) TOBI Podhaler (tobramycin inhalation powder) recently received
US Food and Drug Administration (FDA) approval for the treatment
of bacterial lung infection in cystic fibrosis patients caused by
the Pseudomonas aeruginosa bacterium.
The approval was based on a study conducted on 95 pediatric and
adult patients suffering from cystic fibrosis. Patients received
TOBI Podhaler or placebo for the first 28 days of the study.
After that they were treated with TOBI Podhaler.
A statistically significant increase of 12.5% in forced
expiratory volume in one second (FEV1) was achieved in patients
treated with TOBI Podhaler compared to 0.09% in patients treated
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We are positive on the FDA approval of TOBI Podhaler. TOBI
Podhaler's regulatory path in the US has not exactly been smooth
with the company receiving a complete response letter from the
FDA in Oct 2012. Subsequently Novartis responded to the CRL. The
FDA approved the drug on the basis of resubmitted application.
TOBI Podhaler is currently approved in the European Union,
Canada, Switzerland and other countries. TOBI's (TOBI nebulizer
solution and TOBI Podhaler) sales in 2012 were up 7% year over
year (up 9% year over year in constant currency) to $317million.
The recent bout of regulatory approvals at Novartis is
encouraging. A few weeks back, the Jetrea intravitreal injection
(ocriplasmin) was approved by the European Commission for the
treatment of vitreomacular traction and macular hole.
Novartis carries a Zacks Rank #4 (Sell). Large-cap pharma
companies that currently look better-positioned include
). All three are Zacks Rank #2 (Buy) stocks.