we present

Staying Ahead of the Game Through Innovation:

Regulatory and Product Development Strategies

3 March 2016

OTCToolbox/PLG Conference

London

Agenda

• Motivation and Targets in innovative development

• Regulatory options: characteristics, current challenges and examples

• Cosmetic Products

• Food Supplements

• Medical Devices

• Medicinal Products

• Inspiration / Outlook

Motivation and Targets

OTC Business is….

• Growing

• Trend-driven

• Fast moving

• Cost sensitive

• Attractive for companies

• Valuable to consumers

• Responsible for consumers

self-medication supply OTC trend market approach

Motivation and Targets

Innovation in OTC business is no OPTION, but a MUST…

…¼ of OTC products in Germany originates from the past 5 years!*

* IMS Health; information provided during selfmedication meeting

Motivation and Targets

What can be an innovation…?

• new API

• new indication, claim

• new combination

• new formulation

dosage form, galenic improvement, measuring device, taste…

• new technology

• new classification

• new distribution channel

• new pricing structure

consumers

degree and perception

of

innovation

entrepreneur

Approaches to development strategies

I want to…

• …use certain API(s)

• …target certain INDICATION

• …target certain POPULATION

• …FEED or BUILD my BRAND

• …SAVE an existing PRODUCT

• … use ready available OPPORTUNITIES

Deliberately

chose

category

Deliberately

chose

product characteristics

(composition, claims…)

Regulatory Options – Overview

Category Intended Use Target Group Mode of

Application Mode of Action Typical Form

Cosmetics cleaning, protecting, keeping in

good condition, correcting body

odours…

average

population

external parts of

the human body not pharmacological semi-solid, liquid

Food

Supplements

Supplementation of normal

diet

average

population

‘eaten’ in line with

recommended

daily intake

physiological

dosed form,

measured small

unit (capsules,

pills, tablets…)

Medical

Devices

diagnosis, prevention,

monitoring, treatment or

alleviation of disease

patients ingested, applied,

inserted…

physical,

physico-chemical various

Medicinal

Products

treating or preventing

disease in human beings patients

ingested, applied,

inserted…

pharmacological,

immunological or

metabolic

various

Regulatory Options – Overview

Category EU Harmonized Claims Development Costs Time-to-market Registration Procedure

Cosmetics +++ ++ + + NO (Notification; tell and do)

Food

Supplements

+ + + + NO (exemptions, e.g. BE)

Medical

Devices +++ +++ ++(+) +(+)

NO (Certification at own risk evaluation)

Medicinal

Products +++ +++ +++(+) +++(+) YES (national, MRP, DCP)

Cosmetic Products – Current Challenges

Justification of claims

• meet principles (655/2013/EC)

• “Legal compliance, truthfulness, honesty, fairness…”

Restrictions reg. special substances:

• nanomaterials (e.g. TiO2 / UV filters)

Cosmetovigilance

• continuous observation after marketing

• communication of serious undesired effects

Cosmetic Products – Current Examples

Mitosyl Tri-active face cream / body lotion

Sanofi (Spain)

cosmetics - children’s daily care for very dry

skin or atopic persistent itching -

claim: • compound Stimu-Tex AS, the combination of 3 natural ingredients rich in essential fatty acids:

germinated barley, shea butter and argan oil: this compound is responsible for blocking histamine

properties, producing a comparable effect of corticosteroids, preventing inflammation and relieving the

symptoms of dry, sensitive and irritated skin

• also contain polidocanol and Evosina Na2GP (from lichen): reinforce skin defences

• allow to restore the protective barrier of the skin and soothe the itch, regenerate the lipid structure,

ensuring a prolonged hydration and strengthen skin defences

result: the nutrition & hydration booster for very dry skin !

