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`' ()  
` #(
`)     * +(
`
` ,
`
`Apotex v. Novartis
`IPR2017-00854
`NOVARTIS 2031
`
`

`

`11/13/2017
`
`FTY720 For Relapsing Multiple Sclerosis - Phase II Data Shows Sustained Efficiency And Good Tolerability
`
`The most frequently reported adverse events in patients treated up to 18 months were non—
`
`serious infections (colds, influenza) and headache. Effects initially seen in the first six months
`
`of treatment (i.e. first dose heart rate reduction, increase in blood pressure, alteration in liver
`
`function, mild increase in airway resistance) did not appear to progress with continued dosing
`
`beyond six months. There were also no unexpected safety findings during the extension
`
`phase compared to the six—month placebo—controlled phase. All patients in the extension
`
`study are now continuing with the 1.25 mg dose since both the 5 mg dose, which had a
`
`higher rate of adverse events, and 1.25 mg doses were equally effective in reducing disease
`
`activity.
`
`Phase II study design
`
`and Canada). In the initial, placebo—controlled part of this study, 281 patients were randomized
`
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`
`' ()  
` #(
`)     * +(
` ,
`
`The results are from a large Phase II study conducted at 32 centers in 11 countries (Europe
`
`in equal numbers to receive either placebo, 1.25 mg or 5 mg of FTY720 orally once—daily for
`
`six months. The study evaluated the effect of FTY720 on disease activity as measured by MRI
`
`and clinical relapses as well as its tolerability and safety. After six months, patients had the
`
`option to enter the extension phase evaluating the longer—term effects. Patients in the
`
`placebo group were re—randomized to receive either 1.25 mg or 5 mg, while patients already
`
`on FTY720 continued their originally—assigned treatment. Having completed the 12 month
`
`time point, the 5 mg dose arm was discontinued and patients previously receiving this dose
`
`were continuing in the study on a dose of 1.25mg.
`
`Analysis of the 24—month data is expected to be presented at a key neurological congress in
`
`the second half of 2006.
`
`Phase III study program
`
`Novartis has initiated its first Phase III pivotal study called "FREEDOMS" (Fingolimod Research
`
`Evaluating Effects of Daily Oral therapy in Multiple Sclerosis). The 24—month, randomized,
`
`double—blind, placebo—controlled FREEDOMS study will include more than 1,000 patients with
`
`relapsing—remitting MS between age 18—55. Study participants will be equally randomized to
`
`either receive either 1.25 mg or 0.5 mg of FTY720 or placebo once daily for up to 24 months.
`
`This study has begun enrolling patients in several European countries. Novartis is currently in
`
`discussions with the US Food and Drug Administration (FDA) on Phase III initiation in the US.
`
`"Oral fingolimod has a novel mode of action different from all available MS therapies. If the
`
`https://www.medicalnewstoday.com/releases/41281.php
`
`2/6
`
`

