Bioactive Nutrition.

Transcription

1 Bioactive Nutrition

2 ur journey Colostrum Scientific basis Bioactive nutrition Proven efficacy ColoPlus AB Immune deficiency Gastrointestinal health Diarrhoea & malnutrition HIV & AIDS ColoPlus ONCARE ColoPlus IMCARE CAMPIO clinical study in Gothenburg with ColoPlus ONCARE in Oncology Care Nigeria (2005) Port Harcourt Hospital Scandinavian Journal of Gastroenterology Clinical Studies Uganda (2008) Gulu Referral Hospital Submitted for publication Intellectual Property Patents granted South Africa Europe (selected countries) India Australia New Zealand Pending USA Market Introduction ColoPlus IMCARE: Proof-of-concept pilot,south Africa 2010 Exploring partner options in India

3 ColoPlus AB ColoPlus is biotechnology company developing and commercialising highly effective functional food products with global commercial potential The company is based in the Medicon Valley region in southern Sweden. It traces its origins to research and development teams at Lund University Hospital. ColoPlus is privately owned by nine individual shareholders, seven of whom comprise the Board of Directors, including renowned scientists and senior business leaders from Sweden and New Zealand. Professor Göran Grosskopf Chairman Jur. Phd, Ekon.dr. h.c. Chairman Ingka Holding BV and Peab AB (fmr Chairman of Tetra Laval Group) Conny Hagman Managing Director MSc. Economics Former Deputy Chairman TKF, Swedish Technology Transfer Association Margareta Nilsson Director Med.dr.hc. Econ.dr.hc Director of the Crafoord Foundation Mission to deliver proven therapeutic benefits ColoPlus develops innovative nutraceutical food products based on rich bioactive properties of bovine colostrum and natural nutrition In contrast to other marketers of colostrum-based food products, ColoPlus philosophy is to develop and market products with clinically proven efficacy and defensible intellectual property. Results from clinical studies of ColoPlus products must qualify for publication in a renowned medical journal. Professor Ingemar Ihse Director MD, PhD. Former Medical Director of Lund University Hospital Professor CH Floren Director MD, PhD. Professor of Gastroenterology at Lund University Hospital Lidia Elfstrand Director PhD Pharmaceutical Technology, MSc Food technology Our mission is to deliver clinically proven therapeutic benefits and nutritional support to those people who need it most Kris Nygren Director BSc, Former Strategy Manager, Incubator Business Manager, Fonterra Co-operative Group

4 oloplus IMCARE ColoPlus IMCARE is an innovative nutraceutical food product based on rich bioactive properties of bovine colostrum and natural nutrition ColoPlus IMCARE has been specifically designed for HIV and AIDS patients who commonly suffer from life threatening diarrhoea resulting in malnutrition and fatigue, especially in developing countries with limited access to clean water and nutritional support options. ColoPlus IMCARE offers long lasting positive effects and the promise of improved quality of live for tens of millions of people globally. Bioactive Nutrition The core ingredient in ColoPlus IMCARE is bovine colostrum contributing rich bioactive agents including anti-bodies (immunoglobulin), growth factors and antimicrobial peptides and high nutritional value ColoPlus IMCARE delivers nutritional support for immune-compromised patients that suffer from gastrointestinal health complications. The product solution has been designed to preserve its bioactive properties during production and storage and to deliver maximum exposure of bioactive agents and nutrients to the human intestine after intake. Clinically proven benefits to people living with HIV include: ColoPlus IMCARE stops diarrhoea ColoPlus IMCARE significantly improves nutritional status ColoPlus IMCARE significantly reduces fatigue ColoPlus IMCARE increases CD4+ counts ColoPlus IMCARE normalises patients weight and BMI Manufacturing & Packaging ColoPlus IMCARE is packaged in powder form in convenient 25gram single-portion sachets. The powder is mixed with lukewarm water (into a kind of porridge ) immediately before consumption. ColoPlus IMCARE will be manufactured and packaged in the local market. ColoPlus provides a complete packaging solution the final consumer product: High barrier single-portion sachet Display box Shipper box

5 Clinical Studies ColoPlus IMCARE ColoPlus has completed two successful clinical studies validating the therapeutic benefits of ColoPlus IMCARE in alleviating HIV-related diarrhoea and resulting malnutrition: 1. Study comprising 30 adult HIV and AIDS patients at Braithwaite Memorial Specialist Hospital in Port Harcourt, Nigeria in Study comprising 87 HIV and AIDS patients 2 at the Gulu Regional Referral Hospital in Uganda in ColoPlus ONCARE ColoPlus has started a clinical study in collaboration with a distinguished Swedish oncology group at Sahlgrenska University Hospital, Gothenburg, Sweden "CAMPIO" (Colostrum Affords Mucosal Protection In Oncology) is a phase II study to evaluate the efficacy, safety and feasibility of ColoPlus ONCARE, as prophylaxis against gastrointestinal side effects of chemo-or radiotherapy in patients with colorectal cancer.

