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					OTC Business News
Strategic insight into the global consumer healthcare industry
www.informa.com 20th March 2002 Vol. 8 Issue 186

Schering-Plough sets the scene for OTC anti-allergy battle
S
announced that it is seeking approval from the US Food and Drug Administration (FDA) for the Rx-to-OTC switch of all versions of its best-selling antihistamine drug Claritin, prior to the expiry of its main patent on 19 December 2002. The company said it wanted to introduce a safe, nonsedating antihistamine into the OTC marketplace and position its products, including its new prescription drug Clarinex, as the premier brands in the prescription and OTC categories. The decision means a torrid battle for market supremacy in the anti-allergy category is set to begin at the end of the year. Schering-Plough will be able to use its brand name in the OTC market, which, with a loyal customer following, could generate as much as $400.0 million (£280.6 million) in annual sales. However, it will have to contend with generic competition in the form of McNeil Pharmaceuticals, a unit of Johnson & Johnson, and WhitehallRobins, part of Wyeth (formerly American Home Products). Both companies announced in January of this year that they had filed new drug applications (NDAs) with the FDA for OTC versions of loratadine, leaving Schering-Plough little choice but to apply for a switch itself. The critical loser in the OTC market, according to analysts, could be Pfizer’s Benadryl, the current top seller in the OTC rhinitis category. Benadryl is indicated for children aged six and over. However, some forms of Claritin are approved for use in children as young as two years old, meaning that Claritin
CHERING-PLOUGH HAS

HIGHLIGHTS

COMPANY WATCH
SSL disposes of 21 OTC brands Numico to axe 600 jobs and appoint new management 3

could well take a considerable bite out of Pfizer’s OTC share. The battle is reminiscent of the switch of ulcer medications like Pepcid (McNeil), Tagamet (GSK), Zantac (Pfizer) and Axid (Whitehall) in 1995. The battle for a then new heartburn category created an estimated $1 billion in annual revenues for the OTC industry. However, over the following years, court suits to litigate between appropriate and inappropriate claims also ensued. The surprising winner in that battle was Pepcid AC, the OTC version of Pepcid, which emerged as an also-ran for Merck in the branded prescription war between Zantac and Tagamet. The estimated annual revenue for the category is now about $600 million, following the expiry of three-year market exclusivity protecting the brands from generic competition. Advertising and awareness have expanded category sales for the entire OTC stomach relief category. A fourth potential challenger to Schering-Plough’s OTC version of Claritin is Californian company Impax Pharmaceuticals. The specialty pharmaceutical company was planning to sell a generic prescription version of Claritin when the patent expired on 19 December, but disclosed last Friday that it had already struck a deal with Novartis for marketing rights and supply of an OTC loratadine product. Impax also said that it was in talks with potential OTC partners for two additional generic formulations of Claritin. “We are constantly looking at business opportunities,” said Charlie Hsiao, the CONTINUED ON PAGE 2

4

PHARMACY FOCUS
National pharmacy federation accused of price fixing 5

MARKETING NEWS
Bayer divests household insecticides in bid to create “new Bayer” 6 Baidyanath invests in FMCG brand 6 OTC patches in isolation not the solution

7

POLICY & REGULATORY AFFAIRS
MEPs vote to standardise vitamins industry Bill aims for nationwide OTC availability of EHC in US 9

10

Avanir hopeful of patent extension on Abreva 11

E-HEALTH
Security is key, but brand presence builds trust Health information on the Internet still unreliable 13

14

CLINICAL RESEARCH UPDATE
Painkillers may prevent prostate cancer 15

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company’s chairman, “and we will evaluate our OTC strategy in response to this announcement by Schering-Plough. This is a very complex situation and it is too early to tell what the overall impact will be on our generic Claritin filings.” The impact of the switch on the OTC market as a whole is likely to be positive and in the absence of a market leader, the obvious winner is the OTC industry itself. The industry has been in the doldrums due to a lack of switches and the fact that key retailing players, like Wal-mart and giant supermarket and drug store chains, are offering big incentives to private label manufacturers like Perrigo to provide products at the lowest possible prices. Another winner is Wellpoint, the California health insurer which petitioned for the switch in 1999. A hearing on that petition in May 2001 concluded that Claritin would be safe as an OTC and recommended a switch. However, in the face of a potential legal battle with Schering-Plough, Aventis and Pfizer that it was unsure it could win, the FDA backed off. In an interview with the New York Times, Robert Seidman, chief medical officer of Wellpoint, said the company would likely save $90 million annually on the cost of Claritin Rx, $45 million for the drug and $45 million in doctors’ visits in order to have it prescribed. Government health plans as well as programmes paid for by state, federal and local governments will also benefit. The length of exclusivity awarded to Schering-Plough will be key in terms of

how well it is able to establish its position in the market. Because Schering-Plough conducted separate clinical testing for individual products in the Claritin franchise, each brand should be entitled to three-year exclusivity for its product under the HatchWaxman Act. A lawyer who practices before the FDA doubted whether Schering-Plough would win three-year exclusivity under HatchWaxman and said that, “without exclusivity, both McNeil and Whitehall-Robins will be tough competitors for [the company] in the loratadine OTC market”. “You can win exclusivity based on the fact you have conducted clinical studies essential to that approval,” the lawyer said. However, he believes Schering-Plough may only get exclusivity for that indication. The current cost for a 30-day prescription-only supply of Claritin is about $80. Estimates of a 30-day supply of the same product through the OTC market are as low as $15, according to an industry consultant. Analysts estimate that the market for Claritin, Allegra and Zyrtec, now about $5 billion, could plummet by about half. However, Pfizer said last Friday it had no intention of switching Zyrtec. “Our position is that the FDA cannot switch a drug without granting a hearing to the owner of the NDA [new drug application].” The patent on the product extends to 2007 and, in 2001, prescription sales of Zyrtec in the US were $990 million. However, some analysts believe Pfizer may be forced to switch Zyrtec before that, in order to protect its Benadryl market. Dave Postal

In brief

Company news
US MANUFACTURER of vitamin and mineral supplements Stryka has filed for Chapter 11 in the Bankruptcy Court in New Jersey. The application asks for authorisation to pay priority claims and pre-petition salaries and wages. The company said that it had suffered, as had many companies, from a slowdown in the industry. However, it admitted that internal inefficiencies and conflicts with a minority shareholder regarding the strategic direction of the company had contributed to its downfall. Tom Christensen, founder and chairman of Stryka left the company in February. Reckitt Benckiser, the household cleaning and healthcare company has said it intends to acquire the outstanding 49 per cent minority in its subsidiary Reckitt Benckiser (India) through a voluntary offer of Rs250 (£3.60) per share in cash, subject to statutory approval. The offer values the minority at approximately £58.5 million and the whole of Reckitt Benckiser (India), therefore, at £119 million. Hungarian drug producer Pharmavit, which specialises in the production of Plussz soluble vitamin tablets, is to lose its leading position in the Hungarian market, due to increased competition. There have been rumours that Pharmavit’s owner, UK pharmaceutical company Bristol-Myers Squibb, plans either to liquidate the company or to sell its vitamins producing division.

2 20 March 2002

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OTC Business News
COMPANY WATCH Divestiture

Company Watch

SSL disposes of 21 OTC brands
SSL INTERNATIONAL, MANUFACTURER of healthcare products including the Durex condom and Scholl foot care brands, has completed the disposal of 21 active over-the-counter brands, as well as a further 13 inactive trademarks, to Thornton & Ross. Sales of the brands, which include Dermidex, Lloyds Cream and Crampex, up to 31 March 2001 were approximately £8.6 million ($12.5 million), generating profits of around £5.7 million. Thornton & Ross has paid SSL a cash consideration of £13.5 million for trademarks, know-how and other intellectual property relating to the brands, as well as selected dedicated manufacturing equipment and £0.6 million of stock. The reason for the sale, according to Brian Buchan, chief executive of SSL, was that the complexity of the company’s UK OTC portfolio, which comprised over 50 brands, was having an adverse impact on its manufacturing efficiency, customer service and marketing effectiveness. The disposal, he said, would allow the company to focus on its remaining OTC portfolio, which includes brands such as Meltus cough medicine, hangover cure Resolve and Remegel indigestion relief. However, in July 2001, the Serious Fraud Office (SFO) announced that it was reviewing activities at SSL following a discovery by accounting company KPMG that sales at SSL had been overstated by around $22 million. Profits and tax had also allegedly been overstated by around $19 million. Should the SFO find cause to bring a case against the company, SSL and its previous accountants, Andersen, could face significant fines. SSL’s OTC brands are a good match for Thornton & Ross, whose pharmaceutical portfolio is built around minor lines and led by the Covonia brand of adult cough medicines. Its second most prominent brand is the Care brand, which consists of well over OTC 100 lines covering most of the major selfmedication categories including pain relief, cold relief, skin care and cough/sore throat treatment.

