Transcript Presentation on New Product Developments

Presentation
on
New Product Developments
Annual General Meeting
15th June 2004
Two Low-Risk Developments
APL 202
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(intra-vaginal misoprostol for induction of labour)
Short-term introduction
Low development costs (<£1m)
High awareness amongst physicians
Already used “off-licence”
Eagerly awaited - Royal College has called for the development
APL 510 (1.5mg SR melatonin for sleep disorders)
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Medium-term introduction
Moderate development costs (£4-5m)
High awareness amongst physicians
Already used “off-licence”
Market research very positive
APL 202 – Market Background
Around 20-25% of labours in UK (150,000 - 175,000 pa) are induced
(many more are augmented)
Two drug interventions in assisted labour
• 1. Dinoprostone (a prostaglandin) for induction
 “Ripens” (softens) cervix
 Stimulates uterus to contract
• 2. (Syntocinon – Alliance Pharma) for induction and augmentation
 Is used to stimulate uterus to contract (if cervix is ripe)
 Maintains contractions after labour has been started
Improvements sought over dinoprostone (ex market research)
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Greater efficacy (more predictability, more deliveries achieved within 24hrs)
Reduced need for Caesarean sections
No need for refrigeration of the drug
Suitable for home initiation
APL 202 – Current Knowledge on Misoprostol
Originally introduced to reduce gastric acid secretions
Large bibliography in obstetrics
• Early usage was given orally
• Current preference is for vaginal administration
 Local action
 Reduced side-effects
• Some trials show greater efficacy than dinoprostone
• Published trials unsuitable for registration
High awareness
• Already used “off-licence”
• But requires 4 serial cuts to the oral tablet (200mcg to 25mcg)
Does not require refrigeration
APL 202 – Status of Development
Clinical Trial Application submitted
Ethics Committee submission imminent
Trialists currently being recruited (multi-centre)
Trials expected to commence September 2004
Marketing Authorisation Application H1 2005
Possible introduction H2 2005
APL 202 - Commercialisation
Alliance Pharma to market in UK & Ireland
• Existing Specialist Hospital sales force in UK
• Existing GP / Hospital sales force in Ireland
Introduction is eagerly awaited
Specialist marketing – low cost
Will probably license out in rest of EU
EU labour induction market estimated at £32m
APL 510 – Market Background (Sleep Disorders)
Sleep disorders are of many types
Anti-histamines are available OTC
GPs (and patients) are reluctant to use current therapies
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Benzodiazepines
 concerns over habituation and hangover effects
 seen as unsuitable for children
Nevertheless UK prescription hypnotics market is £49m
Key product improvements desired (ex market research)
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Non-addictive, especially for long term usage
No drowsiness or hangover the next day
 Particularly for school children, teenagers and working adults
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Product that will restore sleep to a normal pattern
APL 510 – Market Background (Melatonin)
Melatonin freely available OTC in USA
• Classified by FDA as a nutritional supplement
Melatonin sales banned in EU
• Needs to be registered as a medicine
Melatonin used “off licence” in UK
• Initiated by NHS specialists
• Patient-specific usage continued by GPs
• “Named patient” supply regulated by Dept of Health
 manufactured under a “Specials” licence
 controlled importation
• Usage estimated at £3-4m per annum
Currently melatonin used mainly for sleep disorders in
• Children with Special Needs ( a wide variety of conditions)
• Blind patients
APL 510 – Current Knowledge on Melatonin
Melatonin – hormone that regulates circadian rhythm (body clock)
Therapeutic melatonin has been shown to promote sleep in many
different sleep disorders
• large bibliography, but unsuitable for registration
Seen as a “natural” product
Current prescribers (ex market research)
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Are very enthusiastic about its results
Biggest complaint is restrictions imposed by not having a marketing authorisation
Seek a formulation that is quick acting but has a prolonged release
High awareness in GPs (ex market research)
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100% awareness
>50% had been involved in its usage via specialists
APL 510 – Status of Development
Special release formulation has been developed
Phase 1 trials in human volunteers completed
• Rapid production of therapeutic blood levels
• Blood levels then maintained for 5 hours
Phase 3 clinical trials to commence H2 2004
Regulatory submission planned for H1 2006
Possible introduction H2 2006
Will gain 10 yr data protection in EU regulatory system
APL 510 - Commercialisation
Alliance Pharma to market in UK & Ireland
• To Specialists initially to gain endorsement for GPs
• Will need GP sales force to accompany Hospital sales force
• Existing GP / Hospital sales force in Ireland
GP marketing – significant investment
License out in rest of EU
• Down payments plus royalty stream
EU sleep disorders market estimated at £500m
Summary
Two low risk developments
Smaller investment reaches market first
Proof of principle well known on each
Developments funded and underway
EU registration strategy
Possible introductions in H2 2005 and H2 2006
10 yr data protection for larger opportunity (APL 510)
Commercialisation strategy in place