Novartis (NVS) 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 myositis (sIBM).
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.
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