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Mar 11, 2013

MRSA-Battling Antibiotic to Take on Pneumonia in Europe

  • Theravance has granted Clinigen exclusive commercialization rights to skin infection drug Vibativ® (telavancin) in the EU and certain other European countries (including Switzerland and Norway) for the treatment of nosocomial pneumonia (hospital-acquired)—including ventilator-associated pneumonia, which is known or suspected to be caused by methicillin-resistant Staphylococcus aureus (MRSA)—when other alternatives are not suitable. According to the firms, Vibativ is a bactericidal, once-daily injectable lipoglycopeptide antibacterial agent with a dual mechanism of action against Gram-positive bacteria, including resistant pathogens such as MRSA. The FDA approved the drug for treating complicated skin and skin structure infections in 2009. 

    In exchange, Theravance will receive a $5 million up-front payment from Clinigen and is entitled to receive tiered royalties on net sales of Vibativ, ranging from 20% to 30%. The agreement has a term of at least 15 years, with an option to extend exercisable by Clinigen.

    “This agreement is of strategic importance to us as it not only strengthens our anti-infective offering with a product that has patent protection into the next decade, but it is an exciting opportunity to commercialize Vibativ and Foscavir® while leveraging their operational synergies,” said Peter George, CEO of Clinigen. “Vibativ is a second product for Clinigen’s Specialty Pharmaceuticals (SP) portfolio, complementing the division’s anti-viral product, Foscavir.”

    Theravance once had a global license, development, and commercialization agreement for Vibativ with Astellas Pharma; however, Astellas ended that agreement in January of 2012. Also, Theravance received mixed news stateside in November when an FDA panel, the Anti-Infective Drugs Advisory Committee (AIDAC), voted that the results of data presented by Theravance, including analyses of clinical cure and 28-day all-cause mortality, did not provide substantial evidence of the safety and effectiveness of Vibativ for the treatment of NP including ventilator-associated pneumonia caused by susceptible isolates of the Gram-positive microorganisms Staphylococcus aureus (both methicillin-susceptible and -resistant) and Streptococcus pneumoniae. However, the same panel voted 13–2 that the results provide evidence of the safety and effectiveness of the drug for the treatment of NP when other alternatives are not suitable.


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