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Aging female population presents NEW CHALLENGES in HRT MARKET

The growing number of postmenopausal women translates into new challenges for clinicians and is leading to increased focus on the hormone replacement therapy market. Hormone Replacement Therapy, a study from Decision Resources Inc., identifies opportunities for products competing in the HRT market. For example, companies are trying to expand the number of combi nation products available in transdermal formand,in some cases, provide them in once weekly doses. Singleagent patches will offer transdermal formulations of several molecules, such as norethis terone and testosterone, previously available only in pill form. Companies are looking to combine estro gen with a host of progestational agents that have not yet been made available for the management of HRT. These agents are expected to have fewer pro gestogenrelated side effects than some currently available agents. The most exciting area of HRT development involves selective estrogen receptor modulators,also known as SERMs. Continued development of these agents may lead to a product that canalleviate vaso motor symptoms, or at least will not exacerbate these symptoms. Research focuses on SERMs’ ability to prevent osteoporosis and Alzheimer’s disease, as well as on its cardioprotective properties, and its effect on breast and endometrial tissues. Two novel SERMs are in latestage development: . WyethAyerst/Ligand’s TSE424 . Pfizer/Ligand’s lasofoxifene Promising evidence has emerged from prelimi nary trials with these agents,as measured in terms of bonedensity markers, cholesterol levels, and lack of vasomotor side effects. WyethAyerst’s conjugated equine estrogen products — Premarin, Prempro, and Premphase — are expected to continue to lead the market through 2010. New SERMs, novel combination HRT products, and synthetic steroidal hormones,however,will make some inroads in the next decade.The most promis ing oral combinations under development include Aventis/WyethAyerst’s estradioltrimegestone and CEEtrimegestone combinations. Trimegestone promises to have more benign side effects than other progestogens currently on the market. Once released, the drugs are expected to boost sales of oral combination products from $850 million in 2000 to almost $1.5 billion in 2010. 66 N o v e m b e r / D e c e m b e r 2 00 1 PharmaVOICE PHARMA TRAX SALES, MARKETING, AND R&D TRENDS AFFECTING THE HEALTHCARE INDUSTRY WyethAyerst/ Ligand’s TSE424 Pfizer/ Ligand’s lasofoxifene TWONOVEL SERMS ARE IN LATESTAGE DEVELOPMENT segments, respectively commanding a 48% and 42% market share. In addition, inhaled proteins such as pulmozyme, and other small molecules represent the greatest market growth opportunities with current shares of 4% and 2% each.The protein segment share is fore cast to grow from $293 million in 2000 to just more than $1.2 billion by 2005.Driving this growth will be several product launches including Exu bera, a drypowder inhaled insulin treatment from Aventis Pharmaceuticals Inc. that is cur rently in latestage development. Exubera is expect ed to lead its category. The U.S. represents about 44% of the worldwide market due to a large number of asthma suffer ers and a favorable reimbursement policy from thirdparty payers. Nutritional awareness INCREASES DEMAND in NUTRACEUTICALS market Demand for products that claim health and medicinal benefits is expected to expand rapidly as awareness of the link between nutrition and health grows. A new report by Frost & Sullivan, Strategic Analy sis of the U.S. Nutraceuticals Market, indicates the total market for functional ingredients, functional foods, functional beverages, dietary supplements, and foods for special dietary use is about $50 billion at present. “Realizing the potential of this industry segment will greatly depend on government regulations, which currently do not offer the necessary frame work to ensure the future success of the nutraceuti cals market,” says Carlos Ayala, an analyst at Frost & Sullivan. Nutraceuticals and functional foods currently do not have official definitions from the government. Large pharmaceutical and food companies recog nize the promise of these products,but are reluctant to commit significant resources until there are regu latory assurances that their investments will be rewarded. Mergers have become key strategies for market participants.While some companies continue to use mergers to gain dominance in a particular segment, others hope to acquire complementary technolo gies. For small companies, alliances will allow access to established distribution channels and necessary research resources. “The middle and lowertier companies will ben efit most from strategic partnering,” says Aninditta Savitry, a Frost & Sullivan analyst.