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Presentation on New Product Developments Annual General Meeting 15th June 2004 Two Low-Risk Developments APL 202 • • • • • (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) • • • • • 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) • • • • 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 • 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) • • Non-addictive, especially for long term usage No drowsiness or hangover the next day Particularly for school children, teenagers and working adults • 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) • • • 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) • • 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