New data for Novartis drug Lucentis confirms long-term efficacy and safety profile and benefits of individualized treatment
• REPAIR study shows an average of three Lucentis®
injections improve visual acuity in patients with myopic choroidal
neovascularization
• RESTORE extension study demonstrates DME patients fully
maintained initial vision gains with an average of 13.9 Lucentis
injections over three years
• Retrospective analysis reinforces Lucentis
well-characterized safety profile in wet AMD; ongoing LUMINOUSTM
program now involves over 10,000 patients
Basel, September 5, 2012 - New data for Lucentis®
(ranibizumab), the only anti-VEGF therapy licensed across three
ocular indications, show that individualized treatment with
Lucentis provides sustained improvement in vision with a low number
of injections. It is estimated that over 80% of visual impairment
is preventable when due to conditions such as wet age-related
macular degeneration (wet AMD), diabetic macular edema (DME), and
visual impairment due to macular edema secondary to retinal vein
occlusion (RVO)[1]. These conditions can eventually lead to
blindness if left untreated.
"Lucentis has become the standard of care in wet AMD and has helped
to significantly improve vision in a majority of patients with this
disease." said Tim Wright, Global Head of Development, Novartis
Pharma. "These new data confirm that an individualized treatment
approach can lead to optimal improvements in vision with a low
average number of treatments, thus ensuring that patients with
retinal diseases are not over- or under-treated. In addition, these
data add to the well-characterized safety profile of
Lucentis".
Lucentis also demonstrated benefits in visual acuity outcomes in
patients with visual impairment due to choroidal neovascularization
(CNV) secondary to pathological myopia (PM). Lucentis is currently
not approved to treat this condition. Novartis will submit for
regulatory approval in this indication in the European Union in the
third quarter of this year and in Japan by the end of 2012.
Novartis is dedicated to the research, development and
manufacturing of ophthalmic pharmaceuticals. The mission of
Novartis in the field of ophthalmology is to discover, develop and
manufacture innovative products to improve eye health and enhance
people's lives.
Lucentis study highlights at the 12th European Society of Retina
Specialists (EURETINA) Congress in Milan, Italy
include[2]-[4]:
REPAIR
This one year study performed in twelve centers in the United
Kingdom explored the efficacy and safety profile of 0.5 mg Lucentis
administered on an individualized basis in 65 patients with myopic
CNV. After six months of treatment, mean visual acuity improved by
twelve letters. Patients received an average of three Lucentis
injections with 29 % requiring no further treatment beyond the
first injection. This analysis shows that Lucentis therapy leads to
improvement in visual acuity in patients with this condition. The
six month interim results and the full one year data will be
presented at Euretina. Currently, photodynamic therapy with
Visudyne® (verteporfin) is the only approved medical treatment
for this condition.
RESTORE
In the RESTORE extension study, 240 patients with DME received
individualized treatment with Lucentis according to a regimen
consistent with the European Union label. Results showed that
patients who were originally treated with Lucentis received an
average of 13.9 injections over three years. 19-25% of patients
across all study arms did not require any Lucentis injections
during years two and three. An average of 3.7 injections in the
second year and 2.7 in the third year were sufficient to fully
maintain the mean of seven letters of visual acuity gained in the
RESTORE core study. The safety profile was consistent with previous
studies conducted in other indications. There were no cases of
endophthalmitis reported within the RESTORE core and extension
studies.
"The results of this study show that individualized treatment with
Lucentis can lead to a significant improvement in vision and that
these improvements are sustained in the long term" said Professor
Francesco Bandello, Department of Ophthalmology, Hospital San
Raffaele, University Vita Salute San Raffaele, Milan, Italy and
president elect of EURETINA. "It is important that we explore how
these insights apply to real-world clinical practice to ensure that
we are providing the best possible care for our patients".
LUMINOUS
The Luminous program is one of the largest observational studies in
ophthalmology and consists of two parts launched in 2011. The
retrospective part comprises pooled data from four European
registries of nearly 4,500 patients with wet AMD treated with
Lucentis. These data showed no new safety signals for Lucentis and
reinforces its well-characterized safety profile. The registries
revealed low incidences of key adverse events at 12-months.
Additionally, a low number of Lucentis injections were observed
during the first year. The mean number of Lucentis injections over
twelve months ranged from 4.3 to 5.0 (based on all patients) and
4.7 to 5.5 (based on patients completing one year).
