Convergence 2012 by Paul Howells

The global magazine for the NUTRACEUTICAL and pharmaceutical industry

SEPTEMBER/OCTOBER 2012

SPECIAL SUPPLEMENT

The Meeting of Pharma and Nutra Is it time to meet in the middle?

ALSO

Health Claims The Medicalization of Food | War Games | Medical Foods New Routes to Drug Discovery | OTC Trends |

COMMUNICATIONS

CONTENTS

Pharma/NBT Supplement Contributors

Editorial Director

Kevin Robinson Tel. +44 (0) 1392 202 591 kevinrobinson@viacommsgroup.com

Sales Steve Robinson Tel. +44 (0) 1372 364 127 steverobinson@viacommsgroup.com

Editor Corrine Lawrence Tel. +44 (0) 01244 659 428

Joshua Nathan Tel. +44 (0) 1372 364 124 joshuanathan@viacommsgroup.com

Art Director/Production Paul Howells Tel. +44 (0) 1372 364 126 paulhowells@viacommsgroup.com

Gill Healy Tel.+44 (0) 1372 364 128 gillhealy@viacommsgroup.com

Content/Marketing Manager Claire Day Tel. +44 (0) 1372 364 129 claireday@viacommsgroup.com

Financial Officer Cherelle Saunders +44 (0) 1372 364 123 cherellesaunders@viacommsgroup.com

Jörg Grünwald President Analyze & Realize ag John Kurstjens Marketing Manager Lipid Nutrition Chris Lee Event Director IIR Exhibitions Ulla Freitas Manager Scientific Affairs, Nutrition Lonza AG

Theodor Graser Head Pharma Industry DSM Nutritional Products Ltd

Dr Paul Berryman Chief Executive Leatherhead Food International

Denzil Phillips Founder Denzil Phillips International Pedro Vieira Marketing Manager Kemin Health Europe

Norbert Weitkemper Managing Director Vital Solutions GmbH

Robin Ward Managing Director Excelsa Pharmaceuticals Sagl

04 War Games

Designer Foods to Grow through M&A Activity Leonard Fuld

Health Claims The Medicalization of Food: Risks and Benefits Nigel Baldwin

10 OTC Trends

Prostate Health Cocktail: Not Your Average Vitamins! Cheryl Strelko

Editorial Advisory Board

Susanne Fässler Marketing Communication Manager Frutarom Switzerland Ltd

Contents

Dr Michelle H. Jones Manager, Regulatory and Scientific Affairs Archer Daniels Midland Company

John Wilkinson Consultant Phytochemist and Director Herbal Sciences Int. Ltd

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Professionals working within the industries we cover may purchase a year’s subscription by sending a cheque for £100.00 made payable to Via Communications Ltd, Wesley House, Bull Hill, Leatherhead, Surrey KT22 7AH, UK No part of this magazine may be reproduced, stored in a retrieval system or transmitted in any form without permission. Copyright © 2012, Via Communications Ltd. All Rights Reserved. The publisher endeavours to collect and include complete, correct and current information in Convergence, but does not warrant that any or all such information is complete, correct or current. The publisher does not assume, and hereby disclaims, any liability to any person or entity for any loss or damage caused by errors or omissions of any kind, whether resulting from negligence, accident or any other cause. Convergence does not verify any claims or other information appearing in any of the advertisements contained in the publication, and cannot take any responsibility for any losses or other damages incurred by readers in reliance on such content.

12 Nutraceuticals on the Increase Christina Khoo

Consumer Choice

Medical Foods

Packaging and Labelling

In Sickness and In Health Charlotte Frederiksen

Opening New Doors to Drug Discovery Stella Metsaovas and Paolo Pontoniere

Blurring Boundaries Peter Belden

26 Regulatory Affairs

Managing the Dietary Supplement Landscape in an Overregulated Environment Golan Raz

Targeted Healthcare and WellBeing What the Functional Food Industry Can Learn from Big Pharma Jordi Cuñé Castellana

30 Last Word

An Industry in Transition Kevin Robinson

PHARMA/NBT SUPPLEMENT | 2012 |

WAR GAMES

‘Designer Foods’ to Grow Through M&A Activity

A business war game on 30 April between Oxford University’s Saïd and Cambridge’s Judge Business Schools, run by Fuld & Co., predicted the outcome of the so‑called Battle for Designer Foods (nutraceuticals). The world of food is about to change, and the companies represented by the MBA students in the war game (Abbot Nutrition, Danone, GlaxoSmithKline and Nestlé) are amongst those that will be part of the revolution. It is uncertain whether consumer packaged goods or pharmaceuticals will take control of this new space. Can the food companies compete against the pharmaceutical companies? Pharma companies, looking for growth opportunities as drug patents expire, may be better equipped to endure the costly and time‑consuming clinical trials for products. So which industry — food or pharma — and which companies, were best‑positioned to win “The Battle for Designer Foods”? A strategy game, or ‘War Game,’ is an enlightening and engaging analytical exercise that can lead to truly creative strategies. Briefly, two sets of MBA student teams represented the companies mentioned. Working in breakout rooms they created a picture

of the company and developed strategic options it expects to pursue. The teams reassembled and presented their company’s marketing strategy. Teams, judges and observers had an opportunity to analyse and critique each others’ strategies. Based on what they learned they retreated to their breakout rooms to refine their strategies then returned for a further critiquing session. The facilitators then offered a fictional, but plausible, surprise event for the teams to consider. At that stage, they could talk to each other if they wished and negotiate deals. One of the war game’s predictions include the fact that giant consumer packaged goods companies are likely to join forces with their pharmaceutical counterparts to catapult the nutraceuticals business in Europe

Andrew Lake, Managing Director of Health at Vivactis Global Health and judge of “The Battle for Designer Foods”

“The importance of getting into the minds of your competition, and understanding their market position and their potential future moves, cannot be understated. In the real world we often find ourselves mired in day‑to‑day fire‑fighting and the challenges of succeeding in our own space. “When food manufacturers go head‑to‑head with the pharmaceutical industry, the outcome is far from a foregone conclusion. One business sector is exceptionally talented at communicating directly with consumers, the other has unrivalled skills in the generation of robust evidence and communication to the healthcare profession. “The battleground will be (in my opinion) one of consumer branding versus healthcare recommendation and health branding. That is to say that the segment of nutraceutical consumers who do not seek medical advice (the healthy or health conscious) will likely gravitate towards brands that are available through food manufacturers as a result of their innate ability to establish trusted consumer brands. “The segment of consumers who are seeking medical advice for a condition or ailment (patients) will likely be most influenced by their doctor: patient interface, where physician or nurse recommendation for a specific brand or product will result in its use and adoption. There may well be two ‘theatres’ of war: the winning of consumer ‘hearts and minds’ and the winning of professional ‘hearts and minds.’ Who wins and who loses in each of these areas cannot be predicted, but the favourites for each customer group are clear.”

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WAR GAMES

and in the US into a major market, projected to be worth $250 billion in just a few years.1 With the European Food Safety Agency beginning to regulate designer foods, the war game arguments made it clear that this category will be subject to increased regulatory scrutiny on both sides of the Atlantic, requiring some of the clinical trial expertise and capabilities that pharmaceutical companies bring to the market with consumer companies adding their knowledge of customer segmentation and mass market resources. “We are confident about this prediction, as past competitions have accurately forecasted events and competitive activities in a number of industries,” commented Leonard Fuld, Fuld & Company president. “This is the ninth such event run in as many years and the first between these universities with a centuries’ old rivalry.” In addition to the above general prediction, other key insights emerged, including • Tailored foods will be coming to a grocer near you: a ‘one size fits all’ model will be supplanted in the future nutraceuticals market. Consumers present many nutritional challenges and will require companies to offer variety in their nutraceutical portfolio to fulfil the need for each consumer segment. • Regulators will impose stricter requirements, forcing producers to demonstrate either a product’s efficacy or health claims: currently, the designer foods industry offers products that are not required to be put through advanced, scientific testing to prove more than basic health claims. As the interest in companies of designer food products increases, companies will migrate to issuing products that may contain compounds offering specific medicinal value; for example, treating diabetes or cardiovascular disease. Although the games’ judges cited the difficulty in adding drug compounds to foods because of dosing and other issues, companies that do seek to differentiate with drug‑like treatments to achieve higher value and possibly higher prices for products in this category will find regulators likely to

require firms to conduct rigorous and far more expensive clinical trials — particularly for designer foods sold by consumer package goods companies. • The greatest advances in designer foods will come from firms with highly focused objectives and highly focused portfolios: large multinational players are likely to be at a disadvantage by having to manage too wide a portfolio of products, which will not allow them to focus on the designer foods segment. Smaller — perhaps start‑up — companies will be the ones to discover breakthroughs in this industry sector. In the “Designer Foods War Game” Fuld conducted in the US in 2011 on the same topic, risk, or fear of risk, was a central theme, but this was less of a discussion point between the Oxford–Cambridge participants. In the Oxford–Cambridge game, teams demonstrated some concern about the risk of investing in functional foods, but chose instead to form alliances and propose acquisitions.

