Novartis and Procter & Gamble enter into commercialization agreement for Enablex®

7/6/2005, 5:30 PM (Source: GlobeNewswire)

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Corporate news announcement processed and transmitted by Hugin ASA. The issuer is solely responsible for the content of this announcement. ---------------------------------------------------------------------- -------------- Companies to collaborate on U.S. promotion of newest overactive bladder treatment

East Hanover, NJ, and Cincinnati, OH, July 6, 2005 - Novartis
Pharmaceuticals Corporation and Procter & Gamble Pharmaceuticals,
Inc. (P&GP), a division of The Procter & Gamble Company, today
announced that they have entered into an agreement for the
co-promotion and further development of Enablex® (darifenacin)
extended release tablets for the treatment of overactive bladder
(OAB) in the United States. Novartis will continue to record
revenues for Enablex and will pay royalties to P&GP based on the
product's performance.

"Our initial launch has been successful, and we've been pleased that
physicians have found Enablex to be a valuable tool in treating OAB,"
said Alex Gorsky, Chief Operating Officer, Novartis Pharmaceuticals
Corporation. "Combining P&GP's and Novartis' knowledge of the
consumer will increase our ability to meet the unique needs of the 33
million Americans living with OAB. This collaboration will result in
the creation of an expanded sales force and additional resources that
will allow us to reach more physicians and their patients."

OAB is a condition marked by the strong, immediate need to go to the
bathroom (urgency), desire to go to the bathroom quite often
(frequency), and involuntary loss of bladder control (incontinence).
Enablex is a potent muscarinic receptor antagonist that helps reduce
incontinence episodes, increases the amount of urine the bladder can
hold, reduces the frequency of urination episodes and decreases
urgency.

"We look forward to collaborating with Novartis and combining both
companies' expertise in consumer-understanding to better serve the
needs of providers and their patients coping with OAB," said Mark
Collar, President, P&G Global Pharmaceuticals. "The strong synergies
between this product category and P&GP's expertise, which is focused
on improving the lives of women, will enable us to immediately help
reach more patients in an area where connecting with the patient is
so important." The agreement also provides P&G and Novartis Consumer
Health the option to collaborate in over-the-counter (OTC)
commercialization should both parties decide to pursue that
opportunity.

At least 16 percent of the population over the age of 40 suffers from
the chronic and troublesome symptoms of OAB. Although prevalence
increases with age, the problem affects people of all ages. Fewer
than one in three sufferers will seek appropriate medical treatment,
and more women than men suffer from the symptom of incontinence.
People with OAB often limit travel, social and even work activities
to avoid potentially embarrassing episodes that can occur with this
condition.

More About Enablex
Enablex was approved for the treatment of OAB with symptoms of urge
urinary incontinence, urgency and frequency by the U.S. Food & Drug
Administration (FDA) in December 2004 and is available by
prescription in pharmacies nationwide.

Enablex offers a selective receptor profile with rates of nervous
system and cardiovascular side effects similar to placebo. It has
been studied in 98 clinical trials involving more than 10,000 people.

In clinical trials, the most frequently reported adverse events
associated with Enablex were dry mouth, constipation, indigestion and
abdominal pain; however, patient discontinuation rates due to these
events were low. The majority of adverse events in Enablex treated
subjects were mild or moderate and mostly occurred during the first
two weeks of treatment. As with other OAB medications, Enablex is
contraindicated in patients with urinary retention, gastric retention
or uncontrolled narrow-angle glaucoma and in patients who are at risk
for these conditions. Enablex is also contraindicated in patients
with known hypersensitivity to the drug or its ingredients.

Novartis: This release contains certain forward-looking statements
relating to Novartis Pharmaceuticals Corporation's business, which
can be identified by the use of forward-looking terminology, such as
"will", "will increase ability to meet", "look forward to", "will
enable", "will allow . to reach more" or similar expressions, or by
express or implied discussions regarding potential future sales of
Enablex. Such forward-looking statements involve known and unknown
risks, uncertainties and other factors that may cause the actual
results with Enablex to be materially different from any future
results, performance, or achievements expressed or implied by such
statements. There can be no guarantee that Enablex will reach any
particular level of sales. Any such results can be affected by,
among other things, uncertainties relating to clinical trials,
regulatory actions or delays or government regulation generally, the
ability to obtain or maintain patent or other proprietary
intellectual property protection, competition in general, government,
industry, and general public pricing pressures, as well as factors
discussed in the Company's Form 20-F filed with the 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 described
herein as 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.

