Key Developments: Novartis AG (NVS)
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17 May 2013
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Latest Key Developments (Source: Significant Developments)
Novartis AG's Drug Ilaris Approved By FDA To Treat Active Systemic Juvenile Idiopathic Arthritis
Novartis AG announced that the US Food and Drug Administration (FDA) has approved Ilaris (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(1). SJIA is a rare and disabling form of childhood arthritis characterized by spiking fever, rash and arthritis that can affect children as young as two years old and can continue into adulthood(2,3). This approval was based on two Phase III trials in SJIA patients, aged 2-19, showing improvement in the majority of Ilaris-treated patients. Study one 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). The primary endpoints for Study 1 and Study 2 were all met. Full Article
US Court Finds Bayer AG’s Yaz Contraceptive Patent Claims Invalid; Actavis Inc, Drug Unit of Novartis AG And Lupin Ltd Involved in Rulling-Reuters
Reuters reported that a federal appeals court has ruled against Bayer AG, reversing a ruling by a lower court and finding that parts of a patent for the Company’s Yaz oral contraceptive were invalid. The United States Court of Appeals for the Federal Circuit ruled on April 16, 2013 that a district court in Nevada had erred in finding two claims of a patent for the contraceptive to be not invalid. It reversed the ruling. The generic companies involved in the ruling, Watson Pharmaceuticals, which now goes by the name Actavis Inc, Sandoz Inc - the generic drug unit of Novartis - and Lupin Ltd, had argued that the patent was invalid and had told the United States Food and Drug Administration that they planned to bring out generic versions of the contraceptive. The patent expires on June 30, 2014. Full Article
Pfizer Inc, Novartis AG And Abbott Laboratories Weigh Bids For Brazil's Ache Laboratorios Farmaceuticos-Reuters
Reuters reported that at least three of the world's top drugmakers are bidding for Brazil's Ache Laboratorios Farmaceuticos in an auction that may value the group at more than $5 billion. Pfizer Inc, Novartis AG and Abbott Laboratories are all weighing second-round bids to acquire the company. Bids are due in the second half of April. Privately owned Ache is attractive to drug companies looking to increase their footprint in the growing market of Latin America. GlaxoSmithKline Plc showed early interest but has dropped out of the running. Full Article
India Supreme Court Rejects Novartis AG Plea On Cancer Drug Patent-DJ
Dow Jones reported that India's Supreme Court on Monday decided against granting patent protection to Novartis AG's blockbuster cancer drug Glivec, in a landmark judgment that delivers far-reaching ramifications for multinational pharmaceutical companies operating in the South Asian nation. The two-judge bench of the court rejected the company's plea, saying Novartis can't be given a patent for Glivec. The Swiss company's legal fight, which began after India rejected its application for a patent for Glivec in 2006, is the most prominent of several high-stakes drug-patent battles that will determine how much protection foreign companies can get from Indian competitors that make lower-cost generic versions of their products. Full Article
Novartis India Ltd Announces Proposed Reduction In Shareholding of Novartis AG
Novartis India Ltd announced that the Company has received a letter dated March 27, 2013 from Novartis AG, Basel, the promoter company of Novartis India Limited informing the Company that it intends to reduce its shareholding in the Company through Stock Exchange mechanism. Full Article
Clinigen Group PLC Acquires Oncology Support Therapy Cardioxane From Novartis AG
Clinigen Group PLC announced he acquisition of Cardioxane (dexrazoxane) from Novartis for USD33 million in cash, payable in two tranches. Under the terms of the agreement, Clinigen will assume responsibility for manufacturing, registration, distribution, and commercialization of the product in countries where current marketing authorizations exist, including key European, Asian and Latin American territories. Cardioxane, an oncology support therapy, is a cardioprotective agent used to prevent the cardiotoxicity of anthracycline chemotherapy for patients with advanced and/or metastatic breast cancer. Full Article
UK Cost Body Rejects Novartis AG's Breast Cancer Drug-Reuters
Reuters reported that Novartis AG's drug Afinitor has been rejected by Britain's health cost agency NICE due to uncertainty over its survival benefits in breast cancer. The Novartis drug is also used to treat patients with other types of cancer, including kidney and a rare type of pancreatic cancer. Full Article
Novartis AG's Alcon Unit Gets EU Approval For Jetrea Eye Drug-Reuters
Reuters reported that Novartis AG's Alcon unit got a green light from the European Commission for Jetrea, a drug that treats an eye condition that can lead to blindness. Jetrea is the first eye drug to treat vitreomacular traction (VMT) associated with macular hole that can cause progressive sight-threatening symptoms and irreversible vision loss. Novartis has acquired the rights to sell Jetrea outside the United States from ThromboGenics NV. In October 2012, Jetrea was approved in the U.S. for the treatment of patients with symptomatic vitreomacular adhesion (VMA). Full Article
Orexo AB Announces Agreement with Novartis AG on OX17 for GERD Terminated
Orexo AB announced that Novartis AG sent a notice of termination of the license agreement dated August 27, 2009. The OX17 program was aimed for the treatment of gastroesophageal reflux disease (GERD) and is still in early clinical phase. Under the license agreement, Novartis AG was responsible for all development, production and marketing of future products. The OX17 program has not developed according to plans and given the strategic direction which Orexo AB has taken, the program will be discontinued. The termination of OX17 will have no impact on the financial position of Orexo AB, both from a cost and revenue perspective. Full Article
UK Cost Agency Says No To Novartis AG's Blood Cancer Drug Jakavi-Reuters
Reuters reported that A new drug from Novartis AG for myelofibrosis, a rare blood cancer, is not worth using on the state health service, Britain's healthcare cost watchdog said. The National Institute for Health and Clinical Excellence (NICE) said it had issued new draft guidance not recommending Jakavi because it could not be considered a cost-effective use of resources. Full Article
Novartis, BT push European shares to fresh 5-yr peak
LONDON, May 10 - European shares scaled fresh five-year highs on Friday, led by healthcare group Novartis and telecoms firm BT on positive corporate news, and traders said key indexes had scope for more gains.
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