February 26, 2016

    PENDOPHARM launches VIBATIV In Canada

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    (telavancin hydrochloride for injection) for Treatment of cSSSI and HAP/VAP Caused by Gram-Positive Bacteria, Including MRSA

    Montreal (Canada), February 2016 – PENDOPHARM, a division of Pharmascience Inc., headquartered in Montreal, Canada, announced today the launch in Canada of VIBATIVTM (telavancin hydrochloride for injection), 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 and methicillin-resistant S. aureus (MRSA)). It is also approved for the treatment of adult patients with complicated skin and skin structure infections (cSSSI) caused by susceptible strains of Gram-positive microorganisms.

    New VIBATIV is a bactericidal, once-daily, injectable lipoglycopeptide antibiotic with in vitro potency and a unique dual mechanism of action whereby telavancin both inhibits bacterial cell wall synthesis and disrupts bacterial cell membrane function. It effectively treats infection in patients with cSSSI or HAP/VAP caused by difficult-to-treat pathogens, such as MRSA.

    S. aureus, including MRSA is one of the most common causes of health care-associated infections in Canada and is spread from person to person through direct contact and by contact with contaminated surfaces. Initially, MRSA was found mainly in health care settings where it can cause serious infections such as bone and bloodstream infections, which can lead to death. Canadian prevalence studies have estimated that approximately 4.2% of hospitalized patients will become infected or colonized with MRSA resulting in an annual hospital cost of about $36.3 million. Over the past decade, the frequency of community-acquired MRSA (CA-MRSA) infection has been increasing in Canada, especially in certain vulnerable populations (e.g., homeless people, intravenous drug users). In the community it causes mostly skin and soft tissue infections.1,2

    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, including MRSA” said Hugo Boisvert, General Manager & Vice President, PENDOPHARM. “This launch represents an important milestone in the diversification of our product portfolio and we are pleased to partner with Theravance Biopharma in order to bring the therapeutic benefits of VIBATIV to Canadian patients.

    About VIBATIV™ (telavancin hydrochloride for injection)

    VIBATIV was discovered by Theravance Biopharma in a research program dedicated to finding new antibiotics for serious infections due to Staphylococcus aureus and other Gram-positive bacteria, including MRSA. It has been licensed by Theravance Biopharma to PENDOPHARM for commercialization in Canada. 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 is approved approved in the U.S. for the treatment of adult patients with cSSSI caused by susceptible Gram-positive bacteria and for the treatment of adult patients with HAP/VAP caused by susceptible isolates of Staphylococcus aureus when alternative treatments are not suitable. VIBATIV is approved in the European Union for the treatment of adults with nosocomial pneumonia, including ventilator-associated pneumonia, known or suspected to be caused by MRSA when other alternatives are not suitable.

    The drug’s proven efficacy against difficult-to-treat 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 vitro activity against a broad collection of bacterial pathogens, including those that are considered difficult-to-treat and multidrug-resistant.

    Hospital-acquired pneumonia is a lethal infection, reaching mortality rates as high as 60% in intensive-care unit (ICU) cases. Skin and soft tissue infections (SSTI) represented the largest proportion (43%) of MRSA infections identified from clinical sources other than blood.* Telavancin is a rapidly bactericidal antimicrobial agent against Gram-positive infections and is an option in cases of difficult-to-treat MRSA infections” said Dr George G Zhanel, Professor-Department of Medical Microbiology and Infectious Diseases College of Medicine, Faculty of Health Sciences, University of Manitoba Winnipeg, Canada.

    About PENDOPHARM

    PENDOPHARM is a division of Pharmascience Inc., a Canadian privately-owned company. Established in 1983, Pharmascience Inc. is the largest pharmaceutical company in Quebec, with a highly-skilled workforce of 1,600 people. It commercializes nearly 300 products, including branded prescription, OTC and BTC products as well as generic products in Canada and with its affiliates and distributors in Europe, Asia, Middle East, Africa and Oceania.

    Strategically committed to growth, PENDOPHARM is actively engaged in licensing, partnering, developing and marketing specialty prescription medicines as well as consumer brands.

    About Theravance Biopharma

    The mission of Theravance Biopharma (NASDAQ: TBPH) 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. With its successful drug discovery and development track record, commercial infrastructure, experienced management team and efficient corporate structure, Theravance believe that it is well positioned to create value for our shareholders and make a difference in the lives of patients.

    For more information, please visit www.theravance.com.

    For further information:

    François David
    Senior Director, Marketing
    PENDOPHARM, a division of Pharmascience Inc.
    Tel: (514) 340-9800 #3055
    Email: fdavid@pendopharm.com

    VIBATIV and the VIBATIV logo are trademarks of the Theravance Biopharma group of companies and are used under license by PENDOPHARM, a division of Pharmascience Inc.

    1Etchells E, Mittmann N, Koo M, et al. The economics of patient safety in acute care: Technical report. Toronto ON: Canadian Patient Safety Institute; 2009.
    2Simor AE, William V, McGeer A, Raboud J, et al. Prevalence of colonization and infection with Methicillin-Resistant Staphylococcus aureus and Vancomycin-Resistant Enterococcus and of Clostridium difficile Infection in Canadian hospitals. Infect Control Hosp Epidemiol. 2013;34:687-93.