drug monitoring, which helps reduce healthcare professionals' exposure to patients.