When Do You Need a War Game?

War games are about anticipating competitive moves before your rivals make them. A war game is a structured strategic exercise. It allows companies to understand unexplored, or unforeseen, strategic options. Most importantly, a war game shows the implications of corporate decisions months or years ahead. Typically, companies consider a war game when they face one or several of the following: • a threat from current competitors • imminent entry of new rivals • industry consolidation • change in the external environment • a threat for a new technology of a similar discontinuity.

Conclusion

War games never truly end. Although the game itself stops, the player often learns a great deal about its rivals and the competitive forces that drive the industry. What management also learns is what it does not know! If this game were run privately for one of the companies portrayed in this public

Dr Todd Abraham, Senior Vice President, Research & Nutrition at Kraft Foods and judge of “The Battle for Designer Foods”

“Having served previously as a judge for Fuld & Co.’s war games, I have seen the value a war game brings to the companies involved. It forces companies to strategize about alternative scenarios and be better prepared for the future as the dynamic competitive environment continues to change. “In the growing nutrition and consumer well-being space, the overlap between foods and supplements or even drugs continues to get blurred. This allows companies firmly planted in the food industry to anticipate competitive threats from sources not usually considered. Competitive intelligence — anticipating what others may do based on publicly available information — is critical to preparing for the future and identifying areas where advanced scientific and business exploration should target. “In addition, as a judge for this event, I have a wonderful opportunity to evaluate potential candidates for employment, as well as hear how outsiders view our industry and its threats. Both of those benefits have made participating in the business school war games extremely valuable and rewarding.”

event, inevitably management would identify the knowledge gaps that arise, including questions about rivals’ R&D initiatives, ability to go to market, lack of information about promotional strategy, new products in the pipeline … the list goes on. War games reveal strategic options, as well as your own flaws. They are clear mirrors for anyone wishing to see the competition and the opportunities that lie ahead. And, as this war game revealed, the nutraceuticals space certainly offers an intriguing opportunity for all those who wish to compete in it.

Reference

1. P. Malik, “Value-Added Nutrition,” Can. J. Cardiol. 23(12), 956 (2007).

For more information Leonard Fuld President Fuld & Company www.fuld.com

PHARMA/NBT SUPPLEMENT | 2012 |

H E A LT H C L A I M S

The Medicalization of Food: Risks and Benefits

As many of you in will be aware, 14 December of this year marks a very important milestone in the development of the functional foods and food supplement industry in Europe. From this date, enforcers from all over Europe will have a simple list of approved and rejected health and nutrition claims. They will be able to walk into health food stores, supermarkets, browse on EU-registered websites, mail order catalogues and so on and look at product labels and check against the EU Register, which can be viewed on a simple smartphone. Moreover they will be able to review the commercial presentation of these products, including advertisements in all forms of media, including editorial articles! The exception is, of course, those claims based on “botanical ingredients.” The jury is still well and truly out as to whether the “one-size fits all” approach of EFSA’s scientific claims assessment process can be applicable to materials with a history of traditional use. Critics have rounded from all directions on the Commission, Member States and indeed on EFSA and are indignant

that a medicines approach is being taken towards foods. But is it really the case that foods are moving towards medicines and what if they are? What does that mean for the long-term future of the industry? The pharmaceutical sector is one of high investment, high risks and high rewards, based on the protection of intellectual property for newly developed drugs and the cost-effectiveness of generics. When I am approached (as I often am) by clients that have experience in the pharmaceutical industry and want to develop products in the food industry, their first statement is usually along the lines, that “there are strict procedures and data requirements in the pharmaceutical industry; we cannot make sense of the food industry as the legislation is all over the place.”

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And it’s true! In the pharmaceutical industry, everything is focused on the product as presented to the patient. A license application brings together everything from the active and nonactive ingredients, the dose, the target patient, labelling, packaging, the production process and so on. In effect, everything is covered in one document that genuinely allows the reviewer to take the risk and benefit to the patient together and make the correct decision. Sure, this costs a great deal of money and time in the development process, but patents and so on allow drug makers to recoup that investment until a reasonable point when generic products can be considered. Conversely, I am not aware of any example in the food industry in which the whole presentation, formulation,

H E A LT H C L A I M S

production, safety and efficacy of the final product has been considered together. I can think of no example when the risk–benefit profile of a specific product has been considered (apart from, maybe, Unilever’s first novel food application for plant sterolbased spreads … and that was pretty much a one-off) before going for approval to market. Of course, we have separate legislation controlling manufacture and hygiene; we have specific legislation covering the approval of new food ingredients. We even have specific legislation — as discussed above — for health claims. But it does not come together. You can get approval for a health claim on an ingredient … but it can be banned elsewhere under the Novel Food regulation. But if you are not an expert on food legislation, it could be easy to assume that if something has an approved health claim then it must be OK to use! There are very few obvious crosslinks between the differing parts of EU legislation. It is not easily approachable; it is not a one-stop shop. Now, the Commission and Member States have recognized that the “onestop shop” approach is exactly what’s needed. The new food information to consumer legislation is a really positive first step on the road to addressing this issue: a single piece of legislation that combines the rules of everything that you can put on the label of a product. But, as yet, it does not extend to the approval and use of new foods and ingredients. So, really, when the food industry complains about the medicalization of the food industry, this is only partially true. Because, in practice, it’s only a partial approach. If we had complete medicalization of health foods and supplements, what would that mean? The final product submitted for review would have to include information regarding labelling, the dosage, usage instructions, safety of the product and its ingredients and their combination, potential interactions, nutritional conflicts and nutrient profiles for example! Fees would have to be charged, of course, but new products

and technology could be protected, and exclusive products would eventually become generic with time (which would be the case for most vitamin and mineral forms) to provide reward for investment. A product licensing approach indeed! But some will say that this goes too far, these are foods. Yes, but they are complementary foods or food supplements in most cases. However, it’s important to note that, especially in the case of supplements, the EU is actually at odds regarding how supplements are regulated elsewhere in the world. In Australia and Canada, supplements are, in effect, regulated as medicines. To get supplements approved in those markets, you have to make a product license application in the same way you do for a full-blown pharmaceutical. The claims, intended market and safety are all reviewed together. And whereas the Natural Health Products Directorate of Health Canada has had a lot of problems with the sheer volume of license applications when it first started, it is now getting on top of it and in Australia the Therapeutic Goods Administration has a well-defined procedure for “complementary medicines.” Lessons to be learnt? So, in summary, yes they are foods, and certainly our supplements are being medicalized to a degree. But is that a bad thing? Maybe when the EU first decided that supplements were foods, when in many countries, historically, they had been treated as medicines, was that — with hindsight — a bad thing? Should we revisit this approach and consider the benefits of a complete medicinal approach versus the risk and potential failure of a partial one?

For more information

Nigel Baldwin European Director of Scientific and Regulatory Consulting Intertek Cantox nigel.baldwin@intertek.com www.intertek.com/cantox The views expressed in this article are his own.

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OTC TRENDS

Prostate Health Cocktail: Not Your Average Vitamins!

With enough clinical evidence and a market hungry for inexpensive new therapies, supplements such as Prostate Health Cocktail (PHC) are capable of changing the minds of both clinicians and consumers. To many people, the idea of using an over-the-counter (OTC) supplement to treat prostate cancer is laughable. The American Cancer Society warns against such a practice, stating that such alternative treatments are rarely shown to have any clinical efficacy and may do more harm than good. A number of currently active clinical trials are, however, exploring the benefits of dietary supplements to prostate cancer patients (Table I). Data from these trials may drastically change public opinion on the merits of such treatments. Armed with clinical evidence of efficacy, safety and minimal side‑effects, these dietary supplements may infiltrate the prostate cancer treatment algorithm. In August, OncoNatural Solutions Inc. was awarded a US patent for its PHC, a dietary supplement that contains epigallocatechin (green tea extract), lycopene, saw palmetto, selenium and other vitamins and minerals. According to the company, each ingredient in the PHC was independently shown to prevent prostate cancer development, kill prostate cancer cells or improve the symptoms of benign prostate

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cancer enlargement. The patent (US 8,221,803) was based on results from an FDA‑approved clinical study showing the dietary supplement stabilized or reduced prostate specific antigen (PSA) levels in men with recurrent prostate cancer. In February, the clinical trial data from the Phase II trial was presented at the American Society of Clinical Oncology (ASCO) 2012 Genitourinary Cancers symposium. The single-arm study examined whether treatment with PHC alone (three times daily) could stop PSA levels from increasing in men whose PSA levels continued to rise following localized treatment. In general, stabilization of PSA levels does not guarantee that a drug will offer patients overall survival benefits. Yet, as increasing PSA levels are often correlated with disease progression, FDA still considers it to be a valid endpoint representing clinical benefit in Phase II trials. The clinical trial data showed that PHC stabilized the PSA levels in 83% of men who had previously undergone radiotherapy or radical prostatectomy. Moreover, in nearly 30% of subjects with recurrent prostate cancer, PSA levels declined without a significant decline in subjects’ testosterone levels, indicating that erectile dysfunction (ED) is not a side‑effect of PHC treatment. With only 28 participants enrolled, the current trial is quite small, which will limit the reliability of the final data. The well‑defined study design, however, helped to compensate for the small sample size. The study criteria included stipulations on the duration between initial cancer treatment(s) and the start of PHC treatment, the types of previous treatments that were allowed, the staging of the disease and the initial PSA levels and doubling time.

