Following the announcement by the High Court that NICE must reconsider the current TAG 160 and 161 for the primary and secondary prevention of postmenopausal osteoporosis (following the appeal by Servier Laboratories), Procter & Gamble Pharmaceuticals (P&GP) issue the following statement.
Within the scope of its guidance (TAG 160 and 161), which, following the outcome of the judicial review, will now be reconsidered but will not necessarily change, NICE recommended a range of treatment options. These were: alendronate first line, risedronate and etidronate as the first alternative treatment options, followed by strontium ranelate, raloxifene and teriparatide (secondary prevention only) by taking into consideration both the clinical efficacy and the acquisition costs of the treatmentsi.
P&GP welcomed the recommendation of risedronate as one of the first alternative treatment options to generic alendronate, given its proven fracture protection at all key osteoporotic sitesii,iii,iv,v,vi and favourable tolerability profile for postmenopausal osteoporosis patients who are intolerant to alendronatevii. TAGs 160 and 161 remain in force until they are confirmed or revised.
P&GP also acknowledge the concerns with the NICE TAG 160 and 161 due to the complexity of its clinical implementation. The High Court has announced that the guidance should be reviewed as a result of the cost economic data on which the guidance was based, not being shared transparently amongst stakeholders.
A pragmatic approach to prescribing based on individual patient needs is required. By balancing the overall proven efficacy profiles of the drugs with their proven cost effectiveness, the treatment pathways recommended in the NICE TAGs can still be useful until such time as this guidance is confirmed or revised.
Oral bisphosphonate treatments are the most used pharmacological intervention for osteoporosis, with alendronate and risedronate as the most commonly prescribed treatments in the UKviii. There are differences between oral bisphosphonates, such as chemical structure, tolerability profiles and proven fracture protection efficacy at vertebral, hip and other non-vertebral sites that need to be considered when making prescribing choicesix.
About Procter & Gamble Pharmaceuticals [NYSE:PG]
Procter & Gamble Pharmaceuticals has a rich heritage in health care that extends back more than 150 years. Then and now, P&G is driven by our mission to improve the lives of people around the world every day. P&G's health care products include prescription medicines, over-the-counter medications and oral care products. P&G began developing and marketing prescription products in the late-1960s.
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 Actonel®, Asacol®, Crest®, Fibresure®, Intrinsa®, Metamucil®, Oral-B®, Pepto-bismol®, Vicks®, Pampers®, Ariel®, Always®, Pantene®, Herbal Essences®, Mach3®, Fairy®, Ace®, Lenor®, M. Propre®, Tampax®, Tempo®, Dash®, Pringles®, Iams®, Eukanuba®, Duracell®, Olay®, Head & Shoulders®, Wella, Gillette®, and Braun. The P&G community consists of 138,000 employees working in over 80 countries worldwide. Please visit pg for the latest news and in-depth information about P&G and its brands. For more information about P&G Pharmaceuticals, please visit pgpharma
Forward Looking Statements
For 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. 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; and (13) the ability to stay on the leading edge of innovation and maintain a positive reputation on our brands. 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.
Procter & Gamble Pharmaceuticals
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