Product line expansion

Cost cutting

Dr Morepen abandons acquisition but sizes up Eno
DR MOREPEN, THE fast moving health goods division of Indian company Morepen Laboratories, has dropped its plan to buy the cold and cough medicine Coldact from Sun Pharmaceuticals, deciding to launch its own product rather than reformulating an acquired one. Dr Morepen is currently driving to expand its over-the-counter offering with the aim of becoming a household name and Coldact may not have fitted within this structure. According to Dr Morepan’s managing director, Kartik Raina, the formulation of Coldact prevented the product from being sold over the counter. He said the company never really went beyond reviewing the proposal and negotiations had not begun. However, Mr Raina added that Dr Morepen was currently considering a number of other potential brands in the cough, cold and analgesics sector, and would be announcing other acquisitions shortly. 2002 looks to be a busy year for the company. It has recently announced its intention to extend the Dab product range by April with two new
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Twinlab downsizes with plant closure
US MANUFACTURER of vitamins, minerals and sports nutrition products, Twinlab, is to close or sell its Health Factors International (HFI) plant in Arizona as part of an ongoing streamlining programme aimed at reducing costs and increasing productivity. This follows the sale of three subsidiaries in 2001 – Changes International, PR Nutrition and Advanced Research Press. The company is looking to recover from disappointing third quarter results for fiscal 2001. Sales decreased by 20 per cent to $54.0 million (£37.9 million) during the quarter, equal with earnings for the same period in 2000. The restructuring is expected to result in around 100 job losses. Twinlab’s chief information officer, Bill Rizardi, said that the decision to close the plant was not an easy one, but admitted that the company was in “production enhancement mode”. Of Twinlab’s plants, Arizona was the smallest. HFI’s production responsibilities will be transferred to the company’s facilities in Utah and New York. 20 March 2002 3

products, Dab Tab digestive tablets and Dab Gel digestive syrups. Dr Morepan said its aim was to reach Dab sales of Rs8 million (£115,000, $164,000) and to take on the established Eno Fruit Salt brand (GlaxoSmithKline), which began marketing its products in 1880. Mr Raina said, “Unlike Eno, which is available just in powder form, or Digene (Knoll Pharmaceuticals) and Gelusil (Parke Davis) which are present in tablet and gel form, Dab will be the first complete brand catering to all the three categories.” Dr Morepan’s OTC activity does not stop there. Supported by a Rs50 million advertising and marketing campaign, the company plans to re-launch the antiseptic cream Burnol in April 2002. Dr Morepen acquired Burnol from Reckitt Piramal in December 2001 for Rs89.5 million. Summer launches are also planned for a new health drink, which is to be positioned as a consumer lifestyle brand, rather than a medicine, and a sweetener, which it is calling Y-Sugar (see OTC Business News, 23 January 2002, page 8).

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Company Watch

OTC Business News

Stock purchase

Boots buys back shares
UK HIGH STREET retailer Boots has announced that it is to buy back £300.0 million ($427.5 million) worth of shares, representing just over 5 per cent of its share capital. This move comes less than two months after Boots chief executive Steve Russell said that the results for 2001 were not at a level with which the company could be satisfied. Mr Russell said, “This is just one way in which we are aiming to enhance value for shareholders. The company is highly cash generative and remains well placed to invest in future growth opportunities.” Boots’s rating at credit rating agency Standard & Poor’s is A+. However, according to one London analyst, the market’s overall reaction to the news was “so what?” He said, “It’s a piece of shareholder appeasement. Steve Russell is under shareholder pressure and this is his way of trying to appease them.” What the market is really worried about, he continued, is whether Boots can “keep holding its 30 per cent UK market share and still make a 12 per cent return on sales”. Boots’ sales during 2001 increased by just 2.4 per cent over the previous year. However, Nathan Cockrell, an analyst at Credit Suisse First Boston believed that sales of Boots own brand products might keep its margin firm. Boots announced in February that it was to operate an overseas strategy that concentrated on reducing operating losses. This involved expanding the Boots product line through local and regional retail partnerships, rather than opening new stores. While investors remain cautious, some believe that the company is showing prudence in sticking to what it knows, instead of investing in overseas expansion, which could “catch them out”.

Restructuring

Forecast earnings

Numico to axe 600 jobs and appoint new management
US DIETARY SUPPLEMENT maker Numico has announced plans to cut 600 jobs as part of a restructuring programme in the US. The company said it had experienced a difficult year in 2001 with the poor performance of subsidiary Rexall Sundown and a profit warning in October that saw shares plummet to a three-year low. Numico did not give details on where the cuts were to be made, however they are expected to occur across all three units in the US – General Nutrition Centers (GNC) and Unicity, as well as the ailing Rexall Sundown. In its report, the company also said that new management would be consolidated under Peter van Wel, who replaces former GNC executive Greg Horn, and $40.0 million (£28.1 million)
Boiron positive despite low ’flu sales
French homoeopathy specialist Boiron has reported an increase in sales for 2001 of 4.3 per cent to €266.4 million (£165.2 million, $235.4 million). Profits rose by 1.0 per cent to €19.7 million. The company said performance was all the better considering the absence of a ’flu epidemic during the winter months, which would have encouraged sales of the group’s profitable ’flu remedy, Ocillococcinum. In addition, results for 2000 had been boosted by income from the exceptional sales of a minority holding in India. The group has been moving away from relying on its ’flu remedy. During 2001, it developed a syrup as a sleep aid for children, as well as a sedative for adults. It has also developed new homoeopathic treatments – drops to treat eye irritations and a medicine for the treatment of vaginal thrush. Additional growth in 2001, according to the company, has come from the manufacture of non-proprietary homoeopathic medicines. Boiron also established an operation in Tunisia during 2001, bringing the total number of overseas operations to 12. Some 32.0 per cent of the company’s sales now come from outside France, with 9.0 per cent in the US. Grzegorz Smosarski

Clairol drives P&G volume growth
PROCTER AND GAMBLE said it expected earnings growth for the third quarter ending 31 March 2002 to exceed previous guidance, with core earnings per share in double digits. Behind this growth is an expected 910 per cent increase in sales volume, which the company attributed to its acquisition of the Clairol hair care brand. Procter & Gamble bought the unit from Bristol-Myers Squibb in 2001 for $2.5 billion (£1.8 million). It said that continued strong performances had also been seen in the healthcare business, building on the strong second quarter sales of Actonel, for osteoporosis, and the Crest dental brand. The fabric and home care business units also performed well. A survey of 13 analysts by Thomson Financial/First Call yielded a consensus earnings estimate of $0.81 per share for the quarter. Procter & Gamble said it expected sales growth to be in the high single digits, though foreign exchange is forecast to negatively impact the top line by about 3 per cent due to weakness of the euro, the Argentinean peso and the yen. A Lafley, chief executive of Procter & Gamble said that a focus on better consumer value and improved cost and cash management was starting to pay off. “While we still have more to do, we feel good about Procter & Gamble’s progress, he said.”

would be cut in annual expenses. Marketing efforts are to be stepped up for key brands and product development is to be reorganised. Outgoing chief executive officer, Hans van der Wielen, said, “We are addressing the issues in the US, have new management in place and are working hard to leverage our research expertise to capture the benefits of our unique market position.” He added that he hoped the reorganisation would pay off. Mr van der Wielen is due to retire from his position when he reaches 60 this year and is expected to be replaced by Jan Benninck, a member of the board at the French consumer products group Danone. Numico has yet to confirm the appointment but said it would be making an announcement sometime this year.

