Video: Novartis Launches Prevacid(R)24HR Over-the-Counter for Full 24-Hour Frequent Heartburn Treatment
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Video: Novartis Launches Prevacid(R)24HR Over-the-Counter for Full 24-Hour
Frequent Heartburn Treatment
- Prevacid(R)24HR prevents acid production that causes frequent heartburn pain
for a full 24 hours with one pill a day
BASEL, Switzerland, Nov. 12 /PRNewswire/ -- Novartis announced the
availability of Prevacid®24HR (lansoprazole delayed-release capsules 15
mg/acid reducer) over-the-counter in pharmacies and retail stores across the
US to treat frequent heartburn. Prevacid®24HR received US Food and Drug
Administration (FDA) approval in May 2009. It is the first and only
over-the-counter (OTC) Proton Pump Inhibitor (PPI) for the treatment of
frequent heartburn in its original formulation.
To view the Multimedia News Release, go to:
http://multivu.prnewswire.com/mnr/prevacid/40945/
(Photo: http://www.newscom.com/cgi-bin/prnh/20091112/NY09975 )
"It is well known that Americans are taking more ownership of their
health-care decisions. The launch of Prevacid®24HR for the treatment of
frequent heartburn is a milestone in the over-the-counter medicine category,
expanding the treatment choices for the millions of adults who suffer from
frequent heartburn," said Dirk Van de Put, Global Head, Over the Counter
Business Unit, Novartis Consumer Health. "We're looking forward to providing
frequent heartburn sufferers with broad access to this very effective
treatment and expect the launch to drive strong incremental growth for the OTC
Digestive Health category."
Prevacid® (lansoprazole)(2) was one of the most prescribed acid reducer brands
in the US over the last decade(3) based on IMS Data. The same medicine in
Prevacid is now available over-the-counter in Prevacid®24HR for the treatment
of frequent heartburn. Frequent heartburn is defined as heartburn that occurs
two or more days per week.
Prevacid®24HR is clinically proven to work for a full 24 hours, both day and
night. It is the only PPI approved for OTC treatment of frequent heartburn
that contains the active ingredient lansoprazole. Starting today,
Prevacid®24HR is expected to be available in more than 100,000 pharmacies,
drug stores, supermarkets, mass merchandisers and other retail locations
throughout the US.
Prevacid®24HR is clinically proven to treat frequent heartburn
Prevacid®24HR prevents acid production that causes frequent heartburn pain for
a full 24 hours, with one pill a day. Clinical study data shows that
Prevacid®24HR provides frequent heartburn sufferers more heartburn-free days
and nights than placebo(4,5). Prevacid®24HR starts working early to treat
frequent heartburn and maintains its effectiveness for the full 14-day course
of treatment. In two clinical trials, 88% of people who used Prevacid®24HR for
frequent heartburn were satisfied.(6)
In addition to Prevacid®24HR, Novartis Consumer Health, Inc. has demonstrated
success with switching other prescription products over the counter, enabling
more consumers to get access to the medicines they need, while continuing to
build the brands. Three of the company's biggest and most successful global
switches come from the Pharmaceuticals Division of Novartis AG -- Voltaren®,
Lamisil® and Nicotinell® and account for 30 percent of Novartis Consumer
Health global sales.
Frequent heartburn significantly affects sufferers' quality of life
While frequent heartburn is a common condition, its impact on sufferers may be
under-estimated. According to the Experience of Frequent Heartburn in America,
2009(7), a national study of 1,075 frequent heartburn sufferers conducted by
the Center for Health Outcomes Research & Evidence Based Medicine, LLC and
United BioSource Corporation, frequent heartburn is not only painful, but can
also significantly impact sufferers' quality of life. The study, conducted in
consultation with leading physicians and gastroenterologists, was designed to
measure and validate the quality of life impact that frequent heartburn
currently can have on sufferers. It found that frequent heartburn can affect
sufferers' ability to get a good night's sleep, be productive at work, have
positive personal relationships and enjoy social activities. The study also
showed that those with more severe frequent heartburn pain can experience a
greater impact on their quality of life.
"Until now, frequent heartburn has been largely misunderstood in America. The
data from this study confirms how frequent heartburn affects my patients'
daily lives -- it can interrupt sufferers' work, social activities and a full
night's sleep," said Dr. Brian Fennerty, practicing gastroenterologist and
professor of Medicine in the Division of Gastroenterology at Oregon Health &
Science University in Portland, Oregon. "The over-the-counter availability of
a proven molecule like lansoprazole provides choice and options to the
millions of frequent heartburn sufferers and empowers them to treat their
symptoms."
The study, which was funded by Novartis Consumer Health, Inc. revealed
that(7):
-- About 75% of frequent heartburn sufferers experienced some sleep
problems as a result of their heartburn - either problems falling
asleep
or staying asleep.
-- Living with frequent heartburn pain can affect personal relationships,
including social activities with family and friends, quality time with
children and spouses, and even sexual relationships.
