Shortly after announcing promising phase II data on its
hepatitis C virus (HCV) regimen,
) outlined its plans for the late-stage development of the
Abbott Labs is investigating a regimen consisting of three
direct acting antivirals (DAA), with and without ribavirin, for
the treatment of HCV in genotype 1 (GT1) non-cirrhotic,
treatment-naïve as well as treatment-experienced patients. The
DAAs that will be evaluated in the study are ABT-450/r (protease
inhibitor and ritonavir), ABT-267 (NS5A inhibitor) and ABT-333
(non-nucleoside polymerase inhibitor).
Phase III studies will be conducted to evaluate the safety and
efficacy of the 12-week regimen in the above-mentioned patient
population. Abbott Labs plans to conduct another phase III study
which will study the DAAs plus ribavirin in patients with
cirrhosis for 12 or 24 weeks.
The phase III program will involve more than 2,000 patients.
While the duration of treatment will be 12 weeks for
non-cirrhotic patients, cirrhotic patients receive treatment for
12 or 24 weeks. Post-treatment follow-up period will be 48 weeks
for all the patients.
Top-line intent-to-treat results from the phase IIb AVIATOR
study showed that 97.5% of treatment-naïve GT1 patients and 93.3%
in GT1 null responder patients achieved SVR12. These results were
presented at the recently held annual meeting of the American
Association for the Study of Liver Disease (AASLD).
The HCV market represents huge commercial potential. It is
estimated that about 170 million people suffer from HCV infection
across the world. However, a huge number of HCV patients go
untreated leaving the field open for new treatments.
Besides Abbott Labs, companies like
are trying to develop the next crop of drugs, which are expected
to change the treatment paradigm for HCV patients by providing
them with all-oral treatment regimens. The development of a
treatment which does not require the administration of
interferon, thereby doing away with a whole range of side
effects, would be a major boon for patients and would find
several takers. The treatment duration will also be shorter.
Treatments being developed include HCV polymerase inhibitors
and HCV NS5A inhibitors. The future HCV market will most likely
consist of cocktail treatment regimens developed by combining
different oral treatments.
We currently have a Neutral recommendation on Abbott Labs,
which carries a Zacks #3 Rank (short-term 'Hold' rating). Abbott
Labs remains on track to split into two separate publicly traded
companies on January 1, 2013. While one company will deal in
diversified medical products, the other (AbbVie) will focus on
We are positive on the split which should allow the two
separate entities to perform in a more focused manner. Moreover,
with Humira continuing to perform well, concerns regarding
AbbVie's growth prospects should abate. The company's pipeline is
also moving along. The successful development of the
interferon-free HCV regimen would be a major boost for the stock.
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