AirFluSal® Forspiro® showed superiority at 12 months over Seretide® Diskus®[1] in persistence to treatment
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Novartis International AG /
AirFluSal® Forspiro® showed superiority at 12 months over Seretide® Diskus®[1]
in persistence to treatment
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The issuer is solely responsible for the content of this announcement.
* New study shows that rate of patient persistence using Sandoz AirFluSal
Forspiro is twice as high as for reference product Seretide® Diskus®.
* Study highlights importance of improving treatment "persistence" over time
for long-term respiratory diseases.
* Analysis, published in leading medical journal, is largest European Real-
World Evidence study ever conducted in asthma and COPD.
[1] Seretide(®) and Diskus(®) are registered trademarks owned by Glaxo Group
Ltd.
Holzkirchen, August 31, 2016 - New data just published in a leading medical
journal shows for the first time that the rate of treatment persistence for
patients using the innovative Sandoz AirFluSal Forspiro respiratory inhaler is
more than twice as high as for the reference product.
Persistence to treatment is defined as the duration of time from initiation to
discontinuation of treatment [1]. Dr. Bruce Bender, the lead author on the
paper, said: "COPD and asthma are long term diseases requiring long-term,
persistent adherence to therapy. While adherence has been widely studied to
date, a growing awareness of the large number of patients who abandon their
asthma treatment suggests that persistence to treatment may be more relevant for
longer-term outcomes."
Poor persistence to treatment rates are likely to result in poor outcomes
including disease exacerbations, reduced quality of life, hospitalization,
increased mortality, increased burden on the healthcare system and high economic
costs [2],[3],[4]. Relatively few studies have investigated persistence in
patients taking inhaled therapies, but those that have report sub-optimal rates
in these patients [5],[6],[7].
The results are reported in the latest edition of the leading Journal of Allergy
and Clinical Immunology: In Practice. The comparative analysis study is the
largest European Real-World Evidence (RWE) study ever conducted in asthma and
COPD (chronic obstructive pulmonary disease).
The study, entitled "Comparative analysis of persistence to treatment among
patients with asthma or COPD receiving AirFluSal(®) Forspiro(® )or Seretide(®
)Diskus(® )salmeterol / fluticasone propionate combination therapy", concluded
that patients using the Sandoz device showed a persistence rate of 22.9%,
compared to 10.5% for those using the reference product device.
"These results fully validate our decision at Sandoz to develop our inhaler
device in close collaboration with patients, incorporating their feedback", said
Dr. Spencer Jones, Sandoz Head of Global Medical Affairs, Respiratory. "This
approach, which results in the device being effectively designed to give direct
feedback to users, is the key to success in treating chronic conditions."
He added: "What the data also highlight is the need for even more research to
better understand patient persistence behaviors and to develop strategies to
address what are still unacceptably low overall levels."
The study was designed to retrospectively analyze persistence rates between the
two devices, using dispensing data from a large German pharmacy database. While
retrospective database analyses have some limitations, the strengths of this
data include the fact that 11,744 patients were included in a matched pair
analysis, controlled for gender, age and month of treatment initiation (to limit
seasonal effects).
All patients were first time users of salmeterol/fluticasone propionate and
persistence to treat was analyzed for a 12 month period.
About AirFluSal Forspiro
AirFluSal Forspiro offers the proven combination of salmeterol (a long-acting
inhaled ß2-agonist) and fluticasone propionate (an inhaled corticosteroid) in an
innovative device. Safety, efficacy and equivalence have been proven in multiple
clinical trials.
It was developed at Aeropharm GmbH in Rudolstadt, Germany, Sandoz's global
respiratory Center of Excellence. Sandoz collaborated with UK-based Vectura
Group plc, a respiratory product development company, in the design and
development of the product. The innovative and intuitive-to-use inhaler was
invented at Vectura and its design was awarded the Red Dot Product Design award
in 2011, an internationally recognized quality seal awarded by the Design
Zentrum Nordrhein Westfalen in Essen, Germany.
In order to improve patient experience with inhalation devices, Sandoz and
Vectura collaborated closely with patients during the development process. The
device includes multiple feedback mechanisms such as visual control features,
which help reassure the patient about dosing and a simple lever arm to load the
dose.
