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Yay, for Ms families. No one understands dealing with a long term

medical issue like ASD families. So I thought I would send out this

article on a new treatment for MS that actually stops the progression

of the disease. Remember watching the MS telethon every Memoral or

was it Labor day and now they have a med that will do more then

allieve the pain but stop the diese in it tracks. This artcle helps to

see that Our day will come too!!!!!!

http://www.therapeuticsdaily.com/news/article.cfm?contentvalue=1954080 & contentty\

pe=sentryarticle & channelID=30

Novartis Oral MS Therapy FTY720 Shows Reduced Risk of Confirmed

Disability Progression as Published in New England Journal of Medicine

Canada Newswire - Jan. 21, 2010

<<

- Combined data from TRANSFORMS and FREEDOMS studies show significant

efficacy in reducing relapses, disability progression and MRI lesions

in MS

- In FREEDOMS, FTY720 0.5 mg dose reduced the risk of 3-month and

6-month confirmed disability progression by 30% and 37% over two years

versus placebo

- FTY720 clinical program provides safety experience in over 2,300 MS

patients, including some patients in their sixth year of therapy

- Robust clinical trial program strengthens potential for oral FTY720 to

be the first approved product in new therapeutic class called S1P

receptor modulators

- FTY720 0.5 mg dose submitted for regulatory approval in US and EU in

December 2009

Link to the Newsmarket.com for multimedia content

>>

BASEL, Jan. 21 /CNW/ - Results of the TRANSFORMS(1) and FREEDOMS(2)

studies, the two pivotal Phase III clinical trials with oral FTY720

(fingolimod), have been published in The New England Journal of

Medicine, providing comprehensive evidence to support the efficacy and

safety profile of this first-in-class therapy for multiple sclerosis

(MS).

The data, from one of the largest Phase III programs conducted in MS,

were included in the applications for regulatory approval submitted to

the US Food and Drug Administration (FDA) and European Medicines

Agency (EMEA) in December 2009. In both studies, two doses of FTY720

were examined (0.5 mg and 1.25 mg). Approval is sought for the lower

0.5 mg dose as the results from the studies indicate that this dose

has the most positive benefit-risk profile.

" Innovative science leading to new medicines for MS patients is badly

needed, " said Richert, MD, Executive Vice President of Research

and Clinical Programs for the US National Multiple Sclerosis Society.

" The positive results published in The New England Journal of Medicine

showing benefit of fingolimod on the clinical and MRI outcomes

assessed is very encouraging for MS patients, their families and their

physicians. "

The one-year TRANSFORMS study involving 1,292 patients showed that

oral FTY720 0.5 mg reduced relapses by 52% compared to interferon

beta-1a (Avonex®)†given by intramuscular injection, while the

reduction with FTY720 1.25 mg was 38% (both p(less than)0.001). The

two-year FREEDOMS study, involving 1,272 patients, showed that FTY720

reduced the relapse rate by 54% for the 0.5 mg dose and 60% for the

1.25 mg dose compared to placebo (both p(less than)0.001). Patients on

FTY720 0.5 mg also had a 30% lower risk of disability progression,

three month confirmed (p=0.02) and a 37% lower risk of disability

progression, six month confirmed (p=0.01) over two years compared to

placebo. Similarly, the FTY720 1.25 mg dose reduced the risk of

3-month and 6-month confirmed disability progression by 32% (p=0.02)

and 40% (p=0.006) respectively.

In both studies, treatment with FTY720 also resulted in statistically

significant reductions in brain lesion activity and reduced loss of

brain volume as measured by magnetic resonance imaging (MRI).

" The TRANSFORMS data demonstrate the efficacy of fingolimod compared

to a current standard of care. These findings may represent a real

step forward in the fight against MS, " said Cohen, MD,

TRANSFORMS study lead investigator and staff physician at the

Cleveland Clinic Mellen Center for Multiple Sclerosis Treatment and

Research in Cleveland, Ohio, USA. " Current disease-modifying therapies

for relapsing-remitting MS are administered by injection or infusion,

which may negatively affect tolerability, convenience, and compliance

for patients on these therapies. "

Professor Ludwig Kappos, MD, principal investigator for the FREEDOMS

clinical trial and Chair of Neurology and Research Group Leader in the

Department of Biomedicine at the University Hospital in Basel,

Switzerland, said: " FTY720 demonstrated clear clinical superiority

over placebo in terms of reducing relapse rates and disability

progression. The positive findings of TRANSFORMS and FREEDOMS give an

increasingly complete understanding of the efficacy and safety of

FTY720. "

Up to 2.5 million people worldwide are affected by MS, an inflammatory

and neurodegenerative condition that often begins when patients are in

the prime of their lives(3).

FTY720 has the potential to be the first approved therapy in a new

class of drugs called sphingosine 1-phosphate (S1P) receptor

modulators. These medicines reduce inflammation and may also have a

direct beneficial effect on cells in the central nervous system (CNS).

FTY720 acts selectively by retaining certain lymphocytes (a sub-group

of white blood cells) in the lymph nodes, reducing the number of

lymphocytes that reach the brain where they can cause inflammatory

destruction. This lymphocyte retention is reversible, allowing

circulating lymphocytes to regain normal levels if treatment is

stopped.

