Express Pharma

The journey from cow to consumption

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What does it take to transform bovine colostrum into a nutritional supplement, ensuring that all the immunoglobins, vitamins and other nutrients are preserved from cow to consumption? After years of research, Sweden-based ColoPlus perfected a method to achieve this and backed it up by publishing three observational field studies in peer reviewed journals to prove its efficacy. Post Diwali, ColoPlus sachets will be launched in India, thanks to a collaboration between ColoPlus and the Rs1,450 crore Pune-based Parag Milk Foods. Viveka Roychowdhury speaks to Conny Hagman, Chief Executive Officer, ColoPlus and Shirish Upadhyay, Senior Vice President – Strategic Planning, Parag Milk Foods to get more details

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Go ColoPlus concept pack shot

The benefits of colostrum, the milk produced just before and after pregnancy, are well known and new mothers are encouraged to breast feed their babies as soon as possible after birth and as frequently in the few days after birth. In fact, traditional sweets made from bovine colostrum are part of Indian cuisine, in an attempt to extend the benefits to other age groups as well.

This traditional knowledge has stood the test of time and science. It has been proven that the main benefits of colostrum are due to the high levels of immunoglobins, vitamins and other nutrients present, which increase resistance to disease and today, is not just newborns who benefit from colustrum.

Observational field studies done by Sweden-based ColoPlus AB, a company active in developing and clinical studies of medical food products based on colostrum, in children with HIV showed a marked strengthening of the immune capacity as well as a significant improvement of the nutritional state and quality of life thanks to a reduction of symptoms such as diarrhoea, related to the immune deficiency.

Come November, ColoPlus products will be available in India, thanks to an agreement signed on February 12, 2014 between the Swedish company and Pune-based dairy firm, Parag Milk Foods. For the makers of the Govardhan and GO range of milk products, this marks a deeper foray into the value-added health and nutrition business, which already reportedly contributes 80 per cent of the turnover. The two-decade plus dairy major is also reportedly planning an IPO and will file a Draft Red Herring Prospectus (DRHP) by end September.

According to Shirish Upadhyay, Senior Vice President – Strategic Planning, Parag Milk Foods, the launch strategy will be ready by end September in time for a post Diwali launch, in the form of single serve sachets as well as probably 200 gm and 500 gm SKUs.

The Pune-based firm has aggressive plans and is reportedly targeting a turnover of Rs 2,100 crore in 2015-16 against Rs 1,450 crore in the last financial year.

Besides counting celebrities like Amitabh Bachchan and Sachin Tendulkar as clients for its Rs 80 per litre ‘happy’ Holstein cow milk under the ‘Pride of Cows’ brand, the group also has plans for the other segments of the market. The ColoPlus product will be marketed under the GO range, along with other value-added products like whey-based drinks, powders and supplements.

A new take on tradition

According to Conny Hagman, Chief Executive Officer, ColoPlus, the decade-old company was started based on scientific work done on colostrum by Dr Lidia Elfstrand PhD, a food/pharmaceutical technologist. In terms of product positioning, they realised that a dairy-based product for the non-healthy elderly and children with decreased immunity should have good taste, long shelf-life and be easy to prepare. They realised that most colostrum products were either capsules or pure powder and not food.

Securing the natural bioactive benefits from colostrum called for controlling both the processing of colostrum as well as administration/composition of the final product. As Hagman puts it, the challenge was to develop a food product tasty enough to eat, yet with all the benefits of colostrum preserved from ‘cow to consumption.’

Hence, the industrial processes for colostrum and its products needed to be adjusted in order to preserve its very sensitive components. Thus the processing avoids fractionation, high temperatures and pressure. Additionally, transport time in intestine must be controlled and long enough to allow maximum absorption.

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Signing of the license agreement on February 12, 2014 (From left to right): Shirish Upadhyay, Vice President, Parag Milk Foods, Conny Hagman, Chief Executive Officer, ColoPlus, Devendra Shah, Chairman, Parag Milk Foods, Gowardhan, and BM Vyas, Director of Board, Parag Milk Foods

Different lab studies ended in the product ColoPlus IMCARE, designed as a porridge (dry powder product mixed with water) because this format protected the bioactivities of colostrum from denaturation in the gastrointestinal (GI) tract and showed superior function intestinally.

In addition, as Hagman points out, the porridge format allowed the company to add nutritional components to the mix, which made ColoPlus a combi solution, both bioactivity and nutrition. This form of controlled administration of immunoglobulins etc. (in colostrum) in combination with nutrition, was granted patents in several countries, including India as a food product and not a supplement.

In terms of patient populations, individuals with manifest or risk of immunodeficiency and/or malnutrition such as children, the elderly, patients with acquired immune deficiency, show the most clinical benefits from such a product. Different variants of the product for these patient/consumer populations were prepared by varying the concentration of immunoglobulins (colostrum) and selected organic matter.

The proof of the product
Once they developed the product, Hagman, with Elfstrand and two medical experts, professors Ingemar Ihse and Claes-Henrik Florén, all related to Lund University, Sweden, set out to prove the efficacy with international clinical studies. The first clinical study was conducted in Port Harcourt, Nigeria and published in the Scandinavian Journal of Gastroenterology. This was followed by a second study conducted in Uganda, the results of which were published online in December 2011 in the Indian Journal of Gastroenterology. The latest study/programme was conducted once again in Uganda and covered 850 children, supported by IKEA Foundation, results of which were published in the June 2015 edition of the World Journal of AIDS.

All three studies showed a marked strengthening of immune capacity as well as a significant improvement of nutritional state and quality of life in patients with acquired immune deficiency and malnutrition. A profound reduction of symptoms such as diarrhoea, related to the immune deficiency was also registered. These effects reflect the unique composition of ColoPlus ameliorating both the immune system and the nutritional state. Results are transferable to other medical conditions where a weak immune system and a state of malnutrition negatively influence health.

Beyond ColoPlus IMCARE, the Swedish company is looking at developing specific medical applications of colostrum-based therapeutic food, and getting these too ready for new clinical studies.

Tapping into tradition
Supplements like ColoPlus will never replace medicines but have an important role to play in supplementing their action. For instance, the authors of the June 2015 paper in the World Journal of AIDS point out that while Anti-Retroviral Therapy (ART) and Highly Active Antiretroviral Therapy (HAART) will remain the mainstay of therapy for HIV patients, these therapies may not be easily available in poverty-stricken areas. In such cases, colostrum-based food supplements could play a crucial role in sustaining CD4+ levels (an indicator of immunity) and could postpone the need for ART or HAART. This could result in considerable benefits in terms of healthcare spend by governments and NGOs as well.

Colostrum-based supplements could also act as adjuvants to the therapy, reducing diarrhoea, an AIDS defining condition, possibly by restoring the intestinal immune system. However, these studies were done without a placebo control and future randomised placebo controlled studies are needed to verify these results.

ColoPlus is thus a perfect example of the synergies that can be explored between traditional practices/remedies and new age technologies and science, using evidence-driven methods to further fine tune the product and prove efficacy.

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