novartis ag-adr (NVS) Key Developments
Novartis AG's Leukemia Treatment CTL019 Gets FDA Breakthrough Therapy Status
Jul 7 14
Novartis AG announced that the United States Food and Drug Administration has granted breakthrough therapy status to CTL019, an investigational chimeric antigen receptor (CAR) therapy for the treatment of pediatric and adult patients with relapsed/refractory acute lymphoblastic leukemia. The breakthrough therapy filing was submitted by the University of Pennsylvania's Perelman School of Medicine which has an exclusive global agreement with Novartis to research, develop and commercialize personalized CAR T cell therapies for the treatment of cancers. The FDA Breakthrough Therapy designation is intended to expedite the development and review of new medicines that treat serious or life-threatening conditions if the therapy has demonstrated substantial improvement over an available therapy on at least one clinically significant endpoint.
Sandoz Launches Hypertension and Hypercalcemia Drugs in Japan
Jun 27 14
Sandoz, the generic pharmaceutical division of Novartis, has launched Valsartan, Losarhyd and zoledronic acid, in Japan. Valsartan and Losarhyd are indicated for the treatment of hypertension and Zoledronic Acid for hypercalcemia of malignancy. Valsartan is a generic version of Novartis' Diovan Tablets, zoledronic acid is a generic version of Novartis' Zometa for i.v. infusion 4mg/5mL and Losarhyd is a generic version of MSD's Preminent Tablets LD.
Sandoz Commercialises Generic Version of Avelox in Spain
Jun 24 14
Sandoz, the generics division of Novartis has begun the marketing in Spain of the antibiotic "Sandoz moxifloxacin tablets 400 mg". The new antibiotic marketed by Sandoz is the bioequivalent of Avalox/Avelox produced by Bayer (Germany), whose patent protection has expired. The European Medicines Agency has approved Avalox/Avelox for the treatment of bacterial infections: acute exacerbation of chronic bronchitis; community-acquired pneumonia, except severe cases; and acute bacterial sinusitis (adequately diagnosed). The Sandoz generic version of the product in the Spanish pharmaceutical market will be available for the same indications and will provide more patient access to the antibiotic with a more affordable price.
Questcor Pharmaceuticals Closes Transaction to Acquire International Rights to Synacthen and Synacthen Depot from Novartis Pharma AG and Novartis AG
Jun 23 14
Questcor Pharmaceuticals Inc. announced that the transaction acquiring rights to Synacthen and Synacthen Depot from Novartis Pharma AG and Novartis AG in certain countries outside the U.S. has now closed. Available in more than forty countries for multiple indications, Synacthen (tetracosactide) is a synthetic 24 amino acid melanocortin peptide. Synacthen Depot is a depot formulation of Synacthen. The products are approved outside the U.S. for multiple indications, including certain autoimmune and inflammatory conditions as well as for diagnostic use, but have never been developed or approved for patients in the U.S. Questcor is presently engaged in pre-clinical development for Synacthen in the U.S. Under the terms of the transaction agreements, Questcor will have the right to develop, market, manufacture, distribute, sell and commercialize Synacthen in all countries worldwide except for 13 European countries in which Novartis has previously granted rights to another third party. This process will involve the transfer to Questcor of individual marketing authorizations in more than forty countries outside the U.S. With the first transfer expected to take place mid-2014, Questcor anticipates that the marketing authorizations for Synacthen currently held by Novartis will be transferred to Questcor on or before the end of 2016.
Novartis Announces Withdrawal of Galvus, Eucreas from German Market over Pricing Disagreement
Jun 19 14
Novartis has announced that it is going to cease the marketing of its oral type 2 diabetes drugs Galvus (vildagliptin) and Eucreas (vildagliption + metformin) in Germany from 1 July. The company has stated that it has been in negotiations with the Association of Statutory Health Insurance Funds (GKV-Spitzenverband) for several months concerning the prices of these products. Mark Never, the head of Novartis's German unit, has reportedly stated that the company will not accept a price at the generics level. The source reports that these products are marketed in more than 120 countries and are used by around four million patients with type 2 diabetes. Reportedly, Novartis reduced the prices of the products by 30% in May, but it has set a limit on a further reduction to the generics level. The company is said to have already informed the GKV-Spitzenverband about its decision, while there remains around two months' worth of these products in circulation, enabling doctors and patients sufficient time to choose alternatives.