Theravance Biopharma, Inc. announced the commercial launch of Vibativ (telavancin) in Canada. Vibativ is a bactericidal, once-daily antibiotic with in vitro potency and a dual mechanism of action against Gram-positive bacteria, including difficult-to-treat pathogens such as methicillin-resistant Staphylococcus aureus (MRSA).
The drug is approved in Canada for the treatment of adult patients with hospital-acquired bacterial pneumonia (HAP) and ventilator-associated bacterial pneumonia (VAP) known or suspected to be caused by susceptible isolates of Staphylococcus aureus including methicillin-susceptible S. aureus (MSSA) and MRSA. Vibativ is also approved in Canada for the treatment of adult patients with complicated skin and skin structure infections (cSSSI) caused by susceptible strains of Gram-positive microorganisms.
Vibativ is being marketed and sold in Canada by Pendopharm, a division of Pharmascience Inc. Under terms of their development and commercialization agreement, Theravance Biopharma will supply commercial product to Pendopharm for sale in the Canadian market. In addition, the company will receive potential future contingent payments and a royalty on net sales of Vibativ in Canada from Pendopharm.
"As the challenge of treating MRSA-related infections continues to increase, it is essential that patients and healthcare practitioners around the world have access to potent agents with the proven ability to resolve these often difficult-to-treat pathogens. With this in mind, we are pleased that the Canadian healthcare community will now have access to one of the industry's most potent antibiotics against susceptible Gram-positive pathogens," said Frank Pasqualone, senior vice president, Vibativ Development and Operations at Theravance Biopharma. "This launch represents an important milestone in our strategic expansion of Vibativ as a global brand, designed to bring the therapeutic benefits of the drug to the largest number of patients possible. In addition to treating individual patients, we believe that broadening the availability of Vibativ, an antibiotic with demonstrated efficacy against difficult-to-treat and multidrug-resistant infections, may also play an important role in combatting the growing global threat of antibiotic resistance."
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.
Vibativ was discovered internally in a research program dedicated to finding new antibiotics for serious infections due to Staphylococcus aureus (S. aureus) and other Gram-positive bacteria, including MRSA and MSSA. 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. Vibativ for injection is approved in the US 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 for 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.
In addition to the US, Vibativ is approved for marketing in Europe, Canada and Russia. Theravance Biopharma plans to market Vibativ outside the US 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, Russia, China and India.
The mission of Theravance Biopharma is to create value from a unique and diverse set of assets: an approved product; a development pipeline of late-stage assets; and a productive research platform designed for long-term growth.