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OTC TRENDS

Table I: Selected dietary supplements enrolled in clinical trials for the treatment of prostate cancer. Supplement

Sponsor

Indication

Phase

Isoflavones

University of South Florida

Stage I/II Prostate Cancer

III

Prostate Health Cocktail

USC/Norris Comprehensive Cancer Center

Biochemical recurrence of prostate cancer after initial local treatment

Vitamin D/soy extract

Wake Forest University

Recurrent prostate cancer

Selenium

University of Arizona/National Cancer Institute

Patients practicing watchful waiting

Lycopene

North Central Cancer Treatment Group/NCI

Asymptomatic metastatic prostate cancer

Source: GlobalData, www.clinicaltrials.gov

Although safety data have not yet been reported, it is highly unlikely that PHC will have severe side‑effects as all of its ingredients are already available as OTC dietary supplements. One in six American men will be diagnosed with prostate cancer. In the US, the disease kills more than 30,000 men annually, making it the second leading cause of cancer death in males. After undergoing prostatectomy or radiation, nearly 30% of patients relapse and there is currently no curative option once surgery and/or radiotherapy have failed. Androgen Deprivation Therapy (ADT) is universally accepted as a first-line treatment of advanced prostate cancer. ADT, however, is far from perfect: it is costly, has a number of unpleasant side‑effects, including ED and an increased risk of developing osteoporosis. Furthermore, with time, prostate cancers become androgen independent, rendering ADT ineffective. The results from the clinical trial indicate that PHC has the potential to become an alternative option to ADT for men with recurrent prostate cancer; it may also contribute to healthy outcomes for men with an enlarged prostate or early prostate disease. GlobalData spoke with a representative from OncoNatural Solutions Inc. who stated that PHC is designed to complement existing

prostate cancer treatments. But the reality is that the shortcomings associated with ADT could provide ample room in the market for another palliative treatment akin to PHC that is cost-effective and free from harmful side‑effects. It remains to be seen whether PHC can extend the overall survival of patients when compared with ADT. The representative was unable to confirm to GlobalData whether OncoNatural Solutions was interested in launching any additional studies. We believe, however, that if the current trial continues to be successful, a Phase III trial with a primary endpoint of increased overall survival is on the horizon. If such data were positive, GlobalData believes PHC could cannibalize market share currently dominated by AstraZeneca’s Zoladex (goserelin) and Casodex (bicalutamide), and Abbott’s Lupron (Leuprolide). Even if future trial results for PHC are positive, OncoNatural will struggle to successfully market an OTC ‘nutraceutical’ such as PHC as a treatment option for a life‑threatening disease. OncoNatural must first shed the inevitable stigma that dietary supplements such as PHC are significantly less effective than pharmaceuticals for treating serious, complex diseases. This will be challenging — studies have long

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suggested the benefits of taking vitamins and minerals for the prevention of various diseases, but nutraceuticals are yet to claim solid ground in the treatment regimen of high‑stakes ailments such as cancer. Yet, by enrolling patients in an FDA‑approved Phase II clinical trial studying the effects of PHC on PSA levels, the company is taking a critical step to foster the credibility of its product. The mindshare of PHC will also be boosted by the reputation of its developer, Dr Jacek Pinski, MD, PhD. His experience as Co-Director of the Prostate Cancer Research Program at the University of Southern California (USC) Norris Comprehensive Cancer Center and Hospital (which has no stake in OncoNatural Solutions Inc., but sponsored the clinical trial) will certainly help to strengthen the legitimacy that PHC needs to be considered as a valid treatment option.

For more information Dr Cheryl Strelko Oncology and Infectious Diseases Analyst GlobalData Tel. +44 1204 543 537 pr@globaldata.com www.globaldata.com

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OTC TRENDS

Nutraceuticals on the Increase The nutraceutical market is growing rapidly and is predicted to reach $250 billion worldwide by 2015. As more advances in science are being made, viable alternatives to accepted pharmaceutical products are emerging that have the potential to help accelerate this growth. There is increased consumer demand for natural and healthy ingredients that are backed by science. This has led to the popularity of natural alternatives such as cranberries. The unique properties of cranberries may help to prevent certain bacterial urinary tract infections. The properties of cranberries may also help to reduce our dependence on antibiotics by helping to decrease the risk of recurrent infection by maintaining urinary tract health.

The Rise of Antibiotics

Since the discovery of antibiotics in 1928, their use has steadily increased: from the original penicillin to the current combination of antibiotics, they are routinely prescribed to treat a wide range of illnesses. However, a recent study has estimated that unnecessary antibiotic prescriptions cost the UK National Health Service (NHS) £8 million a year.1 Unnecessary or excessive antibiotic use can be the result of antibiotics being prescribed for viruses instead of bacterial infections. This is ineffective, as viruses don’t respond to antibiotics. The incorrect use of antibiotics can contribute to bacteria developing resistance.

What Can Nutraceuticals Offer?

The benefits of nutraceuticals are numerous. For example, cranberry juice may have the potential to reduce the occurrence of urinary tract infections (UTIs), helping to reduce the use of antibiotics.2 In the US, a study has estimated that a 20% reduction in antibiotic resistant infections would save $3.2–5.2 billion dollars in healthcare costs each year.3 As urinary tract infections are the second most common type of infection in the body, the prevention of UTIs by using cranberry juice could make a significant impact on reducing healthcare costs in general, as well as those resulting from antibiotic resistance. In the UK, the NHS estimates that at least half the women in the UK will have a urinary tract infection at least once in their life.4 The increasing number of UTIs has been widely noted as an opportunity for growth by the nutraceutical industry, to suit changing consumer preferences for more holistic and less invasive remedies. There is an upward trend for natural products as consumer awareness of the implication of diet on health continues to increase.

The Cranberry: An Example

The North American cranberry (Vaccinium macrocarpon) has a long heritage in whole body health: native Americans used cranberry paste to heal wounds and cure various ailments, and this has evolved with time. Following the original use of cranberries for medicinal

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use, further independent studies commissioned by Ocean Spray during the past 30 years have turned folklore into fact, showing that cranberries represent a natural alternative that could help to reduce recurrences of UTIs. There is a substantial bank of research that indicates that cranberries may help reduce recurrent UTIs, including a study published in Clinical Infectious Diseases in 2011.2 The study, done by a group of Finnish researchers, found that, compared with a placebo, regularly drinking cranberry juice limited the number of UTI recurrences

References

1. www.bmj.com/content/344/bmj.d7955. 2. J. Salo, et al., “Cranberry Juice for the Prevention of Recurrences of Urinary Tract Infections in Children: A Randomized Placebo-Controlled Trial,” Clinical Infectious Diseases 54(3), 340–346 (2011). 3. S.M. Schappert and E.A. Rechtsteiner, “Ambulatory Medical Care Utilization Estimates for 2006,” National Health Statistics Reports 8 (National Center for Health Statistics, Hyattsville, Maryland, USA, 2008). 4. www.nhs.uk/Conditions/Urinary-tractinfection-adults/Pages/Introduction.aspx. 5. A.B. Howell, et al., “A-Type Cranberry Proanthocyanidins and Uropathogenic Bacterial Antiadhesion Activity,” Phytochemistry 66, 2281–2291 (2005). 6. J.A. Greenberg, S.J. Newmann and A.B. Howell, “Consumption of Sweetened Dried Cranberries Versus Unsweetened Raisins for Inhibition of Uropathogenic Escherichia coli Adhesion in Human Urine: A Pilot Study,” J. Altern. Complement. Med. 11(5), 875–878 (2005).

