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

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.

 

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.

 

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.

 

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.

 

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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

 

 

 

Novartis Pharmaceuticals Corporation

862 778 0323 (direct)

917 330 5981 (mobile)

 

Procter & Gamble Pharmaceuticals, Inc.

513 622 3923 (direct)