AirFluSal Forspiro has been launched to date in approximately 30 countries, in
Europe and elsewhere.
Disclaimer
This press release contains forward-looking statements that can be identified by
terminology such as "long-term," "persistent," "growing," "suggests," "may,"
"likely," "strategies," or similar terms, or by express or implied discussions
regarding potential additional marketing approvals for AirFluSal Forspiro, or
regarding potential future revenues from AirFluSal Forspiro. 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 AirFluSal Forspiro 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 AirFluSal Forspiro will be commercially
successful in the future. In particular, management's expectations regarding
AirFluSal Forspiro could be affected by, among other things, the uncertainties
inherent in research and development, including unexpected regulatory actions or
delays or government regulation generally; unexpected clinical trial results and
additional analysis of existing clinical data; 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, quality or 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 as a result of
new information, future events or otherwise.
About Sandoz
Sandoz is a global leader in generic pharmaceuticals and biosimilars. As a
division of the Novartis Group, our purpose is to discover new ways to improve
and extend people's lives. We contribute to society's ability to support growing
healthcare needs by pioneering novel approaches to help people around the world
access high-quality medicine. Our portfolio of approximately 1000 molecules,
covering all major therapeutic areas, accounted for 2015 sales of USD 10.1
billion. In 2015, our products reached more than 500 million patients and we
aspire to reach one billion. Sandoz is headquartered in Holzkirchen, in
Germany's Greater Munich area.
Sandoz is on Twitter. Sign up to follow (at)Sandoz_global at
http://twitter.com/Sandoz_Global.
# # #
References
[1] Bender BG, Vecino RAH, McGrath K, Jones S. Comparative analysis of
persistence to treatment among
patients with asthma or COPD receiving AirFluSal® Forspiro® or Seretide® Diskus®
salmeterol/fluticasone proportionate combination therapy. J Allergy Clin Immunol
Pract 2016;4:884-9.
[2] Cramer JA, Bradley-Kennedy C, Scalera A. Treatment persistence and
compliance with
medications for chronic obstructive pulmonary disease. Can. Respir. J
2007; 14(1):25-29.
[3] Bender BG. Advancing the science of adherence measurement: implications for
the clinician.
J Allergy Clin. Immunol. Pract. 2013; 1(1): 92-3.
[4] Antoniu SA. Adherence to inhaled therapy in COPD: effects on survival and
exacerbations.
Expert Rev Pharmacoecon. Outcomes Res. 2010; 10(2):115-7.
[5] Hasford J, Uricher J, Tauscher M, Bramlage P, Virchow JC. Persistence with
asthma treatment
is low in Germany especially for controller medication-a population based study
of 483 051
patients. Allergy 2010; 65:347-354.
[6] Penning-van Beest F et al. three-year dispensing patterns with long-acting
inhaled drugs in
COPD: a database analysis. Respir Med. 2011; 105(2):259-65.
[7] Barnes CB, Ulrik CS. Asthma and adherence to inhaled corticosteroids:
current status and
future perspectives. Respir. Care 2015; 60(3):455-468.
Novartis Media Relations
Central media line: +41 61 324 2200
E-mail: media.relations(at)novartis.com
Eric Althoff Duncan Cantor
Novartis Global Media Relations Sandoz Global Communications
+41 61 324 7999 (direct) +49 8024 476 2497 (direct)
+41 79 593 4202 (mobile) +49 170 650 6067 (mobile)
eric.althoff(at)novartis.com duncan.cantor(at)sandoz.com
Chris Lewis Bernhard Schneider
Sandoz Global Communications Sandoz Global
+49 8924 476 1906 (direct) Communications
+49 174 244 9501 (mobile) +49 8024 476 2594
chris.lewis(at)sandoz.com bernhard.schneider(at)sandoz.com
Novartis Investor Relations
Central investor relations line: +41 61 324 7944
E-mail: investor.relations(at)novartis.com
Central North America
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Media release (PDF):
http://hugin.info/134323/R/2038399/759693.pdf
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Source: Novartis International AG via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 31.08.2016 - 07:15 Uhr
Sprache: Deutsch
News-ID 491876
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