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20.01.2020 15:31:54

Press Release: Novartis announces EU approval of -2-

a single clinical event suggestive of MS.

In the US, the Sandoz Division of Novartis markets Glatopa(R)

(glatiramer acetate injection) 20mg/mL and 40mg/mL, generic versions of

Teva's glatiramer acetate.


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*Clinically isolated syndrome (CIS) is defined as a first episode of

neurologic symptoms that lasts at least 24 hours and is caused by

inflammation or demyelination in the central nervous system(18).

As measured by prolonged time to wheelchair dependence for patients with

SPMS by an average of 4.3 years versus placebo.


1. National MS Society Brochure. Disease Modifying Therapies for MS.


Accessed January 2020.

2. Kappos L, Cree B, Fox R, et al. Siponimod versus placebo in

secondary progressive multiple sclerosis (EXPAND): a double-blind,

randomized, phase 3 study. Lancet. Published online March 22, 2018.


3. Mayzent(R) (siponimod) Summary of Product Characteristics.

Novartis International AG. January 2020.

4. Multiple Sclerosis International Federation. Atlas of MS 2013.

http://www.msif.org/wp-content/uploads/2014/09/Atlas-of-MS.pdf. Accessed

January 2020.

5. Gold R, Kappos L, Bar-Or A, et al. Efficacy of Siponimod in

Secondary Progressive Multiple Sclerosis Patients With Active Disease:

The EXPAND Study Subgroup Analysis. P750. 35th Congress of the European

Committee for Treatment and Research in Multiple Sclerosis, September


6. Gergely P, Nuesslein-Hildesheim B, Guerini D, et al. The selective

sphingosine 1-phosphate receptor modulator BAF312 redirects lymphocyte

distribution and has species-specific effects on heart rate. Brit J

Pharm. 2012; 167:1035-47.

7. Tavares A, Barret O, Alagille D, et al. Brain distribution of

MS565, an imaging analogue of siponimod (BAF312), in non-human primates.

Eur J Neurol. 2014;21(Suppl 1):504-PP2067.

8. Briard E, Rudolph B, Desrayuad S, et al. MS565: A SPECT tracer of

evaluating the brain penetration of BAF312 (siponimod). Chem Med Chem.

2015; 10(6):1008-18.

9. Bigaud M, Perdoux J, Ramseier P et al.

Pharmacokinetic/Pharmacodynamic Characterization of Siponimod (BAF312)

in Blood versus Brain in Experimental Autoimmune Encephalomyelitis Mice.

Neurology. 2019;P2.2-066.

10. Mannioui A, Vauzanges Q, Fini JB, et al. The Xenopus tadpole: An in

vivo model to screen drugs favoring remyelination. Mult Scler.


11. Martin E, Urban B, Beerli C, et al. Siponimod (BAF312) is a potent

promyelinating agent: preclinical mechanistic observation. P1376. 35th

Congress of the European Committee for Treatment and Research in

Multiple Sclerosis, September 2019.

12. Dietrich M, Hecker C, Ramseier P, et al. Neuroprotective potential

for siponimod (BAF312) revealed by visual system readouts in a model of

experimental autoimmune encephalomyelitis-optic neuritis (EAEON). P844.

35th Congress of the European Committee for Treatment and Research in

Multiple Sclerosis, September 2019.

13. Vermersch P, Gold R, Kappos L, et al. Siponimod Delays the Time to

Wheelchair in Patients with SPMS: Results from the EXPAND study. 35th

Congress of the European Committee for Treatment and Research in

Multiple Sclerosis (ECTRIMS), September 2019.

14. National Multiple Sclerosis Society. Definition of MS.

https://www.nationalmssociety.org/What-is-MS/Definition-of-MS. Accessed

January 2020.

15. MS Society. Types of MS.

https://www.mssociety.org.uk/what-is-ms/types-of-ms. Accessed January


16. National Multiple Sclerosis Society. Secondary Progressive MS



Accessed January 2020.

17. Hauser S. Efficacy and safety of ofatumumab versus teriflunomide in

relapsing multiple sclerosis: results of the phase 3 ASCLEPIOS I and II

trials. Oral presentation. ECTRIMS 2019.

18. National MS Society. Clinically Isolated Syndrome (CIS).


Accessed January 2020.

# # #

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Antonio Ligi Michael Amos

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(END) Dow Jones Newswires

January 20, 2020 09:32 ET (14:32 GMT)