Industry Trend Analysis - Anti-Infective Approvals In 2017 Will Not Mirror Blockbuster Success Of 2016 - MAR 2017


BMI View: The coming year will not li ve up to 2016 in terms of novel anti-infective drug approvals , even though the overall number of FDA approvals is expected to increase . Shingrix, GlaxoSmithKline ' s shingles vaccine, is likely to see the largest peak revenue s of the potential market approvals in 2017 with its distinct advantage over competitors. AbbVie ' s glecaprevir /pibrentasvir (G/P) regimen will also have a key advantage over competitors by targeting all genoty pes of chronic h epatitis C. However, the G/P regimen will have limited revenue potential in the US with the number of cases dramatically reducing.

The coming year will be a slow one for novel drug approvals in the anti-infectives arena when compared to 2016. In 2017, there is a total of five PDUFA dates currently scheduled for novel anti-infective drugs and these include: Melinta Therapeutics' Baxdela (delafloxacin) in June; Symbiomix Therapeutics' Solosec (secnidazole oral granules) in July; Kamada/ Kedrion Biopharma's KamRAB (anti-rabies immunoglobulin [human]) in August; GlaxoSmithK l ine's Shingrix (herpes zoster vaccine) in October; and AbbVie's glecaprevir/pibrentasvir (G/P) regimen in December. Alongside these PDUFA dates, Cempra and Dyna v ax Technologies have submitted complete response letters (CRLs) for solithromycin to treat community-acquired bacterial pneumonia (CABP) and for Heplisav-B (HBsAg-1018) to treat hepatitis B, respectively, and could see approval dates this year.

Melinta's Baxdela

Limited Blockbuster Value In 2017
Product Revenue Forecasts (USDmn)
f= Bloomberg forecast. Source: Bloomberg, BMI

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