) recently received Breakthrough Therapy Designation from the
U.S. Food and Drug Administration (FDA) for pipeline candidate
BYM338. The designation was granted for sporadic inclusion body
This designation should speed up the development and review
process for the candidate.
The designation was based on positive results from a phase II
study wherein it was observed that BYM338 substantially benefited
patients with sIBM compared to placebo.
Novartis is developing BYM338 in collaboration with Morphosys.
We note that BYM338 was granted orphan drug designation for the
sIBM indication in the U.S. as well as in Europe in 2012.
BYM338 is also being evaluated for the treatment of chronic
obstructive pulmonary disease (COPD), cancer cachexia, sarcopenia
and in mechanically ventilated patients.
We note that Novartis already has Arcapta Neohaler/Onbrez
Breezhaler and Seebri Breezhaler in its kitty indicated for the
treatment of COPD.
Last month, Novartis received a positive opinion from the CHMP
on Ultibro Breezhaler as a maintenance bronchodilator treatment
to relieve symptoms in adult patients with COPD.
We are encouraged by the recent pipeline progress at Novartis.
We remind investors that Novartis upped its 2013 guidance based
on a solid performance in the first half and lower-than-expected
generic erosion. The delayed entry of generic Diovan Mono in the
U.S. continues to positively impact results.
Novartis now expects sales to increase in the low single
digits in 2013 as compared to the earlier expectation of being in
line with 2012. Sales in the Pharmaceutical Division are expected
to be in line with 2012 compared to the previous estimate of a
low single-digit decline.
Novartis currently carries a Zacks Rank #3 (Hold). Right now,
) look attractive, each carrying a Zacks Rank #2 (Buy).
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