Swiss pharmaceutical giant
) recently provided an update on its pipeline candidates. The
company also discussed its commercialization plans for these
candidates so as to drive growth through 2017.
Novartis' pharmaceutical division currently has 139 projects
in clinical development of which 73 are New Molecular Entities
(NMEs) covering several disease areas.
Boasting 56 approvals since 2007 in the US, Europe, Japan and
China, Novartis undisputedly is one of the leading players in the
pharmaceutical industry. To date, the company received 9
approvals or positive recommendations this year.
The company is expecting several data read-outs, filings and
regulatory decisions in the next two years. In the next one year,
Novartis is expecting data read outs from 13 pivotal studies
along with 9 filings and 7 regulatory decisions. The following
year will see 11 pivotal trial read-outs, 11 filings and 10
Novartis' oncology portfolio also performed well year to date
with 6 indications including 2 NMEs getting approved. The company
is expecting further growth in this area over the next five
years. Afinitor, one of the leading growth drivers in the
oncology segment, is expected to exceed sales of $2 billion in
breast cancer alone by 2017.
We note that Afinitor is approved in five indications
including breast cancer. Moreover the scheduled product launches
and launches of pipeline projects are expected to contribute
another $1 billion by 2017.
The company already has given a new dimension to the Ph+
chronic myeloid leukemia (CML) area. Novartis' Tasigna, a potent
2nd generation targeted therapy for CML, has shown reduced risk
of progression and deeper and more sustained molecular response
in comparison to Glivec. The company is planning additional
clinical trials on Tasigna next year.
However, Novartis recently announced mixed data from a phase
III study of its acute heart failure (AHF) candidate RLX030
(serelaxin). Though the company expects to initiate regulatory
findings in early 2013 in the US and the EU, we believe the
company may need to conduct an additional study depending on the
Meanwhile, Novartis announced positive results from a phase II
study of LCZ696, which showed significant reduction in a key
indicator of morbidity and mortality in patients suffering from
chronic heart failure with preserved ejection fraction (HF-PEF).
The heart failure market currently has players like
Takeda Pharmaceutical Company Limited
Merck & Co
Novartis will also be focusing on areas like chronic
obstructive pulmonary disease (COPD), psoriasis, ankylosing
spondylitis, rheumatoid arthritis and multiple sclerosis.
The company will be looking to increase its efficiency and
productivity without increasing costs. Novartis intends to
introduce novel technologies and methods to reduce recruitment
time and trial costs along with improving study quality and
patient comfort and safety.
Currently, we have a Neutral recommendation on Novartis.
Novartis carries a Zacks #3 Rank (Hold rating) in the short
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