OTC TRENDS

in children by 43% and reduced the need for antibiotics to be taken by 34% — the equivalent of 6 days per patient a year. Unique A-type proanthocyanidins (PACs) contained in cranberries may contribute to reducing the adhesion of certain E. coli bacteria to the urinary tract walls.5 Furthermore, the results of a pilot study, published in the Journal of Alternative and Complementary Medicine, show these antiadhesion properties in the cranberry are also present after the consumption of dried cranberries.6 Cranberry ingredients can be used in a number of different nutraceutical applications, including dietary supplements, capsules and tablets. With numerous cranberry formats available, there’s a great opportunity to reach a large consumer audience as these applications become widely accessible and well known. Cranberry powder, for example, is a convenient way to deliver a concentrated dose of

PACs to supplements, confectionery and beverage applications. It can be supplied in a highly soluble format to offer excellent stability and blendability in manufacturing, and provide a premium quality replacement for artificial colours and flavours in applications such as drymix beverages.

A Bright Future

There is emerging potential to reduce our dependence on antibiotics, and the cranberry is an example of how nutraceutical products may help to reduce the risk of initial infection by maintaining urinary tract health. The impact of prolonged antibiotic use should not be ignored and the industry needs to look for natural alternatives that help prevent infection. As companies such as Ocean Spray continue to support scientific research, the potential for the industry to provide viable alternatives is increasing.

For more information

Christina Khoo Senior Manager, Research Sciences Ocean Spray www.oceansprayitg.com www.oceanspray.com

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CONSUMER CHOICE

In Sickness and In Health

In today’s world, the consumer is king. People want to make informed purchases and, whereas previous generations might only have sought the advice of a medical professional, there is now a wealth of information available to empower consumers to make their own health decisions. Often, the choice facing the consumer is ‘drug’ versus ‘non-drug.’ The health benefits of functional foods, beverages and dietary supplements are increasingly well known and the global nutraceutical industry is predicted to reach nearly $207 billion by 2016.1 With declining revenues and slim pipelines, the pharmaceutical sector is facing big challenges and the growth in the

Diapharm to Conduct Bundled GMP Audits for DSM

DSM Nutritional Products and DSM Pharmaceutical Chemicals have mandated Diapharm GmbH to conduct bundled audits on the production of numerous vitamins, medical pharmaceuticals and fatty acids in compliance with the European Guide to Good Manufacturing Practice (GMP). The arrangement will allow the company to more efficiently structure the regularly required GMP audits. Pharmaceutical service provider Diapharm will monitor the manufacturing processes being used at DSM’s production sites in Grenzach (Germany) and Dalry (UK), and perform the necessary audits. Pharmaceutical companies are obliged to regularly audit the GMP standards of their suppliers. Often, auditors travel round the globe to audit just one active substance: “Our goal is to bundle GMP audits and thereby increase inspection depth,” said Stephan Heck, Director of DSM Nutritional Products AG. “With Diapharm, we’ve found a partner that not only fulfils the legal requirements but goes beyond these to also fulfil our Swiss quality expectations.” In 2011, Diapharm audited the production of numerous vitamins and carotenes at DSM locations in Sisseln (Switzerland) and Village-Neuf (France). This year, the production of vitamins B1, B2, B5, B6, C, D3, active pharmaceutical ingredients and polyunsaturated fats, among others, for the pharmaceutical industry will be inspected at Grenzach, Dalry and Linz. Now, instead of conducting their own audits, DSM customers can obtain the officially approved monitoring reports from Diapharm. The pharmaceutical service provider bundles the individual monitoring requirements of pharmaceutical companies and co-ordinates the respective GMP audits. The on-site audits are done by the independent, officially accredited, inspection agency blue inspection body GmbH (www. diapharm.com).

nutraceutical market is seen by some as an additional threat with which drugs manufacturers must contend. How will the nutraceutical and pharmaceutical sectors continue to coexist? Dietary supplements offer a popular and effective approach to maintaining health and well-being and there is no doubt that there are clear parallels between the nutraceutical and pharmaceutical sectors. The industries are based on different business models, however, and nutraceutical and pharmaceutical organizations take diverse approaches to marketing their products to consumers. To give an example, docosahexaenoic acid (DHA) is a long-chain omega-3 fatty acid that is used as an active component in a number of successful dietary supplements and at least one drug. Although used in varying concentrations, the core ingredient is basically identical — whereas the promotion and positioning of the products, both in terms of messaging and price points, are quite different.

Regulatory Minefield

Scientific research is the key to new product development in both the nutraceutical and pharmaceutical sectors. Historically, hurdles in the nutraceutical arena have been much lower; but, regulations have become a lot more stringent in recent years. The European Union (EU) is leading the way, with new health claims or existing claims currently made in relation to food and dietary supplement products needing to be authorized by the European Food Safety Authority (EFSA) before they can be used in product labels and marketing. In the US, manufacturers are required to notify the Food and Drug Administration (FDA) if they are to market a dietary supplement that contains “new dietary ingredients.”

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The pharmaceutical industry must also adhere to strict guidelines before bringing products to market. Current Good Manufacturing Practices (cGMPs) have been designed to establish the foundation for both dietary supplement and drug product quality in the US and the FDA has recently taken action against those that failed to seek the appropriate regulatory approval. It can, therefore, be much more challenging for dietary supplement manufacturers to bring new products to market than it was previously. Significant time, money and resources must be invested if a product is to meet the regulatory bodies’ stringent claims and safety requirements. In the future, new product development will inevitably be impacted as research is scrutinized by the companies that fund it. There is now a need for more, higher quality clinical studies to answer business questions. It is increasingly likely that, going forward, we will see less research by manufacturers and marketers and more by institutes and academia. The shape of the nutraceutical industry will change with time and we can expect acquisitions and consolidation within the sector as manufacturers look to find new routes to market. An in-licensing agreement from a specialized start-up or small biotech firm, for example, can cut new product development costs and lead times for larger, marketing oriented firms, as well as reducing the risk of a rejected claim.

The Future of Health Claims

Such pressures have led some in the industry to question the value of health claims to brand owners. The EU regulatory framework was put in place to protect consumers and ensure that any claim made on a food label is clear and substantiated by scientific evidence. The level of substantiation

CONSUMER CHOICE

required for a claim to be verified by EFSA is significant and, where existing awareness of a particular health benefit is high, companies may choose not to pursue a claim application and take a consumer education approach instead. This alternative route has been adopted by a leading probiotics brand with success. There is also an emerging trend for manufacturers to capitalize on the intrinsic health benefits of a product, rather than looking to incorporate additional functional ingredients and health claims. For example, one brand has recently

Format: 210 x 148,5 mm

changed the base formulation of its vegetable spreads to take advantage of growing consumer interest in and awareness of omega-3s. Next year (2013) may be a very pivotal one. The approved EFSA health claims will go into law in December 2012 and products using claims that have not been authorized will be considered to be carrying misleading and illegal information. The relative merits of health claim versus consumer education will play out during the coming months; whichever has most resonance with an increasingly health savvy consumer will be the approach that leads to product success. Whatever the future holds, consumers will be in a better position to make an

Mineral Salts for Direct Compression

informed choice — benefiting both the nutraceutical and pharmaceutical industries as they continue to exist alongside one another.

About the Author

Will Black Global Marketing Director, Human Health and Nutrition DSM Nutritional Products

Reference

1. www.bccresearch.com/report/nutraceuticalsmarkets-processing-technologies-fod013d. html.

For more information Charlotte Frederiksen External Communications DSM Nutritional Products Tel. +41 61 815 8354 charlotte.frederiksen@dsm.com www.dsm.com

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MEDICAL FOODS

Opening New Doors to Drug Discovery

Imagine being in pain. Imagine the worry, the confusion and bewilderment that accompanies the sudden onset of the unwelcome symptom. Imagine rushing to put an end to that suffering. In such a situation, the majority of us would reach for a quick countermeasure for some speedy relief. And, usually, that solution would come in the form of a pill, an ointment, a liquid, an injection, a suppository or even a spray. But whatever form this may take, for the majority of us, the remedy of choice will be a designer compound engineered by researchers in some laboratory: in short, a pharmaceutical drug. Chemically manufactured and designed compounds for the medical treatment of human diseases, pharmaceutical drugs are solutions bearing the promise of a cure ... or of verifiable signs of health improvement.

