Healthcare Industry News:  osteoporosis 

Biopharmaceuticals Litigation

 News Release - February 28, 2008

Procter & Gamble Wins Patent Infringement Lawsuit for Osteoporosis Therapy Actonel

CINCINNATI, Feb. 28 (HSMN NewsFeed) -- Today the United States District Court of Delaware ruled in favor of The Procter & Gamble Company (P&G) in the patent infringement lawsuit filed by P&G against Teva Pharmaceuticals USA, Inc. The positive ruling protects P&G's rights in the U.S. to exclusively market the osteoporosis therapy Actonel® (risedronate sodium tablets).

On August 13, 2004 P&G filed a patent infringement lawsuit against Teva to enforce P&G's U.S. composition of matter patent for risedronate, the active ingredient in Actonel. Teva was seeking to market a generic version of Actonel in the United States under the assertion that the Actonel patent was not valid due to obviousness of the invention. Today's Court ruling upheld the P&G patent, expressly rejecting Teva's validity challenge.

"We are pleased that the Court recognized and acknowledged the uniqueness of the risedronate molecule," said Tom Finn, P&G President, Global Health Care. "We are very proud of the extensive R&D efforts which brought Actonel to market, providing patients help that they need to manage their osteoporosis and prevent fractures."

The Actonel patent life extends through the end of 2013, excluding any potential extensions. Actonel was approved in 2000 by the U.S. Food and Drug Administration for the prevention and treatment of osteoporosis in postmenopausal women. Actonel is the only oral osteoporosis therapy proven to reduce the risk of vertebral fractures in just one year.

About osteoporosis

osteoporosis is a silent disease that affects millions of postmenopausal women, making their bones weak and more likely to fracture over time. In fact, in the U.S. today, 8 million women are estimated to already have osteoporosis, and almost 27 million more are estimated to have low bone mass, placing them at increased risk for fracture. Each year the incidence of osteoporosis-related fractures is greater than the incidence of heart attacks, strokes, and breast cancer combined. The good news is that there are prescription medications available that effectively reduce both vertebral and nonvertebral fracture risk.

About Actonel

Actonel® (risedronate sodium tablets) is indicated for the treatment and prevention of osteoporosis in post-menopausal women. In clinical trials, Actonel was generally well tolerated. Actonel is contraindicated in patients with hypocalcemia, known hypersensitivity to any component of this product, or inability to stand or sit upright for at least 30 minutes. Hypocalcemia and other disturbances of bone and mineral metabolism should be effectively treated before starting Actonel therapy. Actonel is not recommended for use in patients with severe renal impairment (creatinine clearance < 30 mL/min).

Bisphosphonates may cause upper gastrointestinal disorders such as dysphagia, esophagitis and esophageal or gastric ulcer. Patients should pay particular attention to the dosing instructions, as failure to take the drug according to instructions may compromise clinical benefits and may increase the risk of adverse events.

Among patients treated with bisphosphonates, there have been infrequent reports of severe and occasionally incapacitating bone, joint and/or muscle pain. Rare occurrences of osteonecrosis, primarily of the jaw (ONJ), have been reported in patients receiving bisphosphonates. Most ONJ cases have occurred in cancer patients undergoing dental procedures. In the majority of cases reported, patients had received intravenous bisphosphonate therapy.

In clinical trials of up to 3-years duration, the overall incidence of adverse events with Actonel 5 mg daily was comparable to placebo. The most commonly reported adverse events regardless of causality were infection (primarily upper respiratory, placebo 29.7% vs Actonel 5 mg 29.9%), back pain (23.6% vs 26.1%), and arthralgia (21.1% vs 23.7%).

In a clinical trial comparing Actonel 35 mg Once-a-Week and Actonel 5 mg daily for 1 year, the overall safety and tolerability profiles of the two dosing regimens were similar. The most commonly reported adverse events regardless of causality were infection (Actonel 35 mg 20.6% vs Actonel 5 mg 19.0%), arthralgia (14.2% vs 11.5%) and constipation (12.2% vs 12.5%).

In a clinical trial comparing Actonel 75 mg two consecutive days/month and Actonel 5 mg daily for 1 year, the overall safety and tolerability profiles of the two dosing regimens were similar. The most commonly reported adverse events regardless of causality were arthralgia (Actonel 75 mg 10.4% vs Actonel 5 mg 9.5%), dyspepsia (9.1% vs 7.3%), and back pain (8.8% vs 10.8%).

Please see full prescribing information for Actonel® (risedronate sodium tablets) for additional safety information. For a copy of the full prescribing information for Actonel visit the Actonel Web site at www.actonel.com.

About Procter & Gamble (NYSE: PG )

Three 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®, Mach3®, Bounty®, Dawn®, Gain®, Pringles®, Folgers®, Charmin®, Downy®, Lenor®, Iams®, Crest®, Oral-B®, Actonel®, Duracell®, Olay®, Head & Shoulders®, Wella, Gillette®, and Braun. The P&G community consists of over 138,000 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.

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. Such statements are based on financial data, market assumptions and business plans available only as of the time the statements are made, which may become out of date or incomplete. We assume no obligation to update any forward-looking statement as a result of new information, future events or other factors. Forward-looking statements are inherently uncertain, and investors must recognize that events could differ significantly from our expectations. 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 merger with The Gillette Company, and to achieve the cost and growth synergies in accordance with the stated goals of these transactions; (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 intellectual property matters as well as those related to the integration of Gillette and its subsidiaries), 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, interest rate and commodity cost exposures; (8) the ability to manage 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 competitive factors, including prices, promotional incentives and trade terms for products; (10) the ability to obtain patents and respond to technological advances attained by competitors and patents granted to competitors; (11) the ability to successfully manage increases in the prices of raw materials used to make the Company's products; (12) the ability to stay close to consumers in an era of increased media fragmentation; (13) the ability to stay on the leading edge of innovation and maintain a positive reputation on our brand; and (14) the ability to successfully separate the company's coffee business. 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.


Source: Procter & Gamble

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