New Data Shows Greater In Vitro Potency for VIBATIV(R) (Telavancin) Against Multidrug-Resistant Gram-Positive Bacteria, Including MRSA, Compared to Alternative Antibiotic Treatments - Seite 3

Theravance Biopharma plans to market VIBATIV in markets outside the United States where the drug is approved through a network of partners. To date, the company has secured partners for VIBATIV in the following geographies - Europe, Canada, Middle East, North Africa, Israel, and Russia.

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 should be used only in situations where it is known or suspected that other alternatives are not suitable. VIBATIV is not currently indicated for the treatment of cSSSI in Europe.

Clinigen Group holds the commercial rights to market and distribute VIBATIV in Europe.

VIBATIV^® Important Safety Information (U.S.)

Mortality

Patients with pre-existing moderate/severe renal impairment (CrCl ≤50 mL/min) who were treated with VIBATIV^® for hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia had increased mortality observed versus vancomycin. Use of VIBATIV in patients with pre-existing moderate/severe renal impairment (CrCl ≤50 mL/min) should be considered only when the anticipated benefit to the patient outweighs the potential risk.

Nephrotoxicity

New onset or worsening renal impairment occurred in patients who received VIBATIV. Renal adverse events were more likely to occur in patients with baseline comorbidities known to predispose patients to kidney dysfunction and in patients who received concomitant medications known to affect kidney function. Monitor renal function in all patients receiving VIBATIV prior to initiation of treatment, during treatment, and at the end of therapy. If renal function decreases, the benefit of continuing VIBATIV versus discontinuing and initiating therapy with an alternative agent should be assessed.

Fetal Risk

Women of childbearing potential should have a serum pregnancy test prior to administration of VIBATIV. Avoid use of VIBATIV during pregnancy unless the potential benefit to the patient outweighs the potential risk to the fetus. Adverse developmental outcomes observed in three animal species at clinically relevant doses raise concerns about potential adverse developmental outcomes in humans. If not already pregnant, women of childbearing potential should use effective contraception during VIBATIV treatment.