) recently announced that its inhalational anthrax candidate,
raxibacumab, has received US Food and Drug Administration (FDA)
approval. Raxibacumab was approved for inhalational anthrax
caused by bacillus anthracis in patients (both adult and
pediatric) in combination with appropriate antibacterial drugs
and for prevention of inhalational anthrax when other therapies
are not available or appropriate.
We note that raxibacumab is the first monoclonal antibody to
be cleared by the FDA as per its Animal Efficacy Rule. The rule
facilitates the approval of candidates solely on the basis of
efficacy data from animal trials, when it is not possible to
conduct human trials.
The candidate was initially developed by the Biomedical
Advanced Research and Development Authority (BARDA), US
Department of Health and Human Services (HHS) and Human Genome
Sciences, which was later acquired by Glaxo.
We currently have a Neutral recommendation on Glaxo. The stock
carries a Zacks #3 Rank (Hold) in the short run.
Several products in Glaxo's portfolio including Valtrex,
Arixtra, Evoclin, Lamictal, Imitrex, Requip, Combivir and Epivir
are facing declining sales due to intense generic competition. We
expect the company's top line and gross margins to remain under
pressure in the coming quarters. EU pricing pressure will
continue to affect sales as well.
Glaxo is aiming to maximize the potential return from its
pipeline. The company is looking toward deals and acquisitions to
drive growth. Further, the company is focusing on increasing the
rights on its partnered products and promising pipeline
candidates, so that it stands to benefit more from their
Glaxo's acquisition of Cellzome and Human Genome Sciences,
increasing investment in
) and amended agreement between ViiV Healthcare and Shionogi
indicate its efforts to expand the pipeline.
Apart from this, Glaxo continues to progress on its
cost-cutting initiative, which should help reduce the impact of
increasing generic competition over the next few years and boost
Large-cap pharma stocks currently holding a Zacks #2 Rank
include companies like
Johnson & Johnson
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