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2014-05-09

Novartis International AG: Novartis data at ARVO 2014 confirm transformational real world outcomes and highlight the safety profile of Lucentis®

Novartis International AG / Novartis data at ARVO 2014 confirm
transformational real world outcomes andhighlight the safety profile of
Lucentis® . Processed and transmitted by NASDAQ OMX Corporate Solutions.The
issuer is solely responsible for the content of this announcement.
* LUMINOUS, the largest ongoing trial in medical retina, presented 1-year
results on the effectiveness and safety profile of Lucentisin patients with
wet AMD[1]

* COMRADE-B study indicates BRVO patients treated with Lucentis had
significantly higher vision gains at month 6 compared with dexamethasone[2]

* New real-world data demonstrates significant differences in rates of
endophthalmitis with aflibercept and Lucentis[3]

Basel, May 9, 2014
-
Novartis reports that considerable data on the eye drug Lucentis®
(ranibizumab), first licensed in June 2006, have been presented at the 2014
Association for Research in Vision and Ophthalmology (ARVO) annual meeting
this week. The work spans the five indications that Lucentis is licensed for
(treatment of wet age-related macular degeneration (wet AMD), treatment of
visual impairment due to diabetic macular edema (DME), branch retinal vein
occlusion (BRVO), central retinal vein occlusion (CRVO) and myopic choroidal
neovascularization (myopic CNV)), and highlights the effectiveness and safety
profile of Lucentis through both pivotal clinical trials and real-world
observational studies.

"Lucentis has already shown proven effectiveness in reducing vision loss
across indications, and this is evident by the clinical trial findings
presented at ARVO 2014," said Dr Timothy Wright, Global Head Development,
Novartis Pharma AG. "What is key is that the efficacy and safety findings are
also reflected in the real world clinical setting. The LUMINOUS 1-year
interim results, for example, confirm the safety profile of Lucentis in
patients with wet AMD."

Lucentis ARVO highlights include:
Real-world evidence
: The LUMINOUS trial - the largest ongoing trial in medical retina to enroll
30,000 patients, is a 5-year prospective, multinational, observational study
across all approved indications of Lucentis - presented 1-year results on the
effectiveness and safety of Lucentis. Of the first 2,112 patients with wet
AMD recruited, those prior treated patients, including those with more than 6
years of Lucentis treatment, maintained their vision in the first year of the
LUMINOUS study. New Lucentis patients gained nearly a line of vision (+4.1
ETDRS letters from baseline). No new safety findings were identified[1].
[Paper session 335]

Safety profile and efficacy
: Results from the COMRADE-B study, which compared the efficacy and safety of
Lucentis and dexamethasone in patients with BRVO, were reported. Patients
treated with Lucentis (0.5 mg Lucentis intravitreal injections for 3 months
followed by PRN dosing) compared to patients treated with dexamethasone
(0.7mg implants for 6 months) had significantly higher vision gains at month
6. Both treatment groups exhibited low rates of ocular and non-ocular safety
events, although there was a nine-fold higher incidence of increased
intraocular pressure in the dexamethasone arm[2]. [Poster session 239]

Wet AMD: A retrospective cohort study of the injection number, associated
costs and endophthalmitis rate in patients who received Lucentis or
aflibercept for wet AMD in the US from November 2011 to July 2013 were
reported. The US claims data showed that there was no significant difference
between first-line Lucentis and aflibercept treatment for injection frequency
(5.02 and 5.04, respectively), ophthalmologist visits (6.08 and 5.24,
respectively) and annual costs (USD 9,894 and USD 10,288, respectively).
However there was a significantly higher rate of endophthalmitis reported in
association of aflibercept injections (0.17%) compared with Lucentis (0.08%),
adjusted odds ratio=2.70[3]. [Poster session 507 - sponsored by Genentech]

About Lucentis®(ranibizumab)
Lucentis was designed to save sight and has demonstrated transformational
efficacy with individualized dosing in its licensed indications. As an
antibody fragment with a short systemic half-life, Lucentis was specifically
designed, developed, formulated and licensed for ocular conditions, and is
manufactured to the highest standards for intra-ocular use.

Lucentis is licensed in more than 100 countries, for the treatment of wet
age-related macular degeneration (wet AMD), visual impairment due to diabetic
macular edema (DME) and for visual impairment due to macular edema secondary
to retinal vein occlusion (RVO), including both branch- and central-RVO.
Also, Lucentis is licensed in more than 60 countries, not including the US,
for the treatment of patients with visual impairment due to choroidal
neovascularization (CNV) secondary to pathologic myopia (myopic CNV). In most
countries, including those in Europe, Lucentis has an individualized
treatment regimen with the goal of maximizing visual outcomes while
minimizing under- or over-treating patients.

Lucentis has a well-established safety profile supported by 43 sponsored
clinical studies and real-world experience. Its safety profile has been well
established in a clinical development program that enrolled more than 12,500
patients across indications and there is more than 2.4 million
patient-treatment years of exposure since its launch in the United States in
2006.

Lucentis was developed by Genentech and Novartis. Genentech has the commercial
rights to Lucentis in the United States. Novartis has exclusive rights in the
rest of the world. Lucentis is a registered trademark of Genentech Inc.

Disclaimer
The foregoing release contains forward-looking statements that can be
identified by words such as "indicates," "designed to," "goal," or similar
terms, or by express or implied discussions regarding potential launches of
Lucentis in additional markets, and potential future revenues from Lucentis.
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 Lucentis 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 Lucentis will be commercially successful
in the future. In particular, management's expectations regarding Lucentis
could be affected by, among other things, unexpected regulatory actions or
delays or government regulation generally; global trends toward health care
cost containment, including ongoing pricing pressures; general economic and
industry conditions; the company's ability to obtain or maintain proprietary
intellectual property protection; the uncertainties inherent in research and
development, including unexpected clinical trial results and additional
analysis of existing clinical data; 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, cost-saving generic pharmaceuticals, preventive
vaccines, over-the-counter and animal health products. Novartis is the only
global company with leading positions in these areas. In 2013, the Group
achieved net sales of USD 57.9 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 135,000 full-time-equivalent associates and sell products in
more than 150 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] Mitchell P. Ranibizumab in the real world clinical setting: results from
the one year interim analysis of the LUMINOUS study. ARVO 2014.
[2] Hattenbach L-O. Efficacy and Safety of 0.5 mg Ranibizumab compared with
0.7 mg dexamethasone intravitreal implant in patients with branch retinal
vein occlusion over 6 months: The COMRADE-B study. ARVO 2014.
[3] Kiss S, et al. Treatment Patterns and Associated Costs of Anti-VEGF
Therapy for Neovascular Age-Related Macular Degeneration. ARVO 2014.

# # #

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