New data among 200 Lucentis® abstracts at ARVO show low number of injections with Novartis drug required to achieve and maintain vision gains over 3 years in AMD and DME patients
(Thomson Reuters ONE) -
Novartis International AG /
New data among 200 Lucentis® abstracts at ARVO show low number of injections
with Novartis drug required to achieve and maintain vision gains over 3 years in
AMD and DME patients
. Processed and transmitted by Thomson Reuters ONE.
The issuer is solely responsible for the content of this announcement.
* Data from key studies highlight the value of individualized therapy and
reinforce Lucentis (ranibizumab) well-characterized long-term efficacy and
safety profile
* RESTORE extension study in DME patients shows mean of 3.7 and 2.7 Lucentis
injections required in years two and three, respectively, to maintain vision
gains from core study
* Swiss retrospective study shows mean 8 letter VA gain sustained in wet AMD
patients using individualized Lucentis dosing with mean of 16 Lucentis
injections over 3 years
* Nearly 4,500 patients in retrospective part of LUMINOUS(TM) observational
trial confirm safety profile of Lucentis
Basel, May 10, 2012 - Research on Lucentis® (ranibizumab) is highlighted in more
than 200 abstracts this week at the 2012 Association for Research in Vision and
Ophthalmology (ARVO) annual meeting. Lucentis research across multiple retinal
disease areas continues to further advance our understanding of the long-term
efficacy and safety profile of Lucentis as well as the benefits of an
individualized treatment regimen.
"The research presented on Lucentis this week at ARVO highlights the benefit of
an individualized approach to treating patients rather than a fixed, inflexible
regimen," said Tim Wright, Global Head of Development, Novartis Pharma. "With an
individualized 'as needed' dosing regimen, the goal is for patients to achieve
and maintain maximum vision gains without undergoing more injections than
necessary, which brings benefit to the patient and economic value to the health
system. Several studies presented at ARVO demonstrate how successful an
individualized Lucentis treatment approach can be for patients with wet AMD and
DME."
Lucentis ARVO highlights include:
The RESTORE extension study: In RESTORE, patients with diabetic macular edema
(DME) were treated with Lucentis 0.5 mg (monotherapy or combined with laser) or
laser alone for a duration of 12 months. Lucentis-treated patients received a
mean of seven injections and, on average, achieved a gain in vision of seven
letters at one year[1]. Of the 303 patients who completed the core RESTORE, 240
entered the extension study, all of whom were eligible for individualized
treatment with Lucentis according to a regimen consistent with the European
Union label. Results showed that an average of 3.7 injections in the second year
and 2.7 in the third year of treatment were sufficient to fully maintain the
mean visual acuity gained in the core study[2],[3]. The safety profile was
consistent with previous studies across different indications. There were no
cases of endophthalmitis reported through the RESTORE core and extension
studies. [Paper session 4667]
Three Year Results of Visual Outcome with Disease-Activity-Guided Ranibizumab
Algorithm for the Treatment of Exudative Age-Related Macular
Degeneration[4],[5]: There were 316 wet AMD patients in a Swiss clinic evaluated
following treatment with Lucentis 0.5 mg administered either monthly or
quarterly on a pro re nata (PRN, or 'as needed') basis according to a disease-
activity-guided monitoring and treatment algorithm. This independent,
retrospective, interventional case series showed that at 36 months, patients had
achieved a mean gain of approximately eight letters in visual acuity with a mean
total of 16 Lucentis injections over the three years. [Poster session 438/D1115]
"The vision gains seen at the end of three years of Lucentis treatment in wet
AMD patients were favorable and similar when compared to the pivotal Phase III
trials - MARINA and ANCHOR" said Prof. Sebastian Wolf, University of Bern,
Switzerland. "However the number of injections, a mean of 16 during three years,
is significantly less than the monthly regimen used in those studies. This data
confirms that an individualized treatment regimen, now standard of care in
Europe, is best for patients."
LUMINOUS[6]: Data on nearly 4,500 patients with wet age related macular
degeneration (AMD) treated with Lucentis were pooled for the retrospective part
of Luminous, one of the largest observational studies in ophthalmology that is
expected to provide additional long-term evidence on the effectiveness and
safety profile of Lucentis in its licensed indications and real-world settings.
The retrospective pooled analysis of European registries shows no new safety
risks with Lucentis and confirmed its well characterized safety profile. The
prospective arm of Luminous is ongoing and currently has more than 3,000
patients. It is expected to recruit more than 30,000 patients in all licensed
indications from clinics across Asia, Australia, Europe, North and South
America. [Poster session 2031/D1049]
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.