" These data demonstrate that oral FTY720 has the potential to offer an

important new treatment option for patients with MS, " said Trevor

Mundel, MD, Global Head of Development at Novartis Pharma AG. " We have

a long-term commitment to the MS community, and trust that FTY720,

once approved, will prove to be a valuable treatment option for many

people who live with this disease. "

In both TRANSFORMS and FREEDOMS, adherence to therapy was best for the

FTY720 0.5 mg and control groups compared to the 1.25 mg group. The

most commonly reported adverse events for both FTY720 and control

groups were nasopharyngitis, headache and fatigue. FTY720-related

adverse events included dose-related, transient, generally

asymptomatic heart rate reduction, infrequent transient AV conduction

block, mild (1-3 mm Hg) blood pressure increase, macular edema (more

common with 1.25 mg than the 0.5 mg target dose), and asymptomatic,

reversible elevation of liver enzymes.

The rates of infections overall, including serious infections, were

comparable between treatment groups, although a slight increase in

lung infections (primarily bronchitis) was seen in patients treated

with FTY720. The number of malignancies reported in the two studies

was small with comparable rates between the FTY720 and control groups;

malignancies were reported more frequently with FTY720 than the

control group in the one-year TRANSFORMS study but the opposite

pattern was seen in the two-year FREEDOMS study.

Serious adverse events were comparable between treatment groups,

though generally slightly higher with the 1.25 mg than 0.5 mg dose.

Overall rates of drug-related adverse events, particularly those

related to the mechanism of action, as well as discontinuations due to

adverse events, were more common with 1.25 mg than 0.5 mg.

The completed MS FTY720 studies and their extensions include more than

2,300 patients with approximately 4,000 patient-years of exposure,

including some patients now in their sixth year of treatment. Safety

is also being monitored in approximately 1,000 additional patients in

ongoing MS studies.

The publication in The New England Journal of Medicine marks the first

presentation of full results from the two studies. Top line results of

FREEDOMS and TRANSFORMS have been disclosed in Novartis press

releases, and the TRANSFORMS study has also been presented at

scientific congresses(4).

†Avonex® is a registered trademark of Biogen Idec.

Dr. Cohen conducts research and is a paid consultant for Novartis.

Disclaimer

The foregoing release contains forward-looking statements that can be

identified by terminology such as " risk, " " potential, " " encouraging, "

" may, " " can, " " commitment, " " will, " or similar expressions, or by

express or implied discussions regarding marketing approvals for

FTY720 or regarding potential future revenues from FTY720. You should

not place undue reliance on these statements. Such forward-looking

statements reflect the current views of management regarding future

events, and involve known and unknown risks, uncertainties and other

factors that may cause actual results with FTY720 to be materially

different from any future results, performance or achievements

expressed or implied by such statements. There can be no guarantee

that FTY720 will be approved for sale in any market. Nor can there be

any guarantee that FTY720 will achieve any particular levels of

revenue in the future. In particular, management's expectations

regarding FTY720 could be affected by, among other things, unexpected

regulatory actions or delays or government regulation generally;

unexpected clinical trial results, including unexpected new clinical

data and unexpected additional analysis of existing clinical data; the

company's ability to obtain or maintain patent or other proprietary

intellectual property protection; competition in general; government,

industry and general public pricing pressures; the impact that the

foregoing factors could have on the values attributed to the Novartis

Group's assets and liabilities as recorded in the Group's consolidated

balance sheet, and other risks and factors referred to in Novartis

AG's current Form 20-F on file with the US Securities and Exchange

Commission. Should one or more of these risks or uncertainties

materialize, or should underlying 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 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.

About Novartis

Novartis provides healthcare solutions that address the evolving needs

of patients and societies. Focused solely on healthcare, Novartis

offers a diversified portfolio to best meet these needs: innovative

medicines, cost-saving generic pharmaceuticals, preventive vaccines,

diagnostic tools and consumer health products. Novartis is the only

company with leading positions in each of these areas. In 2008, the

Group's continuing operations achieved net sales of USD 41.5 billion

and net income of USD 8.2 billion. Approximately USD 7.2 billion was

invested in R & D activities throughout the Group. Headquartered in

Basel, Switzerland, Novartis Group companies employ approximately

99,000 full-time-equivalent associates and operate in more than 140

countries around the world. For more information, please visit

http://www.novartis.com.

References

<<

1 Cohen J. et al. Oral Fingolimod vs. Intramuscular Interferon in

Relapsing Multiple Sclerosis. N Eng J Med. Vol.362 No.5, Feb 4, 2010

(printed version).

2 Kappos L, et al. Placebo-Controlled Study of Oral Fingolimod in

Relapsing Multiple Sclerosis. N Eng J Med. Vol.362 No.5, Feb 4, 2010

(printed version).

3 National Multiple Sclerosis Society website.

http://www.nationalmssociety.org/about-multiple-sclerosis/what-is-ms/index.aspx.

Last accessed Jan 15, 2010.

4 Cohen J. et al. Oral Fingolimod (FTY720) Versus Interferon Beta-1a in

Relapsing-Remitting Multiple Sclerosis: Results from a Phase III

Study (TRANSFORMS). Slide deck associated with Oral Presentation

at the

American Academy of Neurology Annual Meeting 2009. (S21.004).

>>

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