Greater in vitro Potency for VIBATIV Compared to Other Well-Known Antibiotics Such as Vancomycin, Daptomycin and Linezolid Highlighted in Presentations at ASM Microbe 2016

Theravance Biopharma, Inc.  today announced new positive data from several studies of VIBATIV® (telavancin) showing potent in vitro activity against isolates from a range of difficult-to-treat infections, including methicillin-resistant Staphylococcus aureus (MRSA). Challenging infections against which VIBATIV demonstrated potent in vitro activity included Staphylococcus aureus (S. aureus) bacteremia, infective endocarditis caused by daptomycin-resistant MRSA, and bone and joint infections. The presented findings further supplement the extensive and well-documented evidence demonstrating that VIBATIV possesses greater in vitro potency against MRSA and other difficult-to-treat clinical pathogens as compared to widely prescribed antibiotics such as vancomycin, daptomycin and linezolid. Results from these studies were presented at the American Society of Microbiology (ASM) Microbe 2016 Conference held in Boston, MA, on June 16-20, 2016.

“The number of difficult-to-treat, Gram-positive pathogens that are non-susceptible and/or resistant to various widely-prescribed antibiotics continues to grow and presents significant treatment challenges for healthcare practitioners in the U.S. and abroad,” said Frank Pasqualone, Senior Vice President and Global Head, Acute Care Business at Theravance Biopharma. “As we continue to evaluate VIBATIV against a range of these infection-causing clinical isolates, we are impressed to consistently see that the drug has potent in vitro activity, regardless of the isolates’ phenotype and resistance profile. Importantly, in many cases this potency is demonstrated to be several fold greater than other antibiotics routinely used for the treatment of Gram-positive infections.”

Highlights from data presentations include:

♦  Results showed that VIBATIV possessed the greatest in vitro activity of all antibiotics evaluated against a broad, global collection of contemporary S. aureus clinical isolates causing bacteremia, including endocarditis. Overall, the minimum inhibitory concentrations (MICs) for VIBATIV were eight-fold lower than for daptomycin and 16- to 32-fold lower than for vancomycin and linezolid against the S. aureus isolates that were evaluated, including MRSA, MSSA and multi-drug resistant subsets. MICs are a measure used to express in vitro activity of an antibiotic against a pathogen.

♦  Data from a second study demonstrated potent in vitro activity for VIBATIV against multiple daptomycin-resistant MRSA strains causing infective endocarditis in a rigorous animal model. VIBATIV significantly reduced the levels of MRSA found in all three target tissues (heart, kidney and spleen) that were evaluated as compared to the untreated control and daptomycin-treated groups (p < 0.000001). Additionally, VIBATIV produced a high percentage of target tissues (ranging from 71 to 100 percent) that were classified as culture-negative for MRSA, while daptomycin did not sterilize any of the target tissues. Finally, there was no mortality observed in animals treated with VIBATIV, as opposed to a 29 percent mortality rate for those animals in the standard daptomycin treatment group.

♦  Findings from a third study demonstrated potent in vitro activity for VIBATIV against a broad, global collection of contemporary Gram-positive pathogens, including S. aureus clinical isolates such as MRSA, causing bone and joint infections. This potency was demonstrated against all S. aureus isolates evaluated, regardless of phenotype. Additionally, all clinical isolates that were shown to be daptomycin-resistant or teicoplanin-resistant remained susceptible to VIBATIV.

“The threat of antibiotic resistance and how to best address this challenge remain topics of urgent discussion within the healthcare community. This growing concern highlights the importance of the demonstrated potent in vitro activity for VIBATIV against challenging pathogens that have lost susceptibility to popular treatments such as vancomycin and daptomycin. This is especially true as the number of effective treatment options at the disposal of healthcare practitioners to combat these difficult treatment continues to dwindle,” stated Jon Bruss, M.D., Vice President Clinical Development & Medical Affairs at Theravance Biopharma. “S. aureus bacteremia, infective endocarditis and bone and joint infections are just the latest examples of difficult-to-treat pathogens against which VIBATIV may have a therapeutic role.”