4 20 March 2002

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OTC Business News
PHARMACY FOCUS Anti-trust action

Pharmacy Focus

National pharmacy federation accused of price fixing
ITALY’S ANTI-TRUST AUTHORITY has slapped a €100,000 (£62,010, $88,370) fine on pharmacy associations for forming a cartel to stifle competition and fix prices. While the charges concern alleged price-fixing for socalled parapharmaceutical products, the action is seen as a forerunner of measures likely to affect medical products whose prices are not set by the government and whose cost is fully borne by consumers. The Anti-Trust Authority, a government-appointed panel in charge of overseeing fair competition, stated that Federfarma, the national federation representing some 16,000 pharmacies and local associations, resorted to practices that denied competition for parapharmaceutical products including eye drops and hygienic products, as well as products used in dental care. Annual sales of these products amount to €3.2 billion. Specifically, the authority claimed that Federfarma had circulated a list of suggested prices to members, urging them to abstain from advertising. In addition, the federation allegedly asked pharmacies to abstain from making home-deliveries, a service that could have established loyalty with customers. Federfarma responded to the allegations by saying that the ruling needed careful study and, while it did not rule out possible appeal, insisted that it had suggested that members keep prices low for the benefit of consumers. Consumer associations said the ruling should mark the beginning of the liberalisation of the sale of OTC products, at present, confined to pharmacies. The OTC industry sees pharmacists as a key partner in dispensing advice to consumers. Sophie Marland and Hilmi Toros

Trading regulations

Community pharmacies fear the onslaught of retail giants
THE TASMANIAN BRANCH of the Pharmacy Guild of Australia has urged the Australian government not to allow unrestricted trading on Sundays, believing that it will lead to hundreds of job losses. The government has been told by the National Competition Council to deregulate trading hours by the end of the year, or show why it is not in the public interest. The Pharmacy Guild said that Sunday trade is largely the will of the large retail chains and a “continuation of the quest to expand their empires at the expense of small and local retailers”. It said it called upon the government to stop the “bullying” by these large chains and to “stand up for Tasmanian interests”. In support of trading hours as they currently stand, the Tasmanian Small Business Council said Sunday trade would create a situation “similar to that left by Ansett’s demise, with a lack of competition and choice leading to higher prices”. Community pharmacies are desperately trying to fight off the onslaught of the large retail chain stores. Legislation was due to be implemented in Australia by the Australian Capital Territory (ACT) government this year to stop supermarkets swallowing up community pharmacists. However, the implementation of the Pharmacy Act 2001 has now been delayed after the ACT government was informed that the Legislative Assembly may not have the power to make the law. To make the legislation possible, it may be necessary for the Commonwealth government to amend the ACT Act of 1988, which enabled self-government in the ACT. This is likely to result in yet further delay.
Student pharmacists lacking basic facts
A survey published in the March issue of the Journal of Nutrition has revealed that 55 per cent of students enrolled on a university pharmacy programme were unable to state what the recommended daily allowance is for folic acid. The survey, conducted by Midwestern University in the US, looked at 98 students over a three-year period. Whilst 94 per cent were able to identify the role of folic acid in preventing birth defects, only 58-65 per cent knew of a good food source for the nutrient. According to the researchers, students will need to learn these details, if they are to counsel women effectively after graduating.

Results

Low exchange rate dampens South American expansion
ARGENTINIAN-BASED drugstore chain Farmacias Ahumada said sales in 2001 increased by 23.8 per cent over the previous year to 289,772 million Chilean pesos (£309.7 million, $441.4 million). Income also increased, up by 53.3 per cent to 6,580 million pesos, however, as a percentage of sales, this represents an after tax gain of just 0.5 percentage points, up to 2.3 per cent, compared with 1.8 per cent in 2000. Income in the last quarter of 2001 fell in comparison to the same period in
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2000, which the company attributed to the effect of the lower exchange rate and non-recurring expenses. The low exchange rate’s effect on sales for the whole year resulted in consolidated sales of 71,424 million pesos. Strong performances were seen in Peru, where sales grew by 27 per cent and Brazil, by 21 per cent. The company opened 11 new stores in Peru this year, and a further 33 in Brazil, bringing the total number of operations to 369 across 60 cities in South America.

20 March 2002 5

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OTC Business News

MARKETING NEWS Restructuring

Bayer divests household insecticides in bid to create “new Bayer”
GERMAN-BASED BAYER AG plans to divest its Household Insecticides Business Unit, which is part of the Consumer Care Business Group, as part of its restructuring programme. The company is in the process of transforming into a management company with legally independent subsidiaries. The company said that the insecticides business, which comprises the Baygon insecticide and Autan repellent brands, is no longer a good fit with the rest of the group. Bayer wants to concentrate on the research, manufacturing and marketing of human and animal healthcare products, which it describes as its core competencies. The insecticides business generated around €400.0 million (£248.0 million, $353.5 million) in revenues during 2001, making it the global number two in its market segment, according to Bayer. However, its limited product range would seem to be somewhat of a hindrance for the company. A spokesperson for Bayer told OTC Business News the insecticides business had to compete against other companies that generate billions of dollars from broad product ranges. Despite being number two in the market, he said, these two products were “isolated”, adding that Bayer had “no power regarding product placement in stores”. The company feels that, whilst it is in a strong position in Asia and Latin America, it lacks the critical mass to capture market share from its larger competitors in the North American and European markets. In a statement, it said, “Bayer would need to invest heavily to continue growing this business and, as such, investment is not planned in view of the focus on other major areas in the future portfolio of Bayer Healthcare.” Bayer admitted that it had to contend with “problems and challenges on an unprecedented scale” in 2001. The pharmaceutical business experienced a number of problems and poor performances in the polymers and chemicals business areas it attributed to the weakness of the economy. Bayer’s management board chairman, Manfred Schneider, said the numbers were “sobering”. Group sales declined by 2 per cent to €30.3 billion, while operating profit dropped by 51 per cent to €1.6 billion and net income declined by 47 per cent to €965.0 million. Despite this, the loss of the insecticides business is unlikely to leave too much of a hole in revenue. Performance in the Consumer Care Business Group was strong in 2001, with sales of €2.1 billion, an increase of nearly 9 per cent over figures for 2000. Combined OTC and prescription revenues from Aspirin, the consumer care’s most prominent product, alone amounted to €723.0 million Bayer’s spokesperson refused to comment as to whether any company had yet expressed an interested in purchasing its insecticides business. However, he said that there were a number of companies with existing household businesses in excess of $2.04.0 billion, with significant market share and a broad product range within which Baygon and Autan would sit comfortably. The market leaders in the household products sector include the likes of FC Johnson, Reckitt Benckiser and Sara Lee. However, he said that equally, with the business being “number two” in its market segment, it might suit a company looking to enter the market for the first time. Dr Schneider said the products would have better growth prospects within a company specialised in such products. “To a suitable purchaser,” he said, “the business offers significant potential for expansion, especially at the regional level”.

Expansion

Baidyanath invests in FMCG brand
BAIDYANATH AYURVEDIC, THE Indian company that manufactures over 700 ayurvedic products including health food supplements, herbal teas and hair oils, is to expand into the fast moving consumer goods (FMCG) sector with the acquisition of the Puma skin and hair care brand. It has acquired the brand from Nagpur-based export company Puma Herbal Products for an undisclosed sum and intends to market the product under a newly floated subsidiary company called Ayurvedananta. This is a departure from the company’s somewhat traditional offering of ayurvedic products, which it has manufactured since 1917, but 6 20 March 2002 follows in the wake of Indian companies Himalaya and Zandu, both which have also recently expanded their product range into the FMCG sector. An analyst for the FMCG sector said the acquisition made sense. He said, “As long as the company has not overspent on buying the brand, it makes sense for [players such as Baidyanath] to make an entry into this industry without the hassles of having to create an in-house brand.” But a lot depends on the investments the company has made for its FMCG foray, the analyst added. Baidyanath is clearly determined not to rely solely on its strong OTC distribution network of 700 distributors with a reach of 100,000 retail outlets, but to create a strong brand presence for Puma. It is using a female celebrity to endorse the brand and strengthen brand recall. Mr O Khanduja, general manager, sales and marketing Ayurvedananta, said that with strong ayurvedic credentials, the company would like to launch an “urban brand”. There are plans to expand the Puma franchise into therapeutic lifestyle products. However, he said, “we do not intend benchmarking ourselves with any FMCG giant, but want to go slowly into the business”. Current “pure and herbal” offerings under the Puma brand include a shikakai shampoo, creams for skincare and foot care and an antiseptic cream. Vimta Govind

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Marketing News

Smoking cessation

OTC patches in isolation not the solution
A JOINT SURVEY between Cancer Research UK and ASH, the antitobacco lobbying group, has found a yawning gap between smokers’ “wildly over-optimistic expectations of future quitting” and reality. However, according to John Banzhaf, executive director of ASH in Washington, US, using nicotine patches or gum on their own is not the answer to giving up. Of nearly 1,000 smokers questioned in the UK, as many as 80 per cent of 16-29 year olds said they would quit smoking within ten years. Yet, only one or two per cent of people actually manage to quit in any given year, despite as many as 25-30 per cent of smokers trying to give up, Martin Jarvis, principal scientist at Cancer Research UK, told OTC Business News. The difficulty of the task is born out by the high levels of regret shown by older smokers. More than 90 per cent of 45-64 year-old smokers wish they had never started. “This delusion gap probably reflects wishful thinking more than hard headed calculation,” said Professor Jarvis. However, it does tend to confirm that most smokers have a desperate desire to be rid of tobacco, he added. Mr Banzhaf said the problem is one of ritual. Whilst nicotine addiction is a very obvious problem to overcome, it is the “psychological habituation” – where smoking becomes part of a person’s daily routine – that makes it doubly hard to quit. “Even if somebody could wave a magic wand and totally eliminate the addictive element, he said, “it’s awfully difficult for somebody who smoked two packs a day for 20 years to suddenly put it down and give up all that ritual”. Doctors need to take a multipronged approach to help their patients quit, Mr Banzhaf suggested. “It isn’t enough to tell smokers to use nicotine patches or gum and send them on their way,” he said. Nevertheless, it is clear that the overthe-counter availability of nicotine replacement therapies (NRTs) such as nicotine patches and gum is an important weapon in the fight against smoking addiction. Clive Bates, director of ASH in the UK said that the study results should add urgency and a professionalism to quit attempts and encourage people to go into pharmacies and purchase over-the-counter nicotine replacement therapies. Ultimately, the results proved how important it was to promote help for smokers to quit, Doreen McIntyre, chief executive of “No Smoking Day”, said. “It is tempting for smokers to believe that quitting will just somehow happen sometime in the near future, but the truth is that it will not until they start taking action.”

