Novartis announces restructuring of global collaboration with
Schering-Plough to develop fixed-dose combination respiratory
therapies
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* Novartis assumes exclusive worldwide development and marketing
rights for investigational once-daily QMF149 being developed for
COPD and asthma
* QMF149 combines QAB149 (indacaterol) with mometasone and is
presently being developed on Schering-Plough's Twisthaler®
inhalation system
* Agreement marks an important step for Novartis toward a potential
innovative respiratory portfolio centered around QAB149
(indacaterol)
* Respiratory diseases, such as chronic obstructive pulmonary
disease (COPD) and asthma, have enormous health and economic
costs
Basel, May 19, 2009 - Novartis has assumed exclusive worldwide rights
to develop and commercialize QMF149, a fixed-combination of its
investigational QAB149 (indacaterol) with Schering-Plough
Corporation's inhaled corticosteroid mometasone, in changes announced
today to the companies' collaboration to develop fixed-dose
combination respiratory therapies.
In development for chronic obstructive pulmonary disease (COPD) and
asthma, QMF149 combines the anti-inflammatory properties of
mometasone with the bronchodilation of QAB149, a long-acting
beta2-adrenergic agonist.
"Novartis is seeking to build a portfolio of innovative respiratory
treatments centered around indacaterol to relieve suffering from COPD
and asthma, two of the most prevalent respiratory ailments," said
Trevor Mundel, MD, Global Head of Development at Novartis Pharma AG.
"This strengthens our strategic capabilities to develop key
respiratory health solutions to people with respiratory diseases."
The changes are the latest development in a successful long-term
relationship between Novartis and Schering-Plough that dates back to
2002. Since August 2006, when the collaboration was expanded to
jointly develop and commercialize a fixed-dose combination of QAB149
(indacaterol) and mometasone, this collaboration has completed the
formoterol/mometasone combination's phase II (asthma, COPD) and phase
III (asthma) development, while phase II development of QAB149
(indacaterol)/mometasone (asthma, COPD) continues.
Under the new agreement with Schering-Plough, Novartis assumes
exclusive worldwide rights to develop and commercialize QMF149.
Schering-Plough assumes exclusive rights to develop and commercialize
a fixed-combination of mometasone plus the Novartis product Foradil®
(formoterol), another long-acting beta2-adrenergic agonist.
Novartis will assume the remaining development and commercialization
costs for the QAB149 (indacaterol)/mometasone combination, including
use of the Twisthaler® device, while the remaining development and
future commercialization costs of the formoterol/mometasone
combination, including use of a pMDI device, will be borne by
Schering-Plough. There will be a royalty sharing arrangement based on
sales. Novartis will also recognize sales worldwide for QMF149 upon
commercialization.
QAB149 (indacaterol) is currently under regulatory review. In
December 2008, Novartis submitted regulatory dossiers for approval of
indacaterol in the United States and the European Union. Mometasone
and formoterol are currently marketed under the trade names Asmanex®
and Foradil®, respectively.
This transaction is subject to customary regulatory approvals.
About COPD and asthma
Chronic obstructive pulmonary disease (COPD) is a leading cause of
death that is growing in prevalence. Affecting more than 210 million
people worldwide, COPD accounts for nearly 3 million deaths each
year. The primary cause of COPD is tobacco smoke (through tobacco use
or second-hand smoke). It is also a leading cause of productivity
losses through missed work days.
Asthma is a chronic inflammatory lung disease that affects more than
300 million people worldwide. The health and quality of life for
these patients are often severely affected, with more than 180,000
people believed to die each year from asthma-related complications.
Important Safety Information
Foradil®, belongs to a class of medications known as long-acting
beta2-adrenergic agonists or LABAs. In patients with asthma, LABAs
may increase the chance of asthma related death. Therefore, Foradil®
should only be used as additional therapy for patients not adequately
controlled on other asthma controller medications.
Disclaimer
The foregoing release contains forward-looking statements that can be
identified by terminology such as "to develop," "investigational,"
"being developed," "to develop and commercialize," "in development,"
"seeking," "will," "future," "may," or similar expressions, or by
express or implied discussions regarding potential new marketing
approvals for QMF149 or QAB149, potential future combination products
containing Foradil, a potential future Novartis respiratory
portfolio, or regarding potential future revenues from QMF149,
QAB149, or Foradil or from any such respiratory portfolio. 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 to be materially different from
any future results, performance or achievements expressed or implied
by such statements. There can be no guarantee that QMF149 or QAB149
will be approved for sale in any market. Nor can there be any
guarantee that any future combination products including Foradil will
be approved for sale in any market. Neither can there be any
guarantee that Novartis will successfully bring to market any
respiratory portfolio centered around QAB149 or any other products.
Nor can there be any guarantee that any of the products or the
potential portfolio referred to in this release will achieve any
particular levels of revenue in the future. In particular,
management's expectations regarding such products and such potential
portfolio could be affected by, among other things, unexpected
regulatory actions or delays or government regulation generally;
unexpected clinical trial results, including unexpected new clinical
data and unexpected additional analysis of existing clinical data;
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; 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 AG provides healthcare solutions that address the evolving
needs of patients and societies. Focused solely on healthcare,
Novartis offers a diversified portfolio to best meet these needs:
innovative medicines, cost-saving generic pharmaceuticals, preventive
vaccines, diagnostic tools and consumer health products. Novartis is
the only company with leading positions in these areas. In 2008, the
Group's continuing operations achieved net sales of USD 41.5 billion
and net income of USD 8.2 billion. Approximately USD 7.2 billion was
invested in R&D activities throughout the Group. Headquartered in
Basel, Switzerland, Novartis Group companies employ approximately
98,000 full-time-equivalent associates and operate in more than 140
countries around the world. For more information, please visit
http://www.novartis.com.
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