During the last couple of centuries, pharmaceutical science has been a key driver in the development of biological chemistry.1 A number of discoveries have been leveraged to create — and commercialize — compounds that are capable of interacting with our cell biology, and used to reduce pain and suffering, while at the same time lengthening the lifespan of millions worldwide. Yet, even though this represents huge progress in the medical history of humanity, the quality of life experienced by those actively taking pharmaceuticals is still up for debate ... and is often defined as being substandard. Not only because they

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may be ineffective if used improperly, but also because they present an inborn risk of toxicity and other unwanted side-effects, which may cause lifethreatening adverse health reactions (including morbidity and mortality). According to a Journal of the Medical Association article, adverse drug reactions are one of the leading causes of death in the United States.2 A Public Citizen’s report found that whereas approximtaely 2 million people experience adverse drug reactions, in the USA alone, every year, about 1.5 million Americans need to be hospitalized owing to a prescribed drugrelated incident. This results in a yearly

MEDICAL FOODS

mortality toll of more than 100,000.3 This means that more than 4000 patients experience an adverse drug reaction every day — one that’s so serious that they have to be admitted to hospital. And, besides being one of the major causes of emergency room visits — about 28% of the total — adverse drug reactions are a cross-sectional problem that particularly affect the elderly and the very young.3,4 And although drugs save lives, sometimes they result in a treatment that masks certain symptoms without fixing the root cause of the health issue.5 “Natural therapies are available that are much safer, often more effective and cost much less,” says Jacob Teitelbaum, MD. “Of course, you should never start, change or stop taking medications without first talking to your doctor.”6 Pharmaceutical adverts are among the 3000 advertising sollicitations to which we are exposed every day.7 Typically, however, the most striking part of each drug-related commercial is the list of side-effects, which can include reactions ranging from mild nausea to the most discomforting anal leakage (in some cases) and even death! The intent of pharmaceuticals is to provide relief; but, because they are synthetic compounds, unexpected reactions often occur, especially when taken in combination with other drugs. It can be tough to decipher which exact chemical may be causing the particular outcome because of the significant number of substances we ingest or apply to our body on a daily basis. Negative sideeffects rarely happen, if at all, when naturally derived compounds are

consumed — although precautionary measures should be used with megadosing protocols. Increasing levels of disease and health complications in our current and future generations make it difficult to deny that a solution besides the administration of purely synthetic pills must be researched. Nutraceuticals can, in most cases, provide a safe, natural, sideeffect and toxicity free alternative to current pharmaceutical solutions. Nutraceuticals are prepared using techniques that are very similar to those utilized to create designer compounds. However, instead of being chemically synthesized in a Big Pharma biochemical laboratory, nutraceuticals are manufactured by extracting biologically active compounds from naturally grown food sources. Vitamins A, B, C and omega-3 fatty acids are natural compounds with known and proven health efficacy, which have been supplementing the human diet for centuries.1 As such, they can be considered to be forebearer of modern nutraceuticals, and have paved the way to the advent of new and increasingly more powerful kinds of nutritional supplements. Constituents of the chemical palette of daily consumed foods worldwide, nutraceuticals have been credited with many health benefits. Among the most well known available on the market today, with proven clinical efficacy, are olive polyphenols, flavonoids derived from cocoa, catechins from green tea and lycopene form tomatoes, to name just a few. Despite their differences, and the competition between them,

there has recently been an evident convergence of intents between the pharmaceutical and nutraceutical industries, leading to various mergers and acquisitions. In 2011, Aventis Pharma, a division of the French drug maker, Sanofi, disclosed that they intended to acquire the branded nutraceutical formulation business of Mumbai-based Universal Medicare Pvt Ltd for an undisclosed sum.8 At he beginning of August 2012, Florida based OPKO Health, Inc., a multinational biopharmaceutical and diagnostics company announced that it had acquired Barcelona-based Farmadiet Group Holding, SL. “This acquisition is an excellent strategic fit as we expand our global manufacturing, sales and distribution capabilities for a growing range of products,” commented Phillip Frost, OPKO’s Chairman and Chief Executive Officer. Another major example of pharmanutra convergence concerns fortune 500 company, Procter and Gamble, and their recent acquisition of New Chapter Inc., a leading supplement brand within the natural retail channel. New Chapter Inc. is still free to act as its own entity but now, because of consumer demand for natural products, retail carriers may begin to reposition New Chapter’s products within their stores.9,10 Because of the buyout by a major pharmaceutical company, many customers who traditionally bought New Chapter’s products may begin to rethink their supplement purchases. Although New Chapter Inc. intends to keep most aspects of the company the same, this may change during the next few years under the new ownership. “Clearly this is big news,” declared Dave Janowicz, Vice President of Merchandising, Pharmaca Integrative Pharmacy (Boulder, Colorado, USA). “Time will tell how the story and positioning will evolve. I would love to see P&G continue New Chapter’s focus on the natural channel, but I would not be surprised to see the company expand distribution to other channels. I don’t think we’ll see retailers bottom-shelving the brand and repositioning it in their stores just yet. It’s far too early for that type of reaction. I’m sure there’s a lot

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MEDICAL FOODS

more to come.”10 In another sign of this convergence, Cannabis Science has signed an exclusive joint venture deal

References

1. V. Moreno, “Evolution of the Nutrition Industry, Special Report,” Natural Products Insider (Virgo Publishing LLC, Phoenix, Arizona, USA, 2011). 2. J. Lazarou, B.H. Pomeranz and P.N. Corey, “Incidence of Adverse Drug Reactions in Hospitalized Patients: A Meta-Analysis of Prospective Studies,” Journal of the American Medical Association 279, 1200–1205 (1998). 3. Public Citizen’s Health Research Group, Adverse Drug Reactions (www.worstpills.org/ public/page.cfm?op_id=4). 4. M.A. Steinman, et al., “Beyond the Prescription: Medication Monitoring and Adverse Drug Events in Older Adults,” Journal of the American Geriatrics Society 59(8), 1513–1520 (2011). 5. H.C. Corbett, “Natural Alternatives to the Top 10 Most Prescribed Drugs,” Prevention (www. prevention.com/health/natural-remedies/ top-10-prescription-drugs-and-naturalremedies/#ixzz22yXMQSTb) February 2012. 6. J. Teitelbaum, Real Cause, Real Cure (Rodale Press Inc., Emmaus, Pennsylvania, USA, 2011). 7. Mortar, “How Many Ads Do We See Every Day?,” www.mortarblog.com/2006/07/ average_america.html (27 July 2006). 8. The Hindu Business Line, “Aventis to Acquire Universal Medicare’s Nutraceutical Biz,” www.thehindubusinessline.com/companies/ article2392997.ece (24 August 2011). 9. M. Adams, “New Chapter Sells Out to Procter & Gamble, Part of the Global Corporate Elite,” www.naturalnews.com/035312_New_ Chapter_Proctor_and_Gamble_Monsanto. html (Natural News Network, 21 March 2012). 10. K. Blackwell, “Natural Retailers React to P&G’s Acquisition of New Chapter,” http:// newhope360.com/finance-and-investment/ natural-retailers-react-pgs-acquisition-newchapter (Natural Foods Merchandiser, 19 March 2012). 11. Cannabis Science, “Cannabis Science Signs Exclusive Joint Venture Deal with German-Based Dupetit Natural Products, GmbH to Immediately Expand New and Existing Product Lines Across Europe and Internationally,” www.cannabisscience.com/ news-a-media/press-releases/310-cannabisscience-signs-exclusive-joint-venturedeal-with-german-based-dupetit-naturalproducts-gmbh-to-immediately-expand-newand-existing-product-lines-across-europeand-internationally.html (31 July 2012). 12. S.S. Wang, “Medical Foods and Supplements for Brain Health Advance,” The Wall Street Journal | In the Lab (http://online.wsj.com/ article/SB10001424052702303919504577524 970855874632.html?mod=googlenews_wsj) 24 July 2012.

with German-based Dupetit Natural Products, GmbH, to immediately expand new and existing product lines across Europe and beyond.11 But, as pharmaceutical companies struggle to devise new drugs to treat disease symptoms ranging from diabetes to dementia, and with old patents on leading drugs now expiring, a new realm of converging interests among pharmaceutical and nutraceutical companies is emerging in the area of medical foods.12

The Rise of Medical Foods

Compared with nutraceuticals and more common supplements — which aren’t allowed to claim any curative benefits — medical foods are meant to tackle a specific nutritional deficiency derived from a disease ... and to be used under medical supervision (often in conjunction with pharmaceuticals) to treat a particular ailment. And even though the US Food and Drug Administration does not regulate this field, and they undergo much less stringent testing protocols than drugs, medical foods can provide both a way for patients to tackle their conditions in a more natural way, and an avenue for nutraceutical and pharmaceutical companies to investigate collaborations that could be extended to other areas of development. These collaborations could eventually lead to the creation of new products that could positively affect public health and marketing dynamics worldwide, particularly in the areas of mental health and immunodriven conditions such as diabetes and asthma. Large food companies are also seeing opportunities in medical foods. Nestlé SA recently bought a stake in Accera, a maker of milkshakes for Alzheimer’s disease, and a study showed that Souvenaid, a medical food still being developed by the French food group, Danone SA, may improve cognitive function. “Medical foods is still an evolving area,” states Alzheimer’s Association’s Chief Medical and Scientific Officer, William Thies: “The Alzheimer’s Association is watching the area carefully so we can give people better advice.” But if pharmaceuticals fall

