Vibativ® treats patients with pneumonia and serious skin infections
NASHVILLE – Specialty pharmaceutical companies Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX) and Verity Pharmaceuticals International Ltd. has announced the launch of Cumberland’s VIBATIV® (telavancin) injection in Puerto Rico. The announcement follows an agreement between the companies providing Verity the rights to introduce the product for patients in that market. VIBATIV 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.
VIBATIV is a patented, FDA-approved injectable anti-infective. 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.
Pneumonia caused by secondary bacterial infections is common among patients with viral respiratory infections. The risk of such infections grows as hospitals see more patients with respiratory symptoms due to COVID-19. Research shows that hospital-acquired pneumonia (HAP) and ventilator-associated pneumonia (VAP) have historically accounted for 22% of common hospital-acquired infections.Methicillin-sensitive and methicillin-resistant S. aureus (MSSA and MRSA) are important disease-causing pathogens in these cases.
“Given the global concern on multidrug resistance organisms, Puerto Rico is in need of a product like VIBATIV. Of note, the island has a high number of elderly citizens and residents living with chronic diseases, like diabetes, that increase the risk of hospitalization and infections,” said Howard Glase, CEO and general manager of Verity Pharmaceuticals. “We strongly believe in VIBATIV’s efficacy and safety and are honored to provide this potentially life-saving drug for patients in Puerto Rico.”
While many recently introduced antibiotics 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 – so it is able to attack infections that are not reachable by other antibiotics.
In comparison to vancomycin, VIBATIV is 32 times more potent against MRSA strains when tested under in vitro conditions. Further, in clinical trials, VIBATIV demonstrated superior cure rates of patients with hospital-acquired bacterial pneumonia.
Two recently published studies – one that tested over 24,000 clinical isolates and one that tested over 15,000 – show that VIBATIV is just as potent today against difficult-to-treat and multidrug-resistant bacteria as it was when it was introduced 10 years ago.
“I am very happy to have gained access to VIBATIV here in Puerto Rico, especially in times when effective and timely single-dose therapy is needed for my complicated patients,” said Dr. Carlos Guzmán, an infectious disease physician in San Juan, Puerto Rico.
VIBATIV is intravenously administered with once-daily dosing and does not require therapeutic drug monitoring, decreasing health care professionals’ exposure to the patient.
“Verity has a strong presence in Puerto Rico, which made them a natural fit when we were searching for a partner to introduce VIBATIV to this market,” said A.J. Kazimi, CEO of Cumberland Pharmaceuticals. “We are confident that they will ensure the product reaches as many patients within the territory as possible and we look forward to a successful partnership.”
Under the terms of the agreement, Cumberland is responsible for product supply and Verity will commercialize and promote the product in the local market. The companies will share in the financial contribution from the product within the territory.
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.
