CINCINNATI, Ohio and BRIDGEWATER, N.J., Jan. 4, 2006 /PRNewswire/ -- On Wednesday, January 4, 2006, Procter & Gamble Pharmaceuticals and sanofi-aventis US LLC, a member of the sanofi-aventis Group, co-marketers of Actonel(R) (risedronate sodium tablets), filed a lawsuit under the Lanham Act against Roche Pharmaceuticals and GlaxoSmithKline (GSK) in the United States Federal District Court in the Southern District of New York. The lawsuit alleges that Roche and GSK engaged in false and misleading advertising regarding their prescription osteoporosis medication, Boniva(R) (ibandronate sodium) tablets. The lawsuit seeks an injunction to stop that advertising.
The lawsuit specifically alleges that advertising for Boniva falsely claims, literally or implicitly: (1) that the drug has been proven to reduce the risk of nonspinal (nonvertebral) fractures, and (2) that the drug has demonstrated efficacy against nonspinal fracture comparable to other bisphosphonates, such as Actonel. Claims appear in advertising directed at both consumers and physicians. The complaint further alleges that the Boniva label and clinical study data do not support these claims.
Both Actonel and Boniva have been proven to reduce the risk of spinal (vertebral) fractures at 3 years in women with postmenopausal osteoporosis. The medications have not been compared in head-to-head clinical studies.
However, Boniva has not been proven to reduce the risk of nonspinal fracture. In its pivotal clinical trial, there were a similar number of nonspinal osteoporotic fractures at 3 years in women treated with Boniva and placebo*.
In pivotal clinical trials, Actonel has been proven to reduce the risk of nonspinal fractures at 3 years**. Because they are less common individually than spinal fractures, nonvertebral fractures were measured as a group that included the wrist, hip, pelvis, femur, forearm and clavicle (collarbone).
Procter & Gamble Pharmaceuticals and the sanofi-aventis Group have a rich heritage of improving the health and well-being of women. Part of this heritage is a commitment to providing healthcare professionals and consumers with accurate information about our products and the conditions they are used to treat.
About Actonel(R) (risedronate sodium tablets)
Actonel is indicated for the prevention and treatment of osteoporosis in postmenopausal 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, 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 one-year clinical trial comparing Actonel 35 mg Once-a-Week and Actonel 5 mg daily, the overall incidence of adverse events with the two dosing regimens was 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%).
Please read the full prescribing information available at www.actonel.com.
Boniva is a registered trademark of Roche Therapeutics, Inc. Boniva is indicated for the treatment and prevention of osteoporosis in postmenopausal women.
References
* Chesnut CH III, Skag A, Christiansen C, et al. Effects of oral ibandronate administered daily or intermittently on fracture risk in postmenopausal osteoporosis. J Bone Miner Res. 2004; 19:1241-1249.
** Harris ST, Watts NB, Genant HK, et al. Effects of risedronate treatment on vertebral and nonvertebral fractures in women with postmenopausal osteoporosis. JAMA. 1999; 282:1344-1352.
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(R), Tide(R), Ariel(R), Always(R), Whisper(R), Pantene(R), Mach3(R). Bounty(R), Dawn(R), Pringles(R), Folgers(R), Charmin(R), Downy(R), Lenor(R), Iams(R), Crest(R), Oral-B(R), Actonel(R), Duracell(R), Olay(R), Head & Shoulders(R), Wella, Gillette(R), and Braun. The P&G community consists of almost 140,000 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.
About sanofi-aventis
The sanofi-aventis Group is the world's third largest pharmaceutical company, ranking number one in Europe. Backed by a world-class R&D organization, sanofi-aventis is developing leading positions in seven major therapeutic areas: cardiovascular, thrombosis, oncology, metabolic diseases, central nervous system, internal medicine, and vaccines. The sanofi-aventis Group is listed in Paris (EURONEXT: SAN) and in New York (NYSE:SNY)
For The Procter & Gamble Company (the "Company"): 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.
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts. These statements include financial projections and estimates and their underlying assumptions, statements regarding plans, objectives and expectations with respect to future operations, products and services, and statements regarding future performance. Forward-looking statements are generally identified by the words "expect," "anticipates," "believes," "intends," "estimates," "plans" and similar expressions. Although sanofi-aventis' management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of sanofi-aventis, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include those discussed or identified in the public filings with the SEC and the AMF made by sanofi-aventis, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward- Looking Statements" in sanofi-aventis' annual report on Form 20-F for the year ended December 31, 2004. Other than as required by applicable law, sanofi- aventis does not undertake any obligation to update or revise any forward- looking information or statements.
For more information and copies of the filing, please contact:
Suzette Middleton Terri Pedone
513-622-2093 908-243-6578
middleton.sj@pg.com terri.pedone@sanofi-aventis.com
Source: Procter & Gamble Pharmaceuticals; sanofi-aventis US LLC
CONTACT: Suzette Middleton of Procter & Gamble Pharmaceuticals,
+1-513-622-2093, or middleton.sj@pg.com; or Terri Pedone of sanofi-aventis US
LLC, +1-908-243-6578, or terri.pedone@sanofi-aventis.com