Novartis oral multiple sclerosis development compound Gilenia®* (FTY720) granted US priority review status
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Novartis International AG / Novartis oral multiple sclerosis development compound Gilenia®* (FTY720) granted US priority review status processed and transmitted by Hugin AS. The issuer is solely responsible for the content of this announcement.
* US Food and Drug Administration grants priority review status after
accepting US regulatory submission for 0.5 mg once-daily Gilenia
(fingolimod)
* US and European Union regulatory submissions completed in December 2009 for
Gilenia include more than 4,000 patient years of clinical trial data
Basel, February 22, 2010 - Gilenia®* (FTY720, fingolimod) has been granted
priority review status by the US Food and Drug Administration (FDA), which
accepted the regulatory submission made in December 2009 for this medicine.
Once-daily Gilenia (0.5 mg) has the potential to become the first approved oral
therapy for the treatment of multiple sclerosis (MS).
The FDA grants priority reviews for investigational medicines that could offer
significant advances beyond current treatments or where no adequate therapy
exists. As a result of this designation, the standard 10-month FDA review period
will be reduced to six months.
Since Gilenia involves a new active ingredient (New Molecular Entity), the FDA
is likely to require an Advisory Committee meeting and evaluate the risk
management program, which could result in the FDA extending its review at the
end of the six-month period in June 2010.
"We welcome the decision granting priority review to Gilenia, 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."
Approximately 4,000 patient years of experience have been gained in MS clinical
studies involving Gilenia, with some patients now in their sixth year of
treatment. Data from one of the largest-ever Phase III clinical trial programs
conducted in MS patients were submitted to support the US and European
regulatory submissions, including results of the TRANSFORMS and FREEDOMS studies
that were recently published inThe New England Journal of Medicine[1],[2].
Combined data from these studies provided evidence of the efficacy of Gilenia in
reducing relapses, disability progression and brain lesions in patients with the
relapsing-remitting form of MS as well as safety data. Approximately 85% of
patients with MS are estimated to have the relapsing form at the onset of
disease[3].
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology such as "priority review," "potential," "could," "will,"
"likely," or similar expressions, or by express or implied discussions regarding
potential marketing approvals for Gilenia, or the potential timing of such
approvals, or regarding potential future revenues from Gilenia. 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 Gilenia to be materially different from any future results,
performance or achievements expressed or implied by such statements. There can
be no guarantee that Gilenia will be approved for sale in any market, or at any
particular time. Nor can there be any guarantee that Gilenia will achieve any
particular levels of revenue in the future. In particular, management's
expectations regarding Gilenia 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
ExchangeCommission. 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 visithttp://www.novartis.com.
The brand name Gilenia has been provisionally approved by the FDA for use in
connection with the product, but the product itself has not received marketing
authorization or NDA approval from any regulatory authorities.
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/ind
ex.aspx. Accessed January, 2010.
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