Novartis receives FDA breakthrough therapy designation for BYM338 (bimagrumab) for sporadic inclusion body myositis (sIBM)
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Novartis International AG /
Novartis receives FDA breakthrough therapy designation for BYM338 (bimagrumab)
for sporadic inclusion body myositis (sIBM)
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The issuer is solely responsible for the content of this announcement.
* Designation highlights potential of BYM338 to address an unmet medical need
in a serious disease
* If approved, BYM338 has the potential to be the first treatment for sIBM
patients
* BYM338 is the third Novartis investigational treatment this year to receive
a breakthrough therapy designation by the FDA, highlighting Novartis'
leadership in the industry in breakthrough therapy designations
Basel, August 20, 2013 - Novartis announced today that the US Food and Drug
Administration (FDA) has granted breakthrough therapy designation to BYM338 for
sporadic inclusion body myositis (sIBM).
Breakthrough therapy designation was created by the FDA to expedite the
development and review of new drugs for serious or life-threatening conditions.
This designation is based on the results of a Phase II proof-of-concept study
that showed BYM338 substantially benefited patients with sIBM compared to
placebo. The results of this study will be presented at the American
Neurological Association meeting on October 14 and is expected to be published
in a major medical journal later this year.
sIBM is a rare yet potentially life-threatening muscle-wasting condition.
Patients who have the disease can gradually lose the ability to walk, experience
falls and injuries, lose hand function, and have swallowing difficulties[1].
There are no currently approved, (or established), treatment options for
sIBM[2].
"BYM338 is the third example this year of Novartis' leadership in bringing
breakthrough therapies to patients reinforcing our commitment to innovation
addressing significant unmet medical needs and enhancing the lives of patients,"
said Timothy Wright, M.D., Global Head of Development, Novartis Pharmaceuticals.
"With no effective therapies currently available for sIBM, bimagrumab has the
potential to be the first real option for patients with this condition."
About BYM338 (bimagrumab) and the Novartis commitment to research in muscle
therapeutics
BYM338 (bimagrumab) is a novel, fully human monoclonal antibody developed to
treat pathological muscle loss and weakness. BYM338 was developed by the
Novartis Institutes for Biomedical Research (NIBR), in collaboration with
Morphosys, whose HuCAL library was used to identify the antibody. BYM338 binds
with high affinity to type II activin receptors, preventing natural ligands from
binding, including myostatin and activin. BYM338 stimulates muscle growth by
blocking signaling from these inhibitory molecules.
In addition to being developed for sIBM, BYM338 is in clinical development for
chronic obstructive pulmonary disease (COPD), cancer cachexia, sarcopenia and in
mechanically ventilated patients. BYM338 is administered by intravenous
infusion.
Breakthrough therapy designation
According to the FDA, breakthrough therapy designation is intended to expedite
the development and review of drugs that treat serious or life-threatening
conditions. The designation requires preliminary clinical evidence that
demonstrates substantial improvement over currently available therapy. The
designation includes all of the fast track program features, as well as more
intensive FDA interaction and guidance. The breakthrough therapy designation is
a distinct status from both accelerated approval and priority review, which can
also be granted to the same drug if relevant criteria are met.
About sporadic inclusion body myositis (sIBM)
sIBM is a rare disease, yet it is the most common degenerative disease of muscle
in adults older than 65 years. It is characterized by a slowly progressive,
asymmetric, atrophy and weakness of muscles. Commonly, patients become
wheelchair bound within 10 to15 years of onset. Death may occur due to injurious
falls, infection (aspiration pneumonia), or malnutrition.
Bimagrumab also was granted orphan drug designation in sIBM in both the US and
Europe in 2012.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology "breakthrough therapy", "potential", " will", "expected",
"potentially" and "commitment" or similar expressions, or by express or implied
discussions regarding potential approvals for BYM338 or regarding potential
future revenues from BYM338. 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 to be materially
different from any future results, performance or achievements expressed or
implied by such statements. There can be no guarantee that BYM338 will be
approved for sale in any market, or at any particular time. Nor can there be any
guarantee that BYM348 will achieve any particular levels of revenue in the
future. In particular, management's expectations regarding BYM338 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; unexpected
manufacturing issues; 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 innovative healthcare solutions that address the evolving
needs of patients and societies. Headquartered in Basel, Switzerland, Novartis
offers a diversified portfolio to best meet these needs: innovative medicines,
eye care, cost-saving generic pharmaceuticals, preventive vaccines and
diagnostic tools, over-the-counter and animal health products. Novartis is the
only global company with leading positions in these areas. In 2012, the Group
achieved net sales of USD 56.7 billion, while R&D throughout the Group amounted
to approximately USD 9.3 billion (USD 9.1 billion excluding impairment and
amortization charges). Novartis Group companies employ approximately 131,000
full-time-equivalent associates and operate in more than 140 countries around
the world. For more information, please visit http://www.novartis.com.
Novartis is on Twitter. Sign up to follow (at)Novartis at
http://twitter.com/novartis.
References
[1] Engel & Askanas, Inclusion-body myositis: Clinical, diagnostic, and
pathologic aspects, Neurology 2006;66(Suppl 1):S20-S29
[2] Griggs, The current status of treatment for inclusion-body myositis,
Neurology 2006;66(Suppl 1):S30-S32
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Datum: 20.08.2013 - 07:16 Uhr
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News-ID 289091
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