“Rapid growth rates in key demographics, including healthconscious consumers, should provide the small and midsize acquisitions of niche food companies with more longterm profitability than many of the recent megamergers.” Worldwide PULMONARY drug delivery market FORECASTTO DOUBLE by 2005 The worldwide pulmonary drugdelivery market is expected to double in the next four years to $15.2 billion in 2005 from $8.4 billion in 2001,according to a report from Front Line Strategic Management Consulting. Growth through 2010 is expected to be moder ate but steady, says the report. Contributing to growth are new technologies such as drypowder inhalers, displacing injectable therapies and phased out CFCbased systems. Leading pharmaceutical pulmonary brands include Flovent,Serevent,Pulmicort, Atrovent, Ventolin, Com bivent, and Advair/Seretide. Combined, these brands accounted for $4.7 billion,or 63% of the market, in 2000. According to analysts, generics, however, are expected to continue to increase their share of the bronchodilator and anti inflammatory markets. New combination asth ma therapies are rapidly gaining adoption and con tributing to strong growth. Currently, bronchodila tors and antiinflammatories represent the largest Advair/Seretide Atrovent Combivent Flovent Pulmicort Serevent Ventolin COMBINED THESE BRANDSACCOUNTED FOR $4.7 BILLION (63% OFTHEMARKET) IN 2000 PHARMA trax ACTIVE BABY BOOMERS propel firstaid and sports medicine market Active baby boomers could be the source of a multibilliondollar market in the firstaid and sports medicine arena,according to the latest publication from Packaged Facts. According to the report, the U.S. Market for First Aid andSportsMedicineProducts,theneedsof baby boomers have driven demand for firstaid and sportsmedicine products to new highs, and will, along with several other factors,propel the market to $2.6 billion in annual sales by 2005. Rising healthcare costs also are identified by the report as a factor in the increase of homecare prod uct use. “People are taking medical matters into their own hands,” says Meg Hargreaves, VP of Research Publishing for MarketResearch.com, which owns Packaged Facts. “Consumers are opting to purchase firstaid supplies and sportsmedicine products for use in the home rather than extending hospital stays or even visiting medical facilities at all.” The report outlines the country’s youth as a con siderable force in the market.“Children are demand ing fun alternatives to plain taupe bandages,” Ms. Hargreaves says. “Marketers have been quick to understand the influence children have in the pur chasing habits of their parents and have begun cre ating products that appeal specifically to children.” The U.S. Market for First Aid and Sports Medicine Products provides detailed information about con sumer demographics, as well as distribution and mar keting trends, product development, and emerging retail campaigns. Largest OTC MARKET SEGMENT on the verge of BIG CHANGE Big changes could be in store for the overthe counter (OTC) allergy and asthma product market in the near future, according to a new study from Kalo rama Information and available through MarketRe search.com.Allergy and asthma products,the largest OTC segment in the U.S. with sales surpassing $1.7 billion last year, could be getting some company on the already crowded drugstore shelves. The new study, The U.S. Market for Overthe Counter Allergy and Asthma Products, identifies at least 10 likely candidates for RxtoOTC switches in this area in the next few years. The most important cate gory — nonsedating antihistamines such as Claritin, Allegra,and Zyrtec — will most likely beavailable OTC by 2003,according to the study.These allergy medica tions could grab upwards of 25% of the total market almost immediately after their introduction. Although the study found modest growth to be the norm in most of the areas covered, remedies for ocular allergies generated respectable growth (about 10%) recently, and the potential OTC candi dates likely to reach the market by 2003 are forecast to generate healthy growth rates, more than 12%, in subsequent years. “Modeling OTC markets is notoriously difficult,” says Steven Heffner, acquisitions editor at Kalorama. “There are many more unpredictable variables to take into account than in prescription markets: con sumer behavior and brand loyalty, fierce pricing competition especially in the robust generic area, and uncertain reimbursement policies from phar macy benefits companies. Our