the Danone Research newsletter              04
                                                          APRIL 09


                             MEDICAL NUTRITION

REsEARCH                                                                                                                  ...
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                      MEDICAL NUTRITION
                      R&D LOCATIONs AND REsEARCH
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  1. 1. the Danone Research newsletter 04 APRIL 09 MEDICAL NUTRITION The stakes 4 Danone’s Leading-edge Research: Our Dedication to Improving Nutrition, Improving Lives 6 “The brain is different from other organs” 9 Fortisip Compact: Major technological breakthrough 11
  2. 2. EDITORIAL UNDERsTANDINg MEDICAL NUTRITION In this edition of VIEW we offer an overview What is medical nutrition? of how our Medical Nutrition Research & Medical Nutrition manages disease-related malnutrition and specific disease conditions Development teams are developing innovative in all age groups. It can make medical treatment nutritional products that serve patients’ more effective by controlling malnutrition, meeting special dietary needs, needs and open new growth opportunities and can help to delay disease progression. for Danone. We define it as nutritional intervention that improves clinical outcomes. Scientific credibility is vital to success in this evolving sector and we have deep scientific expertise in understanding physiological disease processes and the role How do people take them? of nutrients. At the same time, a strong The products are administered via the gastro- intestinal tract – taken orally as a beverage, technological expertise is required to deal soup, meal, or dessert, or through a feeding with complex formulations and to create tube. products with a long shelf life, that are good tasting and appealing to our patients. “Medical Nutrition Are these products food or pharmaceuticals? R&D is a very They are not pharmaceuticals. Medical Nutrition products are unique compositions of specific Our goal is that medical nutrition will be ambitious an integral part of disease treatment plans nutrients that cannot be obtained from a normal diet. Our products are ‘advanced for people of all ages – from premature environment nutrition’, and from a legislative perspective, they are classified as food. birth to the terminal phases of life. with a strong The beauty of our work is that we create pioneering spirit.” How are they distributed? Medical Nutrition products are usually new horizons in science and technology, prescribed or recommended by health and at the same time, our products Hanno Cappon VP Medical Nutrition R&D care professionals, and in many markets they are reimbursed by health insurance. They are are having a positive impact on people’s lives. distributed in hospitals, care homes, pharmacies, and special home-delivery channels. 03
  3. 3. THE sTAKEs Nutrison Nutrison reflects our R&D expertise to find innovative The following topics explain the key issues that are impacting the medical solutions. The customized ready-to-use tube feeds facilitate the dietary management of malnutrition nutrition sector today, and in the future. in patients requiring tube nutrition, meeting each patient’s specific needs. Certain varieties contain our patented Multi Fibre mixture (MF6™) proven to reduce constipation and diarrhoea, while others (Diason) have a low glycaemic index to control “The division’s science and R&D capability is Responding diabetes complications. seen by health care professionals as a reference to opportunity in the field of Advanced Medical Nutrition. and challenge This is key to the acceptance of the value of our Medical nutrition is an exciting new sector products in hospitals and community channels.” for Danone with a high growth potential. Flemming Morgan, President of Medical Nutrition at Danone Health care professionals are recognising that our innovative nutritional products can be a healthy complement to a patient’s medical Scientific credibility treatment. These products are for people Regulatory environment Market Position Scientific credibility is a top differentiator for success of any age and intend to manage a range From a European legislative perspective, medical nutrition Danone’s Medical Nutrition division is a high-growth busi- in the medical nutrition sector. Danone has the advantage of conditions, such as childhood epilepsy is food and must comply with a specific legislation called ness. Our financial results for 2008 were very positive, with because science is at heart of our business. This expertise or Alzheimer’s disease. ‘Foods for Special Medical Purposes’. This EU directive 854 million € sales (reflecting 12.7% growth). In Europe, is very important for our relationships with medical authorities ensures product safety and suitability for the intended we are the market leader with about 40% market share. and regulatory bodies. To secure registration and reimbur- Older people are one of the major consumers purpose. It regulates vitamin and mineral composition, and Danone Medical Nutrition products are marketed under of our products and this is a prime market sement by health care policies, scientific substantiation labelling of these foods, including those for infants. Our the Advanced Medical Nutrition brand names Nutricia, segment. As the ageing population in- is crucial. We are making a strong emphasis on informing products are facing a comparable regulatory environment SHS and Milupa Metabolics. We have built a strong scien- creases, managing healthcare