Novartis announced that the US Food and Drug Administration (FDA) has approved Ilaris(R) (canakinumab) for the treatment of active systemic juvenile idiopathic arthritis (SJIA) in patients aged 2 years and older. Ilaris is the first interleukin-1 beta (IL-1 beta) inhibitor approved for SJIA and the only treatment approved specifically for SJIA that is given as a once-monthly subcutaneous injection. SJIA is a rare and disabling form of childhood arthritis characterized by spiking fever, rash and arthritis that can affect children as young as 2 years old and can continue into adulthood. This approval was based on two Phase III trials in SJIA patients, aged 2-19, showing significant improvement in the majority of Ilaris-treated patients. Study 1 showed that 84% of patients treated with one subcutaneous dose of Ilaris achieved the primary endpoint of the adapted pediatric American College of Rheumatology 30 (ACR30), compared to 10% achievement of ACR30 for placebo at Day 15. In the open-label part of Study 2, 92 of 128 patients attempted corticosteroid tapering. Of those 92 patients, 62% were able to substantially reduce their use of corticosteroids, and 46% completely discontinued corticosteroids. In the controlled portion of Study 2, there was a 64% relative reduction in the risk of flare for patients in the Ilaris group as compared to those in the placebo group (hazard ratio of 0.36; 95% CI: 0.17 to 0.75).

United States has filed a second civil false claims lawsuit against Novartis Pharmaceuticals Corp. involving alleged kickbacks paid by the company to health care providers. The governments complaint seeks damages and civil penalties under the False Claims Act and under the common law for paying kickbacks to doctors to induce them to prescribe Novartis pharmaceutical products that were reimbursed by federal health care programs. The lawsuit alleges that the payments violated the Anti-Kickback Statute and, as a result of Novartiss unlawful conduct, the government paid false claims for reimbursement for Novartis pharmaceutical products. Kickback schemes like those alleged in this case not only call into question the integrity of individual medical decisions, but they also raise the cost of health care for all. On April 23, 2013, the United States filed a separate complaint in the Southern District of New York against Novartis, alleging that the company gave kickbacks, in the form of rebates and discounts, to pharmacies in exchange for the pharmacies agreement to switch transplant patients from competitor drugs to a Novartis product. As here, that complaint seeks treble damages and civil penalties under the False Claims Act and remedies under the common law.

Novartis Pharmaceuticals Corporation reported earnings results for the first quarter ended March 31, 2013. For the quarter, the company reported operating income of $2,539 million and core operating income of $2,573 million on net sales of $7,877 million compared to operating income of $2,402 million and core operating income of $2,589 million on net sales of $7,839 million reported a year ago. Net sales were in line with previous year, with strong volume growth of 9% more than offsetting generic competition. Operating income increased 6%, primarily due to restructuring charges taken in 2012 related to the US General Medicine business.