Consumer behaviour

Product launch

Consumers choose “safe” supplements over Rx drugs
A REPORT BY ConsumerLab.com, which provides independent evaluations of nutritional supplements, has found that 33 per cent of people choose to take vitamin or nutritional supplements because they are concerned about the potential side effects of prescription drugs. Of 3,226 people questioned by Harris Interactive in the US, a further 25 per cent believed prescription drugs were not safe. Just 4 per cent of people found the cost to be a prohibitive reason for avoiding prescription drugs. Use of vitamin and nutritional supplements was highest in the treatment of general health. Some 53 per cent took supplements for colds and 29 per cent for lowering cholesterol. Only 36 per cent had used a prescription medication to treat or prevent a condition for which they used a supplement. Prescription use was highest where supplements have been shown to be least effective, such as in the treatment of asthma. Some 87 per cent of
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respondents had treated asthma with a prescription drug. Between 63 – 97 per cent of people reported being satisfied with the brand of supplements they used, with “perceived quality of ingredients” the deciding factor. Most popular amongst consumers was the Nutrilite brand, with Nature’s Way and Puritan’s Pride brands next most popular. In another report by ConsumerLab.com, 24 out of 26 nutrition powders and drinks met their label claims for carbohydrates, fats and proteins. This is in contrast to the results of a report which six months ago found 60 per cent of nutrition bars did not reveal the full carbohydrate content to consumers. The two nutrition powders, which ConsumerLab told OTC Business News it preferred not to name, failed due to the presence of stevia, a non-sugar sweetener which has not been approved for food use in the US due to inadequate safety data. The stevia content was labelled as a food, when it should have been labelled as a supplement.

OTC allergy test may reduce dependence on steroids
A £10.00 ($14.30) ALLERGY test kit has been launched by UK company Clinical Diagnostic Chemicals (CDC) to enable asthma sufferers to quickly self-diagnose their sensitivity to the most common allergens around the house. The company believes that the Imutest kit, which is available over the counter in supermarket pharmacies such as Sainsbury’s and Asda, as well as Pharmacy2U and Weldricks, may reduce patients’ dependence on prescription drugs such as steroids and improve their quality of life. John Rees, the scientist who developed the product, said, “The evidence is that asthma and allergy are closely linked so it makes sense for asthma sufferers to undergo testing to find out if allergy plays a part in their illness.” According to CDC, house dustmites are the most common trigger – affecting up to 85 per cent of sufferers. Cats may also be the cause of 43 per cent of asthmatic cases, it said. 20 March 2002 7

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Marketing News

OTC Business News

Dietary supplement

Campaign tool

Product launch addresses gap in US sleep market
NATROL, MANUFACTURER OF dietary supplements, has launched a new product designed to treat the number one cause of lack of sleep in the US – stress. Natrol Stress Complex contains vitamin B, melatonin and valerian. According to the company, vitamin B plays a crucial role in stress management, whilst valerian supports relaxation and melatonin reduces the amount of time it normally takes to get to sleep. Elliot Balbert, president and chief executive officer of Natrol feels that products on the market in the US are not properly addressing the problem of lack of sleep. He said that despite a myriad of products, “over 100 million Americans still experience problems with a restful night’s sleep, and the number one cause of this is due to stress”. Natrol hopes that the product will be seen both as an aid to stress and as a sleep aid, thus straddling two markets. Mr Balbert said that the Natrol Stress Complex offered the consumer “a higher value” than traditional sleep aids or stress related products”. The product is available throughout the US and will be supported in September 2002 by a national media campaign.

Men educated about thrush
PFIZER IS TO supply pharmacies with educational literature for patients and pharmacists to grow awareness of penile thrush. This campaign is to accompany the new indication of Diflucan One oral thrush treatment, which is now licensed for pharmacy sale for use in men, as well as women. Occurrence of the complaint, known as balantis, is less common than vaginal thrush in women. However, as thrush can be sexually transmitted, Pfizer said the new indication meant that men could use the treatment alongside their female partners. The campaign’s aim is to reduce embarrassment surrounding the condition.

Products and patents

News in brief
Reliv receives patent for anti-ageing supplement

Manufacturer of nutritional supplements Reliv has received a patent from the US government for Reliv ReverseAge, an anti-ageing supplement that it developed in 2000. ReverseAge is comprised of three proprietary complexes in a powdered supplement. According to the company, regular use of the supplement can yield “noticeable results month after month”.
Nutrition 21 receives patent for osteoporosis supplement

potential implications for the treatment of osteoporosis, as well as other conditions and injuries affecting bones and joints.”
Fujisawa launches two new OTC skin products

US company Nutrition 21 has received a patent from the US government for the use of an arginine-silicate-inositol complex as a dietary supplement to “promote bone and cartilage formation, to increase bone density and to promote the healing of bone fractures”. According to the company, Arginine is an amino acid that is a precursor of nitric acid, an anti-inflammatory with bone and joint health benefits. Silicon, it said, has been shown in studies to enhance growth and development of bone, cartilage and connective tissue. Gail Montgomery, CEO of Nutrition 21 said, “The uses for our arginine-silicate-inositol complex covered under this latest patent have significant 8 20 March 2002

Fujisawa Pharmaceuticals has announced the launch of two new topical use OTC medicines indicated for the relief of itching of the skin, Eurax Cool Spray and Eurax Cool Liquid. Cool Liquid is a relaunch of an existing product, now available in 50ml packaging, whilst Cool Spray is a new addition to Fujisawa’s existing Eurax brand dermatological product line. The products contain crotamiton, the main ingredient of the Eurax series, as well as lidocaine as an anaesthetic, diphenhydramine as an antihistamine and isopropylmetylphenol as a bactericide.
Natural herb the “safest product on the market” for smoking cessation

to “physically address the act of smoking”. Depending on the individual, it said, the lozenge will inhibit nicotine addiction for 4-6 hours and “repeated use of Nicodrops lozenges in place of cigarettes will eventually repel the nicotine addiction”. “Most people that quit after a month are unlikely to go back to smoking because their desire is non-existent,” said Nicodrops.
Japanese toothpaste twice as effective

California-based Nicodrops has said its mint-flavoured herbal lozenze, designed to break the nicotine habit without using nicotine, is probably “the safest product on the market” because it contains no nicotine and only natural herbs. The company claims that the sucking action of a lozenge in the mouth works as a pacifier for smokers

Japanese company Kao has developed a toothpaste which it says can double the amount of fluoride and minerals absorbed by teeth, when compared with existing toothpastes. Minerals absorbed from saliva help to prevent tooth decay. When minerals cannot replace those lost from teeth, decay sets in. Kao’s toothpaste contains two types of fluoride which help the teeth absorb minerals and prevent cavities forming. Kao said it plans to launch the product in April 2002 and expand its current 20 per cent share of the toothpaste market in Japan. However, the launch of the product will require novel design. The fluorides become less effective if mixed, so the tube will require two chambers, allowing consumers to mix the two immediately prior to brushing.