P&G: All statements, other than statements of historical fact
included in this release, are forward-looking statements, as that
term is defined in the Private Securities Litigation Reform Act of
1995. In addition to the risks and uncertainties noted in this
release, there are certain factors that could cause actual results to
differ materially from those anticipated by some of the statements
made. These include: (1) the ability to achieve business plans,
including with respect to lower income consumers and growing existing
sales and volume profitably despite high levels of competitive
activity, especially with respect to the product categories and
geographical markets (including developing markets) in which the
Company has chosen to focus; (2) the ability to successfully execute,
manage and integrate key acquisitions and mergers, including (i) the
Domination and Profit Transfer Agreement with Wella, and (ii) the
Company's agreement to merge with The Gillette Company, including
obtaining the related required shareholder and regulatory approvals;
(3) the ability to manage and maintain key customer relationships;
(4) the ability to maintain key manufacturing and supply sources
(including sole supplier and plant manufacturing sources); (5) the
ability to successfully manage regulatory, tax and legal matters
(including product liability, patent, and other intellectual property
matters), and to resolve pending matters within current estimates;
(6) the ability to successfully implement, achieve and sustain cost
improvement plans in manufacturing and overhead areas, including the
Company's outsourcing projects; (7) the ability to successfully
manage currency (including currency issues in volatile countries),
debt (including debt related to the Company's announced plan to
repurchase shares of the Company's stock), interest rate and certain
commodity cost exposures; (8) the ability to manage the continued
global political and/or economic uncertainty and disruptions,
especially in the Company's significant geographical markets, as well
as any political and/or economic uncertainty and disruptions due to
terrorist activities; (9) the ability to successfully manage the
pattern of sales, including the variation in sales volume within
periods; (10) the ability to successfully manage competitive factors,
including prices, promotional incentives and trade terms for
products; (11) the ability to obtain patents and respond to
technological advances attained by competitors and patents granted to
competitors; (12) the ability to successfully manage increases in the
prices of raw materials used to make the Company's products; (13) the
ability to stay close to consumers in an era of increased media
fragmentation; and (14) the ability to stay on the leading edge of
innovation. For additional information concerning factors that could
cause actual results to materially differ from those projected
herein, please refer to our most recent 10-K, 10-Q and 8-K reports.

About Novartis
Novartis Pharmaceuticals Corporation researches, develops,
manufactures and markets leading innovative prescription drugs used
to treat a number of diseases and conditions, including central
nervous system disorders, organ transplantation, cardiovascular
diseases, dermatological diseases, respiratory disorders, cancer and
arthritis. The company's mission is to improve people's lives by
pioneering novel healthcare solutions.

Located in East Hanover, New Jersey, Novartis Pharmaceuticals
Corporation is an affiliate of Novartis AG (NYSE: NVS) - a world
leader in pharmaceuticals and consumer health. In 2004, the Group's
businesses achieved sales of USD 28.2 billion and pro forma net
income of USD 5.6 billion. The Group invested approximately USD 4.2
billion in R&D. Headquartered in Basel, Switzerland, Novartis Group
companies employ approximately 81,400 people and operate in over 140
countries around the world. For further information please consult
http://www.novartis.com.

About P&G (NYSE:PG)
Two billion times a day, P&G brands touch the lives of people around
the world. The company has one of the strongest portfolios of
trusted, quality, leadership brands, including Pampers®, Tide®,
Ariel®, Always®, Whisper®, Pantene®, Bounty®, Pringles®, Folgers®,
Charmin®, Downy®, Lenor®, Iams®, Crest®, Actonel®, Olay® and Clairol
Nice 'n Easy®, Head & Shoulders®, and Wella. The P&G community
consists of almost 110,000 employees working in over 80 countries
worldwide. Please visit http://www.pg.com for the latest news and
in-depth information about P&G and its brands.

# # #

Editor's Note: Full prescribing information is available at
www.enablex.com or by contacting Karen Sutherland of Novartis
Pharmaceuticals Corporation at +1-862-778-0323 or via e-mail at
karen.sutherland@novartis.com


Contacts

Karen Sutherland
Novartis Pharmaceuticals Corporation
862 778 0323 (direct)
917 330 5981 (mobile)
karen.sutherland@novartis.com

Paula Koenigs
Procter & Gamble Pharmaceuticals, Inc.
513 622 3923 (direct)
koenigs.pm@pg.com
View document

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