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     488  0 Kommentare Breadth of data at ECTRIMS underpins Novartis' relentless commitment to decoding the science of multiple sclerosis (MS) and decreasing the patient burden - Seite 3

    About Novartis in Multiple Sclerosis
    The Novartis multiple sclerosis portfolio includes Gilenya (fingolimod, an S1P modulator), which is indicated for relapsing forms of MS. In the United States, Gilenya is the first disease-modifying therapy approved for the treatment of children and adolescents 10 to less than 18 years of age with relapsing forms of multiple sclerosis (RMS). In September 2018, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended approval of Gilenya for the treatment of children and adolescents 10 to 17 years of age with relapsing remitting forms of multiple sclerosis (RRMS). The European Commission will review the CHMP opinion and is expected to deliver its final decision within three months.

    Investigational compounds include siponimod (BAF312). Siponimod is an investigational, selective modulator of specific subtypes of the sphingosine-1-phosphate (S1P) receptor, and has the potential to delay progression and expand possibilities for patients with typical SPMS. Novartis initiated the submission of siponimod for US approval in SPMS in the first half of 2018, which was followed by filing with the EMA in September 2018 for EU approval. The file has been accepted by both agencies.

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    Our other investigational compound is ofatumumab (OMB157), a fully human monoclonal antibody in development for relapsing MS. Ofatumumab targets CD20, and is currently being investigated in two Phase III pivotal studies.

    Extavia (interferon beta-1b for subcutaneous injection) is approved in the US for the treatment of relapsing forms of MS. In Europe, Extavia is approved to treat people with relapsing-remitting MS, secondary progressive MS (SPMS) with active disease and people who have had a single clinical event suggestive of MS. 

    In the US, the Sandoz Division of Novartis markets Glatopa (glatiramer acetate injection) 20 mg/mL and 40 mg/mL, generic versions of Teva's Copaxone.

    *Copaxone is a registered trademark of Teva Pharmaceutical Industries Ltd.

    Disclaimer
    This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as "potential," "can," "will," "plan," "expect," "anticipate," "look forward," "believe," "committed," "investigational," "pipeline," "launch," or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political and economic conditions; safety, quality or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

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