New plans for VIBATIV antibiotic

Theravance Biopharma plans for new clinical studies, expanded commercial program and new study analyses further supporting drug’s in-vitro potency in resolving difficult-to-treat infections

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SOUTH SAN FRANCISCO, Calif.Theravance Biopharma, Inc. today provided a product update for VIBATIV® (telavancin), the company’s proprietary FDA-approved bactericidal, once-daily, injectable lipoglycopeptide antibiotic.  The company detailed plans for additional VIBATIV clinical studies, its strategy for increasing the scope of U.S. commercial efforts and new study analyses presented at recent scientific conferences underscoring VIBATIV’s in-vitro potency and activity.  Today’s announcement was made in conjunction with the 54th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) held September 5-9, 2014 in Washington D.C.
“VIBATIV’s proven efficacy against difficult-to-treat infections has been demonstrated in several large, multinational registrational studies, which involved one of the largest cohorts of patients with methicillin-resistant Staphylococcus aureus (MRSA) infections studied to date.  Given the increasingly urgent need to combat the growing public health threat of antibacterial resistance, we are undertaking a proactive program designed to expand VIBATIV’s product profile, strengthen physicians’ awareness and increase their utilization in the right patient populations,” said Frank Pasqualone, senior vice president, development and operations at Theravance Biopharma.  “Our plans to conduct a Phase 3 registrational trial in Staphylococcus aureus bacteremia, a large observational use patient registry study, a targeted and strategic expansion of our U.S. commercialization efforts, and to build a global network of partnerships to commercialize VIBATIV worldwide, provide clear evidence of our ongoing commitment to building VIBATIV’s success and playing a leadership role in the broader anti-infective market.”
VIBATIV 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 Staphylococcus aureus when alternative treatments are not suitable, and for the treatment of complex 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. VIBATIV, which was discovered and developed internally, 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.
As part of its effort to explore additional potential infection types in which VIBATIV may offer patients therapeutic benefit, Theravance plans to initiate a Phase 3 registrational study for the treatment of patients with Staphylococcus aureus bacteremia.  Bacteremia is the presence of bacteria in the bloodstream and represents a serious medical condition that can lead to the spread of infection throughout the body, as well as the potentially fatal conditions of sepsis and septic shock.  The condition represents a significant unmet medical need with only two antibiotic treatments currently approved for bacteremia.
Theravance believes that VIBATIV’s demonstrated in vitro potency and efficacy in resolving difficult-to-treat infections position it as a potentially medically important treatment for Staphylococcus aureus bacteremia. It is important to note that VIBATIV possesses a dual mechanism of action, the company stated in a press release, which differentiates the product from the two single-mechanism antibiotics currently approved for Staphylococcus aureus bacteremia.
The registrational trial will be a multicenter, randomized, open-label study and is expected to enroll its first patient by the end of 2014.  The study is designed to evaluate the non-inferiority of VIBATIV in treating Staphylococcus aureus bacteremia as compared to standard therapy.
Theravance is also planning to conduct an observational use registry study designed to assess the manner in which VIBATIV is used by healthcare practitioners to treat patients.  By broadly collecting and examining data related to VIBATIV treatment patterns, clinical effectiveness and safety outcomes in the real world, the company aims to create an expansive knowledge base to guide future development and optimal use of the drug.
Named Telavancin Observational Use Registry (TOUR), the study is designed as a multi-center, observational, prospective study that will enroll approximately 1,000 patients from about 50 sites in the U.S.  As a non-interventional study, all treatment decisions will be at the discretion of the patient’s healthcare provider.  The company is targeting enrollment of the registry’s first patient in the fourth quarter of 2014.
During the past year, Theravance Biopharma has undertaken a carefully planned, phased commercial strategy for VIBATIV in the U.S.  This strategy has focused on a limited number of geographic sites across the country, and has succeeded in achieving the goals of the company. Therefore, Theravance is undertaking a targeted expansion into additional regional territories by the end of 2014.
The decision to expand is informed by the company’s analysis of treatment patterns in its initial target markets. Interactions with healthcare practitioners have shown that as they gain more experience with VIBATIV, their utilization of the treatment expands to broader usage in the product’s approved indications.
VIBATIV prescribing information includes a boxed warning and the drug should be used only in situations where it is known or suspected that other alternatives are not suitable. Theravance Biopharma tells DDNews that the company continues to evaluate the data that were presented to the European Congress of Clinical Microbiology and Infectious Diseases to identify the appropriate next steps, if any, including regulatory activities related to these research findings.
Combined, data from these presentations confirm the previously demonstrated in-vitro potency of VIBATIV against a broad collection of difficult-to-treat clinical pathogens using a revised, FDA-approved susceptibility testing method.  These data demonstrated greater in-vitro potency for VIBATIV as compared to vancomycin against a variety of difficult-to-treat isolates with reduced susceptibility to the approved antibiotics vancomycin, daptomycin and linezolid.  These isolates included a range of Staphylococcus strains such as MRSA, MSSA, vancomycin-resistant Staphylococcus aureus (VRSA), and methicillin-resistant Staphylococcus epidermidis (MRSE), as well as various biofilm-related infections. 
Furthermore, in a number of in-vitro studies, results with the revised testing method indicated that the activity of VIBATIV is greater than previously reported, providing a new reference for the drug’s potency.
Theravance believes that these latest findings, combined with previous study results, provide confirmation that VIBATIV is a key alternative for patients in those instances in which vancomycin is not effective or appropriate for treating infections that are susceptible to VIBATIV therapy.
“Theravance Biopharma is dedicated to patients requiring anti-infective therapy and committed to investigating the potentially broad utility of the compound.  As is well documented in the medical, scientific and popular media, there is a critical need for antibiotic research and development given the growing threat from resistance to current therapies, and we believe that VIBATIV will play an important role in helping to address this serious medical problem,” stated Rick E Winningham, chairman and CEO.  “We are proud to be the only company to discover, develop, secure approval for and commercialize a currently available branded antibiotic product.  This demonstrates that Theravance Biopharma is not only committed to the anti-infective area today, but has been for nearly two decades.”
Theravance Biopharma plans to market VIBATIV in markets outside the United States through a network of partners. In Europe, VIBATIV is indicated for the treatment of adults with nosocomial pneumonia (NP) including ventilator associated pneumonia, known or suspected to be caused by MRSA. VIBATIV is not currently indicated for the treatment of cSSSI in Europe.
Theravance Biopharma is a biopharmaceutical company focused on the discovery, development and commercialization of small molecule medicines across a number of therapeutic areas, including respiratory disease, bacterial infections, central nervous system (CNS)/pain, and gastrointestinal motility dysfunction. By leveraging its proprietary insight of multivalency to drug discovery, the company is pursuing a best-in-class strategy designed to discover superior medicines in areas of significant unmet medical need. Theravance Biopharma is a publicly-held corporation, with U.S. headquarters located in South San Francisco, California, and trades on the NASDAQ Global Select Market under the symbol TBPH.

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