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2015-10-10

Novartis International AG: Novartis presents new data showing that the majority of patients are able to maintain clear or almost clear skin with Cosentyx acros

Novartis International AG / Novartis presents new data showing that the
majority of patients are able tomaintain clear or almost clear skin with
Cosentyx across 3 years . Processed and transmitted by NASDAQ OMX Corporate
Solutions.The issuer is solely responsible for the content of this
announcement.
* Late-breaking data at EADV show that 8 out of 10 of psoriasis patients
(83%) achieved 75% skin clearance (PASI 75) with CosentyxTMafter three
years[1]
* 6 out of 10 patients (64%) had clear or almost clear skin (PASI 90 to PASI
100) with Cosentyx 300 mg at year three[1]
* Favorable safety profile seen with no new or unexpected safety signals[1]

The digital press release with multimedia content can be accessed here:

Basel, October 10, 2015 -
Novartis announced today new late-breaking data demonstrating that
CosentyxTM(secukinumab) provides high levels of skin clearance and sustained
efficacy in patients with moderate-to-severe plaque psoriasis while
maintaining a favorable safety profile across three years[1]. The results of
this study - the longest Phase III Cosentyx trial conducted to-date - were
presented at the 24thAnnual Congress of the European Academy of Dermatology
and Venereology (EADV) in Copenhagen, Denmark. Cosentyx is the first fully
human interleukin-17A (IL-17A) inhibitor approved to treat adult
moderate-to-severe plaque psoriasis[2]-[4].

In this extension study, 320 patients received Cosentyx in a fixed dosing
schedule for three years. 69% achieved clear or almost clear skin (PASI 90)
at year one. This response was extremely well maintained after three years
with 64% of patients continuing to have a PASI 90 response. In addition, 43%
of patients maintained completely clear skin (PASI 100) at year three (from
44% at year one). 83% achieved the standard treatment goal of PASI 75 skin
clearance at three years[1].

"Psoriasis patients want therapies that maintain high levels of skin clearance
over the long-term given the impact of the disease on their physical and
psychological wellbeing," said Vasant Narasimhan, Global Head of Development,
Novartis Pharmaceuticals. "In these new data from our longest Phase III trial
to date with Cosentyx, we are pleased to show patients were able to maintain
clear or almost clear skin for up to three years."

The PASI score assesses the reduction from baseline in the redness, scaling
and thickness of psoriatic plaques and to what extent it affects each area of
the body[5],[6],[7]. PASI 75 has historically been considered the goal for
psoriasis treatment. However, with newer treatments with increased efficacy,
there is now a focus on PASI 90 (clear or almost clear skin) and PASI 100
(clear skin) as the ultimate goal for treatment, as recommended by clinical
guidelines and regulatory authorities[5].

In this study, Cosentyx had a favorable safety profile consistent with that
observed in previous Phase III studies[1],[8]-[12].

About the A2304E1 Extension Study (Cosentyx Extension Study to SCULPTURE and
STATURE studies)

A2304E1 is a multicenter, double-blind and open-label, four-year extension to
the pivotal Phase III SCULPTURE and STATURE studies. In SCULPTURE 642
patients who completed 52 weeks of treatment continued into the extension.
During the core study, PASI 75 responders at Week 12 were randomized to
double-blind maintenance treatment of subcutaneous secukinumab 300 mg or 150
mg, administered either at a four-week fixed-interval (FI) regimen (320
patients) or in a retreatment-as-needed (RAN) regimen (322 patients). At
entry into the extension, patients continued with the same blinded
maintenance treatment regimen and dose that they had received in the
SCULPTURE core study[1].

The primary objective of the extension study was to assess the long-term
safety and tolerability of Cosentyx in patients with moderate-to-severe
chronic plaque psoriasis. The secondary objective was to evaluate long-term
efficacy of 300 mg and 150 mg Cosentyx administered in retreatment-as-needed
versus fixed-interval regimens in patients who were PASI 75 responders at
Week 12. Efficacy measures included proportion of patients achieving PASI 75,
PASI 90 and PASI 100 as well as IGA mod 2011 0/1 responses[1].

