Novartis (NVS) announced positive results from a phase III study on candidate LBH589 (panobinostat).
The study was a part of the randomized, double blind, placebo controlled PANORAMA-I (PANobinostat ORAl in Multiple MyelomA) trial. It evaluated LBH589, a pan-deacetylase inhibitor, in patients with relapsed or relapsed and refractory multiple myeloma.
The results from the study showed that LBH589 plus Velcade and dexamethasone met primary endpoint of extending progression-free survival (PFS) as compared to Velcade plus dexamethasone and placebo.
Novartis plans to present the full results from the PANORAMA-I trial at an upcoming medical congress and discuss with regulatory authorities.
It was observed from the previous studies that oral LBH589 in combination with Velcade and dexamethasone recaptured responses in heavily pretreated and Velcade-refractory multiple myeloma patients, paving way for a potential new treatment option.
We remind investors that Novartis is facing generic competition for several key drugs such as Gleevec, Zometa and Diovan. Sales of Gleevec edged down 1% in the first nine months of 2013 due to loss of patent exclusivity in Brazil, Russia, Canada, Turkey and Mexico while sales of Zometa declined 46% in the first nine months due to the loss of exclusivity and consequential generic competition.
Therefore, the successful development and commercialization of the pipeline is very important for Novartis as it will help replace a part of the revenues lost to generics.