Theravance Biopharma Announces FDA Approval of Expanded Label for VIBATIV(R) (telavancin)

DUBLIN, IRELAND--(Marketwired - May 9, 2016) - Theravance Biopharma, Inc. (NASDAQ: TBPH) ("Theravance Biopharma" or the "Company") today announced that the U.S. Food and Drug Administration (FDA) has approved the Company's supplemental New Drug Application (sNDA) for VIBATIV^® (telavancin) to expand the product's label to include data describing the treatment of patients with concurrent Staphylococcus aureus (S. aureus) bacteremia in both of the antibiotic's currently approved indications in the United States. 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 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 & skin structure infections (cSSSI) caused by susceptible isolates of Gram-positive bacteria, including S. aureus, both methicillin-susceptible (MSSA) and methicillin-resistant (MRSA) strains.

Bacteremia is the presence of bacteria in the bloodstream and can occur spontaneously or in the presence of other infections. Bacteremia continues to represent a significant unmet medical need. Concurrent bacteremia, which in its most serious form is fatal, occurs when bacteria spreads from its initial infection site and enters the bloodstream. As a secondary infection, it introduces significant challenges to the treatment of the primary infection, as well as the concurrent bacteremia itself.

"When patients with cSSSI or HABP/VABP present with concurrent bacteremia, their treatment becomes more difficult for healthcare practitioners. With this action by the FDA, we believe an important advance has been made in addressing the unique challenges in this area. The additional data that are now reflected in the VIBATIV label address the use of VIBATIV in cSSSI and HABP/VABP with concurrent bacteremia and we are now implementing a strategy to communicate this information to targeted healthcare practitioners," said Frank Pasqualone, Senior Vice President and Global Head, Acute Care Business at Theravance Biopharma. "With the broader medical need for effective bacteremia treatments in mind, we are also conducting a Phase 3 registrational study of telavancin in primary complicated S. aureus bacteremia, which we expect to complete in late 2017 or early 2018. Should we prove successful with this trial and secure approval in this infection type, VIBATIV would possess the broadest set of indications of any branded anti-MRSA agent."