analysts looked at consumer and regulatory trends and compiled excellent market information from both the retail unit sales side to the manufacturers’dollar volume to analyze this complex market.” NEWNCEP GUIDELINES will lead to significant changes in treating HIGH CHOLESTEROL Physicians will significantly change the way they treat highblood cholesterol, as a result of new guidelines issued in May by the National Cholesterol Education Program (NCEP) Expert Panel on Detec tion,Evaluation andTreatment of HighBloodCholes terol in Adults.According to a Market Measures Inter active study on the impact of the revamped NCEP guidelines, 87% of doctors say they will now place more patients on pharmacologic therapy, with 42% planning to skip experimenting with diet and exer cise alone, moving more of their patients directly to drug treatments. In addition, 87% of physicians indicate they will become more aggressive in treating diabetics with 67 PharmaVOICE N o v e mb e r / D e c e m be r 2 00 1 Discovery and Development of NewMedicines The U.S. pharmaceutical industry leads the world in the discovery and development of new medicines. New treatments are being discovered at a faster rate than ever before,with more than 370newmedicines added to the medicine chest in the last 10 years alone and more than 400 medicines in development to treat cancer. . The pharmaceutical industry is profitable, which enables it to attract the investment needed to research and develop new medicines in a highrisk environment. . Drug price increases are in line with inflation. Total prescription drug expenditures are going up because more people are getting more and better medicines. This is good news because prescription medicines are often the least invasive, most effective, and most costeffective form of healthcare. . The National Institutes of Health (NIH) leads the way in basic research,but this research can’t help patients unless pharmaceutical companies trans late this knowledge into medicines. The industry outspends NIH on biomedical research. To put it in perspective, this year the industry is expected to spend more than $30 billion on R&D, that’s more than the entire budget of the NIH. . According to PriceWaterhouseCoopers,“the pharmaceutical industry pays more tax than 97% of all industries.” And the Congressional Research Ser vice warned that raising taxes on the pharmaceutical industry would mean that drug companies would be able to undertake fewer research projects. . IMS Health reports that the pharmaceutical industry spends far more on R&D than on marketing — $25.7 billion on R&D in 2000 compared with $15.7 billion on marketing. And more than half the marketing expendi tures went to providing doctors with free samples to give patients. . Thanks to a 1984 law, generic drugs can enter the market as soon as an innovator’s patent expires.Today,generic drugs make up about 50% of the pharmaceutical market.Without patents there would be no breakthrough drugs — and no generic copies. Source: Pharmaceutical Research and Manufacturers of America (PhRMA), Washington, D.C. THESE ALLERGYMEDICATIONS COULD GRAB UPWARDS OF 25%OF THE TOTAL MARKET ALMOST IMMEDIATELY. Claritin Allegra Zyrtec LIKELY NONSEDATINGANTIHISTIMINE CANDIDATES FORRXTOOTC SWITCH BY2003 Source:MarketResearch.com PHARMA FACTS PHARMA trax normal lipids; 81% will use higher doses of statin therapies, such as an 80mg dose of Zocor; and 75% will use more combination therapies in a wider range of patient types. The new MMI study also shows that the revised guidelines have doctors looking for new treatment options, with almost half of responding physicians reporting that they are eagerly awaiting the next group of super statins to be approved for marketing by the Food and Drug Administration. Fielded in June via the Internet, the MMI study provided physicians’ realtime responses to ques tions exploring how the new NCEP report would affect their approach to treating dyslipidemia. The study gathered feedback from 294 physicians, including primarycare physicians, endocrinologists, and cardiologists. “Our new Internet study on Lipids demonstrates the power of the Web in helping the industry quick ly evaluate the impact of new developments, fully understand their implications and swiftly take the right actions to seize opportunities,” says Chris Nae gle, managing director of MMI’s Product and Market Assessment Group. Study QUANTIFIES RISK to patients participating in CLINICALTRIALS A recent CenterWatch study finds that the inci dence of deaths attributed to investigational treat ments,during both government and industryspon sored clinical trials, is rare. The study also finds that