Novartis reports acromegaly data, earnings

Novartis AG (NYSE:NVS; SIX:NOVN) said pasireotide met the primary endpoint of normalization of IGF-1 and growth hormone levels vs. the pharma's Sandostatin LAR octreotide in a Phase III trial to treat acromegaly. Novartis disclosed the data on Tuesday in a pipeline update that came with its 1Q11 financial results. The company, which submitted an MAA to EMA in 4Q10 for pasireotide to treat Cushing's disease, did not disclose details on a regulatory plan for the acromegaly indication.

On the regulatory front, Novartis said FDA refused to file an NDA for panobinostat to treat Hodgkin's lymphoma but did not release additional details. The pharma also withdrew an MAA in Europe for Joicela lumiracoxib in combination with a companion diagnostic to treat pain in osteoarthritis (OA) patients who do not carry the 0102 allele of major histocompatibility complex class II DQ alpha 1 (HLA-DQA1). According to EMA, Novartis was unable to provide additional data to CHMP within the time frame allowed. Novartis submitted the MAA in December 2009. Lumiracoxib was previously marketed outside the U.S. as Prexige to treat pain associated with OA but was withdrawn in 2007 due to concerns about hepatic toxicity. Researchers subsequently discovered that the 0102 allele was significantly associated with liver injury in patients taking the cyclooxygenase-2 (COX-2) inhibitor (see BioCentury, Aug. 16, 2010). ...