Astellas Pharma has terminated its global licensing agreement with Theravance to co-market the latter's superbug antibiotic Vibativ, which has been hit by manufacturing problems.
The Japanese drugmaker has exercised an option to pull out of the alliance and stopped promotional sales efforts. There are no termination payments to be made and Astellas will also still receive a ten-year, 2% royalty on net sales of Vibativ (telavancin), an injected bactericidal, once-daily lipoglycopeptide antibiotic.
The drug was approved in Europe in September 2011 for adults with nosocomial pneumonia caused by methicillin-resistant Staphylococcus aureus (MRSA) when other alternatives are not suitable. It was given the green light in the USA in 2009 for adults with complicated skin and skin structure infections (cSSSI) caused by susceptible Gram-positive bacteria.
To "support a smooth transition", Astellas will transfer inventory to Theravance, "manage certain clinical and regulatory activities and respond to medical inquiries with respect to Vibativ until no later than March 31". The rights to the drug now revert back to Theravance, which will look at "global commercialisation alternatives…either alone or with partners".
Theravance chief executive Rick Winningham said the company believes Vibativ "is an important, life-saving medicine" and "we will continue the focus on re-establishing consistent product supply". The firm noted in a regulatory filing that "due to manufacturing issues at the single-source supplier of drug product, Vibativ is currently subject to critical product shortages and regional supply outages".
It added that "if these issues at the manufacturer are not promptly resolved, obtaining supply would require identifying and qualifying an alternative manufacturer, which could take 12 to 24 months". To date, Vibativ has not been a big earner and in the third quarter, Theravance banked just $800,000 in royalties from net sales of $4.5 million.