Sandoz receives first approval for AirFluSal® Forspiro®
Novartis International AG /
Sandoz receives first approval for AirFluSal® Forspiro®
. Processed and transmitted by NASDAQ OMX Corporate Solutions.
The issuer is solely responsible for the content of this announcement.
* Novel inhaler approved for patients with asthma and COPD
* Approval follows completion of EU decentralized procedure (DCP)
* AirFluSal(® )Forspiro(®) strengthens Sandoz respiratory portfolio and
reinforces company leadership in differentiated products
Munich, December 18, 2013 - Sandoz announced today that it has received Danish
marketing authorization for AirFluSal(®) Forspiro(®), an innovative new inhaler
for patients with asthma and/or chronic obstructive pulmonary disease (COPD).
The Danish approval follows the completion of EU decentralized procedures (DCP)
for eight EU countries, including Denmark.
AirFluSal(®) Forspiro(® )offers the proven combination of salmeterol (a long-
acting inhaled ß2-agonist) and fluticasone (an inhaled corticosteroid) in an
innovative new inhalation device. The product's safety, efficacy and equivalence
have been proven in multiple clinical trials[1],[2]. Denmark has approved both
mid and high-strength dosage forms (50-250µg and 50-500µg) for the continuous
treatment of patients above 12 years of age with persistent asthma or for
symptomatic treatment of COPD in the same patient group.
 "The first approval of AirFluSal(®) Forspiro(® )is a key element of our
strategy to introduce differentiated generic medicines," said Jeff George,
Global Head of Sandoz. "This innovative new respiratory device underscores
Novartis's commitment to asthma and COPD patients and further strengthens
Sandoz' global leadership in differentiated products, which comprised 43 percent
of our sales in 2012."
AirFluSal(®) Forspiro(® )was developed at Aeropharm GmbH in Rudolstadt, Germany,
Sandoz' global respiratory Center of Excellence. Sandoz collaborated with UK-
based Vectura, a respiratory product development company, in the design and
development of the product. The innovative and intuitive to use design of the
inhaler 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
collaborated closely with patients during the development of AirFluSal(®)
Forspiro(®). The device features an innovative, patient-friendly design,
including multiple feedback mechanisms:
* Visual control features which helps reassure the patient about dosing
* Simple lever arm to load the dose
* Clear and accurate dose counter
[1] P Kuna, I Gath, U Thyroff-Friesinger, S Jones. Equivalence of an innovative
multidose salmeterol/fluticasone dry powder inhaler vs comparator in paediatric
asthma. Â Submitted ERS - Reference September 2013
[2] Sandoz data on file
Disclaimer
This press release contains forward-looking statements that can be identified by
terminology such as "strategy," "commitment," 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 sale in any additional markets, or at any particular time. Nor
can there be any guarantee that AirFluSal Forspiro will receive regulatory
approval or 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; general economic and industry conditions; global trends toward
health care cost containment, including ongoing pricing pressures; 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 as a
result of new information, future events or otherwise.
About Sandoz
Sandoz, the generic pharmaceuticals division of Novartis, is a global leader in
the rapidly growing generics industry. Sandoz employs over 26,000 employees in
more than 140 countries, offering broad range of over 1,000 high-quality,
affordable products that are no longer protected by patents. With USD 8.7
billion in sales in 2012, Sandoz holds the #1 position globally in biosimilars
as well as generic injectables, ophthalmics, dermatology and antibiotics as well
as strong positions in the treatments for central nervous system disorders,
gastrointestinal medicines, cardiovascular treatments, and hormone therapies.
Sandoz develops, produces, and markets these medicines along with pharmaceutical
and biotechnological active substances. In addition to strong organic growth
since consolidating its generics businesses under the Sandoz brand name in 2003
, Sandoz has benefitted from strong growth of its acquisitions including Lek
(Slovenia), Sabex (Canada), Hexal (Germany), Eon Labs (US), EBEWE Pharma
(Austria), Oriel Therapeutics (US), and Fougera Pharmaceuticals (US).
Sandoz is on Twitter. Sign up to follow @Sandoz_global at
http://twitter.com/sandoz.
# # #
For further information, contact:
Eric Althoff Sreejit Mohan
Novartis Global Media Relations Sandoz Head Biopharma & OI Communications
+41-61-324-7999 +49 (0) 162 429 7971
+41-79-593-4202 sreejit.mohan@sandoz.com
eric.althoff@novartis.com
Novartis Investor Relations
Central phone: +41 61 324 7944
Samir Shah +41 61 324 7944 North America:
Pierre-Michel Bringer +41 61 324 1065 Stephen Rubino +1 862 778 8301
Thomas Hungerbuehler +41 61 324 8425 Jill Pozarek +1 212 830 2445
Isabella Zinck +41 61 324 7188 Susan Donofrio +1 862 778 9257
e-mail: investor.relations@novartis.com e-mail:
investor.relations@novartis.com
Media release (PDF):
http://hugin.info/134323/R/1750945/590141.pdf
This announcement is distributed by GlobeNewswire on behalf of
GlobeNewswire 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 GlobeNewswire
[HUG#1750945]