Novartis presents new data at EULAR and WCD further demonstrating its leadership in severe long-term inflammatory and skin conditions
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Novartis International AG /
Novartis presents new data at EULAR and WCD further demonstrating its leadership
in severe long-term inflammatory and skin conditions
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* New one-year data for secukinumab, the first IL-17A inhibitor to show
significant improvement in ankylosing spondylitis (AS) signs and symptoms,
to be presented at European League Against Rheumatism meeting (EULAR)
* Cosentyx(TM) (secukinumab) data to be revealed in patients with difficult-
to-treat psoriasis of the palms, soles and nails at World Congress of
Dermatology (WCD)
* Late-breaking results at WCD include the impact of Xolair(®) (omalizumab) on
quality of life in patients with Chronic Spontaneous Urticaria (CSU)
Basel, Switzerland, June 2, 2015 - Novartis announced today that important new
data will be presented on secukinumab in ankylosing spondylitis (AS) at the
forthcoming European League Against Rheumatism 2015 Annual Scientific Meeting
(EULAR), from 10-13 June in Rome, Italy. Additionally, new data on Cosentyx(TM)
(secukinumab) in difficult-to-treat psoriasis of the palms, soles and nails, and
on Xolair(®) (omalizumab) in Chronic Spontaneous Urticaria, will be presented at
the 23(rd) World Congress of Dermatology (WCD), from 8-13 June in Vancouver,
Canada. In total there will be 5 oral presentations and 32 posters from
Novartis at these leading congresses.
"Patients with long-term inflammatory joint and skin conditions are too often
living with debilitating physical and psychological effects of their disease,"
said Vasant Narasimhan, Global Head of Development, Novartis Pharmaceuticals.
"We are excited to present further new data on secukinumab for ankylosing
spondylitis, Cosentyx in psoriasis of the palms, soles and nails, and Xolair in
Chronic Spontaneous Urticaria to address the significant unmet needs for these
patients."
At the EULAR congress, data from the pivotal Phase III MEASURE 2 study will
demonstrate that secukinumab improves the signs and symptoms of AS disease
activity through one year of treatment, confirming previous one-year data from
the MEASURE 1 study. AS is a long-term, painful and progressively debilitating
inflammatory disease that leads to excessive formation of new bone, particularly
in the joints of the spine, which can fuse together.[1]-[3] There are limited
therapeutic options available to people with AS and there is a significant unmet
need for new treatment options.[4]
Highlights of dermatology data at WCD include results of Cosentyx in difficult-
to-treat and debilitating types of psoriasis of the palms and soles
(palmoplantar), and nails. Palmoplantar and nail psoriasis have a more severe
impact on patients than psoriasis that is limited to other parts of the
body.[5],[6] Results showing quality of life improvements in Xolair-treated
patients with Chronic Spontaneous Urticaria (CSU), a condition characterized by
persistent itching, swelling and rash, and which is known as Chronic Idiopathic
Urticaria (CIU) in the US and Canada, will also be presented at the congress.
Xolair is the first and only therapy approved to treat CSU patients with
inadequate responses to H1-antihistamines.[7]
Cosentyx is the approved brand name for secukinumab in psoriasis. Secukinumab is
not currently approved in AS or psoriatic arthritis (PsA).
