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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
Dorothee Klöpf
Diapharm GmbH & Co. KG red otc development GmbH
Hafenweg 18-20 · D-48155 Münster Hafenweg 18-20 · D-48155 Münster
[email protected] [email protected]
www.diapharm.com www.red-otc.com
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