Theravance (THRX) received a major setback in the approval process of Vibativ (telavancin) for the treatment of nosocomial pneumonia (NP). Recently, the company received a complete response letter (CRL) regarding this from the US Food and Drug Administration (FDA). Although the original Prescription Drug User Fee Act (PDUFA) date was Nov 26, 2009, the company had earlier indicated that the approval would be extended to the next year.

As per the CRL, Theravance will have to submit additional data and analyses for the NP patient population. While the telavancin NP clinical trials included clinical response as the primary endpoint and all-cause mortality as a secondary endpoint, the FDA has asked the company to evaluate data with all-cause mortality as the primary efficacy endpoint.

In addition, the CRL issued by the FDA requested further rationale for the pooling of data from the two ATTAIN studies, noted the need for a pediatric drug development plan for the NP indication and a customary safety update. We hope Theravance succeeds in presenting satisfactory data, else the New Drug Application (NDA) for Vibativ would either be rejected or the company may have to conduct additional studies. However, we are pleased to note that the company has stated that it has already collected the required information and has completed analysis to respond to the FDA.

Earlier, in September, Vibativ received FDA approval for the treatment of complicated skin and skin structure infections (cSSSI) caused by Gram-positive bacteria. Thereafter, the drug was launched in the US in November. Vibativ has been jointly developed with Astellas Pharma of Japan. While the drug will be marketed and sold by Astellas, Theravance will receive royalties on global sales. In the US, the company will help Astellas in marketing the drug for the first three years post approval. We are Neutral on the stock.

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