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POLICY & REGULATORY AFFAIRS Legislation

Policy & Regulatory Affairs

MEPs vote to standardise vitamins industry
THE EUROPEAN PARLIAMENT has voted in favour of new legislation governing the sale of vitamins and minerals. The new rules require manufacturers to submit evidence on the safety and efficacy of their products within the next three years, in much the same way as is required of pharmaceutical manufacturers with drug applications. The legislation is part of an increased effort by the European Commission to control a largely unregulated industry and standardise labelling on food supplements, following growing concern over the long-term effects of taking high doses of vitamins and minerals. The legislation has generated concern among manufacturers of high dose vitamins and minerals, not least in the UK. At present, any supplement can be sold in the UK, provided it has not been shown to be harmful. However, in France, the situation is quite different; only products that do not exceed the recommended daily allowance may be freely sold. Those exceeding the limit must be sold on prescription. If the commission establishes that the sale of supplements should be restricted in line with French limits, as many as 300 products in the UK could become classed as prescription drugs. There has been considerable opposition to the bill by producers of vitamins and minerals. At the court in Strasbourg, activists accused European commissioners of colluding with pharmaceutical companies, who are keen to gain some control over the increasingly popular supplements business. And according Mary Coronel, spokesperson for the AEGSP, the association representing the European self-medication industry, there have been a lot of last minute attempts by vitamin manufacturers to gain the support of Members of European Parliament to rally against the legislation. Several British MEPs have spoken out against the legislation. Liberal Democrat MEP Sarah Ludford described the proposals as “over-thetop”. And Chris Davis, another Liberal Democrat MEP, said the legislation on vitamins is like using a sledgehammer to crack a nut. He said, “These are not dangerous pharmaceutical drugs – they are food supplements which people use to supplement deficiencies in their diets. If people want to exercise free will, they should be allowed to do so.” However, studies have suggested that there are dangers associated with a high intake of vitamins. In a recent study in the US, the Nurses Health Study, a link was established between high levels of vitamin A and an increased risk of osteoporosis in menopausal women, leading the authors to suggest that “the amounts of retinol in fortified foods and vitamin supplements may need to be reassessed” (see OTC Business News, 9 January 2002, page 10). The Council for Responsible Nutrition dismissed the study for being misrepresentative of the population at large. The European consumer group Consumers for Health Choice believes that the restriction on the use of vitamin and mineral supplements could be denying consumers benefits to their health. Sue Croft, director of the group said, “It took successive governments 17 years before recognising the benefits of folic acid in lowering the risk of neural tube defects. Widely accepted studies also link moderate amounts of vitamin E with a lower risk of heart disease. There must be dozens of other supplements, including minerals such as boron – which is linked with bone health and which may no longer be permitted in supplements – that could be proved to have specific benefit.” However, Ms Coronel told OTC Business News that imposing some form of legislation on the vitamins industry was inevitable. “There is no common market for these products – in some countries they are classed as foods, in others as prescription products.” Contrary to some manufacturers, the AEGSP does not see the legislation as a “clampdown on vitamins”. It said a lot of products did not meet standards of legislation applied to other forms of food and many made unsubstantiated claims, which are not backed up by hard evidence. “We want to make sure there’s a level playing field – certain standards according to good manufacturing practice, as in the pharmaceutical industry,” said Ms Coronel. Having said that, “this new legislation is not absolutely ideal,” she added. However, the AEGSP and its members are “generally in favour” of regulating food supplements. Trevor Jones, from the Association of the British Pharmaceutical Industry (ABPI) agreed. The ABPI supports the idea of legislation being brought in to ensure that the products that will do [consumers] some good are understood and rational, he said. This legislation comes out of a “genuine desire to ensure that the products that people buy are safe and effective,” added Mr Jones.

Group recommends positive action on switching
Existing switch mechanisms should be reviewed to secure the development of a competitive non-prescription medicines market in the European Union. That is one of the recommendations from a meeting of the G10 Medicines Group, the group brought together by the European Commission to examine how best to enhance the competitiveness of the European pharmaceutical industry. The group suggested that for medicines whose indications are currently under prescription, but which are potentially suitable for selfmedication, a regulatory switch mechanism should be in place encompassing appropriate safety measures. It also said the use of the same trademarks for medicines reclassified to non-prescription status was acceptable as long as full account is taken of safety requirements to clearly distinguish between prescription and non-prescription versions of the same medicine. The group also looked at price regulation in the industry, recommending that authority to regulate prices in the EU should extend only to those medicines purchased by, or reimbursed by, the State. For medicines not reimbursed by state systems, the group believed that as a matter of principle, they should be open to full competition. It said this would not undermine the existing right of member states to establish which medicines they chose to reimburse, but might help to establish a viable market outside the state sector for some medicines.

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Legislation

Bill aims for nationwide OTC availability of EHC in US
PROPOSED LEGISLATION has been introduced in the US by pro-choice members of the Senate and the House of Representatives to promote the awareness of emergency hormonal contraception (EHC). According to Senator Patty Murray, the main sponsor of the bill in the Senate, just 12 per cent of women in the US are aware that EHC is available. Under the proposal, $10 million (£7 million) would be provided to the Centres for Disease Control and Prevention for a campaign targeted at women and their doctors over the next five years. Manufacturers of EHC and advocacy groups have welcomed the bill, which they said would serve to assist in promoting their message about the benefit and safety of EHC where they were unable to do so. Pamela Long, a spokesperson for Women’s Capital Corporation, which distributes Plan-B in the US, told OTC Business News, “WCC is not a large pharmaceutical company and it does not have the financial resources to sustain a campaign aimed at raising awareness of EHC.” The US has been much slower than other countries, particularly those in Europe such as France and the UK, to publicly discuss the use of EHC, otherwise known as the “morning after pill”. In France and the UK, EHC is widely available over-the-counter in pharmacies, whereas in the US, it is only available over-the-counter in two states – California and Washington. Kirsten Moore, Project Director at the Reproductive Health Technologies Project, a reproductive freedom advocacy group in the US, told OTC Business News that reproductive health in the US was still largely seen as a “private” health matter, something that is discussed between partners behind closed doors. Where discussion does come into the open, she said, there was a certain stigma attached to girls who “needed” EHC. Abortion politics too have played a role in keeping discussion suppressed, with pro-life supporters suggesting links between EHC and abortifacients. However, Senator Murray said, “This is not an abortion bill and, in fact, it would reduce the number of abortions.” According to Senator Murray, and Louis Slaughter, who is sponsoring the bill with Democrats and moderate Republicans in the House Pro-Choice Caucus, their aim is to see nationwide over-the-counter availability of EHC. “That is obviously the goal we have in mind here,” said Mr Slaughter. However, Ms Moore was sceptical as to whether the bill would actually be passed. She said, “There is no actual calendar for the bill and I would not assume it will go through. It is possible, because it is so rational from a public health and policy point of view. But it is by no means a certainty.” In light of the bill not being passed she added, “It is up to medical and advocacy groups to maintain their pressure on the government.” A more optimistic Ms Long said, “Hopefully the campaign will have women starting dialogue with their GPs or their pharmacists.”

Public funding

Australian government lobbied over funding for adverse effects research
THE AUSTRALIAN MEDICAL Association (AMA) is calling on the Australian federal government to provide A$1 million (£368,541, $525,207) in research funding to evaluate the potential benefits and adverse effects of complementary medicines. AMA president Kerryn Phelps said general practitioners were seeing increasing numbers of patients who were using complementary medicines. “For the best possible health outcomes, it is important that doctors and patients are fully informed on the health claims of these medicines and alert to any possible side effects when used with prescribed medications,” she commented. In the interests of best practice patient care, Dr Phelps said it was vital that all complementary medicines were backed by solid evidence on their safety, quality and efficacy. “Evidence is the key to a constructive and forward-looking joint approach 10 20 March 2002 involving both mainstream and complementary practitioners,” she said. The AMA has adopted a progressive policy on the use of complementary medicines, which accepts that evidence-based aspects of complementary medicine are part of the repertoire of patient care. The association says medical schools should begin teaching student doctors about the use of alternative therapies, and it says general practitioners must also begin questioning patients about their use of such products during consultations. The Australasian Integrative Medicine Association said more than 50 per cent of Australians used complementary medicines, and the AMA’s call for doctors to be better educated about the therapies was long overdue. The AIMA said Australians now spend more on complementary medicines than they do on prescription drugs. Cheryl Norrie

Study links herbal use with illegal substance abuse
A study by the University of Rochester School of Medicine in New York has suggested that high school students who use herbal supplements are more likely to take illegal drugs. The study was based upon the Youth Risk Behaviour Survey, which is an annual survey given to adolescents in the US. Susan Yussman and other researchers added one question to the survey to a sample of students living in Monroe County in New York to ascertain whether supplement use was a factor in adolescent risk behaviour. Of 2,006 students, 29 per cent had used herbal supplements to improve their performance at school, or to feel better. The results also showed that those students were nearly six times more likely to use cocaine, and nine times as likely to use heroin. Dr Yussman said that it seemed the group of teenagers was a particularly experimental group. In wider studies, results are not expected to be as extreme.

