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Warsaw, 16/02/2017

Product Proposal
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Product Name NidiesqueTM

Product Description A new generation of functional cosmetics


cosmeceutical designed to protect the skin
from nickel allergy.
Prepared by KF Niccolum sp. z o.o.
Data 14.02.2017
Target Date for Product Launch: April 2017

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Executive Summary

NidiesqueTM - is the very first cosmeceutical line in the world market which protects from
nickel allergy the most common contact allergy in developed countries. Approximately
30% of people from analysed countries have a nickel allergy problem. Additionally, it can
be developed over time due to unfavourable working conditions. NidiesqueTM is based on
a patented active substance invented by Dr. Izabela Zawisza and professor Wojciech Bal
from the Institute of Biochemistry and Biophysics Polish Academy of Sciences. The
invention a line of barrier cosmeceuticals against nickel allergy symptoms has been
developed by the scientific team of KF Niccolum R&D Laboratory. The product will be
available April 2017, launching first on the domestic Polish market available online, in
pharmacies and wholesale for beauty and hair salons.

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Overview 3
NidiesqueTM 3
How it works 6
Tests and research 7
Who will use NidiesqueTM 12
Customers 14
Statistics about nickel allergy 16
Facts about nickel 18
Substitutes 20
Market Size 20
Milestones 21
Marketing strategy 21
What is next 22

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Overview

Customers
Women
Age 30 - 60
Occupational groups: cashiers, factory workers, surgeons, hairdressers and beauticians
All who are exposed to nickel (women using colourful cosmetics, children exposed to metals from toys etc.

Competitors
One product on the French market

Market size
17% of the global population of women and 3% of the global population of men have a nickel allergy
83 million people in Europe alone

Marketing plan in domestic market


Building brand awareness, PR (Radio, Television interviews with the Inventor (Dr. Zawisza)
Sales online and in chosen distribution channels, eg. pharmacies

NidiesqueTM

Nidiesque is the name of a revolutionary series cosmeceuticals designed to protect the


skin from nickel allergy. A Patented active ingredient creates an effective and
biocompatible barrier against allergic reactions caused by direct contact with nickel
containing products such as: coins, jewellery, and other common household items.
Nidiesque prevents nickel ions from penetrating the skin and provides long lasting
protection against nickel allergy symptoms including redness, swelling, itching and
rashes. With one application NidiesqueTM will offer complete protection to all skin types,
even the most sensitive. Cosmeceuticals contain no parabens, silicones, fragrances.

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Antibacterial packaging. Safe
application. A full size cap to prevent
dirt from contacting the pump head
while not in use.

Neutral, pharmaceutical
30 ml dispenser capacity.
layout of packaging

Customer related information about NidiesqueTM


Barrier cream - cosmeceuticals preventing nickel allergy symptoms
ORIGINAL: contains no parabens delicate fragrance

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NATURAL: contains no parabens, no silicones, no fragrances

Ingredients:

[Normal]
INCI: Aqua, Cetearyl Alcohol, Isopropyl Palmitate, Glycerin, Glyceryl Stearate SE,
Ceteareth-20, Isohexadecane, Paraffinum Liquidum (Mineral Oil), Cyclopentasiloxane,
Aluminum Starch Octenylsuccinate, Phenoxyethanol, Chitosan Glutathionamide,
Butyrspermum Parkii (Shea) Butter, Lactic Acid, Parfum, Ethylhexylglycerin, BHT,
Tocopheryl Acetate.
[Natural]
INCI: Aqua, Isopropyl Palmitate, Caprylic/Capric Triglyceride, Polyglyceryl-6 Stearate,
Glycerin, Glyceryl Stearate, Cetearyl Alcohol, Isohexadecane, Sodium Benzoate, Potassium
Sorbate, Chitosan Glutathionamide, Polyglyceryl-6 Behenate, Calendula Officinalis Flower
Extract, D-Panthenol, Tocopheryl Acetate, Lactic Acid, Citric Acid.