The prospective part of Luminous is expected to provide important
long-term evidence on the real-world effectiveness and safety
profile of Lucentis in its licensed indications. This 5-year study
is ongoing and currently has more than 5,500 patients enrolled. It
is expected to recruit more than 30,000 patients from clinics
across Asia, Australia, Europe, North and South America.
About Lucentis® (ranibizumab)
Lucentis is a humanized therapeutic antibody fragment designed to
block all biologically active forms of vascular endothelial cell
growth factor-A (VEGF-A). Increased levels of VEGF-A are seen in
wet AMD and other ocular diseases such as diabetic macular edema
(DME) and retinal vein occlusion (RVO). Lucentis has been designed,
developed and formulated specifically for use in ocular disease
with the aim of stabilizing and improving visual acuity in these
patients, while minimizing the risk of systemic side effects.
Lucentis is licensed for the treatment of wet AMD in more than 100
countries, in more than 80 countries for the treatment of visual
impairment due to DME and in 80 countries for visual impairment due
to macular edema secondary to RVO, including both branch- and
central-RVO. In many 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.
Novartis and Alcon sponsor 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.
Lucentis has a well-characterized safety profile and Novartis
systematically monitors the safety and tolerability of Lucentis for
licensed indications on an ongoing basis. Its safety profile has
been well established in a clinical development program that
enrolled more than 10,000 patients across indications. Since its
launch in the United States in 2006, there are more than one
million patient-treatment years of exposure for Lucentis.
Serious adverse events related to the injection procedure include
endophthalmitis, retinal detachment, retinal tear and traumatic
cataract. Other serious ocular events observed among
Lucentis-treated patients included intraocular inflammation and
increased intraocular pressure. Non-eye related serious side
effects, although not common, include heart attacks, strokes and
death.
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 terminology such as "can," "ensuring," "will,"
"dedicated," "explore," "expected," "goal," 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 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 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; competition in general; government, industry and
general public pricing pressures; unexpected regulatory actions or
delays or government regulation generally; the company's ability to
obtain or maintain patent or other proprietary intellectual
property protection; 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 2011, the
Group achieved net sales of USD 58.6 billion, while approximately
USD 9.6 billion (USD 9.2 billion excluding impairment and
amortization charges) was invested in R&D throughout the Group.
Novartis Group companies employ approximately 126,000
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 @Novartis at
http://twitter.com/novartis.
References
[1] Pascolini D and Mariotti SP. Global estimates of visual
impairment: 2010. Br J Ophthalmol 2012;96:614-618.
[2] Tufail A on behalf of the REPAIR study group. The REPAIR study:
12 Month, prospective, multi-center trial of ranibizumab in
choroidal neovascularization (CNV) due to pathological myopia (PM).
EURETINA 2012.
[3] Lanzetta P on behalf of the RESTORE study group. Long-term
safety and efficacy outcome of ranibizumab 0.5 mg in patients with
visual impairment due to diabetic macular edema: the RESTORE
extension study. EURETINA 2012.
[4] Bandello F on behalf of the LUMINOUS group. Outcomes of the
retrospective pooled safety analysis of ranibizumab therapy for
neovascular age-related macular degeneration from four european
registries and update on the ongoing prospective analysis for the
LUMINOUS study. EURETINA 2012.
# # #
Novartis Media Relations
Central media line : +41 61 324 2200
Eric Althoff
Novartis Global Media Relations
+41 61 324 7999 (direct)
+41 79 593 4202 (mobile)
eric.althoff@novartis.com
Mark Grossien
Novartis Pharma Communications
+41 61 69 65780 (direct)
+41 79 489 7688 (mobile)
mark.grossien@novartis.com
e-mail: media.relations@novartis.com
For Novartis multimedia content, please visit
www.thenewsmarket.com/Novartis
For questions about the site or required registration, please
contact: journalisthelp@thenewsmarket.com.
Novartis Investor Relations
Central phone: +41 61 324 7944
Susanne Schaffert +41 61 324 7944 North America:
Pierre-Michel Bringer +41 61 324 1065 Helen Boudreau +1 212 830
2404
Thomas Hungerbuehler +41 61 324 8425 Jill Pozarek +1 212 830
2445
Isabella Zinck +41 61 324 7188 Edwin Valeriano +1 212 830
2456
e-mail: investor.relations@novartis.com
e-mail: investor.relations@novartis.com
Posted: September 2012
