Novartis receives approval from FDA to market Prevacid® 24HR as first
and only OTC proton pump inhibitor in original prescription
formulation
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announcement.
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* This approval will provide greater convenience and broader access
to an effective treatment option to the 50 million Americans[1]
suffering from frequent heartburn
* Once-daily, prescription-strength Prevacid® 24HR is the first OTC
proton pump inhibitor approved for the treatment of frequent
heartburn in the US since 2003
* Prescription-strength Prevacid 24HR treats frequent heartburn for
a full 24 hours
Basel, Switzerland, May 14, 2009 - Novartis announced today that
Prevacid® 24HR (lansoprazole delayed-release capsules 15 mg) has been
approved by the US Food and Drug Administration (FDA) as the first
over-the-counter (OTC) Proton Pump Inhibitor (PPI) for the treatment
of frequent heartburn since 2003. Prevacid 24HR is expected to be
available over-the-counter in 2009.
Once-daily Prevacid 24HR is the first OTC PPI approved in its
original prescription formulation. It is the only PPI containing the
active ingredient lansoprazole to be approved for OTC treatment of
frequent heartburn, which is defined as heartburn that occurs two or
more days per week. In three clinical studies, Prevacid 24HR
demonstrated significantly better efficacy in treating frequent
heartburn than placebo. Although some people experienced complete
relief of symptoms within 24 hours, it may take one to four days for
full effect.
The prescription medicine Prevacid® (lansoprazole)[2], a brand that
21 million patients have trusted to treat their acid-related
disorders[3], is one of the top five prescription brands in the US in
terms of total prescription dollar sales[4]. The drug achieved $3.37
billion in annual sales in the US in 2008[5]. Novartis has licensed
the Prevacid® trademark and certain other intellectual property
rights for OTC development and commercialization from Takeda
Pharmaceuticals North America, Inc.
"Our partnership with Takeda Pharmaceuticals on this switch has been
outstanding," said Larry Allgaier, Global Head of the Novartis OTC
Business Unit. "Takeda Pharmaceuticals trusted Novartis to take this
leading product over-the-counter because of our core competencies as
a pharmaceutical company, and our demonstrated history of success
taking prescription products over the counter, providing consumers
with greater convenience and broader access to the effective
treatments they need, while continuing to build the brands."
Prescription-strength Prevacid 24HR treats frequent heartburn for a
full 24 hours. Prevacid 24HR works by stopping the release of acid
into the stomach.
"This is an important development for the 50 million American adults
who suffer from frequent heartburn," said M. Brian Fennerty, MD,
Professor of Medicine, Division of Gastroenterology, Oregon Health
and Science University. "Prescription strength Prevacid 24HR will be
both an effective and well-tolerated option for treating frequent
heartburn."
The FDA approved Prevacid 24HR in the form of 15mg delayed-release
capsules. Prevacid 24HR is a 14-day course of treatment and should be
taken once per day before eating in the morning to treat frequent
heartburn.
For more information about Prevacid 24HR visit www.Prevacid24HR.com.
About Frequent Heartburn
More than 50 million Americans suffer from frequent heartburn, which
is defined as heartburn occurring two or more days per week. Frequent
heartburn is a result of the backing up of stomach acid into the
esophagus. Typically the lower esophageal sphincter muscle opens to
allow food to pass, but then quickly closes. However, in frequent
heartburn sufferers the muscle relaxes and allows food and acid from
the stomach to travel back up into the esophagus. As a result,
sufferers often have a burning sensation in the chest and/or throat,
a sour or bitter taste in the mouth, difficulty swallowing, chronic
coughing and wheezing or other asthma-like symptoms. These symptoms
of frequent heartburn can become worse when one is lying down or
bending over.
Disclaimer
The foregoing release contains forward-looking statements that can be
identified by terminology such as "will," "expected," or similar
expressions, or by express or implied discussions regarding the
potential date on which Prevacid® 24HR will be available for sale
over-the-counter or regarding potential future revenues from
Prevacid® 24HR. 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 Prevacid® 24HR to be materially different from any future
results, performance or achievements expressed or implied by such
statements. There can be no guarantee that Prevacid® 24HR will be
available for sale over-the-counter on any particular date. Nor can
there be any guarantee that Prevacid® 24HR will achieve any
particular levels of revenue in the future. In particular,
management's expectations regarding Prevacid® 24HR could be affected
by, among other things, competition in general; government, industry
and general public pricing pressures; unexpected regulatory actions
or government regulation generally; 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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References
[1] National Heartburn Alliance:
http://www.heartburnalliance.org/heartburn_assessment.php
[2] Prevacid® is a registered trademark of Takeda Pharmaceuticals
North America, Inc., and is used under license by Takeda
Pharmaceuticals North America, Inc.
[3] SDI Total Patient Tracker (TPT) 2002-2008
[4] SDI VONA 12-months ending December 31, 2008
[5] IMS NPA 12-months ending December 31st, 2008
Novartis Media Relations
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Novartis Global Media Relations Novartis Consumer Health, Inc.
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Novartis International AG
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