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Policy & Regulatory Affairs

Increasing drug availability

UK trials “Morning-after-pill” for free
EMERGENCY HORMONAL contraception (EHC) will be made available free of charge in the west of England to girls under the age of 20, as part of a government pilot scheme aimed at preventing unwanted teenage pregnancies. This comes just over a year after EHC was made available over the counter in the country. The UK government announced in January 2001 that it would leave the decision as to whether pharmacies charged for EHC in the hands of regional health authorities. Whilst EHC is available free of charge on prescription, most women are required to pay around £20 ($28) to obtain the product over the counter. This latest scheme is being funded by the local health authority in North Somerset and EHC will be available from Weston-super-Mare and Clevedon stores of retail giant Tesco. The stores have been chosen for their accessible locations and long opening hours. Tesco has said that pharmacists have been specially trained to carry out this work. All applicants for this form of contraception must take part in a detailed interview with one of its pharmacists and the company stated, “only when they meet the necessary criteria” will the medication be issued to them. The North Somerset Teenage Pregnancy Clinic is also taking part in the scheme, offering teenagers advice on pregnancy and sexual health. In answer to critics of EHC, who believe increased availability will encourage teenagers to have sex, Simon Bilous, who works at the clinic, was keen to stress that making EHC more easily available was only one part of a much larger scheme aimed at reducing unwanted pregnancies. “All our work is in the context of encouraging young people to say “no” if they do not want to have sex and only to engage in sexual activity if they feel ready for it,” he said.

Regulation harmonisation

NZ Green party resists Australasian merger for supplement regulation
NEW ZEALAND’S GREEN Party is to fight plans to transfer the regulation of dietary supplements and herbal medicines marketed in New Zealand to a joint Australian/New Zealand therapeutic goods regulator. Both the Australian and New Zealand governments have agreed in principle to set up a joint agency to regulate medicines, medical devices, and complementary medicines. However, Green Party health spokesperson Sue Kedgley said she feared a joint agency would adopt Australia’s tougher stance on complementary medicines – and require all ingredients to be approved and licensed – a process which can cost up to NZ$10,000 (£3,063, $4,365) per ingredient. Dietary supplements are considered to be foods in New Zealand and do not require registration. Ms Kedgley said any move to adopt the Australian system would reduce consumer choice, forcing some dietary supplements to be taken off shelves and increasing the price of others. “Around 200 ingredients can be used in dietary supplements in New Zealand, but not in Australia. If the government pushes its plans through, it is almost inevitable that these same ingredients will not be available here because of the expense and difficulty in getting them approved and licensed,” she said. The joint agency proposal has split the dietary supplements industry in New Zealand, with some companies fearing any increase in regulation could force them out of business, while others welcome the move towards harmonisation. At a recent conference in Auckland, 80 participants agreed to oppose the move towards a joint agency, forming an action group to lobby the government on the issue. Cheryl Norrie

Compensation

Avanir hopeful of patent extension on Abreva
S AN D IEGO - BASED Avanir Pharmaceuticals has said it is hopeful of an extension of the patent on its over-the-counter cold sore treatment to the maximum allowable time of five years, after the US Food and Drug Administration (FDA) determined that the time elapsed between Avanir gaining the patent on the drug and market authorisation had exceeded five years. If the extension is accepted, the patent will be extended until 2014 and Avanir can
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expect to receive substantially increased revenues in royalties from GlaxoSmithKline, to whom Abreva is licensed in the US. In February 2002, Avanir attributed a 21 per cent rise in sales for the first quarter of 2002 to royalties of $1.1 million (£771,875) received from GlaxoSmithKline. The company said it expected to receive further royalties during 2002 of $3.3-4.5 million (see OTC Business News, 20 February 2002, page 3).

The extension falls under the Drug Price Competition and Patent Term Restoration Act of 1984, which states that a patent may be extended for a period of up to five years to compensate for the time taken by the FDA to conduct a regulatory review prior to the product being marketed. The FDA has determined that Avanir’s patent term should be credited for a total of 3,270 days including time spent in the testing and regulatory review phases. 20 March 2002 11

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OTC Business News

Emergency hormonal contraception

WCC applies for OTC switch of Plan-B in Canada
US- BASED W OMEN ’ S Capital Corporation (WCC) has submitted an application to the Canadian regulatory authority, Health Canada, to switch its emergency hormonal contraception, Plan-B, from prescription-only to over-the-counter status. The application, which is co-sponsored by WCC’s Canadian distributors Paladin Labs, the Society of Obstetritions and Gynecologists of Canada and the Canadian Pharmacists Association, comes less than two years after Health Canada first approved the drug for prescription-only sale. WCC has requested a priority review which, it hopes, will see approval within one year. Under the new proposals, Plan B would be available without prescription in pharmacies in Canada, provided it was sold from behind the counter. It is currently available on prescription from pharmacies in British Columbia, Quebec and outside Ontario. Sharon Camp, president of WCC said, “Approval of the application will be a major breakthrough for Canadian women. Allowing more women timely access to emergency contraception is vital, since they only have 72 hours to act after unprotected sex.” The application was accompanied by European post-marketing safety studies, as well as the results of a labelcomprehension study involving nearly 600 US women. According to Ms Camp, the results showed that between 80-98 per cent of women understood the drug’s labelling. She added, “Based on the results, we are confident that women including minorities, lowincome and underage women will be able to use [Plan B].” In support of Plan B’s application for over-the-counter status, Elizabeth Raymond of Family Health International said that the drug met all the essential criteria expected of an over-the-counter product. She said, “It is literally safer than aspirin.” Pamela Long, a spokesperson for Women’s Capital Corporation, told OTC Business News that WCC expected to make a submission for over-the-counter switch of Plan B in the US by the summer. The company had hoped the switch would be approved early last year, when around 70 medical organisations filed a petition with the US Food and Drug Administration. However, because the US does not allow “behind the counter” sales like Canada, where OTC sales may be supervised by a pharmacist, the FDA, according to WCC, required additional information based on a mimicked actual use study.

In brief

Policy news
DIETARY SUPPLEMENT trade organisations in Hong Kong, Poland and Hungary are to join the International Alliance of Dietary/Food Supplements Associations (IADSA). Membership of IADSA, which aims to represent the views of national associations and their members in “shaping policies that affect dietary supplements”, is now up to 38 associations, across 29 different countries. According to IADSA, this represents more than 9,000 manufacturers and distributors of dietary and herbal supplements. Randy Denin, chairman of IADSA said, “National controls are not enough if the world’s consumers are to have equal access to the choice of food supplements and if producers are to meet that requirement efficiently and safely.” California-based Leiner Health Products is recalling 14,000 bottles of its dietary supplement Nature’s Valley Women’s Formula Multivitamin as a preventative measure, after it was discovered that they lacked child-resistant packaging, as required under the Poison Prevention Packaging Act. The 12 20 March 2002 iron in the tablets poses a potential hazard to young children. The bottles being recalled were sold between July 2001 and February 2002. The packaging for products sold since February is child-resistant. The US Pharmacopeia (USP), the non-government organisation that establishes standards on the quality of medicines, has agreed in principle to test a children’s chewable multivitamin that will be used in the Healthy Foundation’s congressionally funded research programme. The programme, which will begin towards the end of 2002, will measure the effect of low-dose vitamin-mineral supplements on academic performance and behaviour in several thousand at-risk schoolchildren in the US (see OTC Business News, 6 February 2002, page 11). Meanwhile, US manufacturer of Nature Made vitamins and dietary supplements, Pharmavite, is to become the first participant of USP’s Dietary Supplement Verification Programme (DSVP). The programme is designed to build consumer confidence in dietary supplements by analysing products and manufacturing facilities for quality and integrity of ingredients. Pharmavite said it anticipated that products featuring the DSVP verification mark would be on retail shelves in the fourth quarter of 2002. A Federal Court ruling in Australia has allowed a multi million dollar class action against a group of vitamin manufacturers to go ahead, despite applications from those manufacturers to be removed from the action. Justice Ron Merkel said that certain companies in the Hoffman-La Roche, Aventis Animal Nutrition and BASF groups had been involved in price fixing and market sharing arrangements in the 1990s. The European Commission has already brought record fines against some of these companies (see OTC Business News, 5 December 2001, pages 10 & 11). The action is being brought in Australia on behalf of people who bought vitamins, foods and other products from the companies between March 1992 and July 1999.

