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Novartis AG (NVS)

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  • Dec. 12, 2014, 7:34 AM
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  • Dec. 8, 2014, 3:26 PM
    • In a 1,144-subject Phase 3 study of Novartis' (NVS +0.1%) Jakafi (ruxolitinib) in myelofibrosis, patients experienced a reduction in spleen size that was maintained over time with a clinically meaningful improvement in symptoms. 69% of the patients achieved >50% reduction in spleen size. The safety and efficacy profile was consistent with previous studies. The results were presented at the American Society of Hematology meeting in San Francisco.
    • Jakafi is the only JAK inhibitor approved in more than 70 countries for patients with myelofibrosis.
    • Previously: Jakavi approval triggers milestone payment (July 8, 2014)
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  • Dec. 8, 2014, 7:46 AM
    • Novartis' (NYSE:NVS) investigational chimeric antigen receptor (CAR) therapy, CTL019, demonstrates profound efficacy in a 39-patient study in children and young adults with relapsed/refractory acute lymphoblastic leukemia (ALL). Thirty-six of the 39 patients (92%) experienced complete remissions.
    • Sustained remissions were achieved up to one year or more. Event-free survival at six months was 70% and overall survival (OS) was 75%, in most cases without further therapy.
    • Lead investigator Stephan Grupp, Ph.D., M.D., says, "We're seeing pediatric patients who have not responded to any other therapy achieve complete remission as a result of treatment with CTL019. Now that these patients have been followed for a longer period of time, we're seeing that a number of them remain in remission for one year or more. This lead me to believe the persistence and durability of CAR-modified cells may help protect against relapse."
    • CTL019 used CAR technology to reprogram a patient's own T cells to attack cancer cells that express proteins called CD19. After the cells have been reprogrammed they are re-infused into the patient where they seek out and kill tumor cells.
    • Novartis has worldwide rights to CARs developed through its collaboration with the University of Pennsylvania. The FDA designated CTL019 a Breakthrough Therapy in July.
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  • Dec. 8, 2014, 7:08 AM
    • In a 218-patient Phase 3 trial, Novartis (NYSE:NVS) unit Sandoz's investigational filgrastim biosimilar demonstrated similarity to Amgen's (NASDAQ:AMGN) Neupogen (filgrastim) in the prevention of severe neutropenia in patients with breast cancer receiving neoadjuvant myelosuppressive chemotherapy. The study also demonstrated that repeated switching at each cycle between in the investigative biosimilar and Neupogen showed no impact on efficacy, safety or immunogenicity.
    • Neutropenia is an abnormally low number of neutrophils, a type of white blood cells that are the primary defense against infections.
    • The FDA accepted for review Sandoz's application for filgrastim in July. It is the first such acceptance in the U.S. under the Biologics Price Competition and Innovation Act of 2009.
    • Neupogen generated ~$1.2B in sales the past four quarters.
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  • Dec. 3, 2014, 6:33 PM
    • Array BioPharma (NASDAQ:ARRY) +24% AH says it reached a deal with Novartis (NYSE:NVS) to regain global rights to its binimetinib cancer treatment as well as an upfront payment of $85M.
    • The agreement is subject to NVS and GlaxoSmithKline (NYSE:GSK) completing a series of transactions which were unveiled in April and remain subject to regulatory approval.
    • ARRY says binimetinib is advancing in three phase 3 clinical trials and that it plans to file for its first regulatory approval in H1 2016.
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  • Dec. 1, 2014, 3:52 PM
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  • Dec. 1, 2014, 12:26 PM
    • Teva Pharmaceutical Industries (TEVA) launches its generic equivalent to Novartis' (NVS -0.1%) high blood pressure med Exforge HCT (Amlodipine, Valsartan, Hydrochlorothiazide) Tablets in the U.S.
    • Teva was the first to file so it has marketing exclusivity against other generic firms for 180 days.
    • Per IMS Health, Exforge HCT generates annual sales in the U.S. of ~$158M.
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  • Dec. 1, 2014, 7:12 AM
    • Novartis' (NYSE:NVS) Gilenya (fingolimod), approved for relapsing multiple sclerosis (MS) in the U.S. and highly active relapsing-remitting MS in Europe, failed to demonstrate a significant difference compared to placebo on a combination of disability measures in a Phase 3 trial evaluating the drug in primary progressive multiple sclerosis (PPMS). PPMS is a disorder of the central nervous system which affects ~10% of the 2.3M MS sufferers worldwide.
    • Two other Phase 3 trials assessing Gilenya in pediatric MS and chronic demyelinating polyradiculoneuropathy are ongoing.
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  • Nov. 28, 2014, 8:15 AM
    • After three people died shortly after receiving Novartis' (NYSE:NVS) Fluad influenza vaccine, Italy's drug regulator AIFA suspends two lots of the product. In an e-mailed statement, Novartis says, "A review of the two batches confirmed that they conform with all production and quality standards and no casual relationship to the vaccine have been established."
    • Fluad was approved in 1997 and has an extensive history of safe use.
    • The three deaths, and another serious adverse event, all occurred in the southern regions of Sicily and Molise. One of the deaths was a 68-year-old man who died ten minutes after being vaccinated.
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  • Nov. 28, 2014, 7:28 AM
    • The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) grants accelerated assessment to Novartis' (NYSE:NVS) LCZ696, an investigational drug for the treatment of heart failure with reduced ejection fraction. This is the first time CHMP has extended such a review for a cardiovascular medicine. The designation shortens the committee's review period by 60 days (210 to 150) so a decision should be forthcoming in 2015.