About psoriasis

Psoriasis affects up to 3% of the world's population, or more than 125 million
people[5]. This common and distressing condition is not simply a cosmetic
problem, even people with very mild symptoms are affected every day[8].
According to an analysis of surveys conducted on 5,600 patients by the
National Psoriasis Foundation (NPF) between 2004 and 2011, 52% of patients
with mild, moderate and severe psoriasis were dissatisfied with their disease
management[13]. Of the patients surveyed, some were receiving no treatment
(9.4-49.2%) or were undertreated[13].

About Cosentyx (secukinumab) and interleukin-17A (IL-17A)

Cosentyx is a human monoclonal antibody that selectively neutralizes
circulating interleukin-17A (IL-17A)[14],[15]. IL-17A is found in high
concentrations in skin affected by psoriasis and is a preferred target for
investigational therapies[14]-[19]. Cosentyx works by inhibiting the action
of IL-17A, a protein found in high concentrations in skin affected by the
disease[14]-[19].

In January 2015, Cosentyx (secukinumab) (at a recommended dose of 300 mg in
the EU/US) became the first IL-17A inhibitor approved in Europe and the US.
In Europe, Cosentyx is the only first-line biologic approved for the systemic
treatment of moderate-to-severe plaque psoriasis in adult patients. In the
US, Cosentyx is approved as a treatment for moderate-to-severe plaque
psoriasis in adult patients who are candidates for systemic therapy or
phototherapy (light therapy). In addition to the EU and the US, Cosentyx has
been approved in Switzerland, Australia, Canada and a number of other
countries for the treatment of moderate-to-severe plaque psoriasis and in
Japan for the treatment of moderate-to-severe plaque psoriasis and psoriatic
arthritis (PsA). More than 9,600 patients have been treated with Cosentyx in
clinical trials across multiple indications, and over 9,000 patients have
been treated in the post-marketing setting[8]-[12],[20].

Disclaimer

The foregoing release contains forward-looking statements that can be
identified by words such as "can," "investigational," or similar terms, or by
express or implied discussions regarding potential new indications or
labeling for Cosentyx, or regarding potential future revenues from Cosentyx.
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 will be submitted or approved for any
additional indications or labeling in any market, or at any particular time.
Nor can there be any guarantee that Cosentyx will be commercially successful
in the future. In particular, management's expectations regarding Cosentyx
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 safety issues; unexpected
manufacturing or quality 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 visithttp://www.novartis.com.

Novartis is on Twitter. Sign up to follow @Novartis
athttp://twitter.com/novartis.

References

[1] Bissonnette R., et al. Secukinumab maintains high levels of efficacy
through 3 years of treatments: results from an extension to a phase 3 study
(SCULPTURE). Presented as a late breaking abstract at the European Academy of
Dermatology and Venereology 2015. October 10 2015
[2] European Medicines agency website, "Enbrel Summary of Product
Characteristics"http://www.ema.europa.eu/docs/en_GB/document_library/EPAR__Product_Infor...(link
is external). Accessed September 2015.

[3] European Medicines agency website, "Humira Summary of Product
Characteristics"http://www.ema.europa.eu/docs/en_GB/document_library/EPAR__Product_Infor...(link
is external). Accessed September 2015.

[4] European Medicines agency website, "Stelara Summary of Product
Characteristics"http://www.ema.europa.eu/docs/en_GB/document_library/EPAR__Product_Infor...(link
is external)

human/000958/WC500058513.pdf (link is external). Accessed September 2015.
[5] International Federation of Psoriasis Associations (IFPA) World Psoriasis
Day website. "About
Psoriasis."http://www.worldpsoriasisday.com/web/page.aspx?refid=114. Accessed
September 2015

[6] Mrowietz, U. Implementing treatment goals for successful long-term
management of psoriasis.Journal of the European Academy of Dermatology and
Venereology,
26:12-20. Doi: 10.1111/j. 1468-3083.2011.04411.

[7] Guideline on clinical investigation of medicinal products indicated for
the treatment of psoriasis. European Medicines Agency Web
site.http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guidelin....
Accessed September 2015.

[8] Langley RG, Elewski BE, Lebwohl M, et al. Secukinumab in Plaque Psoriasis
- Results of T...

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