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E-HEALTH Comment

E-health

@
manufacturers should be well used to security. “They’ve always had to be careful with clinical data and drug espionage has always been a problem.” However, with information on the Internet, people panic. “The truth is that a doctor with medical information on patients in his or her briefcase on the back seat of the car is likely to pose a greater security risk,” said Ms Singh. In the same way, consumers shopping online worry about the security of their credit card details, when handing a credit card to a store assistant is just as much a risk, if not more. You cannot guarantee the integrity of the shop assistant. “What people are scared of with the Internet, however,” said Ms Singh, is that “a security breach is global. With an analogue breach, it is localised.” So how does an e-health site convince the consumer that information he or she chooses to submit will be treated in confidence and be kept secure? Accreditation has been suggested as one answer, however, Ms Singh believes that, whilst there are merits to standards such as the American Healthcare Commission’s (URAC), to which sites such as WebMD and InteliHealth subscribe, there are limits to which accreditation can go. She said there were too many bodies to create a standard. Really, she said, “you can only judge by past performance, not future potential.” Ultimately, she said, that will boil down to brand presence; “quality of brand will be the largest determinant of trust”. Brand performance is “everything”, said Ms Singh. And since brand is created with money, she continued, pharmaceutical manufacturers are always going to be the dominant players when it comes to creating trust. Procter & Gamble is one example of a company that has learned how to build trust amongst its consumers. “Procter & Gamble can tell exactly what Mrs X buys, drives and does at the weekend. Pharmaceutical manufacturers cannot do that yet, and the Internet provides the key,” said Ms Singh. She believes pharmaceutical companies have a lot to learn from Procter & Gamble. “Procter & Gamble is a brand portfolio company – it makes absolutely sure that every single product has a strong brand identity and image, even though most consumers may not realise that the product is produced by Procter & Gamble,” she said. That Procter & Gamble is lined up to market an OTC version of Prilosec is not insignificant. Prilosec, which Procter & Gamble announced earlier in the month that it hoped to switch overthe-counter by the end of 2002, is a brand in its own right. Many consumers may not realise that the patent is held by AstraZeneca, or that Procter & Gamble markets the product. Yet, it is the world’s largest prescription drug with a loyal following. Ultimately, this is a very new business for the pharmaceutical industry. “For hundreds of years, pharmaceutical manufacturers have been marketing to doctors,” said Ms Singh, “so they only ever had to concentrate on clinical details and performance”. However, now, she said, products are marketed direct to the consumer and that means spending billions of dollars over just a couple of years. “This is a five-year old industry – volume has led maturity,” she said. Only now are the pharmaceutical manufacturers beginning to learn how to integrate Internet technologies with brand development to interact and engage with the consumer and build trust. Ms Singh is optimistic however. “Don’t mistake the delay in adoption – timing does not equal significance: there’s a lot to gain from being second; a lot to lose by being too early.”

Security is key, but brand presence builds trust
HEALTHCARE COMPANIES will soon be spending as much as 10 per cent of their revenue on Internet technology, matching the spend of the financial services sector, where technology adoption has traditionally been more widespread. However, according to Simmi Singh, senior vice president of Silverline Technologies, companies that spend wisely on security will be the most likely to achieve success in the eWorld. “The single most important issue for healthcare companies to address in the implementation of Internet technology is security. The minute you go to distributive computing, you compromise your security,” said Ms Singh. In the past, a company information officer asking for the sort of money required to harden a network would have been laughed at, however in healthcare, they are now starting to realise the significant legal implications of not being “secure”, she said. In August 2000, Kaiser Permante, one of largest health insurers in the US mistakenly sent 858 e-mails, featuring correspondence from online nurses and pharmacists, to the wrong members. Although just 19 members in total were affected (some e-mails consisted of hundreds of messages), some of the emails contained sensitive personal medical advice, including information in response to a member’s question about a sexually transmitted disease. Officials at Kaiser said that the mistake was due to human error in conjunction with a technical glitch. “This is not a security breach of our Internet service,” Kaiser spokeswoman Beverly Hayon said. “This is accidentally sending e-mails to the wrong people.” Despite this, the company said that it had made some adjustments to its website to fix the problem, including changing the protocols for sending out e-mails. Ms Singh said that pharmaceutical

Targeted e-offers build relationships with customers
Reckitt Benckiser is adding value to its home care and health products by offering coupons, sweepstakes, tips and advice to customers in the US and the UK over the Internet. The household cleaning and healthcare products company is using a technology platform from US company e-centives, to enable it to build multiple brand websites and develop personalised consumer e-mail newsletters, as well as track data and analyse the success of campaigns. The partnership with e-centives is designed to help Reckitt Benckiser understand how its brands fit into consumers’ lives, enabling it to build relationships with customers and drive sales through targeted offers.

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Quality assurance

Health information on the Internet still unreliable
INFORMATION ON HEALTH websites has improved, but according to a number of recent surveys published in the British Medical Journal, a lot of what is available is still unreliable. Three studies, based in the UK, the US and Italy, looked into the quality and authority of information on health websites. The Italian study found that the quality of information had improved. Some 45 per cent of new health pages in 2001 adhered to most of the accepted quality guidelines, compared with just 8 per cent in 1997. However, results from a study by the Women’s Hospital in Birmingham, UK, were less positive. The study looked specifically at websites that provided information on lung disease, ankle sprains, emergency contraception, period problems and female sterilisation. What it found was that websites that provided details on the source and date of the information featured articles that were only slightly more accurate than those on websites that did not display these details. Findings from the University of Texas echoed those from the UK, with regard to the reliability of information about breast cancer. Researchers there found that information on the more popular websites was not necessarily higher in quality than websites with lower profiles. Paul Cundy, a member of the British Medical Association’s Information Technology committee, said it was not surprising that websites ranged in quality. Whilst there were a number of sites, such as those of the American Journal of Medicine and the British Medical Association which he thought were clearly reliable, he said more and more information is being covered, opening up the increased possibility of inaccuracy. Even the NHS, he said, whilst it had been providing information of higher quality in recent years, is now providing information over a much wider subject range, making its task of assuring quality that much greater. Dr Cundy questioned whether we should worry about what is on the web. Obviously there is a potential danger that incorrect information may lead patients to mistreat minor conditions through the wrong choice of OTC medicine. However, he said, “this concept that the more information there is available to patients, the more they will use that to self-treat, in the process reducing doctors’ workloads, is rubbish”. All it has done, said Dr Cundy, is increase doctors’ workloads. “In the past, where a child with a temperature might be brought into the surgery after four days, they are now brought in after just one hour!” he said. Patients do not look at the alternatives and question what else the symptoms might relate to. They may read information on the Internet, establish that their child does not have the symptoms of meningitis yet still think “my child might have meningitis”. Dr Cundy believes the solution is to make patients aware that, whilst there is information out there, not all of it is reliable. The message is not to trust all information and not to make assumptions. Accreditation schemes, such as the standard recently implemented by the American Healthcare Commission (URAC) and adopted by some of the most popular health websites including WebMD, WellMed and InteliHealth (see OTC Business News, 6 February 2002, page 13) are not the answer according to Dr Cundy. “Someone is always going to be able to bypass the scheme or come up with bogus accreditation,” he said. “Accreditation does not keep the financial world at bay. The big pharmaceutical manufacturers will always have the funds to get round it,” he believed. That more than one accreditation scheme had been attempted in the past was evidence enough that they did not work particularly well, he said.
ISP reinforces health content
UK Internet service provider Supanet has teamed up with medicdirect.co.uk, the health website hosted by National Health Service consultants, to provide its customers with a “new look” health channel. Content provided by medicdirect includes instructions on how to perform self-examinations such as checking moles for signs of skin cancer, as well as features on how to assess and improve lifestyle, including smoking cessation. Advice on smoking informs consumers of the options when quitting and explains the benefits of nicotine replacement therapies and other methods. “Nicotine replacement therapy (NRT) increases a smoker’s chances of quitting successfully,” it says and provides consumers with a link to online pharmacy Pharmacy2U, where gum and patches can be bought.

Point-of-care referencing

Doctors check drug reactions on PDAs
US TECHNOLOGY COMPANY Pepid has launched its Portable Drug Companion, a database of information on dosing and adverse drug reactions for over 1,600 drugs, herbal remedies and overthe-counter medicines. The database is updated on a monthly basis and is downloadable from the Pepid website to personal digital assistants (PDAs), such as Psion and Palm palmtop computers, enabling physicians to reference the information whilst making hospital rounds or house calls. According to a recent report in the Journal of the American Medical Association, medication errors are most commonly made in paediatric diagnoses. Over a six-week period, almost 600 medication mistakes were made in the dosage orders of 1,100 underage 14 20 March 2002 patients. Pepid said the study concluded that the majority of errors could have been prevented by better access to information about drug interactions, allergies to drugs and dosing. Pepid said it expected that systems and protocols developed by healthcare professionals to improve patient care would include the use of PDAs more and more. Mark Rosenbloom, chief executive officer of Pepid said, “The development of clinical databases and tools published to handheld devices is the next generation of clinical decision support.” The content for the database has been compiled by a consortium of physicians, pharmacists and pharmacologists and is reviewed by the American Society of Healthcare System Pharmacists.