expenses while Health Care Professionals (HCPs) and Key Opinion Leaders in other markets, such as the USA. tific reputation and are recognized for our innovation. providing optimal care will be a critical issue. (KOLs) on the benefits and proven scientific evidence Medical nutrition offers key benefits: it is behind our products. Our research results are published in designed to increase quality of life by slowing Consumer concerns high quality peer-reviewed scientific journals and we present the progression of certain diseases and helps People rely on medical nutrition products for their health and them at international scientific conferences. To build strong keep patients independent for longer. From a recovery – from sick infants to the diseased elderly, so the relationships, we regularly invite HCPs, KOLs, and health financial perspective, the nutritional benefits safety and quality of our products has to be uncompromised. policy makers to our research facilities to share and discuss can shorten hospital stays, thus reducing The additional challenge is that people need a pleasant-tas- the science behind our products. healthcare costs. ting, easy-to-consume product – despite complex formula- tions. Along with opportunity there are also chal- We’re going to the next level to ensure positive consumer lenges facing Danone. As we work to grow acceptance. Our technological expertise is enabling us to our market share, we also face competition. develop products that encourage patient compliance while Flemming Morgan, President of Medical delivering maximum clinical outcome. Our dedication to Nutrition at Danone, explains: «Our strategy seeing patients as people first is delivering positive results, in innovation is to drive additional growth Neocate through the development and commercia- both in building market share and recognition in the medical Respifor lisation of breakthrough disease-targeted and scientific research community. Many infants and children have an allergy to cow’s milk. Neocate has become the world leader in this Respifor is an excellent example of our innovation- products and solutions.» market by providing a non-allergenic amino-acid in-action. This specialised nutrition is for patients based substitute for milk-based formulas and foods. with chronic lung-related diseases, for example, He also notes that innovations and upgrades It is manufactured in the world’s only 100% dairy-free lung emphysema. Its low volume formula (125 ml) facility in Liverpool. More than half a million infants is high in protein to rebalance protein metabolism. already make up 30% of new sales growth and children have benefited from Neocate, Respifor is clinically proven to promote superior (2008), and with a very promising pipeline, and parents and prescribing health care professionals weight gain as compared to standard medical this proportion is expected to increase in the alike rely on the product’s safety and purity. nutrition, and also to improve physical performance The popular brand continues to grow in excess - enhancing patient quality of life. coming three years. of 25% annually, due to scientific expertise, clinical evidence and constant innovation. 04 05
  4. 4. REsEARCH Controlling Epilepsy with Nutrition Danone’s Leading-edge consumption and alternated As early as 400 B.C., Hippocrates Highly skilled R&D between recommending high noted that epilepsy can be treated organisation Research Our Dedication or low carbohydrate foods. It by abstaining from food. By the The new Danone Medical Nutrition R&D organisation was also believed that adding 1920’s, the concept of epileptic comprises almost 160 people, with expertises ranging additional protein could slow the seizure control by fasting had from cell biologists and physiologists to nutritionists absorption of carbohydrates and gained substantial support. That’s to Improving Nutrition, Improving Lives and food technology scientists. We operate in 4 stabilise glucose levels. when scientists began to study the countries: The Netherlands (Wageningen, Zoetermeer, mechanism of fasting, discovering Cuijk, Schiphol), UK (Liverpool), Germany (Friedrichs- Today, modern studies are chal- that its benefits could also be dorf) and China (Wuxi). We actively collaborate At Danone, we know that disease isn’t just a clinical term. lenging these traditional beliefs simulated by fat-rich, low-carbo- with the transversal expertise platforms such as and scientists are re-examining hydrate diets. This state, known It’s something that impacts people’s quality of life – quality that the role of protein and fat on as ketonaemia, gave rise to the Gut & Microbiology, Immunology, Consumer Science and Clinical Studies. can be improved with state-of-the-art medical nutrition. Here is glucose response. International ketogenic diet. an update about who we are and how we’re developing products that bodies, such as the European Association for the Study The ketogenic diet’s basic Extensive international of Diabetes (EASD), have released principle is that drastic reduction scientific network work in sync with patients’ treatment plans – leading to better lives. new guidelines for the composition of carbohydrates stimulates the While internal expertise is a critical aspect of our body – and particularly the brain – research focus, our multi-disciplinary teams also of a diabetes patient’s diet, based work in close collaboration with leading international 1 - The Evolving History of Medical Nutrition on the latest scientific insights. to switch from glucose to fat-derived ketones as its primary source scientific centres. We are currently engaged