- April 2008 -

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Gluten and Coeliac Disease

Coeliac Associations

Development of the Project “Suitable for People with coeliac Disease”. CSIC

Product

Launch Plan

Contents

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Coeliac Disease is a chronic disease that is characterised by permanent intolerance

to gluten, which causes a major lesion in the small intestine wall, destroying the intestinal villi and causing intestinal atrophy

Healthy intestine Atrophied intestine

It is an autoimmune disease

Gluten is a protein that is part of certain cereals:• Wheat• Rye• Barley• Oat

Coeliac Disease is defined by gluten intolerance

Ingredient of beer

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- Of every 100 individuals 20 genetically predisposed

At any time in life, an unknown external agent (it may be a virus or stress)

1 will develop it.

Coeliac disease is under- diagnosed

- In the South of Europe, it’s calculated that the possible number of people with the disease is around 10% of the population.

- The number of diagnosed patients in Spain is only 1% of the people suffering from coeliac disease.

Nb of possible patients Nº of diagnosed patients % annual growthEspaña 400.000 40.000 15%Italia 600.000 65.000 9%UK 500.000 125.000

- It is an under- diagnosed diseaseof which only the tip of the iceberg is visible

Data: Face.Letizia

Saturni

from

SIESS. Università

Politecnica

delle

MacheSummary

of

Medical News

Sotry

reported

by PR Newswire

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If a strict gluten-free diet is followed, the intestine reverts to total normality.

They cannot consume products with an amount of gluten > 20 ppm.

Products made of wheat, barley and rye, such as bread, cakes and biscuits are replaced with special products for coeliac patients made from: maize, rice and potato.

Treatment: strict lifelong gluten-free diet

The whole family ends up eating gluten-free products, thus avoiding risks.

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The high cost: one of the major drawbacks of gluten-free products

Chips Ahoy 300 g biscuits: 1.85 €Gluten-free biscuits 200 g: 2.57 €

Gallo macaroni 500 g: 0.68 €Gluten-free Gallo macaroni 500 g: 2.49 €

Loaf of bread 250 g: 0.70€Gluten-free small loaf 75 g: 1.00€

The economic cost of gluten-free products is much higher than wheat-based ones.

Some examples on the Spanish market:

María Biscuits 200 g: 0.65 €

María Biscuits gluten-free 200 g: 3.29 €

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Coeliac patient associations: a great support to patients

Coeliac patient associations provide excellent support to patients and their families.

They provide:

• Information about the disease

• Aid in the explanation of the treatment

• They organise meetings, talks, cooking classes, information from or about associations abroad, etc.

Associations analyse gluten-free products:

• They authorise gluten-free products by including the coeliac symbol.

• They publish lists of gluten-free foods (books, websites).

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SMAP (Celiacos de Cataluña) www.celiacscatalunya.orgJournal published: Tribuna celíaca.6,200 Members

There are numerous associations all over the world.

FACE (Federación Asociaciones Celiacos de España) which groups together all the regional associations with the exception of Catalonia. 20,500 Memberswww.celiacos.orgJournal published: Mazorca

All countries have their own associations, which in turn are in contact with the other international associations.

Spain has the FACE, a national association, as well as different associations in the Autonomous Communities.

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• The social life of the coeliac patient is seriously affected.Due to the limitations caused by their gluten intolerance, eating out is a complication for them since they only feel safe with what they eat when they do so in a controlled setting, such as at home. This leads to a certain isolation and problems at social level.

• Beer, a key element in social normalisationBeer has always been regarded as the social drink par excellence. Until not so long ago, having a beer with their friends was seen as a utopia by people with coeliac disease, since one of its main ingredients is barley. The advent of a beer that is suitable for coeliac patients changes these people's life.

Estrella Damm helps people with coeliac disease to carry a normal life

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Estrella Damm helps people with coeliac disease to carry a normal life

• In 2004, Damm started to allocate resources to be able to market a new beer that would be suitable for people with coeliac disease.

• This research began in-house, although the company quickly sought the help of the Gluten Unit of the National Biotechnology Centre of the Higher Council of Scientific Research (CSIC), with which it started to work in 2005.

• A lengthy and exhaustive work plan eventually led to a beer that maintains the basic properties of the product and contains acceptable levels of gluten for people with coeliac disease.

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Estrella Damm developed a research project in cooperation with the CSIC

CSICHigher Council of Scientific Research.

A public organisation that reports to the Spanish Ministry of Education and Science.

3,202 scientists, 3,802 Investigators and 3,626 support personnel.

Budget: 610 Million Euros

It is the largest Spanish public agency, with 116 centres engaged in scientific and technological research.

It develops the whole strategy of technology transfer to companies by means of R&D projects on demand and cooperative work such as the project undertaken in 2005 with Damm.

www.csic.es

DR. ENRIQUE MENDEZ (Died on the 22/07/2007)

Prestigious investigator and scientist

Director of the Gluten Unit of the National Biotechnology Centre

Creator of the Elisa R5 gluten detection system

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Objectives of the research project:

FIRST PHASE

“Study of the chemical and enzymatic degradation of barley hordein in germinative and fermentative processes”

Define where and why protein denaturalisation takes placeCertify that it is below 20 ppm in the finished product

SECOND PHASE

Control of the manufacturing batches for the “Suitable for people with coeliac disease” marketing

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Main steps in the art of brewing beer

How can protein denaturalisation be prevented during the beer-making process?