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The key words describing the values of the NidiesqueTM are:
Effective
Safe
Non-toxic
Easy to use
Inexpensive
Environmental friendly

The product has been certified and registered according to European law. Nidiesque TM is
manufactured according to GMP standards, which guarantee the quality of the product.
GMP (Good Manufacturing Practice) are adhered to, ensuring a clean environment that
prevents contamination. The product meets formal market requirements.

Active substance of NidiesqueTM in details:

CAS Number: 1513884-52-0


SDS /Safety Data Sheet/
Product Specification
INCI Name: Chitosan Glutathionamide
Trade Name: Chitathione

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How it works

The product is a safeguard cosmetic. The cream produces a barrier in which the active
substances contained in the product will bind metal ions, keeping them within their
structure, thereby preventing the penetration of allergens into the skin all the while
ensuring proper hydration of the skin and a healthy appearance. People with allergies to
nickel will be able to function normally, without the need to avoid nickel containing
objects.

Although the product does not curethe allergy, it brings a revolutionary solution for
people allergic to nickel. It could stop or effectively reduces symptoms connected to skin
allergy.

Tests and research

NidiesqueTM has been dermatologically tested.

Internal tests:
We asked 13 women with a proven nickel allergy to test it. The test consisted of putting a
thin layer of emulsion on the skin and then wearing a piece of silver jewelry (e.g. a
necklace or bracelet) for 3 hours. In each case this piece of jewelry belonged to the tested
person and was known to elicit dermatitis symptoms, such as skin redness and itching.
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The feedback was collected by a standardized questionnaire and in some cases also
additional personal comments. In 11 cases no skin allergy symptoms were observed. In
one case of a severe allergy a significant reduction of allergic reaction was reported (slight
itching only). In the last and most interesting case the piece of jewellery was worn for 6
hours instead of 3 as per protocol. Itching was reported at ca. 5 hours after the application
of the emulsion, confirming the expected period of protection. All tested women declared
eagerness to buy our cosmetic as soon as it is available in the market.

External tests:
Independent testing was conducted between April 25 and 29 in 2016. The testing
assessed subjective evaluation and reactions in methodology before and after application.
The AFAQ, a normalization organization was leading the quality control audit of the tests.
Tests were conducted according to DERMSCAN standard operating procedures.
The most important insights are presented below in tables. 11 participants (women) aged
25 63 with dermatologically proven nickel allergy tested two product prototypes: PSC
3/III and PSC 6/III. The participants wore their own jewelry and/or clothing containing
nickel accessories for 3 hours. The participants chose items that caused dermatitis in the
past.
Two different cosmeceutical formulations with the active substance were tested. The
results show high performance of both prototypes non allergy symptoms declared 72%
and 100% accordingly to PSC 3 /III and PSC/6.

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Acceptability of the product was checked on the basis of the subjective assessment of:
application, time of penetration, consistency, smell and feeling on the skin after
application.

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Under these conditions, the results of the subjective evaluation questionnaire on 11
subjects with allergy to nickel were obtained.
The results presented below are their subjective evaluation of the studied products
characteristics and efficacy:
the product PSC 3 / III:

o 64% of the subjects appreciated it for its moisturizing effect,


o 45% said that it protects the skin from dryness and leaves
a delicate and silky skin sensation,
o 100% appreciated its easy application, quick penetration, consistency and
the fact that it does not leave the skin sticky after use,
o 91% of them found its smell non-irritating,
o 100% of the subjects would like to continue to use it and buy if it was
available on the market.

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the product PSC 6 /III:

o 55% of the subjects appreciated it for its moisturizing effect and protection
from dryness,
o 64% said that it leaves a delicate and silky skin sensation,
o 100% appreciated its easy application, quick penetration and consistency,
o 91% found its smell non-irritating and appreciated the fact that it does not
leave the skin sticky after use,
o 73% of the subjects would like to continue to use it and buy it if it was
available on the market.

The data for the following studies was obtained using the study protocol, current internal
procedures and was executed in the spirit of the note for guidance on Good Clinical
Practice CPMP / ICH / 135 / 95, January 1997. This study was in its entirety performed
under the responsibility of Dermscan.