in research projects and clinical trials with more than 200 The scientific understanding of the role of nutrition on human Research Our first nutritionally complete oral of energy. Since the 1990’s, universities, hospitals and industries across the globe. health has significantly evolved over the last centuries. nutritional supplement, Diasip, the ketogenic diet has enjoyed Traditionally, it was believed that food only provided energy Breakthroughs a remarkable revival as a treatment This strategy will enable us to expand Danone’s was low in carbohydrates to the body. Around 1900, when confronted with deficiency in Diabetes: from and high in fat. It was specifically strategy for intractable epilepsy, leadership position in the specialised nutrition industry. diseases, scientists started to discover the essential role starvation to 21st developed to give a lower glucose with several clinical studies of specific nutrients, vitamins and minerals. Later, the effect century science response after a meal than stan- indicating its effectiveness. of diet on chronic diseases, such as cancer and cardiovascular dard supplements. Then it was diseases, became apparent. Diabetes Mellitus is a metabolic reformulated to meet the new In 2002, SHS International, Today, we know that nutritional ingredients exist that can actively disorder that leads to high blood EASD standards. Launched a subsidiary of Danone and part interfere with disease processes (somewhat like pharmaceutical glucose levels. Scientific understan- in the summer of 2008, second- of the Medical Nutrition division, components). This means that through specific nutritional ding of this disease has continually generation Diasip features launched Ketocal, a ketogenic intervention, we can improve peoples’ health and wellbeing. advanced over the years and a «triple action» for superior medical food that can be used we were at the forefront of early glucose control. Carefully selected as part of the ketogenic diet diabetes studies. The first Nutricia and tested carbohydrates, or as complete ketogenic nutrition. Medical Nutrition product for diabetes combined with proteins In 2008, results of the first-ever The first Nutricia Medical Nutrition patients was developed back and dietary fibre, ensure a healthy randomized controlled clinical in 1905, pioneering the concept trial of the ketogenic diet were product for diabetes patients of specialised nutrition. It was a milk glucose metabolism in the diabetic patient. To date, several published in The Lancet Neurology was developed back in 1905, pioneering product low in lactose. intensive clinical studies in Type journal. This study, supported by 2 diabetes patients have already SHS, confirmed the clinical efficacy the concept of specialised nutrition. By 1915, very controlled food intake provided convincing scientific of the diet and cements its place was the standard treatment evidence to support our claims. as a bona fide therapeutic option for diabetes. When insulin for intractable epilepsy. was discovered in 1921, medical professionals restricted sugar Thanks to Ketocal, people living with epilepsy have a proven tool to manage manage their symptoms through diet. 06 07
  5. 5. 3 questions for... REsEARCH Richard Wurtman 2 - Strategic Competencies of Medical Nutrition R&D “The brain is different from other organs” To identify new nutritional intervention opportunities, Boosting metabolic Advanced Neurosciences Neuroscience, a field VIEW: What is the most intriguing we need to research the complex interaction between nutrition, biological processes and disease mechanisms processes technology Nutrition plays an important role devoted to the scientific finding of the last few years? Diseases, surgery, ageing and Developing a product prototype is in the field of neuroscience. in the human body. That’s why our strategic research axes R.W.: Perhaps the most interesting wound healing impact metabolic a challenge -- we get a “shopping The brain uses nutrients as an study of the central finding is that not only the produc- comprise almost all life science disciplines, as well as energy supply and they influence product technology and sensory sciences. processes. We are examining list” of necessary ingredients as and peripheral tion of neurotransmitters but also how nutritional products well as the desired format, and the synthesis of neurotransmitters. Preclinical studies indicate that nervous system, the synthesis of unique synaptic can boost these processes then we put innovative/ cutting- membranes can be affected Protein metabolism: to enhance and maintain edge technology to work to make as dietary precursors, nutrients is opening the window by nutrition. These processes the base of life functionality, performance, and it happen. Ingredients need to be can synergistically increase Dr. Richard of discovery about can be increased by consuming Protein, one of the body’s basic membrane and synapse J. Wurtman MD, quality of life. stabilized for maximum efficacy Cecil H. Green how nutrition impacts three nutrients: uridine- building blocks, is mostly found in Currently focusing on diabetes, and long shelf life, yet also have a formation, which are essential muscle. Preserving muscle mass for proper brain function. Distinguished Professor of brain cells. mono-phosphate, the omega-3 our researchers are looking at good flavour and pleasant texture. PUFA DHA, and choline. is a challenge in the elderly and The results of the first clinical Neuropharmacology, metabolic responses to diet We have the know-how to create Massachusetts VIEW: What role does nutrition As demonstrated in in-vivo