New Data Analyses From Phase 3 ATTAIN Trials Support VIBATIV(R) (Telavancin) as a Treatment for Staphylococcus Aureus HABP/VABP, Including Cases Caused by MRSA

DUBLIN, IRELAND--(Marketwired - May 16, 2016) - Theravance Biopharma, Inc. (NASDAQ: TBPH) ("Theravance Biopharma" or the "Company") today announced that results from post hoc analyses of the previously completed Phase 3 Assessment of Telavancin for Treatment of Hospital-Acquired Pneumonia (ATTAIN) studies were the focus of a poster presentation at the American Thoracic Society (ATS) 2016 International Conference. The ATTAIN studies were registrational trials which supported the regulatory approval of telavancin (marketed as VIBATIV^®) for the treatment of hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP). 

Presented findings from the post hoc analyses suggest that VIBATIV may serve as an appropriate treatment of select types of monomicrobial Staphylococcus aureus (S. aureus) HABP/VABP. Data showed comparable clinical cure rates for telavancin and vancomycin among the ATTAIN trials' all-treated (AT) patients with monomicrobial S. aureus, including both methicillin-resistant S. aureus (MRSA) and methicillin-susceptible S. aureus (MSSA), and a vancomycin MIC ≥ 1.0 µg/mL across all evaluated patient comorbidities. In an exploratory analysis of the microbiologically evaluable (ME) population, telavancin treatment produced numerically higher clinical cure rates (confidence intervals did not cross zero) as compared to vancomycin when those patients were ≥ 65 years of age or were diagnosed with VABP. ME patients were those with a Gram-positive baseline respiratory pathogen known to cause pneumonia and who adhered to the study guidelines so that their clinical outcomes were reasonably associated with treatment. 

"These post hoc analyses of the ATTAIN studies provide us with a deeper understanding of the therapeutic effect of VIBATIV in the treatment of S. aureus HABP/VABP, particularly as it compares to that of vancomycin, the most commonly prescribed treatment for MRSA and related bacterial infections," said Frank Pasqualone, Senior Vice President and Global Head, Acute Care Business at Theravance Biopharma. "We are pleased that the findings highlight that VIBATIV may be an important option in treating specific types of S. aureus HABP/VABP, including both MRSA and MSSA, particularly for elderly patients and those diagnosed with VABP. As the researchers concluded, the data suggest that these patients may experience efficacy and overall mortality benefits when treated with VIBATIV as opposed to vancomycin."