Breakthrough Therapy designation is a status provided under the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012 to potential candidates that show superiority over existing therapies for the treatment of serious or life threatening diseases or conditions. The designation helps fasten the development and review process for experimental drugs targeting serious and life-threatening diseases. A candidate with Breakthrough Therapy designation could benefit from the FDA’s existing fast track development program features as well as more intensive FDA guidance on efficient development of the candidate.
Ever since the Act was enacted, quite a few pipeline candidates like Bristol-Myers Squibb’s (BMY) all-oral hepatitis C virus (HCV) combination of daclatasvir and asunaprevir have received Breakthrough Therapy designation from the FDA.
A recent recipient is Pfizer Inc.’s (PFE) investigational vaccine, bivalent rLP2086. Pfizer is developing the vaccine for the prevention of invasive disease caused by Neisseria meningitidis serogroup B in people in the age group of 10 years–25 years. Pfizer intends to file a Biologics License Application (BLA) for rLP2086 vaccine by mid-2014. We note that Pfizer gained Breakthrough Therapy status for its breast cancer candidate, palbociclib, last year.
Meanwhile, Pfizer is looking to expand the label of its pneumonia vaccine, Prevenar 13. The company presented detailed results from a Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA) study on Prevenar 13 earlier this month.
Pfizer carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector include Alexion Pharmaceuticals, Inc. (ALXN) and Gilead Sciences Inc. (GILD). Both stocks carry a Zacks Rank #1 (Strong Buy).
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