Food Supplements – Current Challenges

Hinder to innovation

• complicated, expensive procedures (Health Claims, Novel Food)

Non-harmonised situation

• non-harmonised classification and handling

• legal uncertainty

„Dictate“ from Brussels

• EU directives

• no scope for fit to local needs

Food Supplements – Current Examples

Somnolin orodispersible sheets

Kern Pharma (Spain)

food supplement

- symptomatic relief of typical jet lag symptoms -

claim: • every sheet contains 1 mg melatonin, the hormone shown to help establish and normalize circadian

sleep rhythms, and menthol for the fresh flavour

• against typical symptoms of jet lag, as fatigue, or confusion in the cycle of day / night

• administration for adults: take 1 - 2 sheets per night, as necessary

result: discreet and fresh against the fatigue symptoms !

Food Supplements – Current Examples

Vagaline tablets

Laboratoires 3 Chênes (France)

food supplement

- against nausea, vomiting, and travel sickness -

claim: • every tablet contains the composition of the following active ingredients: extracts from ginger,

sage, melissa, as well as essential oils from caraway and peppermint

• helps in every cases of sickness, e.g. due to unpleasant odours, travels, alcohol, food, stress,

fear, pregnancy, … several factors that can cause nausea, vomiting, or travel sickness

• the ingredients act in synergy for an optimal action - ideal in case of nausea, vomiting, travel

sickness; ginger extract helps prevent malaises and vomiting linked to the use of a car or sea

sickness

• administration for adults: in case of nausea take one tablet; in case of travel or transport take

one tablet ½ hour before departure, each time with a plenty of liquid

result: forget your sickness and enjoy your life - naturally !

Medical Devices – Current Challenges

New regulation

• informal trialoge btw EC, EP and Council ongoing

• into force earliest end 2016

• 3-5 year transition period

Increasing requirements

• referring to directive 2001/83/EC

• for clinical evaluations (end of equivalence approach / literature?)

• no class I but higher risk classes

“New” European electronical database

• Registration

• Unique Device Identification (UDI)

• Vigilance…

Withdrawal of products consisting of living microorganism

Medical Devices – Current Examples

Velastisa Cistitis capsules

Isdin (Spain)

medical device

- for the prevention and treatment of urinary infections -

claim: • for the prevention and treatment of urinary bladder infections (caused by E.coli)

• every capsule contains 36 mg of the proanthocyanidin (PAC) type A which inhibits the adhesion

of Escherichia coli to the bladder; bacteria are excreted in the urine rather than remaining

adhered to the bladder wall

• administration for adults: as prevention, swallow one capsule once a day with a large glass of

water; for treatment of cystitis: take one capsule twice daily

result: your best ally against cystitis !

Medical Devices – Current Examples

Arkotos syrup / lozenges

Laboratorios Arkopharma (Spain)

medical devices

- protect the mucosa and relieve sore throat and dry cough -

claim:

• both products contain marshmallow extract that is rich in natural assets (as mucilage,

polysaccharides, ...) and sodium hyaluronic acid: these assets create a hydrogel film

with "barrier" that protects the mucosa, allowing reduce irritations and inflammations

• form a protective film that adheres to the mucosa of the throat, providing relief from

sore throat and dry cough, esp. caused by irritation or allergies

• administration for adults and adolescents 12 years of age and older : twice daily, take one lozenge (lemon flavour) resp. one tablespoon of syrup (honey flavour)

result: your relief from sore throat and dry cough - absolutely natural !

Medicinal Products – Current Challenges

Regulatory overburden

• for well-known, established OTC medicinal products

• simplified procedures only for THMPs

Lack of EU harmonisation

• interpretation of HMPC monographs

• Rx / PO / GSL status

Time to market

• no fixed timelines for national procedures

High maintenance costs

• pharmacovigilance, variations, stability testing, GMP audits etc.