MILING

BOILING

COOLING

FERMENTING

MATURING

BOTTLING / KEGGING

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The initial ingredients are cooked twice at the beginning of the process

These milt grains are mixed with water in the maceration kettles. A first

coction

is

done.Then, hops

is

added

to

this

mash

and

a second

coctiontakes

place.

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When the yeast is added, the fermentation and maturation process begins

The

yeast

is

added

to

the

already

cooled

wort

and

the

fermentation

process

begins

(7days). A temperature

decreasement

is

done (from

10ºC

to

0ºC

) and

the

“young” beer will

be in the maturing tanks for 3 weeks.

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What matters most is the end result of gluten content, not gluten in ingredients

OBJECTIVE:The fact that the ingredients are below 6 ppm is not what

really matters.

The aim is that the final product has a gluten content

of less than 6 ppm

End result:

Beer suitable for people with coeliac disease

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Work plan of the Damm - CSIC research

Sampling in the different phases of the barley malting process .Selection, Storage, Wetting, Germination, Drying and Roasting.

Sampling in the different phases of the beer-making process Starting materials, must, beer, termination and packaging.

Analysis of the native and hydrolysed gluten in the finished product.Those that return values of less than 6 ppm may be labelled as “gluten-free”, and therefore suitable for consumption by the community of coeliac patients.

Analysis of production stability over time.

The analysis in all these phases is performed by means of the ELISA R5 technique (Competitive and Sandwich), Western Blot, EM MALDI-TOF (Mass Spectrometry) and Q PCR

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Innovative work system that has managed to break down the gluten protein in the production process

The whole process has been made possible thanks to a analytical system which the CNB (National Biotechnology Centre) developed for the analysis of hydrolysed gluten (broken down into fragments) in food.

This system, called ELISA R5 Competitive, has been used for the analyse of more than 1,000 foods in which gluten is hydrolysed.

According to Dr. Méndez: “Up until now, detection methods cold not guarantee the determination of levels of hydrolysed gluten in products like beer, and this product could therefore not be recommended”

The finished product is an alcoholic drink that maintains the same levels of alcohol as Estrella Damm (5.4%), whereby moderate consumption may be recommended.

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Messages of the research authorised for advertising

• Limited to the Product Label. Any advertising must be authorised expressly and in writing by the CSIC.

• The use of this mention will require that prior to marketing the company must have the corresponding analytical certificate issued by the head of the Gluten Unit of the CSIC as proof that the labelled batch has been properly analysed.

• The gluten content may be indicated together with this mention, albeit always associated with a limit expressed in parts per million (ppm) of gluten.

• No authorisation whatsoever may be given for the combination, on the same label or unit, of the authorised mention with absolute qualitative and/or quantitative expressions of the “without gluten”, “gluten free” type, or similar.

The inclusion of the following mention on the product labelling is authorised: “Batch analysed at the Gluten Unit of the CSIC” (Consejo Superior de Investigaciones Científicas).

Conditions:

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The product

• Same flavour and properties of the standard beer.

• Acceptable levels of gluten for people with coeliac disease with less than 6 ppm. (well below the 20 ppm accepted by the Food Codex).

• Alcohol content: 5.4% alc.

• Timing international launch: 17th. March, 2008

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Product presentation

• Format: Estrella Damm 2 x 2 pack

• Premium Format / Quality / Safety

• Suitable packaging for on trade and off trade.

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Clear and striking messages on the packaging

International coeliac products symbol

- On the label and bottle neck- On different sides of the pack

Text that certifies that the batch has been analysed

and its properties guaranteed by the CSIC

- On the neck- On different sides of the pack

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Food store shelves have exclusive areas for gluten-free products

Gluten-free products are not on the shelves of each product category. All the gluten-free products are grouped in the same area.

This makes shopping easier for people with coeliac disease.

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Launch in Spain: November 2006

People with coeliac disease are a clearly identified and associated group, with very well-defined communication channels.

This is why a launch plan making a major communication effort targeting associations of people with coeliac disease is highly effective to:

Publicize the product in the community of coeliac patients

Lobby to get the product to the point of sales.

The international associations contacted to date have received the product with enthusiasm:

• The Spanish Association, as well as different associations in the autonomous communities.

• Italian Association

• Association of the UK

• Association of France

• Association of Canada

The launch in Spain: November 2006

Enric Crous (Director General of Damm), Matilde Torralba (President of SMAP) and Dr. Enrique Méndez

Enric Crous (Director General of Damm), Matilde Torralba (President of SMAP), Pablo Portillo (FACE) and Dr. Enrique Méndez

The press conference held at the Cervezas Damm Head Offices (former brewer) generated numerous press releases

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Support to the launch: Sales folder presenting the brand

Material code: UX932

Language: English

Originals may be delivered for translation into local languages

Availability timing: March 2008

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Support to the launch: Pages graphic communication

Graphic creative work is available for translation into local languages on demand.

Use: communication in the media related to the world of patients with coeliac disease.

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Support to the launch: Press dossier

Contents:

• What is coeliac disease?

• Beer, a key element in social normalisation

• Estrella Damm suitable for people with coeliac disease, the first beer for people with coeliac disease

• Corporate information:• Damm• Consejo Superior de Investigaciones Científicas [Higher Council of Scientific Research] (CSIC)• Spanish Federation of Associations of People with Coeliac Disease (FACE)

• Association of People with coeliac Disease of Catalonia (SMAP)

Language: English

Originals may be delivered for translation into local languages

Availability timing: March 2008

PRESS DOSSIER