BURTON-ON-TRENT, UNITED KINGDOM and SOUTH SAN FRANCISCO, CA -- (Marketwire) -- 03/11/13 -- Clinigen Group plc (LSE: CLIN) (AIM: CLIN) and Theravance, Inc. (NASDAQ: THRX) today announced that they have entered into an exclusive commercialization agreement in the European Union (EU) and certain other countries located in Europe for VIBATIV® (telavancin) for the treatment of nosocomial pneumonia (hospital-acquired), including ventilator-associated pneumonia, known or suspected to be caused by methicillin resistant Staphylococcus aureus (MRSA) when other alternatives are not suitable. 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.
Under the terms of the agreement, Theravance has granted Clinigen exclusive commercialization rights to VIBATIV® in the EU and certain other European countries (including Switzerland and Norway). In exchange, Theravance will receive a $5 million upfront 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.
"We are pleased to have Theravance, a leader in antibiotic development, as a license partner," said Peter George, Chief Executive Officer of 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. VIBATIV® is a second product for Clinigen's Specialty Pharmaceuticals (SP) portfolio, complementing the division's anti-viral product, Foscavir®."
"We are very excited to partner with Clinigen and we believe that its innovative business model and experience in specialty pharmaceuticals provide an ideal platform to maximize the growth opportunity for VIBATIV®," said Rick E Winningham, Chief Executive Officer of Theravance. "We look forward to working with Clinigen in making VIBATIV® available to patients with nosocomial pneumonia in the EU."
About VIBATIV® (telavancin)
VIBATIV® is a bactericidal, once-daily, injectable lipoglycopeptide antibiotic with a dual mechanism of action whereby VIBATIV® both inhibits bacterial cell wall synthesis and disrupts bacterial cell membrane function. VIBATIV®, discovered and developed by Theravance, is approved in the United States for the treatment of adult patients with complicated skin and skin structure infections (cSSSI) caused by susceptible isolates of Gram-positive bacteria, including Staphylococcus aureus, both methicillin-susceptible (MSSA) and methicillin-resistant (MRSA) strains, since 2009. In 2011, the European Commission granted marketing authorization for VIBATIV® for the treatment of nosocomial pneumonia (hospital-acquired), including ventilator-associated pneumonia, known or suspected to be caused by MRSA when other alternatives are not suitable. In May 2012, the European Commission suspended marketing authorization for VIBATIV® because the former VIBATIV® drug product supplier, Ben Venue Laboratories, Inc., at that time did not meet current Good Manufacturing Practice requirements for the manufacture of VIBATIV®. Theravance is currently working on re-establishing consistent product supply that will meet European Commission requirements.
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