patients recovering from surgery and how it affects long-term complex formulations with optimal trial are encouraging and we are Institute of play in the field of neuroscience? models, these nutrients or disease. Loss of muscle mass continuing to build the pyramid Technology (MIT). complications in diabetes and ingredient interaction - whilst R.W.: The brain has all of increase both the lipid portions naturally occurs with ageing and metabolic syndrome patients. remaining stable after sterilisation. of evidence (see diagram on page the nutritional needs as the rest of these membranes and is accelerated by inflammatory By understanding the Our R&D expertise drives the full 10). Additional longer-term trials of the body. Deficiencies in some the specific proteins that are conditions, inadequate dietary relationships between disease, product lifecycle, from checking with Souvenaid® (in Europe and nutrients – like B vitamins, glucose, essential for neurotransmission. protein intake and cancer. treatment, GI homeostasis, the feasibility of new processes, USA) have been designed and will essential fatty acids, or protein Consequently, the neurons make By identifying the gap between metabolic stress, and immunity, ingredients and food forms, to start in 2009. A large, dedicated – can impair brain function and surface structures, dendritic dietary protein intake and we can create specialised working with supply points for EU consortium called LipiDiDiet cause well-established syndromes. spines, which can produce need, we can support protein products designed to impact implementation and optimisation will conduct one of the trials. But the brain is different from additional synapses. Theoretically, metabolism with products such the progression of disease and of new technologies in the factory. Building on the knowledge gained other organs – it has a special these nutrients could be used as Fortimel, our high-protein treatment complications. in our Alzheimer project, we have dependence on nutrient intake. to restore synapses when formula. Developing new specific a great opportunity to bridge the protein compositions enables us The power gap between Alzheimer’s patients It’s because many of the enzymes they’ve been damaged by disease. that the brain uses to convert to stimulate synthesis of muscle of immunity and the general population nutrients to essential products VIEW: What could be the most protein – increasing muscle mass IImmunity is the body’s defence of elderly people. We are now have a low affinity for these promising application for nutrition and function. This can improve mechanism against infection focussing on other diseases that nutrients. If more of a nutrient in neurological disease in the quality of life while reducing and disease. Using nutritional impact the growing number is provided – usually by eating it – future? complications and hospital stays. concepts, we search for of older people in today’s society. the brain rapidly proceeds to make R.W.: One encouraging application intervention opportunities to more of the product. is Nutricia’s Souvenaid®, a formula support the immune system Brain cells, called brain neurons, containing uridine-mono-phosphate, of elderly and immuno- compromised individuals such as “Our medical communicate with each other DHA, and choline, as well as the cancer patients. The Immunology nutrition relies through synapses located necessary supporting nutrients. at the ends of the neurons. It’s currently being tested for Platform has a strategic alliance heavily on technology These synapses release messenger the management of Alzheimer’s with the Utrecht Institute for Pharmaceutical Sciences - this expertise molecules (neurotransmitters) disease. Virtually all neurologic to transmit the message scientists agree that Alzheimer’s and a network of academic enables us to the next cell. Specific nutritional patients suffer cognitive impair- and industrial partners who continuously investigate and to produce best- ingredients can influence the ability ments because of synapse loss. evaluate our products. in-class products.” of brain neurons to synthesize Perhaps the reduction in the neurotransmitters, thus rapidly number of synapses can be com- affecting the information carried pensated by a synapse-producing across the brain’s synapses. preparation like Souvenaid® 08 09
  6. 6. CAsE sTUDy Systematic review & meta analysis Fortisip Compact: db-RCT KEy INNOvATION in target group AxE - BUILDINg Cohort Gastrointestinal Sensory pyRAMID and case studies functionality & and consumer Of EvIDENCE Expert opinion Major technological breakthrough tolerance science KOLs One of our key competences Patients know that medical Proof of concept is a thorough understanding nutrition products are not Healthy volunteer data of nutrient metabolism a dietary treat, but they still want Mechanistic Danone Research responded to the technological challenge of producing a complete yet in the gastrointestinal tract. them to taste good and have experimental evidence condensed oral nutritional supplement (ONS). The result? Fortisip Compact, the first This enables us to understand a pleasing texture to ensure how the body breaks down compliance. Our challenge State of the art nutritionally complete ONS in the world that offers 300 kcal, and 12 g protein in only 125 ml. ingredient knowledge nutrients so that they can be used is that many ingredients in these to promote healing or support products naturally do not taste optimal health. Our products must good (such as high levels of fish What is a medical In February 2009, Fortisip Compact began its rollout in the