30.04.2019 22:30:26
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Press Release: New data at AAN reinforce Novartis -2-
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 or the
collaboration with Amgen. 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. Neither can there be any guarantee that the collaboration with
Amgen will achieve any or all of its intended goals, or within any
particular time frame. Nor can there be any guarantee that such products
or the collaboration with Amgen will be commercially successful in the
future. In particular, our expectations regarding such products and the
collaboration with Amgen 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 and requirements
for increased pricing transparency; our ability to obtain or maintain
proprietary intellectual property protection; the outcome of litigation
and legal disputes, including the legal dispute with Amgen regarding our
collaboration agreements in the field of migraine; 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.
*The brand name Zolgensma has been provisionally approved by the FDA for
the investigational product AVXS-101 (onasemnogene abeparvovec-xioi),
but the product itself has not received marketing authorization or BLA
approval from any regulatory authorities.
About Novartis
Novartis is reimagining medicine to improve and extend people's lives.
As a leading global medicines company, we use innovative science and
digital technologies to create transformative treatments in areas of
great medical need. In our quest to find new medicines, we consistently
rank among the world's top companies investing in research and
development. Novartis products reach more than 750 million people
globally and we are finding innovative ways to expand access to our
latest treatments. About 105 000 people of more than 140 nationalities
work at Novartis around the world. Find out more at www.novartis.com.
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References
[1] Dabbous O, et al. Event-Free Survival and Motor Milestone
Achievement Following AVXS-101 and Nusinersen Interventions Contrasted
to Natural History for Type I Spinal Muscular Atrophy Patients. Oral
presentation. 2019 AAN.
[2] Dabbous O, et al. The Value of AVXS-101 Gene Replacement Therapy
for Spinal Muscular Atrophy Type 1: Improved Survival, Pulmonary and
Nutritional Support, and Motor Function with Decreased Hospitalization.
Poster Presentation. 2019 AAN.
[3] Day J, et al. AVXS-101 Gene-Replacement Therapy (GRT) for Spinal
Muscular Atrophy Type 1 (SMA1): Pivotal Phase 3 Study (STR1VE) Update.
Poster presentation. 2019 AAN.
[4] Droege M, et al. Number Needed to Treat (NNT) in Spinal Muscular
Atrophy Type 1 (SMA1) with AVXS-101 Relative to Nusinersen. Poster
presentation. 2019 AAN.
[5] Droege M, et al. Early Diagnosis and Speed to Effect in Spinal
Muscular Atrophy Type 1 (SMA1). Oral presentation. 2019 AAN.
[6] Finkel R, et al. Phase 1 Study of Intrathecal Administration of
AVXS-101 Gene-Replacement Therapy (GRT) for Spinal Muscular Atrophy Type
2 (SMA2) (STRONG). Poster presentation. 2019 AAN.
[7] Leonard H, et al. Establishing Clinical Trial Readiness of the
Rett Syndrome Hand Function Measure. Poster presentation. 2019 AAN.
[8] Mendell J, et al. AVXS-101 Gene-Replacement Therapy (GRT) in
Spinal Muscular Atrophy Type 1 (SMA1): Long-Term Follow-Up From the
Phase 1 Clinical Trial. Oral presentation. 2019 AAN.
[9] Powers S, et al. Rett syndrome gene therapy improves survival and
ameliorates behavioral phenotypes in MeCP2 null. Oral presentation. 2019
AAN.
[10] Schultz M, et al. AVXS-101 Gene-Replacement Therapy (GRT) in
Presymptomatic Spinal Muscular Atrophy (SMA): Study Update. Poster
presentation. 2019 AAN.
[11] Thomsen G, et al. Intrathecal AAV9-SOD1-shRNA Administration for
Amyotrophic Lateral Sclerosis. Oral presentation. 2019 AAN.
[12] Deconinck N, et al. Serum Neurofilament Light Chain as a Potential
Biomarker for Spinal Muscular Atrophy Type I Disease Activity and
Therapy Response. Oral presentation. 2019 AAN.
[13] Benedict R, Fox R, Tomic D, et al. Effect of Siponimod on
Cognition in Patients with Secondary Progressive Multiple Sclerosis
(SPMS): Phase 3 EXPAND Study Subgroup Analysis. Poster presentation.
