Theravance's Infection Drug Vibativ Positive in TOUR Study

Theravance Biopharma, Inc.TBPH recently released positive interim data from the ongoing TOUR (Telavancin Observational Use Registry) study evaluating how Vibativ (telavancin) is used to treat patients with bacteremia or infective endocarditis (IE). We note that Vibativ is the only marketed product of the company. Tour study is designed to generate useful data across a range of difficult-to-treat infections.

Shares of Theravance have significantly outperformed the Zacks classified Medical-Drugs industry in the last six months. The stock gained 32.8% during the period, while the broader industry lost 4.4%.

TOUR is a multi-center, observational study designed to enroll and report the treatment procedure of approximately 1,000 patients from about 50 sites in the U.S. The aforesaid study focused on a subset of registry patients suffering from bacteremia or IE (n=45). It demonstrated positive clinical responses (cure or improvement leading to step-down oral therapy) in 64.4% of patients. The remaining 6.7% of patients failed treatment and 28.9% were considered non-evaluable. Data were presented at an oral presentation at the Society of Critical Care Medicine's (SCCM) 46th Critical Care Congress.

We note that Vibativ is already approved in the U.S. for the treatment of adults with complicated skin and skin structure infections (cSSSI) caused by susceptible isolates of gram-positive bacteria, including both methicillin-resistant and methicillin-susceptible strains of staphylococcus aureus. In addition, 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. Notably, Vibativ was jointly developed with Japan's Astellas Pharma.

The product is also approved in the EU for the treatment of adults with nosocomial pneumonia, including ventilator-associated pneumonia, known or suspected to be caused by MRSA.

Moreover, Theravance plans to market Vibativ outside the U.S. through a network of partners. It has agreements with several companies for the commercialization of Vibativ in Canada, the Middle East, North Africa, Israel, Russia, China and India.

Theravance is also working on expanding Vibativ's label. In May 2016, the product's label was updated to include data concerning concurrent bacteremia in cases of HABP/VABP and cSSSI. In addition, the company is evaluating Vibativ in a phase III study for the treatment of patients with S. aureus bacteremia, which is expected to be complete in 2018. Label expansion would help the product reach out to higher patient population and increase the drug's commercial potential significantly.

However, we remain concerned about competition from other drugs targeting infectious diseases. Vibativ faces competition from currently marketed products like Merck & Co., Inc.'s MRK Cubicin and its generics as well as Sivextro, Allergan plc's AGN Teflaro and Dalvance, and The Medicines Company's MDCO Orbactiv.

Theravance Biopharma, Inc. Price

Theravance Biopharma, Inc. Price | Theravance Biopharma, Inc. Quote

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Theravance currently carries a Zacks Rank #3 (Hold). You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here .

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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