Medicinal Products – Current Examples

Flonase allergy relief nasal spray

GlaxoSmithKline Consumer Healthcare (USA)

medicinal product (PO)

- prescription-strength allergy treatment that works directly on the source -

claim:

• with fluticasone propionate: treats nasal symptoms such as congestion, sneezing,

itchy & watery eyes, itchy & runny nose caused by seasonal or year -round allergies

• direction for adults and adolescents 12 years of age and older : for 24-hour relief, use

2 sprays per nostril twice a day (after the 1st week: one spray per nostril once a day,

unless the symptoms are not yet under control go back to 2 x 2 sprays);

children between 4 and 11 years: one spray in each nostril once daily for everyday

use up to 6 months - no habit forming; non-addictive and non-drowsy

result: be greater than your allergy - now also without prescription !

Medicinal Products – Current Examples

Buttercup BronchoStop syrup / pastilles

Omega Pharma (United Kingdom)

traditional herbal medicinal products (PO)

- herbal cough relief for any type of cough -

claim:

• 15 ml of oral syrup contains 120 mg dry extract from Thyme herb and 830 mg

liquid extract from Marshmallow root; without sugar or alcohol; non-drowsy

• the pastilles (especially for “on the go”) contain dry extract from Thyme herb

• direction for adults and adolescents 12 years and above: take 15 ml of syrup resp.

1 - 2 pastilles every 4 hours, 4 times per day (maximum: 6 doses (90 ml / 12

pastilles every day) for a period of 7 days

result: take the hassle out of any cough - dry, tickly, chesty, mucus or catarrh !

Medicinal Products – Current Examples

Nytol herbal simply sleep & calm elixir

Omega Pharma Ltd. (United Kingdom)

medicinal product (PO)

- for the temporary relief of symptoms of mild anxiety & to aid sleep -

claim:

• each 5 ml of liquid contains 1.5 ml of tincture from dried valerian root

• traditional herbal medicinal product used for the temporary relief of symptoms of mild anxiety

and to aid sleep

• direction for adults aged over 18 years: for the symptomatic relief of mild anxiety, take two 5

ml spoonfuls three times a day (with water or a fruit juice if desired); to aid sleep, take two 5

ml spoonfuls 30 minutes before bedtime with an earlier dose during the evening if necessary

• especially aimed at women aged over 35 years - as difficulty sleeping is “particularly

prevalent amongst this group as a result of their busy lifestyles”

result: good mornings follow a good Nytol - now also as delicious elixir !

Before you start…

Conceptual

Planning

Budget

Development

costs

Cost of goods

API Source

Inhouse manufacturing

CMO Licensing

Territory

Regulatory route

Time to market

Copy protection

Inspiration / Outlook

• Licensing Sharing

• Maximum commercialisation of dossiers

• Simultaneous use of marketing authorisations („Piggyback Registration“,…)

• Co-development e.g. with CMOs

Cooperation

• Regulatory changes (e.g. MDs, HMPC monographs,…)

• Switches from Rx to OTC

Anticipation

• Existing licenses of existing (old) MAs

• (new) MAs from developing companies

Acquisition

Inspiration / Outlook

• Switching regulatory classes for long-time security

Mixed Strategies

• current literature for interesting indications

• old literature revitalisation of old MAs / THMPs

Screening

• Look across national borders for products, switches, ideas…

• Look across other markets for technologies, packaging, taste…

• sources: IMS, DiapharmKlick, regulatory databases, print media, Internet, regulatory databases

Scouting

Best way?

Thank you!

Dr. Annemarie Dengler

annemarie.dengler@red-otc.de

Dorothee Klöpf

dorothee.kloepf@diapharm.de

mailto:annemarie.dengler@red-otc.demailto:annemarie.dengler@red-otc.demailto:annemarie.dengler@red-otc.demailto:dorothee.kloepf@diapharm.de

Diapharm GmbH & Co. KG red otc development GmbH

Hafenweg 18-20 · D-48155 Münster Hafenweg 18-20 · D-48155 Münster

info@diapharm.com info@red-otc.com

www.diapharm.com www.red-otc.com

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