6 bstract ColoPlus, a new product based on bovine colostrum, alleviates HIVassociated diarrhoea Claes-Henrik Floren, Sonny Chinenye, Lidia Elfstrand, Conny Hagman, Ingemar Ihse Published in Scandinavian Journal of Gastroenterology Objective HIV-associated diarrhoea occurs in nearly all patients with acquired immunodeficiency syndrome (AIDS) in the developing countries. Diarrhoea is caused by the HIV-related immune dysfunction and is pivotal in the decrease of the helper T-cell (CD4+) population. Enteric pathogens in HIVassociated diarrhoea are, for example, Cryptosporidium, Amoeba and Campylobacter species. Bovine colostrum is the first milk the suckling calf receives from the cow. It is rich in immunoglobulins, growth factors, antibacterial peptides and nutrients. It supplies the calf with a passive immunity before its own active immunity is established. ColoPlus is a product based on bovine colostrum and is designed for slow passage through the gastrointestinal tract, as well as having a high nutritional value. The aim of the study was to investigate whether ColoPlus given orally can influence the severe diarrhoea associated with HIV infection. Method The study was carried out at Braithwaite Memorial Specialist Hospital, Port Harcourt, Nigeria. Thirty patients with HIV-associated diarrhoea were included in the study. The patients were treated with ColoPlus for 4 weeks in an open-labelled non-randomized study, after an observational period of one week. After a post-treatment period of another two weeks, treatment with anti-hiv drugs was started, if deemed appropriate. The effects on the frequency of stool evacuations per day, on bodyweight, fatigue, haemoglobin levels and CD4+ counts before (week 1) and after treatment with ColoPlus (week 7) were measured. Results There was a dramatic decrease in stool evacuations per day from 7.09+/-2.7 to 1.39+/-0.5 (+/- SD), a substantial decrease in self-estimated fatigue of 81%, an increase in body-weight of 7.3 kg per patient and an increase in CD4+ count by 125%. Conclusion ColoPlus may be an important alternative or additional treatment in HIV-associated diarrhoea.

7 Effects of ColoPlus IMCARE in Treatment of Patients with HIVassociated Diarrhoea in Northern Uganda Kaducu Felix Ocaka, Okia Simon Angura, Angwech Pamela, Conny Hagman, Lidia Elfstrand, Claes-Henrik Florén, Upenytho George Submitted for publication. Background Northern Uganda, a region that is just emerging from over 20 years of conflict, has HIV prevalence of about 8.2%, much higher than the national average of 6.4%. Chronic diarrhoea is a common manifestation in patients with acquired immunodeficiency syndrome (AIDS) in developing countries. With inadequate food availability in poor households, HIV-associated diarrhoea often leads to malnutrition and worsening of HIV disease especially for those with no access to anti-retroviral therapy. Nutritional intervention is a key component of comprehensive management of HIV/AIDS patients. ColoPlus, a nutritional product made from bovine colostrum, is rich in nutrients, immunoglobulin, growth factors and peptides that have anti-bacterial effects. The aim of the study was to determine the effects of ColoPlus on stool frequency, nutritional and immunological status of patients with HIVassociated diarrhoea. Method The study was carried out between October 2007 to June 2008 at Gulu Referral Hospital and 4 other outreach clinics in internally displaced persons camps in Gulu and Amuru districts. Eighty seven patients participated in the open-labeled randomized clinical trial. Forty five patients received 50 grams of ColoPlus twice a day for 4 weeks, besides regular care. The control group of 42 patients received only the regular care for diarrhoea which included fluid and electrolyte replacement, antibiotic and anti-diarrhoeic drug use. Participants were followed up for 9 weeks. Effects of ColoPlus on daily stool frequency, fatigue level, body weight, and body mass index, haemoglobin, serum albumin and CD4+ cell counts were measured for all patients. Results There was a significant decrease in mean daily stool frequency from 7.5 ± 2.9 to 1.3 ± 0.7 (±SD) in patients on ColoPlus, representing 83% reduction. Patients on regular treatment had a 60% reduction in mean daily stool frequency (6.9±3.2 to 2.7±1.8). On average, diarrhoea ceased by day 7 for patients on ColoPlus and day 21 for the controls. Self-estimated fatigue remarkably reduced by 85% for patients on ColoPlus compared to 43% for the controls. Mean weight and body mass index (BMI) increased by 11% in patients on ColoPlus with no significant change in the controls. Patients on ColoPlus had a 14% increase in mean CD4+ cell count compared to a 12% reduction in the controls. No significant effect of ColoPlus was demonstrated on serum albumin and haemoglobin by week 9. Conclusion ColoPlus is an effective treatment of HIV-associated diarrhoea.

8 ntellectual Property ColoPlus Patents o o o o o o European Union (selected validated countries) South Africa India Australia New Zealand USA (pending) In 2007, the validity of the ColoPlus European patent was challenged at the European Patent Office. The opposition against the patent decision was rejected by the Office with a decision completely in favour of ColoPlus AB published in February 2009 ColoPlus is registered trademark in Sweden ColoPlus Protected IP

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11 Market Introduction Key Opportunities The HIV and AIDS epidemic continues to be a major public health problem the world over. Globally, an estimated 33 million people were living with HIV in 2007 with 2.7 million new infections occurring in that year. Over 95% of people infected with and those worst affected by HIV live in the developing world. The key opportunities for ColoPlus IMCARE is characterised by 1. ColoPlus patent protection; 2. Limited access to clean water and advanced nutritional support options; and 3. Large populations with high instances of HIV. In the first instance, this translates into an addressable market for ColoPlus IMCARE of 8.1 million people living with HIV and AIDS in South Africa and India. South Africa The UNAIDS, 2008 report on the Global AIDS Epidemic estimated that 5.7 million South Africans 11% of the population - were living with HIV/AIDS in In 2007, it was estimated that only 1/3 of South Africans infected by HIV had access to anti-retroviral medication ColoPlus will conduct proof-of-concept pilots with ColoPlus IMCARE in South Africa in The purpose of the pilots is to establish a practical programme encompassing ColoPlus IMCARE in the South African healthcare environment. The pilots include local manufacturing, distribution and observation in collaboration with key partners. India The Indian National AIDS Control (NACO) estimates that 2.5 million Indians were living with HIV and AIDS in ColoPlus is actively exploring partnering options to introduce ColoPlus IMCARE on the Indian sub-continent in the next months.

12 Bioactive Nutrition ColoPlus AB Sergels väg 14B S MALMÖ Sweden