) recently announced that the US Food and Drug Administration
(FDA) rendered Breakthrough Therapy designation to its pipeline
The Breakthrough Therapy designation includes all the features
involved in a fast track program in addition to a more intensive
FDA guidance. This designation from the FDA expedites the
development and review of drugs for the treatment of
life-threatening diseases provided the therapy is able to show
substantial improvement over an available therapy on at least one
clinically significant endpoint.
Novartis is developing LDK378 for the treatment of patients
with anaplastic lymphoma kinase positive (ALK+) metastatic
non-small cell lung cancer (NSCLC). These patients were
The phase I study of LDK378 demonstrates preliminary clinical
response in ALK+ NSCLC patients who were previously treated with
Subsequently, Novartis initiated two phase II studies to
further evaluate the compound. The company intends to commence
several phase III studies on the candidate for the above
indication later in 2013. The first regulatory filing is
anticipated by early 2014.
A prevalent form of lung cancer, NSCLC affects 85%-90% of all
lung cancer patients. We note that Sandoz, the generic arm of
Novartis, launched Docetaxel in the US in 2011, a generic version
) Taxotere which is indicated for breast, ovarian and
Earlier in the month, the European Commission (EC) approved
Novartis' llaris (canakinumab, ACZ885) for an additional
indication. The EC cleared llaris for treating adults suffering
from gouty arthritis (gout) - a serious, chronic and progressive
Ilaris is already approved for treating children and adults
suffering from cryopyrin associated periodic syndrome (CAPS) in
the EU, US, Switzerland and Japan.
However, the approval process of Ilaris in the US has been
bumpy. In Aug 2011, Novartis received a Complete Response Letter
(CRL) from the FDA asking for additional information to evaluate
the risk benefit profile in refractory gout patients. Novartis
continues to work with the FDA to determine the next steps for
llaris in the gout indication.
Novartis carries a Zacks Rank #3 (Hold). Right now,
) looks attractive with a Zacks Rank #2 (Buy).
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