2019 AAN.
[14] Reuter U, et al. Assessment of the Efficacy of Erenumab During the
Open-Label Treatment (13-24 Weeks) of Subjects with Episodic Migraine
Who Failed 2-4 Prior Preventive Treatments: Results of the LIBERTY
Study. Poster presentation. 2019 AAN.
[15] Reuter U, et al. Long-term Efficacy of Erenumab in Patients With
Episodic Migraine Who Have Failed Prior Preventive Migraine Therapies.
Poster presentation. 2019 AAN.
[16] Tepper S, et al. Assessment of the Long-Term Safety and Efficacy
of Erenumab During Open-Label Treatment of Patients With Chronic
Migraine. Poster presentation. 2019 AAN.
[17] Lipton R, et al. Efficacy of erenumab in chronic migraine patients
with and without allodynia. Poster presentation. 2019 AAN.
[18] Lipton R, et al. Conversion from Chronic migraine to episodic
migraine with long term erenumab treatment. Oral presentation. 2019 AAN.
[19] Ohlsson L, et al. Erenumab (AMG334) An Antagonist to Canonical
CGRP-Receptor Does Not Impair Vasodilatory or Contractile Responses to
Other Agents In Human Isolated Cerebral Arteries. Oral presentation.
2019 AAN.
[20] Dodick D, et al. Efficacy of erenumab in chronic migraine patients
with medication overuse and prior preventive treatment failure. Oral
presentation. 2019 AAN.
[21] Chou D, et al. Sustained Efficacy Over 1 Year of Treatment With
Erenumab: Results From the Extension Phase of the STRIVE Study in
Episodic Migraine. Oral presentation. 2019 AAN.
[22] Schaetz L, et al. Healthcare Expenditure in Migraine Compared to
Other Leading Causes of Disability: Adequate or Not? Poster
presentation. 2019 AAN.
[23] Rahn K, Slusher B, and Kaplin, A. Cognitive Impairment in Multiple
Sclerosis: A Forgotten Disibility Remembered. The Dana Foundation.
http://www.dana.org/Cerebrum/2012/Cognitive_Impairment_in_Multiple_Sclerosis__A_Forgotten_Disability_Remembered/.
Accessed April 2019.
[24] Cree B, Goldman M, Corboy J, et al. Efficacy and safety of
fingolimod 0.5 mg and 0.25 mg versus glatiramer acetate 20 mg in
patients with relapsing-remitting multiple sclerosis - ASSESS Study
Group. Poster presentation. 2019 AAN.
[25] Ziemssen T, et al. Validation of the Scoring Algorithm for a Novel
Integrative Secondary Progressive Multiple Sclerosis (SPMS) Screening
Tool. Poster presentation. 2019 AAN.
[26] Dawson J, et al. Effect of Subcutaneous Treatment With Anti-CD20
Antibody on B-cell Depletion in a Lipopolysaccharide-Induced
Inflammatory Mouse Model. Poster presentation. 2019 AAN.
[27] Kappos L, et al. Baseline Characteristics of Patients with
Relapsing Multiple Sclerosis in ASCLEPIOS Phase 3 Trials of Ofatumumab
Versus Teriflunomide. Poster Presentation. 2019 AAN.
[28] Migotto M, et al. Effect of Route of Administration on the
Biodistribution of a Novel Anti-CD20 Antibody in Experimental Autoimmune
Encephalomyelitis-Variant Mice. 2019 AAN.
[29] Torres J, et al. Distribution and Efficacy of Ofatumumab and
Ocrelizumab in Humanized-CD20 Mice following Subcutaneous or Intravenous
Administration. Poster presentation. 2019 AAN.
[30] Kuhle J, et al. The Predictive Value of Neurofilament Light Chain
Levels in Blood for Cognitive Impairment in Patients with Secondary
Progressive Multiple Sclerosis. Oral presentation. 2019 AAN.
[31] Kuhle J, et al. An Integral Measure of Serial Neurofilament Light
Chain Assessments in Blood is a Predictor of Long-Term Disability
Progression in Relapsing-Remitting Multiple Sclerosis. 2018 ECTRIMS.
[32] Kappos L. Neurofilament Light Levels in the Blood of Patients with
Secondary Progressive MS are higher than in Primary Progressive MS and
may Predict Brain Atrophy in both MS Subtypes. Oral presentation. 2018
ECTRIMS.
[33] Reinert M, et al. Neurofilament Light Chain is a Useful Biomarker
in Paediatric Multiple Sclerosis. 2018 ECTRIMS.
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