New data for Novartis drug Lucentis® reinforces transformational efficacy and well-established safety profile across four indications
(Thomson Reuters ONE) -
Novartis International AG /
New data for Novartis drug Lucentis® reinforces transformational efficacy and
well-established safety profile across four indications
. Processed and transmitted by Thomson Reuters ONE.
The issuer is solely responsible for the content of this announcement.
* Pivotal myopic CNV trials with Lucentis(®) (ranibizumab) show visual
acuity improvement of nearly 14 letters with a median of two injections at
one year[1]
* New data suggest early treatment initiation with Lucentis results in better
vision gains in DME patients[2]
* Meta-analysis of 14 trials and 6504 patients confirms well-established
Lucentis safety profile reported from real-world experience and extensive
clinical trials[3]
Basel, September 27, 2013 - New clinical and real world data for Lucentis®
(ranibizumab) presented in over 40 abstracts at this week's EURETINA congress
confirm its transformational and well-established safety profile in four retinal
diseases. Designed for intraocular use, Lucentis is an antibody fragment with a
short systemic half-life and was first launched in Europe in 2007. Lucentis is
now indicated in many countries for the treatment of wet age-related macular
degeneration (wet AMD), for visual impairment due to diabetic macular edema
(DME), macular edema secondary to branch- and central-retinal vein occlusion
(BRVO and CRVO), and choroidal neovascularization secondary to pathologic myopia
(myopic CNV).
"The abundance and quality of new data presented at EURETINA, in addition to the
real-world long-term experience with Lucentis, speak to the importance of this
anti-VEGF treatment for providing vision gains to patients and affirms its role
as the standard of care in retinal medicine," said Dr Timothy Wright, Global
Head Development, Novartis Pharmaceuticals. "Further to its transformational
patient outcomes in wet AMD, DME, and RVO, Lucentis has now established its
superior efficacy in myopic CNV compared with verteporfin photodynamic therapy
as well."
Lucentis study highlights at the 13th European Society of Retina Specialists
(EURETINA) Congress in Hamburg, Germany include:
Myopic CNV: In the RADIANCE global, Phase III, 12-month study, Lucentis was
superior to current standard of care and improved mean visual acuity by around
14 letters at one year with a median of two injections[1]. [Free paper session
6] In REPAIR, a Phase II, 12-month study, a mean visual acuity gain of 13.8
letters from a low number of injections to month 12 (mean 3.6, median 3) was
demonstrated. Myopic CNV patients treated with Lucentis experienced high overall
treatment satisfaction as measured using the Macular Disease Treatment
Satisfaction Questionnaire. The overall score increased from 55.0 at month 1 to
64.9 at month 12 (p = 0.0001)[4]. [Free paper session 6]
Safety profile of Lucentis: In a meta-analysis of 14 Phase II/III trials and
6504 patients across three Lucentis licensed indications - treatment of adults
with wet AMD, visual impairment due to DME and visual impairment due to macular
edema secondary to BRVO or CRVO - the safety profile of Lucentis was reported to
be consistent with that from individual randomized, controlled clinical
trials[3]. [Free paper session 6]
The overall baseline characteristics of the first cohort of wet AMD patients
included in LUMINOUS, a global long-term study being conducted in the routine
clinical practice setting, were as expected and are representative of patients
from a real-world setting[5]. [Poster session]
DME: It was reported in the pivotal RESTORE trial that baseline visual acuity
and duration of both diabetes and DME are strong predictors of best-corrected
visual acuity (BCVA) changes over 36 months. Patients with a shorter duration of
DME had better visual acuity outcomes, which highlights the requirement for
prompt treatment initiation[2]. [Poster session]
The RELIGHT study demonstrated that switching to bimonthly follow-up after the
initial dosing maintains improvements in vision. Median visual acuity gains of
5 letters, consistent with those from RESTORE and DRCR.net studies, were
achieved with reduced monitoring frequency[6]. [Free paper session 6]
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 AMD,
visual impairment due to DME and for visual impairment due to macular edema
secondary to RVO, including both branch- and central-RVO. Also, Lucentis is
licensed in more than 30 countries for the treatment of patients with visual
impairment due to 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 extensive
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 1.7 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.