-- For 52% of sufferers, discomfort from frequent heartburn has some
impact
on their work, including their ability to focus in meetings and their
overall ability to be productive.
The study also found that reducing the frequency and severity of frequent
heartburn pain could result in significant improvements in a sufferer's mood,
relationships with family, productivity at work, diet and enjoyment of social
activities(7). Additional results of the study are available at
www.Prevacid24HR.com.
As part of the launch of Prevacid®24HR, Novartis Consumer Health is partnering
with Dr. Fennerty and MSN.com Lifestyle Expert Kelley Moore to educate the
public about frequent heartburn and motivate them to take action. Through the
Heartburn Action Plan, Dr. Fennerty and Ms. Moore will share treatment options
and lifestyle tips that will help empower frequent heartburn sufferers to
treat their symptoms. Log on to www.HeartburnActionPlan.com for more
information.
About Frequent Heartburn
More than 50 million American adults suffer from frequent heartburn,(1) 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.
About Prevacid®24HR
Prevacid®24HR is now available over-the-counter to treat frequent heartburn
for a full 24 hours with one pill a day. It received US Food and Drug
Administration (FDA) approval in May 2009. It is the first and only
over-the-counter PPI for the treatment of frequent heartburn in its original
formulation.
Prevacid®24HR is clinically proven to work for a full 24 hours, both day and
night. Although some people get complete relief of symptoms within 24 hours,
it may take one to four days for full effect. Consumers should use
Prevacid®24HR as directed for 14 days to treat their frequent heartburn and
may take one 14-day course of treatment every four months, or as directed by
their doctor. If their heartburn continues or worsens, they should stop use
and ask a doctor.
Prevacid®24HR is expected to be available in more than 100,000 retail store
locations nationwide, starting at an average retail price of $11.99.
For more information about Prevacid®24HR, including instructions for use,
visit www.Prevacid24HR.com.
Disclaimer
The foregoing release contains forward-looking statements that can be
identified by terminology such as "look forward to," "expect," "expected,"
"can," "could," "will," "may," 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, the extent of the distribution of
Prevacid®24HR, 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
regarding the extent of the distribution of Prevacid®24HR, or 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, unexpected difficulties in manufacturing or
distribution; 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 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 each of 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 99,000 full-time-equivalent associates and operate in more than
140 countries around the world. For more information, please visit
http://www.novartis.com.
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. Based on IMS Data of the total number of Prevacid® prescriptions from
1998 - 2008
4. Peura, DA et al. Aliment Pharamcol Ther. 2009; 30:459-468
5. Kushner PR, et al. Postgrad Med.2009; 121(4):67-75
6. Novartis Consumer Health, Inc. Data on file.
7. The Experience of Frequent Heartburn in America, 2009" Research
conducted
by the Center for Health Outcomes Research & Evidence Based Medicine,
LLC
and United BioSource Corporation
Novartis Media Relations:
Central media line: +41 61 324 2200
Eric Althoff Julie Masow
Novartis Global Media Relations Novartis Consumer Health, Inc.
+41 61 324 7999 (direct) +1 973 503 7663 (direct)
+41 79 593 4202 (mobile) +1 862 579 8456 (mobile)
eric.althoff@novartis.com julie.masow@novartis.com
e-mail: media.relations@novartis.com
Novartis Investor Relations:
Central phone: +41 61 324 7944
Ruth Metzler-Arnold +41 61 324 9980 North America:
Pierre-Michel Bringer +41 61 324 1065 Richard Jarvis +1 212 830 2433
John Gilardi +41 61 324 3018 Jill Pozarek +1 212 830 2445
Thomas Hungerbuehler +41 61 324 8425 Edwin Valeriano +1 212 830 2456
Isabella Zinck +41 61 324 7188
e-mail: e-mail:
investor.relations@novartis.com investor.relations@novartis.com
SOURCE Novartis Consumer Health
Novartis Media Relations: Central media line: +41-61-324-2200, e-mail:
media.relations@novartis.com, Eric Althoff, Novartis Global Media Relations,
+41-61-324-7999 (direct), +41-79-593-4202 (mobile), eric.althoff@novartis.com,
Julie Masow, Novartis Consumer Health, Inc., +1-973-503-7663 (direct),
+1-862-579-8456 (mobile), julie.masow@novartis.com; Novartis Investor
Relations: Central phone: +41-61-324-7944, Ruth Metzler-Arnold,
+41-61-324-9980, Pierre-Michel Bringer, +41-61-324-1065, John Gilardi,
+41-61-324-3018, Thomas Hungerbuehler, +41-61-324-8425, Isabella Zinck,
+41-61-324-7188, e-mail: investor.relations@novartis.com, North America:
Richard Jarvis +1-212-830-2433, Jill Pozarek +1-212-830-2445, Edwin Valeriano,
+1-212-830-2456, e-mail: investor.relations@novartis.com
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