Based on this research we have chosen a 100% effective prototype and created the line of
NidiesqueTM cosmeceuticals. To ensure safety for all types of users, a third-party
laboratory, ITA TEST, was contracted to conduct a human skin tolerance test on the
NidiesqueTM line. There were 40 people tested (38 women and 2 men). This group
included: 33 with atopic dermatitis, 4 with a proven contact allergy, and 40 with high
sensitivity to cosmetics, washing powders and detergents or other chemicals. All
participants confirmed that the products provide a positive and non-irritating feeling.

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Number of Age Sex Skin type Result
Candidate
1 32 W D (-)
2 48 W D (-)
3 27 W N (-)
4 33 W N (-)
5 37 W N (-)
6 25 W N (-)
7 50 W D (-)
8 50 W D (-)
9 40 W D (-)
10 52 W D (-)
11 60 W D (-)
12 37 W (-)
13 23 W N (-)
14 41 W N (-)
15 42 W D (-)
16 50 W D (-)
17 26 W D (-)
18 26 W N (-)
19 37 W D (-)
20 50 W D (-)
21 61 W D (-)
22 37 M N (-)
23 65 W D (-)
24 34 W D (-)
25 65 W D (-)
26 65 W N (-)
27 63 W D (-)
28 62 M N (-)
29 65 W D (-)
30 59 W D (-)
31 34 W D (-)
32 62 W D (-)
33 59 W D (-)
34 47 W D (-)
35 62 W D (-)
36 64 W D (-)
37 65 W D (-)
38 32 W N (-)
39 21 W N (-)
40 60 W D (-)
Assessment done by
dermatologist
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0 or (-) -
No
reaction
1 or (+/-) -Short term
itchiness
2 or (+) - Short term
itchines and redness
3 or (++)- Itchiness and
redness
4 or (+++) - Itchiness,
redness, papules
*** itchiness is misspelled in the above table

The tested group, in a range of ages, showed that the products is 100% safe and causes no
reaction in sensitive skin types.

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The company is still researching the product, in the interest of constant improvement.
Ongoing research is conducted in cooperation with professor Radosaw piewak,
affiliation: Professor of Collegium Medicum, Jagielonian University and specialist in the
field of dermatology and allergology. Future tests will have 50 candidates and will be
finished in October.

Who will use NidiesqueTM?

NidiesqueTM is dedicated to all people allergic to nickel, with all skin types. It is estimated
that around 83 million people in the EU are allergic to nickel. On average, in countries
outside of Europe, 30% of the population suffers from nickel allergy.
North
Japan China Singapore Ethiopia
Country America
Nickel
30% 23,1% 19,9% 18,8% 40%
Allergy

Similar proportions are observed when looking at the four main geolocations in Europe.
In all parts of Europe the problem of nickel allergy seems to be on the same level.

Europe
Western Central Southern North-eastern
Region
Nickel
20,8% 19,7% 24,5% 22,4%
Allergy

According to the WebMD Health Foundation, allergy to nickel is the most common contact
allergy. This may be the result of the fact that components of many alloys contain nickel.
So it is easy to have skin contact with this material in many tools and items like jewellery,
watches, glass frames, metal items of clothing, coins, cutlery, crockery, home appliances,
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door handles, etc.

NidiesqueTM will react on the verified demand in the global market. In Europe, Japan,
China, Australia, all around the world, people have constant contact with nickel.
Workplaces are equipped with many items containing nickel ions. Most metal tools cannot
be replaced by anything else and using them is mandatory. It is commonly known that
nickel allergy can be also developed over time, therefore we present a solution for many
occupational groups.
Because of work environment exposure, the nickel allergy is listed as occupational disease
in the EU. According to the Eurostats reports (European Statistical Office) and Eurogip
(French information agency about labor protection at the European level) the losses due
to occupational skin disease are approximately 3 million working days, and amount to
about 600 million euros per year.
NidiesqueTM can solve the problem of uncomfortable plastic gloves used by allergic people
during the job. Without the protection of a barrier cream those allergic people will suffer
or will be forced to change their workplace. Nickel is omnipresent in many household
kitchens: pots, cutlery, scissors, etc.