Novartis sponsors the eXcellence in Ophthalmology Vision Award (XOVA). XOVA is
an annual award launched in 2010 that provides funding to non-profit initiatives
and projects that will have a positive impact on improving the quality of eye
care and make a significant impact in addressing unmet needs in the fields of
ophthalmology and optometry.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology such as "suggest," "being conducted," "will," or similar
expressions, or by express or implied discussions regarding potential new
indications or labeling for Lucentis or regarding potential future revenues from
Lucentis. 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 Lucentis to be materially different from any
future results, performance or achievements expressed or implied by such
statements. There can be no guarantee that Lucentis will be approved for any
additional indications or labeling in any market. Nor can there be any guarantee
that Lucentis will achieve any particular levels of revenue in the future. In
particular, management's expectations regarding Lucentis could be affected by,
among other things, unexpected clinical trial results, including unexpected new
clinical data and unexpected additional analysis of existing clinical data;
unexpected regulatory actions or delays or government regulation generally; 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] Wolf S. RADIANCE: Ranibizumab versus verteporfin photodynamic therapy in the
treatment of visual impairment due to myopic choroidal neovascularization.
EURETINA 2013.
[2] Mitchell P et al. Baseline predictors of 3-year responses to ranibizumab and
laser therapy in patients with visual impairment due to diabetic macular edema -
the RESTORE study predictors analysis. EURETINA 2013.
[3] Korobelnik JF et al. Safety profile of intravitreal ranibizumab in age-
related macular degeneration, diabetic macular edema and retinal vein occlusion:
A meta-analysis of 14 phase II/III clinical trials. EURETINA 2013.
[4] Amoaku W et al. Impact of ranibizumab treatment on patient-reported outcomes
for individuals with myopic choroidal neovascularization participating in the
REPAIR study. EURETINA 2013.
[5] Holz F. LUMINOUS: Ranibizumab in routine clinical practice - baseline
characteristics of the first cohort of patients from the prospective part of the
multinational study. EURETINA 2013.
[6] Pearce I. RELIGHT- ranibizumab treatment of diabetic macular oedema (DMO)
with bimonthly monitoring after initial treatment. EURETINA 2013.
# # #
Novartis Media Relations
Central media line : +41 61 324 2200
Eric Althoff Mark Grossien
Novartis Global Media Relations Novartis Pharma Communications
+41 61 324 7999 (direct) +41 61 69 65780 (direct)
+41 79 593 4202 (mobile) +41 79 489 7688 (mobile)
eric.althoff(at)novartis.com mark.grossien(at)novartis.com
e-mail: media.relations(at)novartis.com
For Novartis multimedia content, please visit www.thenewsmarket.com/Novartis
For questions about the site or required registration, please
contact: journalisthelp(at)thenewsmarket.com.
Novartis Investor Relations
Central phone: +41 61 324 7944
Samir Shah +41 61 324 7944 North
America:
Pierre-Michel +41 61 324 1065 Stephen +1 862 778 8301
Bringer Rubino
Thomas +41 61 324 8425 Jill +1 212 830 2445
Hungerbuehler Pozarek
Isabella Zinck +41 61 324 7188
e-mail: investor.relations(at)novartis.com e-
mail: investor.relations(at)novartis.com
Media release (PDF):
http://hugin.info/134323/R/1731649/578982.pdf
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Novartis International AG via Thomson Reuters ONE
[HUG#1731649]
Unternehmensinformation / Kurzprofil:
Bereitgestellt von Benutzer: hugin
" alt="Arrowstar Receives Approval for Drilling ProgramDatum: 27.09.2013 - 07:15 Uhr
Sprache: Deutsch
News-ID 300792
Anzahl Zeichen: 13811
contact information:
Town:
Basel
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 272 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"New data for Novartis drug Lucentis® reinforces transformational efficacy and well-established safety profile across four indications"
steht unter der journalistisch-redaktionellen Verantwortung von
Novartis International AG (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