Dermatology presentations at WCD 2015
* Late-breaking oral presentations:
* Evidence of improvements in CSU patients' quality of life with Xolair
(omalizumab) (Thursday 11 June, 8:35 PDT / 17:35 CET and 8.55 PDT /
17.55 CET)
* Oral presentations:
* Pivotal Phase III study of Cosentyx (secukinumab) efficacy and safety in
moderate-to-severe palmoplantar psoriasis patients (Thursday 11 June,
14:35 PDT / 23:35 CET)
* Highlights of electronic posters available throughout the congress:
* Late-breaking: Secukinumab effective in patients with nail psoriasis:
16 week results from the TRANSFIGURE study
* New results reporting CSU patients' clinical characteristics and
treatment patterns, and CSU impact on quality of life, use of medical
services and work productivity
AS and PsA presentations at EULAR 2015
* Oral presentations:
* Secukinumab significantly improves signs and symptoms of active
ankylosing spondylitis: 52-week data from MEASURE 2, a randomized,
double-blind, placebo-controlled Phase 3 trial with subcutaneous loading
and maintenance dosing (Friday 12 June, 10:35 CET)
* Anti-IL-17A treatment blocks inflammation and new bone formation in
experimental SpA in HLA-B27 transgenic rats (Friday 12 June, 10:50 CET)
* Highlights of posters available at the congress:
* MEASURE 1: Secukinumab provided rapid and sustained reductions in spinal
inflammation in patients with active AS
* FUTURE 2: Secukinumab improved signs and symptoms of psoriatic arthritis
in both anti-TNF-naive and anti-TNF-IR patients
* FUTURE 1: Sustained inhibition of radiographic disease progression with
secukinumab in patients with PsA
About Novartis in Immunology & Dermatology
Novartis is committed to developing innovative, life-changing therapies,
redefining treatment paradigms and transforming patient care in immunology and
dermatology where there are remaining high unmet medical needs. The Novartis
immunology and dermatology portfolio includes Cosentyx(TM) (secukinumab), which
is approved for moderate-to-severe plaque psoriasis and is in Phase III
development for AS and PsA; Xolair(®) (omalizumab), which is approved for CSU
and specific forms of allergic asthma; and sonidegib for advanced basal cell
carcinoma. In the US, Xolair for subcutaneous use in appropriate allergic asthma
patients is co-promoted by Novartis Pharmaceuticals Corporation and Genentech,
Inc.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by words such as "to be presented," "to be revealed," "will," "forthcoming,"
"can," "excited," "not currently," "committed," or similar terms, or by express
or implied discussions regarding potential new indications or labeling for
Cosentyx (secukinumab) or Xolair (omalizumab), regarding potential marketing
approvals for sonidegib, or regarding potential future revenues from the
products and development projects in the Novartis immunology and dermatology
portfolio, including Cosentyx, Xolair and sonidegib. You should not place undue
reliance on these statements. Such forward-looking statements are based on the
current beliefs and expectations of management regarding future events, and are
subject to significant known and unknown risks and uncertainties. Should one or
more of these risks or uncertainties materialize, or should underlying
assumptions prove incorrect, actual results may vary materially from those set
forth in the forward-looking statements. There can be no guarantee that Cosentyx
or Xolair will be submitted or approved for any additional indications or
labeling in any market, or at any particular time. Neither can there be any
guarantee that sonidegib will be submitted or approved for sale in any market,
or at any particular time. Nor can there be any guarantee that any of the
products and development projects in the Novartis immunology and dermatology
portfolio will be commercially successful in the future. In particular,
management's expectations regarding such products and development projects could
be affected by, among other things, the uncertainties inherent in research and
development, including unexpected clinical trial results and additional analysis
of existing clinical data; unexpected regulatory actions or delays or government
regulation generally; the company's ability to obtain or maintain proprietary
intellectual property protection; general economic and industry conditions;
global trends toward health care cost containment, including ongoing pricing
pressures; unexpected manufacturing issues, and other risks and factors referred
to in Novartis AG's current Form 20-F on file with the US Securities and
Exchange Commission. 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 and cost-saving generic pharmaceuticals. Novartis is the only global
company with leading positions in these areas. In 2014, the Group achieved net
sales of USD 58.0 billion, while R&D throughout the Group amounted to
approximately USD 9.9 billion (USD 9.6 billion excluding impairment and
amortization charges). Novartis Group companies employ approximately 120,000
full-time-equivalent associates. Novartis products are available in more than
180 countries around the world. For more information, please visit
http://www.novartis.com.
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References
[1] American College of Rheumatology (ACR) website. "Spondylarthritis
(Spondylarthropathy)."
http://www.rheumatology.org/Practice/Clinical/Patients/Diseases_And_Conditions/S
pondylarthritis_(Spondylarthropathy)/. Accessed May 2015.
[2] Lories R. The balance of tissue repair and remodeling in chronic
arthritis. Nat Rev Rheumatol. 2011;7:700-07.
[3] Barkham N, Kong KO, & Tennant A. The unmet need for anti-tumour necrosis
factor (anti-TNF) therapy in ankylosing spondylitis. Rheumatology.
2005;44:1277-81.
[4] Dougados M, Baeten D. Spondyloarthritis. Lancet. 2011; 377:2127-37.
[5] Radtke MA, Langenbruch AK, Schafer I et al. Nail psoriasis as a severity
indicator: results from the PsoReal study. Patient Relat Outcome Meas.
2011;2:1-6
[6] Pettey AA, Balkrishnan R, Rapp et al. Patients with palmoplantar psoriasis
have more physical disability and discomfort than patients with other forms of
psoriasis: implications for clinical practice. J Am Acad Dermatol. 2003;49(2)
:271-275.
[7] Xolair Summary of Product Characteristics.
https://www.medicines.org.uk/emc/medicine/24912. Accessed May 2015
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