Customers

Both women and men can suffer from nickel allergy but figures show that women are
more likely to have this kind of skin problem. About 17% of women and 3% of men in the
global population are affected by nickel-induced dermatitis. Moreover, there are almost 1
bln people around the world with nickel allergy. Its important to note that people can
acquire the allergy by prolonged contact with nickel issues, especially at work. The
problem of contact allergy concerns approx. 40% of adults and 20 to 30% of children and
adolescents. According to estimates, approx. 83 million people in Europe suffer from
contact allergy caused by contact with nickel.
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Therefore the company KF Niccolum is focused on:
Patients with diagnosed nickel allergy
Current workers in an environment with a high potential of direct contact with
metal (cashiers, barbers, surgeons, musicians, factory workers etc.)
-hospitals: operating room, dental office,
-beauty salons
-barber, hair salons
-cashiers
Current users of cosmetics which soften the visual symptoms
Economically active people ages 19 50

More women than men are at risk in developing allergy symptoms. These figures can be
explained by trends of wearing jewellery and piercings.

United
Sex Denmark Germany Italy
Kingdom
Women 64,6% 62,2% 67,1% 67,1%
Men 35,5% 37,8% 32,9% 32,9%

Additionally research shows that slightly over 50% of the population of men and women
ages 30 60 have nickel allergy.
This statistic ensures that KF Niccolum will be targeting economically active people. The
general trend is presented below.

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Statistics about nickel allergy

According to the Regulation Council of Ministry from June 30, 2009 regarding
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occupational diseases (Journal of Laws of 2009 no. 105, item. 869) the occupational
diseases of the skin include contact dermatitis and contact dermatitis of the irritant.
Nickel is a particularly strong contact allergen because it undergoes corrosion sweat.
The only recommendation is to reduce contact with nickel, but its extremally difficult.
Metal tools, cutlery, jewellery, home items like pots, ovens, handles are often made from
stainless steel (contains ca. 30% nickel). Contact with these products can cause allergy.

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Daily contact with nickel-containing items:
Jewellery
Cutlery
Money/coins
Glasses
Accessories: belts, metal buttons
Technology: phones, laptops
Contact dermatitis is characterized by:
Itching
Burning
Redness
Flaking
Rashes
Blisters
Cracking
Hyperkeratosis

On the basis of current data, it is estimated that more than 19.1% of the population of the
EU-28 and 18,8 % of US citizens suffer from a nickel allergy (Garg et al., Br J Dermatol,
2013, 169, 854).
It is hard to avoid nickel-containing items (according to the physicians
recommendations) therefore the allergy becomes a serious problem. Nickel sensitization
happens so frequently that the concentration of this metal in products has become
regulated by EU law (EU Directive 94/27/EC and 2014/84/UE from 30 June of 2014).
According to Eurostat's and Eurogip's reports, losses due to occupational skin disease are
approx. 3 million working days and the costs reach 600 million per year
(http://ec.europa.eu/environment/chemicals/reach/pdf/reach.pdf).

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Facts about nickel

Nickel is a widely distributed and used metal - worldwide production in 2014


reached almost 2 million tons
Ores of nickel are mined in over 23 countries and are smelted or refined
in 25 countries the most important are Russia, Canada, New Caledonia, Australia,
Indonesia, Cuba, China, South Africa, Dominican Republic, Botswana, Colombia,
Greece and Brazil
Nickel and nickel compounds have many industrial and commercials uses.
About 40% of the global production of this metal is used for the manufacture of
stainless steel (0,5-30% Ni). Nickel is used in the production of alloys for motor
vehicles, technical devices, military equipment, electrical tools, fittings, jewelry,
laboratory equipment, surgical instruments, as well as in welding technology,
electroplating and ceramics
Nickel is a component of white gold (10-15%), nickel-silver alloys (10-15%)
and cupronickel (30%)

The tendency of production and usage of nickel is rising accordingly to International


Study Group, 2015

Nickel world production 2009- 2014.


Primary Nickel Production ('000
tonnes)
2009 2010 2011 2012 2013 2014
Africa 36,6 36,3 36,7 41,2 59 75,2
America 234,1 223,1 268 306,1 293,3 295,7
Asia 432 537,6 631,2 728 922,5 939,6
Europe 446,1 503,4 515,7 510,3 498,3 483,4
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EU 27 81,5 108,7 119,2 117,8 116,6 109,6
Oceania 167,6 141,4 150,2 174,1 189,9 199,8
World
Total 1316,4 1441,8 1601,8 1759,7 1963,1 1993,6

Nickel world usage 2009- 2014.