    • Novartis expects to submit its Marketing Authorization Application (MAA) in early 2015. The basis for the submission is he Paradigm-HF study where LCZ696 demonstrated superiority compared to ACE-inhibitor enalapril.
    • The drug candidate is under Fast Track review in the U.S. The company's rolling submission should be complete by the end of next month.
    • Previously: Novartis chief says new heart failure drug will be a winner
    • Previously: Novartis heart failure drug candidate beats enalapril
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  • Nov. 26, 2014, 3:48 PM
    • The Federal Trade Commission approves GlaxoSmithKline's (GSK +0.4%) proposed acquisition of Novartis' (NVS +0.6%) vaccines business and the proposed creation of a consumer healthcare joint venture between the two firms.
    • As a condition of the positive vote, Novartis will divest its private label nicotine replacement therapy transdermal patch, Habitrol, in the U.S. to Dr. Reddy's Laboratories SA (RDY +1.5%).
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  • Nov. 25, 2014, 8:18 AM
    • Pharmacy benefits manager Express Scripts (NASDAQ:ESRX) is at the forefront of an increasing wave of resistance to the high prices of new drugs from pharma and biotech firms, some which cost as much as $50K per month. Pharmaceutical spending in the U.S. is $270B and may breach $500B in five years. ESRX's method of controlling costs is to refuse to pay for them. For 2015, for example, it is excluding 66 branded drugs from its main formulary, an increase of 18 from 2014's 48. On the list is Johnson & Johnson's (NYSE:JNJ) rheumatoid arthritis drug Simponi (golimumab) which costs $3K per month.
    • Other prescription benefits managers are employing similar tactics. CVS Health (NYSE:CVS) will exclude 95 drugs from its 2015 formulary including Pfizer's (NYSE:PFE) multiple sclerosis med Rebif (interferon beta-1a) which costs $5K for a four-week supply.
    • Governments are pushing back as well. Among 42 state Medicaid programs, 27 pay for Gilead Sciences' HCV med Sovaldi (sofosbuvir) only for patients with severe liver damage while others impose coverage limitations for patients with recent substance-abuse problems. In the U.S., the full regimen cost is $84K. Recently, Britain's National Institute for Health and Care Excellence (NICE) balked at recommending reimbursement for Roche's (OTCQX:RHHBY) blood cancer drug Gazyvaro (obinutuzumab).
    • Ninety percent of commercial health plans require pre-approval of specialty drugs, up from 82% in 2011.
    • Previously: Roche's Gazyvaro not NICE in the UK
    • Previously: Global drug tab will breach trillion dollar mark this year
    • ETFs: IBB, BIB, IRY, BIS, IXJ, DRGS
    • Related tickers: (NYSE:NVS) (NYSE:AZN) (NASDAQ:AMGN) (NASDAQ:BIIB) (NASDAQ:CELG) (NYSE:LLY) (NYSE:SNY) (NYSE:ABT) (NYSE:ABBV) (NYSE:BMY) (NYSE:MRK) (NYSE:GSK)
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  • Nov. 25, 2014, 7:10 AM
    • The FDA extends its priority review period by up to three months for Novartis' (NYSE:NVS) panobinostat in combination with bortezomib and dexamethasone for the treatment of patients with previously treated multiple myeloma.
    • The company submitted the NDA in March 2014. The FDA granted priority review status in May which reduced the standard 12-month review period to eight months. The extension follows the Oncologic Drugs Advisory Committee meeting earlier this month which voted 5-2 that the the benefits of panobinostat do not outweigh the risks.
    • Previously: Ad Comm votes against panobinostat
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  • Nov. 24, 2014, 8:18 AM
    • The European Commission approves Novartis' (NYSE:NVS) Signifor (pasireotide) for the treatment of adult patients with acromegaly for whom surgery is not an option or has not been curative and who are inadaquately controlled on treatment with a first-generation somatostatin analogue (SSA).
    • The once monthly injection directly targets the pituitary tumor and gives patients an alternative treatment option for those who are inadaquately controlled by SSAs.
    • Signifor is currently approved in over 60 countries for the treatment of Cushing's disease.
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  • Nov. 24, 2014, 8:02 AM
    • The European Commission approves AstraZeneca's (NYSE:AZN) Duaklir Genuair (aclidium bromide/formoterol fumarate 340/12 mcg) for the maintenance bronchodilator treatment in adults with chronic obstructive pulmonary disease (COPD).
    • The product is a fixed dose combination of two approved long-acting bronchodilators with different mechanisms of action. Aclidium bromide is an anticholinergic or long-acting muscarinic antagonist that produces bronchodilation by inhibiting the muscarinic M3 receptor in the airway smooth muscle. Formoterol fumarate is a long-acting beta-agonist that stimulates the B2-receptors in the bronchial smooth muscle resulting in bronchodilation. Both are currently approved as stand-alone therapies for the maintenance treatment of COPD in the U.S. and Europe.
    • Genuair is a multi-dose pre-loaded dry powder inhaler that utilizes optical and acoustic signals to inform the patient that the correct dose has been delivered.
    • COPD-related tickers: (NYSE:GSK) (NYSE:NVS) (NASDAQ:THRX) (NASDAQ:REGN) (NYSE:SNY) (NYSE:TEVA) (OTCQX:RHHBY)
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  • Nov. 24, 2014, 7:05 AM
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Company Description
Novartis AG is engaged in the research, development, manufacturing and marketing of healthcare products and pharmaceuticals.