Theravance Biopharma’s VIBATIV Approved in Canada for Treatment of Adults With Ventilator-associated Bacterial Pneumonia

Theravance Biopharma’s VIBATIV Approved in Canada for Treatment of Adults With Ventilator-associated Bacterial Pneumonia

Recently, Health Canada announced the approval of VIBATIV® (telavancin), from Theravance Biopharma, for treatment of adult individuals with hospital- (HAP) and ventilator-associated (VAP) bacterial pneumonia.

It has been described that bacterial pneumonia initiated in hospitals (HAP) and bacterial pneumonia linked to ventilators (VAP) may be caused by susceptible strains of Staphylococcus aureus (S. aureus) like methicillin-susceptible and methicillin-resistant S. aureus (MSSA and MRSA). VIBATIV® has also been currently permitted in Canada for therapy of individuals with complicated skin and skin structure infections (cSSSI) caused by susceptible strains of Gram-positive bacteria.

VIBATIV is an injectable, once a day, lipoglycopeptide drug with anti-bacterial action and with in vitro activity by inhibiting bacterial cell wall synthesis and disruption of bacterial cell membrane function. The efficacy of the drug against infections that are hard to treat has been demonstrated in several large, multinational registered studies. In addition, there are many and well-documented evidences of in vitro activity against several bacterial pathogens, like resistant strains to several available drugs. In 2016 this antibiotic will be available commercially in Canada by PENDOPHARM.

Frank Pasqualone, Senior Vice President, Development and Operations at Theravance Biopharma said in the news release that this approval in Canada came just after the recent marketing permission in Russia for the therapy of several infections caused by Gram-positive bacteria, such as methicillin-resistant S. aureus. He added that these regulatory milestones together with the recent agreement with SciClone Pharmaceuticals for the development and commercialization of VIBATIV in China, stresses the efforts done by us to distribute the VIBATIV trademark globally.

Pasqualone stated that VIBATIV has shown efficacy against some of the infections that are hard to treat and resistant to several available drugs that contribute for the worldwide fast spread of antibiotic resistance. Therefore, extending the accessibility an important alternative antibiotic in crucial markets such as Canada and Russia will contribute for the control of antibiotic resistance.

In USA, VIBATIV is accepted for therapy of  hospitals and ventilator-associated bacterial pneumonia by susceptible isolates of S. aureus when there are no other available therapies. Additionally, VIBATIV is permitted for the therapy of adult individuals with complicated skin and skin structure infections (cSSSI) initiated by susceptible isolates of Gram-positive bacteria, like S. aureus, both methicillin-susceptible (MSSA) and methicillin-resistant (MRSA) strains.

Currently, Theravance Biopharma has gathered partners for VIBATIV in Europe, Canada, Middle East, North Africa, Israel, Russia, and China.

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