one adverse event per research subject is typically reported on newdrug applications approved by the Food and Drug Administration. “To our knowledge, no information about the general risks associated with clinical trial participa tion has ever been assessed,” says Ken Getz, CEO of CenterWatch. “Yet, communicating this information to potential study volunteers should be an impor tant part of health consumer education and of the informed consent process.Our primary goal in pub lishing this information is to stimulate discussion among industry professionals, regulators, and the general public.” In September 2001, CenterWatch gathered data from 130 randomly selected new drug applications (NDAs) that had received approval since 1987. This represented about onethird of all new molecular entities approved by the FDA during this period. In total,more than 122,000 patients participated in the clinical drug trials evaluated.About 3,500 seri ous adverse events (SAEs) were reported. According to the study, the industry reported a total of 13 deaths to study drug effects. According to Mary Jo Lamberti,Ph.D.,manager of CenterWatch Research,the findings present metrics on general risks but these metrics are averages that fail to convey the wide variability in risk between clinical studies. According to analysts, there are numerous vari ables that will impact research risk, including the type of disease, the type of drug being researched, and the study duration. “Our analysis is also based on FDA data from approved NDAs,” Dr. Lamberti says.“We have not yet evaluated the many industrysponsored trials that are terminated before an NDA is filed.” 68 N o v e mb e r / D e c e m b e r 2 00 1 PharmaVOICE THE MMI STUDY SHOWSTHATTHEVAST MAJORITY OFPHYSICIANS — 76% — ARE AWAREOFTHE EXECUTIVE SUMMARY, HIGHLIGHTINGTHE NEWNCEP GUIDELINES. 74% of physicians cite journals as the resource that has been most useful in alert ing them to the revised NCEP standards 43% of physicians cite pharmaceutical reps as being a valuable information source 42% of physicians cite peers 29% of physicians cite the Internet 24% of physicians cite medical symposia 22% of physicians cite news broadcasts JOURNALSCITED ASTHEMOSTUSEFUL INFORMATIONSOURCE CENTERWATCH is a Bostonbased information services company that focuses on the clinical trials industry. CenterWatch offers a variety of publications and services for clinical research and health professionals,patients and health consumers.For more information, please visit centerwatch.com. DECISION RESOURCES INC.,a provider of pharmaceutical research and advisory services, is based in Waltham, Mass.For more information visit dresources.com. FRONT LINE STRATEGICMANAGEMENT CONSULTING INC., offers strategic business consulting and is based in Foster City, Calif. For more information visit frontlinesmc.com. FROST & SULLIVAN is an international strategic marketing consulting and training companybased in San Antonio, Texas.For more information visit food.frost.com. KALORAMA INFORMATION,adivisionof MarketResearch.com,supplies the latest in market research for the life sciences.For more information,contact Steven Heffner,212807 2634or sheffner@marketresearch.com. MARKETMEASURES INTERACTIVE L.P., Livingston,N.J., is an NOPWorld Health company,and a supplier of primary research to the global healthcare community.For more information on the Lipids TCS.net,please contact Chris Naegle, managing director of MMI’s Product and Market Assessment Group, by calling 800 4564405,ext.420 or emailing cnaegle@mmi.nopworld.com.For more information or additional press releases on MMI,please visit mmiresearch.com. PACKAGED FACTS,a division of MarketResearch.com,produces research reports on a wide range of consumer industries and is based in NewYork.For more information call Alison Williams at 212.807.2649 or visit marketresearch.com. Follow up MeetThem on theWeb In the last decade,meetings and events have become a key part of pharmaceutical product promotion. More recently, the Internet has become a hot meeting place for drug companies and their prescription writing customers, according to the Physi cian Meeting & Event Audit (PMEA) from ScottLevinAssociates Inc., Newtown, Pa., a Quintiles Transnational company. From February 2001 through April 2001,ScottLevin surveyed its PMEA panel every month to determine the extent of “eevent” activity. More than 3,100 physi cians participated in the study. 39% of physicians indicate that they hadbeen invited to an event conducted via the Internet 30% have positive attitude 64% will participate in future e events WHAT’S UP DOCS INDUSTRY SNAPSHOT

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