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DewDiligence

07/28/17 12:12 PM

#212721 RE: DewDiligence #212718

EU Commission approves Maviret—ENTA gets $25M milestone from ABBV:

http://ir.enanta.com/news-releases/news-release-details/enanta-announces-european-commission-grants-abbvie-marketing

Enanta Pharmaceuticals…today announced that the European Commission (EC) has granted AbbVie marketing authorization for MAVIRET (glecaprevir/pibrentasvir), a once-daily, ribavirin-free treatment for adults with chronic hepatitis C virus (HCV) infection across all major genotypes (GT1-6).

MAVIRET is a new, 8-week, pan-genotypic treatment for patients without cirrhosis and new to treatment, who comprise the majority of the estimated 71 million people worldwide living with HCV.

MAVIRET is also indicated for patients with specific treatment challenges, including those with compensated cirrhosis across all major HCV genotypes [presumably with a 12-week duration], and those who previously had limited treatment options, such as patients with severe chronic kidney disease (CKD) or those with genotype 3 chronic HCV infection. MAVIRET is the only pan-genotypic treatment approved for use in patients across all stages of CKD.

Following this marketing authorization of MAVIRET in the European Union (E.U.), Enanta expects to receive a $25 million milestone payment from AbbVie.

Inasmuch as ENTA previously disclosed $80M of cumulative milestone payments from ABBV for Marivet approval in the US, EU, and Japan, we now know that the US and Japan approvals sum to $55M (probably $45-50M US and $5-10M Japan).