If you are reading a photocopy of this newsletter please contact Philip Morton to check that you have permission on +44 (0) 20 7017 4095

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OTC Business News
CLINICAL RESEARCH UPDATE Dietary supplementation

Clinical Research Update

Lactase supplementation dries babies’ tears
A STUDY HAS confirmed that intolerance to lactose in milk is one of the principle causes of infant colic, a condition that affects newborn babies between the ages of 3-13 weeks, according to Britannia Health Products, UK manufacturer of Colief Infant Drops. Adding lactase to milk prior to feeding has been found to significantly increase symptomatic benefits for the baby, resulting in reducing crying – one of the tell-tale signs of colic. Lactase is the enzyme in the small intestine that digests lactose, the naturally occurring sugar in milk. A study carried out by the Department of Paediatrics at Guy’s Hospital in London, UK, examined 53 babies who had demonstrated continued crying for three hours per day for three days or more. The results of the study are published in the Journal of Human Nutrition and Dietetics. Of those, formula-fed babies were given bottles of milk pre-treated with the lactase enzyme for ten days, whilst mothers who normally breast-fed their babies were instructed to express their foremilk (which has the highest lactose content) and treat that with lactase. The babies were then given untreated milk for five days before receiving a placebo for another ten days. The results showed that in around a third of all cases, there was a 45 per cent reduction in babies’ crying time. Paul Clayton, one of the study’s authors, admitted that the transient lactose intolerance hypothesis had been tested once before in 1998, but said the trial was so small that its accuracy could not be relied upon. “By using larger numbers and testing breath hydrogen, we were able to confirm that a significant number of colicky babies are unable to digest lactose, leading to bacteriological and metabolic changes in the gut which in turn cause pain and distress,” he said.
Study may have tipped the balance on supplement benefit
The results from a study by the National Eye Institute in the US “may have tipped the balance” in convincing patients of the health benefits of vitamin supplements, according to Thomas Lee, editor in chief of the Harvard Health Letter. The National Eye Institute has discovered that a combination of antioxidants and zinc reduces the odds of patients with a moderate form of the eye disease age-related macular degeneration (AMD) developing a more advanced form of the condition. Over a six-year period, 4,757 participants between the ages of 55-80 were given different antioxidants, including supplements of vitamin E and zinc, either on their own, or as part of a combination. At the end of the study, the combination group showed the lowest chance of the disease worsening – just 20 per cent. Other groups also showed some reduced risk of developing advanced AMD, but at “more moderate rates compared to the antioxidants plus zinc group,” according to the study’s author, Frederick Ferris. Those in the placebo group had the highest risk of developing advanced AMD. Dr Lee said that it was really the combination that made the difference. “Until recently, the evidence that supplements would do any good just was not very convincing. But results from [this study] … may have tipped the balance,” he said.

Dietary supplementation

Folic acid beneficial on heart disease
A STUDY PUBLISHED in the latest edition of the Quarterly Journal of Medicine has suggested that increasing folic acid intake amongst elderly people could reduce the risk of stroke, heart disease and thrombosis. According to researchers at the University of Aberdeen, amounts of folic acid at three times the recommended daily intake have been shown to reduce levels of homocysteine, an amino acid associated with the onset of heart disease. However, too much folic acid can have a negative impact on the amount of vitamin B12 in the body. The British Dietetic Association has said that until improved screening is available to test B12 deficiency, consumers should be cautious about increasing their folic acid doses. Ross Taylor from the University of Aberdeen admitted, “We are not recommending at the moment that people should rush out and start taking folic acid ... [however], this may turn out to be quite important.”

Disease prevention

Painkillers may prevent prostate cancer
A STUDY BY THE Mayo Clinic in the US may have established a link between non-steroidal anti-inflammatory painkillers such as aspirin and ibuprofen and a reduced rate of prostate cancer in men. Researchers have suggested that reducing inflammation may be beneficial to patients, as it has been linked to the development of cancerous cells. Of a sample of 1,362 men examined by researchers over a 66 month period, only 4 per cent of those given painkillers developed prostate cancer. This is compared with 9 per cent, who developed the cancer after not receiving painkillers.
On-line sample copy of this and other related newsletters at www.informa.com

It appeared that benefits of the painkillers were more prominent in older patients, something which has also been found amongst breast and colon cancer sufferers. However, the researchers have said that they need to understand better the relationship between painkillers and prostate cancer before recommending that elderly men use aspirin or ibuprofen as a preventative measure. They acknowledged that there are dangers associated with long-term use of painkillers and said that they needed to determine the duration and dosage use that provided the best protection against prostate cancer.

20 March 2002 15

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Companies/Events

OTC Business News

COMPANIES
Advanced Research Press 3 American Home Products 1 AstraZeneca 13 Avanir 11 Aventis Animal Nutrition 12 Aventis 2 Baidyanath Ayurvedic 6 BASF 12 Bayer 6 Boiron 4 Boots 4 Bristol-Myers Squibb 2,4 Changes International 3 Clinical Diagnostic Chemicals 7 ConsumerLab.com 7 Dr Morepen 3 Farmacias Ahumada 5 FC Johnson 6 Fujisawa 8 General Nutrition Centers 4 GlaxoSmithKline 1,3,11 Himalaya 6 Hoffman La Roche 12 Impax Pharmaceuticals 1 InteliHealth 13,14 Johnson & Johnson 1 Kaiser Permante 13 Kao 8 Knoll Pharmaceuticals 3 Leiner Health Products 12 McNeil Pharmaceuticals 1,2 Medicdirect.co.uk 14 Merck 1 Morepen Laboratories 3 Natrol 8 Nicodrops 8 Novartis 1 Numico 4 Nutrition 21 8 Paladin Labs 12 Parke Davis 3 Pepid 14 Pfizer 2,8 Pharmacy2U 7 Pharmavit 2 Pharmavite 12 PR Nutrition 3 Procter & Gamble 4,13 Puma Herbal Products 6 Reckitt Benckiser (India) 2 Reckitt Benckiser 2,3,6,13 Reckitt Piramal 3 Reliv 8 Rexall Sundown 4 Sara Lee 6 Schering-Plough 1,2 Silverline Technologies 13 SSL International 3 Stryka 2 Sun Pharmaceuticals 3 Supanet 14 Thorton & Ross 3 Twinlab 3 Unicity 4 WebMD 13,14 Weldricks 7 Wellpoint 2 Whitehall-Robins 1,2 Women’s Capital 10,12 Corporation Wyeth 1 Zandu 6

EVENTS
Assocation of the European Self-Medication Industry
Dublin, Ireland, 5-7 June 2002 The new technologies that are fuelling the changes in consumer behaviour and the consumer’s expectation of power and control are obvious. However, less obvious are the changes that are required to the business model. This two-day meeting will seek to examine consumer attitudes concerning information on services around, and access to, non-prescription medicines and other self-care products. For more information, contact AESGP Tel: +32 (0) 2 735 5130 Fax: +32 (0) 2 735 5222 Email: l.gits@aesgp.be

Building a successful brand to attract the OTC consumer
London, UK, 18 & 19 June 2002 The first day of this two-day conference focuses on demystifying the regulatory changes in OTC pharmaceutical sales. This includes understanding and targeting the OTC consumer and looking at ways of building brand. Day 2 looks at RPM a year on, understanding its effects on different market segments. Specifically this involves examining effective pricing strategies for OTC pharmaceutical products and forecasting the future of RPM. For more information, contact Marketing Week Tel: +44 (0) 20 7970 4772 Fax: +44 (0) 20 7970 4797 Email: patricia.mcginnis@centaur.co.uk

World Self-Medication Industry 14th General Assembly & 5th Asia Pacific Regional Conference
Tokyo, Japan, 12-16 November 2002 This event focuses the opportunities and challenges presented by the everexpanding world of self-medication. It will assess the industry from a global viewpoint, as well as taking a closer look at the Asia Pacific region and, in particular, at consolidating regulatory partnerships. Speakers include representatives from regulatory bodies, international health organisations, academia and medical and pharmaceutical circles. For more information contact the registration office of WSMI 14th GA & 5th APRC Tel: +81 3 3263 6474 Fax: +81 3 3263 7537 Email: wsmireg@ics-inc.co.jp

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