`

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`11/13/2017
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`FTY720 For Relapsing Multiple Sclerosis - Phase II Data Shows Sustained Efficiency And Good Tolerability
`
`any indications or labeling in any market. Nor can there be any guarantee of potential future
`
`sales of fingolimod. Neither can there be any guarantee regarding the long—term impact of a
`
`patient's use of fingolimod. In particular, management's expectations regarding fingolimod
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`could be affected by, among other things, unexpected clinical trial results, including new
`
`clinical trial results and additional analysis of existing results; unexpected regulatory actions
`
`or delays or government regulation generally; Novartis' ability to obtain or maintain patent or
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`other proprietary intellectual property protection; competition in general; government,
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`industry and general public pricing pressures, and other risks and factors referred to in
`
`Novartis AG's current Form 20—F on file with the US Securities and Exchange Commission.
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`Should one or more of these risks or uncertainties materialize, or should underlying
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`assumptions prove incorrect, actual results may vary materially from those anticipated,
`
`believed, estimated or expected. Novartis is providing the information in this press release as
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`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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`About Novartis
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`Novartis has been a leader in the neuroscience area for more than 50 years, having
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`pioneered early breakthrough treatments for Alzheimer's disease, Parkinson's disease,
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`attention deficit/hyperactivity disorder, epilepsy, schizophrenia and migraine. Novartis
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`continues to be active in the research and development of new compounds, is committed to
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`addressing unmet medical needs and to supporting patients and their families affected by
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`these disorders.
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`Novartis AG (NYSE: NVS) is a world leader in offering medicines to protect health, treat
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`disease and improve well—being. Our goal is to discover, develop and successfully market
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`the only company with leadership positions in both patented and generic pharmaceuticals.
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`We are strengthening our medicine—based portfolio, which is focused on strategic growth
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`platforms in innovation—driven pharmaceuticals, high—quality and low—cost generics and
`
`leading self—medication OTC brands. In 2005, the Group's businesses achieved net sales of
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`USD 32.2 billion and net income of USD 6.1 billion. Approximately USD 4.8 billion was
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`invested in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ
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`approximately 91,000 people and operate in over 140 countries around the world. For more
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`information, please visit http://www.novartis.com.
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`
`References
`
`1 Multiple Sclerosis International Federation
`
`https://www.medicalnewstoday.com/releases/41281.php
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`4/6
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`11/13/2017
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`FTY720 For Relapsing Multiple Sclerosis - Phase II Data Shows Sustained Efficiency And Good Tolerability
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`(http://www.msif.org/en/ms_the_disease/quick_facts.html)
`
`2 A relapse refers to the appearance of new symptoms or the aggravation of old ones, lasting
`
`for at least 24 hours.
`
`3 PRISMS study group. Randomised double—blind placebo—controlled study of interferon beta—
`
`1a in relapsing—remitting multiple sclerosis. The Lancet 1998; Vol 352: 1498—1504.
`
`4 LD Jacobs et al. Intramuscular Interferon beta—1a for disease progression in relapsing
`
`multiple sclerosis. Ann Neurol 1996, 39: 285—294.
`
`5 IFNB Multiple Sclerosis Study Group. Interferon beta—1b is effective in relapsing—remitting
`
`multiple sclerosis. I. Clinical results of a multicenter, randomized, double—blind, placebo—
`
`controlled trial. Neurology 1993; 43: 655—661.
`
`6 K.P. Johnson et al. Copolymerl reduces relapse rate and improves disability in relapsing—
`
`trial. Neurology 1995; 45: 1268—1276.
`
`7 Multiple Sclerosis International Federation
`
`(http://www.msif.org/en/ms_the_disease/index.html) 8 Weinshenker 86. Natural history of
`
`multiple sclerosis. Ann Neurol 1994,36: S6—SII.
`
`http://www.novartis.com
`
`References
`
`Additional information
`
`remitting multiple sclerosis: Results ofa phase III multicenter, double—blind, placebo—controlled
`
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`Visit our Multiple Sclerosis category page for the latest news on this subject, or sign up to our newsletter to receive the
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`Citations
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`Please use one of the following formats to cite this article in your essay, paper or report:
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`11/13/2017
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`FTY720 For Relapsing Multiple Sclerosis - Phase II Data Shows Sustained Efficiency And Good Tolerability
`
`MLA
`
`Chavez, Daniel. "FTY720 For Relapsing Multiple Sclerosis - Phase II Data Shows Sustained Efficiency And Good
`
`Tolerability." Medical News Today. MediLexicon, |nt|., 10 Apr. 2006. Web.
`
`13 Nov. 2017. <https://www.medica|newstoday.com/re|eases/41281.php>
`
`APA
`
`Chavez, D. (2006, April 10). "FTY720 For Relapsing Multiple Sclerosis - Phase II Data Shows Sustained Efficiency And Good
`
`Tolerability." Medical News Today. Retrieved from
`
`https://www.medica|newstoday.com/re|eases/41281.php.
`
`Please note: If no author information is provided, the source is cited instead.
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