Lucentis is licensed for the treatment of wet AMD in more than 100 countries,
and in more than 60 countries for the treatment of visual impairment due to DME,
and visual impairment due to macular edema secondary to RVO, including both
branch- and central-RVO. In many countries, including in Europe, Lucentis has an
individualized treatment regimen with the goal of maximizing visual outcomes
while minimizing under- or over-treating patients.
In 2011, Novartis launched the Luminous(TM) program, one of the largest
observational studies in ophthalmology, expected to recruit over 30,000 patients
from clinics across Asia, Australia, Europe, North and South America to further
broaden the understanding of ocular disease and the use of Lucentis in its
approved indications. Luminous is a five-year observational, international,
multicenter program that is expected to provide long-term effectiveness and
safety data for Lucentis as well as assess the treatment patterns and health-
related quality of life inpatients treated with Lucentis.
Novartis works closely with reimbursement authorities to ensure that Lucentis is
cost effective for appropriate patients and has an excellent track record of
working with healthcare systems to secure access to medicines for patients. In
fact, Lucentis has been shown to be cost effective and is reimbursed for the
treatment of wet AMD in most countries, including a recommendation by the
National Institute for Health and Clinical Excellence (NICE) in the UK.
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.
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 "expected," "to further broaden," or similar expressions,
or by express or implied discussions regarding potential new 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
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; unexpected regulatory actions or delays or government regulation
generally; competition in general; government, industry and general public
pricing pressures; 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's
continuing operations 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 124,000 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] RESTORE study group, The RESTORE study: ranibizumab monotherapy or
combined with laser versus laser monotherapy for diabetic macular edema,
Ophthalmology. 2011 Apr;118(4):615-25.
[2] Mitchell P, RESTORE extenstion study group, 2-year Safety And Efficacy
Outcome Of Ranibizumab 0.5 mg In Patients With Visual Impairment Due To
Diabetic Macular Edema (DME): An Interim Analysis Of The Restore Extension
Study ARVO 2012,
http://www.abstractsonline.com/Plan/ViewAbstract.aspx?sKey=33d868e0-ab8d-
406c-b25e-15fff568bf34&cKey=ec0a987f-0b49-460c-b2be-
56c6057f79fd&mKey=%7bF0FCE029-9BF8-4E7C-B48E-9FF7711D4A0E%7d
[3] data on file
[4] CeklicL, Framme C, Schnurrbusch-WolfUE, Wolf S, Three Year Results of
Visual Outcome with Disease-Activity-Guided Ranibizumab Algorithm for the
Treatment of Exudative Age-Related Macular Degeneration, ARVO 2012,
http://www.abstractsonline.com/Plan/ViewAbstract.aspx?sKey=6944d5e1-
5205-4822-972f-444971b406d4&cKey=d5015e8f-8d85-4a0d-b1e1-
a9434a2c5fbe&mKey=%7bF0FCE029-9BF8-4E7C-B48E-9FF7711D4A0E%7d
[5] Wolf S, et al, Acta Ophthalmologica, in press
[6] Luminous group, Safety, Efficacy, And Treatment Patterns Of Ranibizumab
Therapy For Neovascular Age-Related Macular Degeneration: The LUMINOUS
Studies, ARVO 2012,
http://www.abstractsonline.com/Plan/ViewAbstract.aspx?sKey=aa3d0ab1-c373-
4ac8-9953-1825cc2a538b&cKey=552535e8-9f6a-4b93-acdd-
4dd02d03e726&mKey=%7bF0FCE029-9BF8-4E7C-B48E-9FF7711D4A0E%7d
# # #
Novartis Media Relations
Central media line : +41 61 324 2200
Eric Althoff Julie Morrow
Novartis Global Media Relations Novartis Pharma Communications
+41 61 324 7999 (direct) +41 61 696 7581 (direct)
+41 79 593 4202 (mobile) +41 79 357 3259 (mobile)
eric.althoff(at)novartis.com julie.morrow(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
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(at)novartis.com e-mail:
investor.relations(at)novartis.com
Media release (PDF):
http://hugin.info/134323/R/1610687/512023.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#1610687]
Unternehmensinformation / Kurzprofil:
Datum: 10.05.2012 - 07:16 Uhr
Sprache: Deutsch
News-ID 144818
Anzahl Zeichen: 16331
contact information:
Town:
Basel
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 174 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"New data among 200 Lucentis® abstracts at ARVO show low number of injections with Novartis drug required to achieve and maintain vision gains over 3 years in AMD and DME patients"
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).
