Vibativ^® treats patients with multidrug-resistant infections

NASHVILLE, Tenn. and RIYADH, Saudi Arabia, March 31, 2022 /PRNewswire/ -- Specialty pharmaceutical companies Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX), headquartered in Nashville, and Tabuk Pharmaceutical Manufacturing Company, a fully owned subsidiary of Astra Industrial Group and a leading pharmaceutical company in the Middle East, headquartered in Riyadh, Saudi Arabia, today announced the launch of Cumberland's Vibativ^® (telavancin) injection in the Middle East. The announcement follows an agreement between the companies providing Tabuk the exclusive rights to register and promote the product for patients in Saudi Arabia, Jordan and potentially other countries in the Middle East.  

Vibativ serves as a potentially life-saving treatment in patients with hospital-acquired and ventilator-associated pneumonia resulting from a range of Gram-positive bacterial pathogens, including those that are considered difficult-to-treat and are multidrug-resistant.

As a once-daily dosed antibiotic, Vibativ does not require therapeutic drug monitoring, decreasing health care professionals' exposure to the patient.

"As part of our role and mission in Tabuk to deliver unique health solutions and save lives of people throughout the Middle East countries we operate in, we believe that Vibativ will provide our physicians with a powerful new tool to battle multidrug-resistant infections including MRSA, hospital-acquired pneumonia and ventilator-associated pneumonia," said Mohammed Al Hagbani, president of Astra Industrial Group.

"Vibativ is a life-saving product for certain difficult-to-treat infections and a key addition to Tabuk's anti-infective portfolio, strengthening our leading market position in this therapy area and delivering on our strategy of building our specialty and innovative business while also reinforcing our leading position in the territory," said Wisam Alkhatib, vice president of strategy & business development at Tabuk Pharmaceuticals.

"Tabuk is a well-respected pharmaceutical company with a strong distribution network throughout the Middle East, and we are proud to partner with them to introduce Vibativ to this market," said A.J. Kazimi, CEO of Cumberland Pharmaceuticals. "They have the resources and experience to ensure that Vibativ reaches as many patients within the territory as possible, and we look forward to a successful partnership."

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. 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. 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.

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 branded generics, 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.

Cumberland Pharmaceuticals Inc. is a specialty pharmaceutical company focused on the delivery of high-quality, prescription brands designed to improve patient care. The company develops, acquires, and commercializes products for the hospital acute care, gastroenterology, and rheumatology market segments. The company's portfolio comprises eight FDA-approved brands, including Sancuso^®, which Cumberland acquired in December 2021. 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, as well as Systemic Sclerosis, and Aspirin-Exacerbated Respiratory Disease.

See more information on Cumberland Pharmaceutical's website at www.cumberlandpharma.com.

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. 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 results of operations. These factors include market conditions, 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, maintaining an effective sales and marketing infrastructure, natural disasters, public health epidemics, and other events beyond its control as more fully discussed in the company's most recent Form 10-Q and any additional updates filed with the SEC. 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.

Cumberland Contact, Shayla Simpson, Cumberland Pharmaceuticals, (615) 255-0068; Tabuk Contact, Rasha Ma'ayah, Tabuk Pharmaceutical Manufacturing Co., +962 6 55 344 41; Media Contact, Molly Aggas, Dalton Agency, (704) 641-6641