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short of safety, the nutraceutical industry has its own shortcomings. Paramount among these is the fact that in a number of meaningful cases have been unable to prove convincingly how its nutritional formulations may benefit human health.1 “The expenses and the resources required to build a coherent body of scientific and clinical evidence to validate the biological activity of a nutrient are considerable, and suppliers often do not have the mass or skills to meet the expenses,” says Victor Moreno, PhD, founder of consulting house Vivex International LLC, and Senior Adviser at San Francisco Bay Area-based nutraceutical manufacturer, CreAgri, Inc., “The result is a substantial number of product claims made by nutrient suppliers and product marketers are not adequately supported, or the claims made are very vague. This leads to a loss of credibility in the eyes of consumers, health professionals and the media.”1 As an individual, it is always important to remember that the safety of a product is based on recently completed research. Clinical drug trials have shown us as much as they can about what happens during acute lengths of time. Unfortunately, because the vast majority of biochemical technology hasn’t been around for a great length of time, longterm side-effects are not part of the results. This is where pharmaceuticals have the capacity to become dangerous. A merging of the industries opens up opportunities to discover new drugs that may contribute to lengthening the lives of those who are suffering while providing opportunities to create new markets for both the pharmaceutical and nutraceutical industries.

For more information

Corresponding author Stella Metsaovas, BS, CCN, is the founder and principal of Stella Metsovas, LLC, a California-based media and health, consulting and clinical company (stellametsovas@me.com), and Paolo Pontoniere, a Californiabased science writer, is Vice-President of Corporate Communications and HIDROX Evangelist at CreAgri, Inc. (ppontoniere@creagri.com).

PAC K AG I N G A N D L A B E L L I N G

Blurring Boundaries

The nutraceutical market is a relatively new product category; however, its growth during the past few years has been both steady and rapid. Covering a range of food-based products with medical or general health benefits, the sector incorporates a number of prominent markets including food, beverages and pharmaceuticals.

The global nutraceutical market in 2011 was estimated to be worth $149.5 billion, with the US, Europe and Japan being the largest regional markets, accounting for nearly 93% of the global nutraceutical demand. With multiple patent expirations challenging worldleading pharmaceutical companies to compensate for declining pipelines through new revenue streams, the prosperous nutraceutical market, as well as the over-the-counter (OTC), cosmeceutical and veterinary markets could present an opportunity to maximize infrastructure investment. Vast research and development budgets — when compared with the functional food and beverage players — as well as unmatched expertise and capacity in terms of clinical trials, mean that there are already some pharmaceutical companies playing in these arenas with varying levels of success. However, it’s not all smooth sailing … and there are inherent difficulties in the pathway of pharmaceutical companies trying to penetrate these sectors. Consumer packaged goods (CPG) companies are already dominating the fields with their strong and unrivalled record of marketing products directly to customers. They are highly experienced in developing consumer friendly packaging and fully embrace that it is in fact the packaging that talks to the customer, something that is ingrained into all their processes. In addition, when moving to a consumer market, pharmaceutical companies will see their audiences change from patients to consumers, bringing with it a whole new set of impulsive purchasing motivations. With these challenges in mind,

pharmaceutical companies need to focus on what they can do differently in these industries to expand their audiences and, as a result, their revenues. In this article, Peter Belden, Managing Director of AndersonBrecon Europe looks at the opportunities that convergence across multiple markets is presenting to pharmaceutical companies and what organizations can do differently to compete against the consumer packaged goods companies.

Contemplating Convergence

Perhaps one of the biggest opportunities for pharmaceutical companies at the moment lies in the conversion of prescription drugs (Rx) to OTC products. Market growth in this sector is being driven by patent expirations and an increasing number of large pharmaceutical companies looking to expand their consumer health businesses. The commonality of conditions such as indigestion, hay fever and fungal infections has led patients to self-prescribe and increasingly use their pharmacists as a first point of call for easily treatable illnesses, helping to shift pressure off primary care and prescribing budgets. Many of the drugs used to treat these conditions have a long history in the post-marketing phase, demonstrating

high efficacy and low risk in the OTC market. In 2012, the worldwide OTC market was estimated to be $104 billion as a result of growth at a CAGR of 6.5% between 2006 and 2010. Most recently, drug makers AstraZeneca and Pfizer announced a deal giving Pfizer future rights to sell a non-prescription version of AstraZeneca’s blockbuster heartburn drug, Nexium, as early as 2014. The future for the OTC market is bright with the sector forecast to grow by a CAGR of 4.6% during 2011 to 2015, generating a revenue of $124 billion. Growth trends are also being seen in the nutraceutical and cosmeceutical sectors. In attempting to maximize their role in the

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pharmaceutical companies will already have the infrastructure in place to pick up their pace and surpass competitive CPG organizations.

Brand Appeal in Consumer Land

highly lucrative OTC, nutraceutical, cosmeceutical and veterinary markets, pharmaceutical manufacturers need to embrace the fundamentals of consumer product marketing and packaging if they are to carve out a lucrative piece of these industries for themselves. If these challenges are addressed now,

Strong marketing campaigns, branding and packaging formats are vital to attract the attention of consumers as it is the pack itself that ‘talks’ to the patient and that provides a clear point of differentiation in even the most competitive markets. It is a critical part of the overall product offering and serves a functional purpose as well as a means of communicating product information and brand character. In addition, packaging also reinforces the quality and value of the product. The packaging of OTC medicinal products provides a platform for communication between the brand and the consumer … who is becoming increasingly aware and demanding in terms of price versus choice and quality. For pharmaceutical and healthcare companies looking to converge with OTC markets, the communication of brand identity through high-end, consumer-friendly holistic packaging is going to be key. In consumer markets, OTC product information — like their Rx cousins — still needs to be delivered in a clear, concise and memorable format that motivates the patient to read. In convergence with consumer markets, pharmaceutical companies must acknowledge that high-value packaging can not only make a product more appealing to the customer, but also increase the success of the product through improving compliance with the treatment. Too often with traditional pharmaceutical packaging, regulatory boxes are being ticked and manufacturing friendly solutions are being used, rather than patient focused thinking being at the forefront of packaging choices. The simplified delivery of important product information will ensure that the consumer is using the product correctly and, as a result, increase the likelihood of repeat purchases and recommendation. In the convergence of prescription and OTC markets, the greatest challenge

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for the pharmaceutical industry is the paradigm shift to thinking of a product in terms of its brand and packaging. The task to break away from traditional, operationally functional packaging to consumer centric packaging is going to need a strong brand and packaging team, willing to work with innovative solution providers to develop packaging that can not only adhere to GMP requirements, but that can also provide manufacturers with a true competitive advantage.

The Need for New Innovations

To leverage new markets and build strong consumer friendly brands, it really is a question of what pharmaceutical companies can start doing differently to set themselves apart from the competition and increase the shelf appeal of their products. There has been much debate regarding how to make a drug as attractive as possible to the consumer, while also adhering to GMP packaging requirements and ensuring that people take the correct products and dosages. In moving a product from Rx to OTC, marketing becomes more important as the purchaser moves from being a patient to a consumer, contributing to a major change in mindset. Well positioned to transition products from Rx to OTC, AndersonBrecon has been involved with several recent high profile convergences. AndersonBrecon anticipated a surge in companies expanding into OTC markets and developed a partnership with Burgopak to help provide solutions to the challenges associated with competitive consumer markets. One of its latest innovations is the Burgopak pocket pack that has been used most recently by Lanes Health for one of the products in its Kalms range of traditional herbal medicines. The pack opens in one slide to reveal 12 tablets in two separate blisters, plus the patient information booklet. This ensures that the product is never separated from its packaging and essential usage guidelines are always available whenever the product is accessed. In addition to patient adherence and ensuring products are used correctly, these new packaging

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solutions are also more consumer and lifestyle friendly, meaning that they can easily fit into customers’ pockets or bags. Ensuring that OTC packaging complies with GMP manufacturing practices is essential. Compliant packaging integrates a range of factors, including innovative design supported by a comprehensive manufacturing process. As the first point of contact for those taking medications, aesthetically pleasing packaging can reap a range of benefits. However, it is essential that compliant packaging also conforms to regulatory constraints concerning child safety and remains ‘senior friendly.’ By incorporating smart designs such as concise graphics that offer visual impact and shelf appeal, while guiding patients to their dosing regime, and other graphics highlighting opening instructions for novel, child-resistant packaging techniques, pharmaceutical companies can ensure compliant packaging.As a growing proportion of Rx guidelines begin to stipulate the need for more stringent measures in the battle against counterfeit drugs entering the supply chain, more and more pharmaceutical companies are implementing track and trace capabilities in the design of their packaging. Although the pharmaceutical industry has not yet established a centralized and regulated database for serialization, it is fully aware that a move into serialized products is essential to ensure the safety of the supply chain. There has been much discussion regarding how vital serialization solutions are to the OTC, nutraceutical, cosmeceutical and veterinary sectors. However, it is these high-value ‘lifestyle’ products that are most likely to be vulnerable to