Primary Nickel Usage ('000 tonnes)
2009 2010 2011 2012 2013 2014
Africa 31,7 24 23,9 24,6 22,9 21,4
America 121,8 153,2 165 166,4 174,8 181,9
Asia 760,4 929,4 1050,6 1109,9 1233,7 1308,6
Europe 317,7 355,9 364,5 364,1 350,8 353,9
EU 27 279,9 317,4 325,5 322 310,6 313,5
Oceania 2,7 2,7 2,7 2,7 2,7 2,7
World
Total 1234,3 1465,2 1667,7 1667,7 1784,9 1868,5

Competitors
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On the world market there is no single entity that produces a product that fully prevents
nickel allergy. The French company Skintifique offers a protective cosmetic in the form of
a cream: Protective Cream HPS and Moisturizing Lotion HP. These formulations do not
include in their composition of (ethylenedinitrilo) tetraacetic acid (EDTA), aromatic
compounds, and harmful additives as parabens, however, in their composition, there
exists no substance having an activity similar to that proposed by the manufacturer of the
NidiesqueTM. The composition of Skintifique preparations is a mixture of hypoallergenic
moisturizing and soothing substances. The disadvantage is the uncomfortable application
of the cosmetic, due to the necessity of applying two coats to achieve the desired
protective effect. Additionally, the price of Skintifique seems to be relatively expensive for
a cosmetic. Their price is 26.90 per Cream (20 ml) and 25,90 for milk (200 ml). The
manufacturer distributes only through its own online store (website in English or
French), Amazon portal or through online shops by online distributors.

Substitutes

We can consider products that provide a universal hydrophobic layer in the form of
creams, gels and ointments as general substitutes, though they provide no specialized
protection against nickel allergy. (Bariderm Cream Uriage / France /; Silic 15 Cream /
Lotion, Ego Pharmaceuticals / Australia / ; Barrier Lotion, Amerigel / USA /; Emolium
cream / emulsion, Nepentes Pharma / Poland /, Wonder-Glove Lotion, Global Consumer
Technologies Incorporated / USA /).
However, the chemical composition of many of these preparations include incorrectly
selected molecules (eg. EDTA), which can actually intensify nickel allergy symptoms.
Therefore these products are not strictly dedicated to the protection of the skin from
contact with nickel.

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Market Size

About 17% of women and 3% of men in the world population are affected by nickel-
induced dermatitis.
In the European Union countries, nickel allergy affects over 15% of residents. A group at
particular risk of exposure to nickel are girls 16-17 years old.

KF Niccolum claimed IP protection in many countries, as listed below.

(USA, Canada, Brazil, Chile, Colombia, Russia, United Arab Emirates, Israel, Thailand,
India, Vietnam, Singapore, China , Japan, Korea, South Africa, Australia, New Zealand)

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Milestones

Expected starting date of production in February 2017


Expected launch on domestic market in April 2017

Marketing strategy

Our domestic strategy includes cooperation with a great positioning partner. NidiesqueTM
should be offered to wholesalers across pharma and hospital suppliers as well
as wholesalers of beauty goods for hairdressers and beauticians.

Our marketing plan to build a recognizable brand will include:

shop online
Landing Page provide more information about product, company,
www.nidiesque.pl nickel allergy problem
collecting information about customers

customer education
Social Media feedback collection
FB, LinkedIn active promotion

customer education
advertising in specialized papers,
Media / press sponsored articles

courses for pharmaceutical specialists


courses for physicians
Offline events campaign - dedicated social events

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What is next

NidiesqueTM is the first step to create a cosmeceutical line for allergic people for other
specific materials e.g metal ions which can cause contact dermatitis. We are starting with
the product dedicated to those allergic to nickel, but we also have plans for solutions to
other metal ions.

For more details and questions about cooperation please contact us directly:
KF Nicollum
biuro@kfniccolum.pl
mobile: + 48 608 614 478

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