DUBLIN, Ireland—Theravance Biopharma, Inc. today announced new positive data from several studies of VIBATIV (telavancin) confirming the product’s in-vitro potency against isolates from a range of difficult-to-treat infections. The findings further supplement the extensive and well-documented evidence demonstrating greater in-vitro activity for VIBATIV against methicillin-resistant Staphylococcus aureus (MRSA) and other difficult-to-treat clinical pathogens as compared to antibiotics such as vancomycin, daptomycin and linezolid. Results from these studies were presented at the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) held in San Diego, CA, September 17 - 21, 2015.
“The new VIBATIV data presented at ICAAC provides additional important support for the product’s profile as one of the industry’s most potent antibiotics against susceptible Gram-positive pathogens,” said Frank Pasqualone, senior vice president, development and operations at Theravance Biopharma. “These study findings confirm the in vitro activity of VIBATIV and highlight the promise of the antibiotic in difficult-to-treat infections for which there is a significant medical need, particularly in light of the growing epidemic of antibiotic resistance.”
Researchers showed that VIBATIV possessed the greatest in-vitro activity of all antibiotics evaluated against a broad collection of contemporary Gram-positive clinical isolates that caused complicated skin and skin structure infections (cSSSIs) in U.S. hospitals. Data showed that the minimum inhibitory concentrations (MICs) for VIBATIV were eight-fold lower than for daptomycin and 16-fold lower than for vancomycin and linezolid against all Staphylococcus aureus strains, including MRSA and methicillin-susceptible Staphylococcus aureus (MSSA) subsets. MICs are a common measure used to express an antibiotic’s in-vitro potency.
Data from a second study demonstrated that VIBATIV possessed the greatest in-vitro activity of all antibiotics evaluated against a broad collection of contemporary Gram-positive cocci from Canadian hospitals. VIBATIV showed greater in-vitro potency than vancomycin, daptomycin and linezolid against such pathogens as MRSA, vancomycin-intermediate Staphylococcus aureus (VISA) and heterogeneous vancomycin-intermediate Staphylococcus aureus (hVISA).
Data from additional studies highlighted the potential of VIBATIV in addressing serious infection types with significant unmet medical need and critical treatment challenges. For example, VIBATIV demonstrated greater in-vitro activity against biofilm-producing MRSA, as compared to vancomycin, daptomycin, teicoplanin, and ceftaroline. Furthermore, results showed VIBATIV to be significantly more effective than vancomycin and daptomycin in animal models of infective endocarditis (IE) caused by MRSA. In these IE models, VIBATIV was significantly better than daptomycin at reducing the levels of MRSA found in target tissues and producing a significantly higher percentage of target tissues that were classified as culture-negative. Vancomycin was relatively ineffective in both of these areas.
“This collection of new, compelling data provides additional support for our belief that VIBATIV represents a critically important antibiotic option for physicians as a range of life-threatening, Gram-positive infections continue to become more difficult to treat,” stated Jon Bruss, M.D., vice president clinical development and medical affairs at Theravance Biopharma. “By continuing to demonstrate greater in-vitro potency against such challenging pathogens, as compared [to] vancomycin, daptomycin and linezolid, we are further supplementing our extensive collection of data that support the competitive profile of the product.”
VIBATIV is a bactericidal, once-daily, injectable lipoglycopeptide antibiotic with in-vitro potency and a dual mechanism of action whereby telavancin both inhibits bacterial cell wall synthesis and disrupts bacterial cell membrane function. The drug’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 MRSA infections studied to date. 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.
VIBATIV was discovered internally in a research program dedicated to finding new antibiotics for serious infections due to Staphylococcus aureus and other Gram-positive bacteria, including MRSA. VIBATIV for injection is approved in the U.S. for the treatment of hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Staphylococcus 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 Staphylococcus aureus, both methicillin-susceptible (MSSA) and methicillin-resistant (MRSA) strains.
In addition to the U.S., VIBATIV is approved for use in several markets around the world including Europe, Canada and Russia. The specific approved indications in these markets vary by region. Theravance Biopharma plans to market VIBATIV outside the U.S. through a network of partners. To date, the company has secured partners for VIBATIV in Europe, Canada, Middle East, North Africa, Israel, Russia and China.
The mission of Theravance Biopharma (NASDAQ: TBPH) is to create value from a unique and diverse set of assets: an approved product; a development pipeline of late-stage assets; and a productive research platform designed for long-term growth.