Bibliography

• www.reportlinker.com/ci02038/Nutraceutical. html. • www.gbiresearch.com/Report.aspx?ID=Rx-toOTC-Switching-Strategies-New-SwitchingOpportunities-in-Weight-Managementand-Smoking-Cessation-but-Encouragingthe-Uptake-of-Self-Medication-Remainsa-Challenge&ReportType=Industry_Repor t&coreindustry=ALL&Title=Pharmaceutica ls_and_Healthcare. • www.burgopak.com.

infiltration by counterfeit products owing to the security issues posed by the less secure retail distribution processes. This is an area in which pharmaceutical companies can exert a true competitive advantage over their CPG competitors. Ultimately, the number one aim of serialization is to protect the patient/ consumer. Although predominantly, securing the supply chain is the number one concern, it is also worth noting the various business and economic benefits that can be reaped from the practice. A counterfeit OTC product can cause a brand’s reputation to be tarnished, leading to reduced revenue and market share. Incorporating serialization methods into the design of existing and new high-value OTC, nutraceutical, cosmeceutical and veterinary products can lead to fewer product returns, recalls and defects and, in turn, minimized revenue losses. In line with this, secure and traceable products that incorporate innovative packaging techniques are much more appealing to customers.

Conclusion

With the so called ‘patent cliff’ looming over some of the pharmaceutical industry’s major players, many companies are being forced to bolster slimming pipelines by identifying alternative revenue streams. The convergence of Rx drugs to OTC status and the growing markets for nutraceuticals, cosmeceuticals and veterinary therapeutics present viable opportunities. As a result, competition looks set to escalate in these markets and packaging innovation is likely to play a key role in brand owners’ strategies. By adopting strong branding and innovative packaging designs that incorporate compliance and anticounterfeit measures, the world’s major pharmaceutical companies can begin to win themselves a significant share of these sectors.

For more information Peter Belden Managing Director AndersonBrecon Europe www.andersonbrecon.com

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R E G U L ATO R Y A F FA I R S

Managing the Dietary Supplement Landscape in an Overregulated Environment

The regulatory changes affecting today’s dietary supplement industry all seem to point in one direction — toward greater regulatory firmness — whether via oversight from the Australian TGA, the European EFSA or the US FDA. What implications does this have for dietary supplement manufacturers and marketers going forward? Furthermore, who among the industry’s participants are prepared to put these trends to work for the better? And, most importantly, how can industry use these trends to support the growth of both individual companies and the industry as a whole?

Regulations Closing the Gap

The most dramatic set of changes that advisory and regulatory agencies have put into force touch upon two main aspects of the industry. First, we’ve seen increasing demands for manufacturing quality control and GMP (good manufacturing practice) compliance in the United States. Second, but substantially more dramatic, are comprehensive new regulations for health-related claims and indication-based statements, mainly in European countries. Both sets of changes aim at the same goal: closing the gap between the dietary supplement and nutraceuticals industry and the pharmaceutical industry … and making the first a far more inspected and regulated environment.

Finding a Solution

In print and other media, the commentary about these regulatory initiatives and their efforts to improve production quality worldwide and manage product claims is extensive. I can comfortably say — and I hope that most of you will agree — that there are sufficient knowledge and consultancy options to keep pace with new production and manufacturing regulations. But when it comes to dealing constructively with the increasing regulatory oversight of health-related claims — or, perhaps more accurately, today’s health-related “claimless” regulatory approach — ample room remains for ideas, discussion and the development of solutions. Each and every company, both as a standalone entity and as a contributor to the industry’s broad field of knowledge, technology and business production, should look at the most suitable way to develop innovative strategies for dealing with these gamechanging regulatory developments, as well as those that are yet to come. Here are few simple, yet necessary, action items that can assist all of us in the process of rethinking the business.

Claimless Markets

Whether in Europe, Australia or the US, there have historically been several markets in which health-related claims were always forbidden. Yet, a review of how these markets operate teaches us that growth and prosperity can still occur. The Israeli market is an interesting example of what can happen when consumer awareness grows rapidly each year, even as supplement companies make no product-based

health claims. Why? Because despite the absence of claims, those companies continue to grow. We analysed developments in both consumer awareness and supplement marketing strategies during the past 10 years and found four key points that stand out as fostering success: Internal Acceptance: Companies and their internal teams must accept today’s regulatory changes and develop a “claimless” product support strategy based on new product innovation. That strategy should meet the consumer on his or her own educational and understanding level because, in the long run, a more educated consumer has less need for overt health claims. Point of Sale: Retailers must join this effort to educate the consumer and improve consumer awareness. In the last 10 years — and mainly in mainstream pharmacy/health food chains — we’ve witnessed a strong trend in which the retailers have provided shelf space and a well-designed shopping environment, but have left the marketing, advertising, education and awareness building to the suppliers. To keep our industry growing, retailers must actively adopt a new strategy. They can do this easily by instituting an ongoing training programme for their staff and customer-service representatives. Genuine advice given to a consumer at the point of sale is nothing but an educational session that is rewarding to both the consumer as well as the retailer. They can then follow that by building a compensation model that appeals to the staff’s interest in “what’s in it for me?” and that rewards

R E G U L ATO R Y A F FA I R S

personnel for “learning more and sharing more.” Media: Both print and digital media should lead the change in mindset. When we talk about education and consumer awareness of the basics of natural health solutions, we’re of necessity talking about the media. And no, I don’t mean sponsored media but editorial content and main headlines. Media must develop a long-term strategy to address today’s regulatory changes by committing to more “common science” articles, expert columns, product reviews (if it is not sponsored it may not be considered a claim) and many more awarenesssupporting public communications. Natural Health Practitioners: Naturopaths, homeopaths and Traditional Chinese Medicine

practitioners play an essential part in changing this mindset. Some practitioners may entertain the notion that fewer claims lead to fewer “OTC” purchases, which may lead to more visits to the practitioners! And this may indeed happen in the very short-term. But in the slightly longer-term, less awareness will translate into less work for the natural health practitioners. These practitioners are the bloggers, chatroom managers and potential hosts of many personal seminars. Each meeting with new and existing patients can and should become a brief, concise educational session.

Putting the Key Points to Practice In both the short- and the long-term, developing such a multipronged approach to education and business building will increase consumer awareness and improve the

understanding of what the industry has to offer in terms of natural health solutions … as well as future well-being and lifestyle support. As we head into an era of digital communication, when knowledge transfer is simpler and more doable than ever before, this should be a task we embrace as individuals, companies and an industry. These four steps are in some ways “back-tobasics,” but in this current period of transition, the basics can point the way toward a new approach and a revised strategy, both on professional and social levels.

For more information

Golan Raz New Business Development Adviser LycoRed raz@lycored.com www.lycored.com

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T argeted H ealthcare and W ell - B eing

What the Functional Food Industry Can Learn from Big Pharma The goal of personalized medicine is to ensure the health and welfare of people, rather than curing disease. Consequently, it is interesting to introduce the concept of prevention (not yet deeply rooted among consumers) as a weapon to fight disease. It should be understood as an aspect of individual behaviour and lifestyle, consistent with their needs and requirements, conditioned by their circumstances. Thus, it is clear that an important contributor to prevention is food. It is well known that food is the source of energy that allows us to conduct our daily activities, as well as the source of material to be used during normal metabolism to build and replace parts of our cells and tissues. Therefore, and taking into account that the ingestion of food takes place several times every day, diet is a key point for health promotion.

