Data From New Retrospective Studies of VIBATIV(R) (Telavancin) Demonstrate Positive Clinical Outcomes for Patients With Difficult-to-Treat, Gram-Positive Infections, Including MRSA

Theravance Biopharma, Inc.

("Theravance Biopharma" or the "Company") today announced new positive data from multiple retrospective studies of VIBATIV® (telavancin) demonstrating positive clinical outcomes for patients with Staphylococcus aureus (S. aureus) bacteremia and methicillin-resistant S. aureus (MRSA) osteomyelitis following treatment with VIBATIV. These study findings, which include clinical cure/improvement rates for VIBATIV-treated patients of 79.4% in bacteremia and 88.9% in osteomyelitis, demonstrate the potential of VIBATIV against two additional difficult-to-treat infections. Results from these studies were presented at IDWeek™ 2015, which was held in San Diego, CA, on October 7 - 11, 2015. In a multicenter, retrospective study of 34 S. aureus bacteremia patients receiving VIBATIV, researchers assessed clinical outcomes and safety measures. Data showed that 27 patients (79.4%) were considered cured or improved at end of therapy (EOT), the study's primary outcome measure. When researchers excluded the seven patients who died before EOT, 95.8% of patients with 30-day follow-up post-EOT were considered cured or improved. It is important to note that the approximately 20% mortality rate observed in this study is consistent with reported mortality rates (20-30%) associated with S. aureus bacteremia, even with appropriate antibacterial therapy.(1-4) There were no adverse events in the study that led to discontinuation of VIBATIV for any patients. In a second poster at IDWeek, researchers presented findings from a retrospective study in adult patients with hospital-onset MRSA pneumonia (HOMP). The study was designed to identify the frequency with which HOMP occurs concurrently with bacteremia and the clinical impact that concurrent bacteremia has on these patients. Results showed that it is common for bacteremia to occur concurrently with HOMP, with 58 out of 513 HOMP patients (11.3%) also presenting with bacteremia. Furthermore, HOMP patients with concurrent bacteremia experienced higher mortality (35.1% vs. 26.2%) and longer post-pneumonia hospital stays (an average increase of 13.5 days) as compared to patients with HOMP alone. "These new data presented at IDWeek provide support for our current development and regulatory efforts for VIBATIV in the area of bacteremia, including our ongoing registrational Phase 3 trial and our recent supplemental NDA filing to expand the product's label to include concurrent bacteremia in both of the drug's two approved indications in the U.S.," said Frank Pasqualone, Senior Vice President, Development and Operations at Theravance Biopharma. "We are encouraged to see the presentation of study data that assess the potential of VIBATIV in S. aureus bacteremia, a difficult-to-treat infection. We are committed to fully exploring the potential of VIBATIV to address serious medical needs." Highlights from additional VIBATIV-related presentations at IDWeek 2015 include: Findings from a retrospective study of 14 patients with methicillin-resistant S. aureus osteomyelitis showed that eight of nine clinically evaluable cases (88.9%) were considered cured/improved at EOT. Five of these patients maintained clinical cure at 12-month follow-up. Importantly, four of the 14 patients had concurrent MRSA bacteremia but had no further positive blood cultures for bacteremia following initiation of VIBATIV therapy. Adverse events were seen in seven of 14 patients with two individuals discontinuing treatment due to infusion-related chills/rigors. Theravance Biopharma believes these study findings demonstrate the potential of VIBATIV in MRSA osteomyelitis, a difficult-to-treat infection. Researchers showed that VIBATIV possessed greater in vitro activity than well-known competitor antibiotics against a broad collection of contemporary Gram-positive clinical isolates causing hospital-acquired bacterial pneumonia (HABP) in U.S. hospitals. Data showed that the minimum inhibitory concentrations (MICs) for VIBATIV were 16-fold lower than for vancomycin and linezolid against MRSA isolates. MICs are a common measure used to express an antibiotic's in vitro potency. "We are pleased to continue to see positive indications of activity for VIBATIV in a growing number of difficult-to-treat infections. Bacteremia and osteomyelitis are just the latest examples of these infections for which we see encouraging data," stated Jon Bruss, M.D., Vice President Clinical Development & Medical Affairs at Theravance Biopharma. "At the same time, we also continue to supplement our collection of data that show greater in vitro activity for VIBATIV in its approved indications as compared to well-known competitor antibiotics." 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.