market, marking the successful Beneficial to patient be well tolerated by vulnerable oils, amino acids, minerals nutrition clinical study? conclusion of a major R&D effort at Danone. and provider people with impaired health. and vitamins) and must be To produce this nutritionally complete, When we identify innovative specially formulated for a long Fortisip Compact is beneficial for both patients Clinical studies are a pivotal part of Danone’s protein-rich and energy dense compact ONS, ingredients and develop new shelf life. Unusual combinations and health establishments. The average hos- Medical Nutrition scientific credibility. These the edges of the laws of physics, state-of- product formats, we perform of these ingredients make pital cost for nutritionally at-risk patients can studies are conducted in patients and healthy the-art innovative processing techniques and clinical studies to be sure that it even more challenging triple when compared to standard patient volunteers to test the safety and efficacy new ingredient sources had to be explored. these products are well tolerated. to develop a pleasant taste. costs, illustrating the high cost of malnutrition. of our products. Trials are set up in close Tolerance is a critical success Our current studies, In studies of hospital and community patients, collaboration with (academic) hospitals, factor for long-term compliance, which are mainly coordinated nursing homes and institutes. Concentrated calories ONS use has been shown to improve energy ensuring that the consumer/ in Wageningen, involve various The investigators are often Key Opinion for optimal nutrition and nutrient intake, increase body weight and functional outcomes, reduce mortality patient can receive all the intended types of patients and healthy Leaders or medical specialists. health benefits of the product. elderly people and children, Clinical trials with medical nutrition are very Fortisip Compact targets the nutritional and complications, and reduce length of stay from different parts in the world. different than product testing for healthy needs of hospitalized patients, nursing home in hospitalized patients when compared with consumers. The people in medical nutrition residents, and older adults. Often these groups routine clinical care. trials are often physically fragile and in health cannot consume enough solid food to main- “Our defining difference care facilities or hospitals. The participants tain a balanced diet, leading to malnutrition. is that with the acquisition in these studies must have the disease that Danone’s liquid compact ONS acts as a com- the product is intended for – this enables us plement to regular meals, ensuring optimal of Numico we are establishing nourishment. to test the safety, efficacy and benefits of the an unprecedented level product in the appropriate target population. of excellence. Danone is truly Trials are conducted in full compliance Danone’s revolutionary supplement is designed with ICH guidelines for Good Clinical Practice to work in tandem with the brain’s signals that a pioneer – setting standards for and applicable local legislation. perceive fullness. These signals correspond clinical trials and speaking These regulations safeguard the rights, more with the volume of food eaten, than safety, and wellbeing of subjects as well with the actual calorie consumption. So peo- Our dynamic simulator of the gut to European Union regulators.” ple tend to eat a certain volume and feel full, is a computer-controlled model as ensure reliable results. that allows us to study how Sven Thormahlen is Executive Vice President We’ve gone a step further with our ISO without taking in sufficient calories for proper (and to what extent) our product of Research and Development 9001:2000 certification as an independent nutrition. Fortisip Compact’s easy-to-drink ingredients are being digested and General Manager of Danone Research. formula gives a limited “full feeling” effect and qualification of our methodology. It’s yet or fermented in the various parts another way we provide credible, convincing provides concentrated calories in a small volume. of the gastrointestinal tract. data for Health Care Professionals and It doesn’t disrupt calorie consumption during authorities. normal meals – guaranteeing increased energy intake in the short-term. 10 11
  7. 7. DID yOU KNOW ? MEDICAL NUTRITION R&D LOCATIONs AND REsEARCH COLLABORATIONs UNITED-KINgDOM THE NETHERLANDs CUIJK: Powdered sWEDEN CHINA LIVERPOOL: product WAGENINGEN: product formulations STOCKHOLM: WUXI: adaptation formulations and clinical preclinical research; SCHIPHOL: medical Ersta Hospital of formulations, research for metabolic consumer sciences; devices and clinical Karolinska diseases & cow’s milk new technologies; Institute studies for allergy. clinical research VU University Chinese market ZOETERMEER : liquid Medical Centre University of Hull product formulations Amsterdam University of Oxford University Hospital Maastricht University of Utrecht UNITED-sTATEs NEW YORK: St. Luke’s-Roosevelt Medical Center ARKANSAS : University for Medical Sciences BOSTON MIT spAIN fRANCE gERMANy ITALy IsRAEL BARCELONA: LYON: Hôpital FRIEDRICHSDORF: ROME: TEL AVIV: University Edouard Herriot Metabolic University Sourasky of Barcelona diseases of La Sapienza Medical Center Locations of R&D facilities for Medical R&D International collaborations Mirjam Govers - - office: +31 317 467 889 Danone Research-Centre for Specialised Nutrition - Bosrandweg 20 6704 PH Wageningen - The Netherlands / Writing: Patricia Philbin / Credits: Jaap van de Beukel / design: pixelis corporate