To use food as a source of health, in addition to procuring supplies of quality food to be consumed in a balanced and varied diet, we developed functional foods: foods with implicit properties that satisfy the nutritional requirements of the body, which elicit a positive effect beyond mere nutrition. That is, foods that can directly improve certain

health conditions. Among the products categorized as functional foods, some are naturally functional — such as the tomato, broccoli and tea, for example — without any intervention or modification by humans, and some others that work as a result of extraction or the inclusion of active ingredients (lactose-free milk with added probiotics, fortified cereals, etc.). It is this second group — thanks to the growth of technologies and techniques in the collection and processing of food, as well as their molecular mechanisms — that has led in some cases to situations in which functional foods can match or replace a number of prescription-based pharmacological treatments. Examples include phytosterols or probiotics for cholesterol treatment and enriched milk and cereals as multivitamin replacers. It is here that we can see the need for treatments that differ from conventional foodstuffs, that are inspired by what is found in the domains of pharmacy and parapharmacy, as they derive physiological and metabolic effects that are in line with those that can be found in drugs. To validate the advertised functionality of food, clinical studies and the requirements requested by the authorities are getting more exigent. This is already common practice in the pharmaceutical industry, wherein products are subjected to numerous studies before they can be marketed, not only from the perspective of security, but also functionality. Therefore, it seems that both the market and the authorities have already blazed a trail for the functional food industry to aspire to the quality standards of the pharmaceutical industry: clinical study protocols that are supervised and approved by an ethical committee, statistically viable patient groups, random, doubleblind, placebo-controlled studies that have to be long enough to assess any

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effects with a greater perspective, defining and controlling the doses that are administered in the final matrix product, rigorous statistical studies, and evaluating the results by taking into account those that are statistically significant and/or clinically relevant. However, it is important to consider a salient point when interpreting and implementing these quality clinical standards: food, under current legislation, cannot be marketed as cures for diseases … but as elements of prevention and risk reduction from contracting a disease. Consequently, the primary decision variables regarding product functionality should be selected according to the potential health claims that may be used. It is important to understand that the effect of these functional foods is not as immediate (in the majority of cases) as prescription-based drugs. To compensate for this increased temporal requirement, the safety margin is much wider. However, it is sometimes necessary (as indicated in advertisements and packaging) to set certain limitations on the intake and the exclusion of certain consumer groups. A such, food companies have an opportunity to learn from pharmaceutical companies, which state in very clear and concise terms the dosage of the active ingredient/ food from the point of view of the final “customer.” To facilitate interpretation and understanding by the consumer, functional food companies should also use clear labels and packaging: larger packs for adult consumers and packs with fewer doses for children, for example. This would make the effective dose more tailored and adapted to each potential consumer group, approaching the paradigm of personalized medicine. Clearly, today, for security and universality reasons, doses are not as tailored as desired. In this sense, clinical studies should be developed

T argeted H ealthcare and W ell - B eing

for each of the target population groups, with food that has been functionalized for each of them.

Does Good, Tastes Good

Understanding functional foods as a novel way to address health prevention and maintenance, it should be instituted early in life: some of the major pandemics today, such as obesity, have their origin in childhood and adolescence. Functional foods, and the benefits they bring beyond nutrition, should not ignore the hedonic aspect of eating … so it is important to respect and present an interesting organoleptic profile. This is an area in which the pharmaceutical industry is working intensely, so it can mirror the food industry: adapting the active ingredient dosage to the predilections and limitations of children. For example, the same active ingredient is administered as drops or a syrup to facilitate swallowing, and efforts are being made to make it more organoleptically attractive. Thus, to facilitate maximum adhesion to the consumption of active principles with health benefits, different products should be offered to ensure that at least one of them will be organoleptically acceptable and included in the lifestyle of every potential consumer.

not, depending on the potential economic gains they offer. This means that groups with rare diseases fall outside the scope of interest of these companies. People or even entire societies with lower purchasing power may also have limited access to these solutions, simply as a result of their high price. The functional food industry can improve this by expanding its range of products (the ones that contain active ingredients or from which the deleterious product has been removed), offering them to groups with allergies (lactose, gluten or less-common allergies), making

them compatible for people with special requirements (children, the elderly, diabetics, vegetarians, vegans, etc.) or even offering mass market products with features for minority groups. Another more democratic form of access would be to facilitate the availability of such developments (through beneficial agreements with owners of intellectual property) to store brands/private labels, whose product prices are reduced, so a significant part of the population can gain access to sources of long-term health.

As in the pharmaceutical formulations of drugs, which minimize or avoid ingredients that may have contraindications for health, such as significant amounts of sugars (oral health, diabetes) or yeast proteins (allergy), the functional food industry must be consistent and create food formulas that are also compliant and objectively interesting for health: there is no point in introducing hypocholesterolaemic compounds in pork sausages with an improper nutritional profile, for example. As a counterpoint, there is one area from which the functional food industry can learn from the pharmaceutical industry and its mistakes of the past: it should provide access to functional food to as wide a population as possible … and also to small groups with specific requirements. The pharmaceutical industry is often criticized because it investigates and markets new drugs, or

For more information

Jordi Cuñé Castellana Chief Research Officer, Microbiology AB-BIOTICS info@ab-biotics.com http://ab-biotics.com

PHARMA/NBT SUPPLEMENT | 2012 |

LAST WORD

An Industry in Transition According to a recent statement from EAS (www.eas.eu), 91 Article 13.1 health claims that are eligible for further assessment might get to know their fates next year … if the European Food Safety Authority (EFSA) finalizes its re-evaluations by the end of 2012 as planned. With EFSA having confirmed its deadline of 31 December 2012 to complete its evaluation work on Article 13.1 health claims, a final European Commission decision, followed by a further 6-month transition, could see these claims finally permitted — or banned — towards the end of 2013. It’s good to see the industry moving rapidly forward. The claims, as many of you are aware, are those that EFSA initially judged to lack sufficient characterization/evidence and for which Member States had submitted further data. They include a wide range of health claims for probiotics, as well as others for vitamin K2 and vascular health, prunes and bowel function, lutein and eye health, soy isoflavones and menopause/bone health, alphacyclodextrin and glucose homeostasis, polyphenols from olive and lipid metabolism and lactotripeptides/ peptides and the cardiovascular system. There is also an additional set of more than 2000 claims that the European Commission has put on hold and for which the length of the transition period is still unknown. This includes many claims for botanicals and some other ingredients for which the European Commission and Member States still need to discuss details regarding methodology of assessment, conditions of use and/or scope. “With so many aspects of claims regulation still being implemented and under discussion, it is difficult for companies to get the concrete advice they need to be able to understand which claims are at which stage and timeline in the process,” said EAS. That is, absolutely nothing has changed … or is changing! And, what’s more, the situation is getting worse. Members of the European Parliament (MEPs) have

“Some of the major pharmaceutical players have hit the wall when it comes to innovation; they’re currently treading water ... so it’s only a matter of time before they start thinking about moving into other segments.” raised an objection to the European Commission’s proposal for an approved list of Article 13.1 claims, asking for more consideration concerning what should be included in the list. The objection, raised by a number of ENVI committee members, was based on concerns that the approach being taken to the substantiation of Article 13.1 claims is pharmaceutical in nature, ignoring the fact that nutrients are foods rather than drugs. Now, I have to ask, albeit rhetorically, is that pharmaceutical per se or “too” pharmaceutical? With the recent announcement that Decas Botanical Synergies (DBS) has obtained a Class IIa Medical Device Status for its patented Cranberry-Active capsule and that many major pharmaceutical companies are “converting” their prescription drugs to over-the-counter (OTC) status, to tap into the non-prescription healthcare market, isn’t there a need for more pharmaceutical-standard claim authorization? I mean, if the products themselves don’t fit into a distinct nutra versus pharma category, how can the regulations? And can we — you — afford to risk any aspect of quality, safety and efficacy? As one of my industry spies put it: “When it comes to any product with a health angle, consumers want the trust that comes from the pharmaceutical

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industry. Yet, because of pricing issues, they might be more open to CPG brands dipping their toe into the healthcare water rather than Big Pharma companies dumbing down to dabble in nutricosmetics, nutraceuticals, VMS and the like. As usual, they want it all.” Plus, it could be argued that some of the major pharmaceutical players have hit the wall when it comes to innovation; they’re currently treading water by tinkering with dosage forms, bilayer tablets, etc., so it’s only a matter of time before they start thinking about moving into other segments. In the US, notes another source, a number of pharmaceutical companies have already shed their “consumer healthcare” divisions to focus on pharma. In general, those that remain run their nutraceutical businesses as wholly owned subsidiaries … with separate company names, marketing budgets, production facilities and legal entities. “I’m not sure Big Pharma can or should leverage their names in the nutraceutical space,” s/he says. “From a marketing perspective, it doesn’t work. Wouldn’t it be better for these companies to start new subsidiaries if they want to venture into functional foods and drinks?” But then, of course, a considerable issue for Big Pharma is that of profit margins. Either they have to offer a perceived benefit that current VMS/nutraceutical players aren’t, to justify the higher cost, or they have to change something about the current pharma model to reduce their costs. If, when all is said and done, it only comes down to finance, then yes, Big Pharma regulations might be costly and difficult to achieve … but at least the industry — or industries — would be moving forward.

For more information Kevin Robinson Editorial Director, Via Communications Ltd www.via-medialtd.com

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