Healthcare Industry News:  Novartis Pharma AG 

Biopharmaceuticals Neurology FDA

 News Release - February 22, 2010

FDA Acknowledges Need for Daily Multiple Sclerosis Pill by Granting Fingolimod Priority Review Status

Developed for UK Consumer and Medical Journalists

FRIMLEY, England, February 22, 2010 -- (Healthcare Sales & Marketing Network) -- Fingolimod, an investigational daily multiple sclerosis (MS) pill, has achieved priority review by the Food and Drug Administration (FDA). Following submission of a new drug application (NDA) in December 2009, the US regulatory body has, for the first time, granted priority review of an oral MS drug. Fingolimod has the potential to answer an unmet clinical need.

Priority review, granted to medicines with high unmet need or in areas with inadequate available treatments, means that the review time will be six months instead of ten. It is hoped fingolimod will be available in the US this year. Fingolimod was submitted for European review at the end of 2009.

"We welcome the decision granting priority review to fingolimod, which underscores the potential benefits of this medicine to patients," said Trevor Mundel, MD., Global Head of Development at Novartis Pharma AG. "MS is a leading cause of neurological disability in young adults, particularly in women, and this medicine has the potential to offer real advances in the care of people with MS."

The submission was based on positive data for fingolimod, which was recently published in the New England Journal of Medicine (NEJM). Data from the Phase III pivotal studies, FREEDOMS and TRANSFORMS, confirm the significant efficacy of fingolimod in reducing relapses and disability progression in patients with relapsing-remitting MS - the most common form of the disease.[1,2,3]

Fingolimod has a well-studied safety profile, with over 5,300 patient years of exposure.[4] The fingolimod MS study programme includes more than 4,000 patient years of exposure, with some patients in the sixth year of therapy, making it the largest Phase III clinical trial programme ever conducted in MS.[4,5] This robust clinical trial programme strengthens the potential for fingolimod to be the first approved product in a new therapeutic class called S1P receptor modulators.[6]

As stated in the NEJM, an available oral treatment option for patients with MS is highly desirable to improve convenience, diminish side effects and improve compliance. Fingolimod's novel mode of action also means that its suppressive effect on the immune system can be reversed if treatment is stopped, allowing circulating lymphocytes to regain normal levels within weeks.[1,7,8]

Disclaimer

The foregoing release contains forward-looking statements that can be identified by terminology such as "priority review," "could," "potential," "will," "anticipates," or similar expressions, or by express or implied discussions regarding potential marketing approvals for fingolimod, or the potential timing of such approvals, or regarding potential future revenues from fingolimod. 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 fingolimod to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that fingolimod will be approved for sale in any market, or at any particular time. Nor can there be any guarantee that fingolimod will achieve any particular levels of revenue in the future. In particular, management's expectations regarding fingolimod 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; competition in general; government, industry and general public pricing pressures; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; 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 these areas. In 2009, the Group's continuing operations achieved net sales of USD 44.3 billion, while approximately USD 7.5 billion was invested in R&D activities throughout the Group. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 100,000 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 2010, 362 (5) 402-415.

2. Kappos L, et al. Placebo-Controlled Study of Oral Fingolimod in Relapsing Multiple Sclerosis. N Eng J Med 2010, 362 (5) 387-401.

3. http://www.mstrust.org.uk/information/aboutms/types.jsp. Last accessed 17 February 2010.

4. Novartis. Data on file.

5. Novartis. Data on file.

6. Foster CA et al. Brain penetration of the oral immunomodulatory drug FTY720 and its phosphorylation in the central nervous system during experimental autoimmune encephalomyelitis: consequences for mode of action in multiple sclerosis. J Pharmacol Exp Ther 2007, 323 (2) 469-76.

7. http://www.mssociety.org.uk/research/potential_therapies/fingolimod.html. Last accessed 17 February 2010.

8. http://www.mstrust.org.uk/research/drugsindevelopment/fingolimod.jsp. Last accessed 17 February 2010.

Please note that fingolimod (FTY720) is an investigational drug and has not been approved or licensed anywhere in the world (February 2010).


Source: Novartis

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