optinose the key to successful nasal drug delivery...drug delivery targeting sites beyond the nasal...
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OptiNose
The Key to Successful Nasal Drug Delivery
Introduction Summary July 2008
ConfidentialNot to be distributed without the written consent of the Company 2
Company Update
• OptiNose AS is a privately owned company founded in October 2000
• Portfolio of patents and patent applications broadly securing its technology• Core patent granted in US and Europe • Follow on patents claiming aspects of technology and
product focussed applications
• Shareholders: Founders, Inspire AS, Andromeda-fund BV, WFD Ventures LLC
ConfidentialNot to be distributed without the written consent of the Company 33
Management Team
CEO – Helena Kyttari Djupesland MBA• VP Operations GE, Kvaerner, Storebrand
CSO Per Djupesland MD, Ph.D.• Otorhinolaryngology specialist, sinus surgeon
Finance Director Henrik Andersen• Finance Director Merck Inc, Arthur Andersen
Head of Commercial Development Martin Waymark• Cardinal Health, Boots, GSK
Head of Device Development Colin Sheldrake Ph.D.• Chiron, PowderJect, Rolls Royce
Head of QA/ Reg Affairs Tony Flint Ph.D.• Thermocore, SGS Notified Body, Quintiles
Head of Clinical Operations Graeme Hewson Ph.D.(interim)• Corgentech, Roche, Parke Davis
ConfidentialNot to be distributed without the written consent of the Company 44
Business Model Focused on Creating Value for Shareholders and Partners
Mission statementTo combine unique and superior nasal drug delivery technology with pharmaceutically active substances to achieve significant therapeutic benefits, improved safety profiles and increased reproducibility
Business ModelOptiNose’s commercial strategy is dual pronged:
•Develop a portfolio of products for out-licensing combining selected off-patent drugs with OptiNose’s patented delivery technology
•Partner with major pharma, specialist pharma and biotech companies to combine OptiNose’s patented delivery technology with proprietary compounds
ConfidentialNot to be distributed without the written consent of the Company 55
Nasal Delivery Offers Significant Advantages for Treating Many Diseases
Topical
Therapeutic fields of interest Classes of substances & drugsTopical steroidsAntihistaminesImmuno-modulatorsDecongestantsVaccines
Allergic rhinitisNon-allergic rhinitisRhinosinusitisNasal polyposisAcute sinusitisCommon coldVaccination
Therapeutic fields of interest Classes of substances & drugsPolar drugs with poor GI-absorptionProteins & peptides degraded in GI-tractHydrophilic & high molecular weight peptidesSmall molecules with intended fast action
Analgesics (fast action)Migraine & headache (fast action)Insomnia & sedation (fast action)ObesityDiabetes I & IIOther endocrine diseases
Systemic
Nose-to-brain
Therapeutic fields of interest Classes of substances & drugsNeuroactive polar drugs with poor GI-absorption
Neuroactive proteins & peptides Neuroactive small molecules with fast action
Analgesics (fast action)Migraine & headache (fast action)Insomnia & sedation (fast action)Alzheimers & Parkinson'sNeurodegenerative diseasesObesityOther endocrine diseases
ConfidentialNot to be distributed without the written consent of the Company 66
Drug Delivery Targets for Treating Disease are Beyond the Nasal Valve
Systemic deliveryTrue nasal mucosa lies beyond nasal valve. Anterior third of nose lined by skin-like epithelium.
Topical & Vaccine deliveryEntrances to sinuses and other structures affected by diseases of the nose lie in the posterior two thirds of the nasal cavity.
Nose-to-Brain deliveryNerves penetrate in the upper olfactory region of the nasal cavity.
NasalvalveNasalvalveNasalvalve
ConfidentialNot to be distributed without the written consent of the Company 77
Traditional Nasal Delivery Devices Do Not Deliver Drug to Targets of Interest
Conclusion:Existing delivery methods are not optimal for nasal drug delivery targeting sites beyond the nasal valve
Traditional nasal delivery methods -spray pumps, pMDIs, powder inhalers and drops - deliver most of the dose (50-100%) anterior to the nasal valve.
The fraction bypassing the nasal valve passes mainly along the floor of the nose and is swallowed.
The assessment of topical nasal drug distribution. Aggrawal R et al. ClinOtolaryngol. 2004, 29, 201-205.
Literature Review:
ConfidentialNot to be distributed without the written consent of the Company 88
OptiNose’s Delivery Technology Reaches Targets Beyond Nasal Valve - How it Works
Breath ActuatedBi-Directional Delivery
While exhaling into the device, the soft palate automatically closes off the nasal cavity completely …
… the breath enters one nostril through a sealing nozzle
… and triggers the release of particles into the airflow - carrying particles beyond the nasal valve to target sites
… the air flow passes through the communication posterior to the nasal septum
… and exits through the other nasal passage in the opposite direction
ConfidentialNot to be distributed without the written consent of the Company 9
Device detailsnot disclosedDevice detailsnot disclosedDevice detailsnot disclosed
Spray nozzleSpray nozzle
OptiNose Delivers Liquids to Targets of Interest Beyond Nasal Valve - Spray Pumps Do Not
OptiNose standard deviceExcellent deposition in middle meatus
OptiNose N2B deviceExcellent deposition in olfactory region
Traditional spray pumpVirtually no delivery to target sites; drug is swallowed
Device detailsnot disclosedDevice detailsnot disclosed
ConfidentialNot to be distributed without the written consent of the Company 1010
OptiNose Achieves >90% Deposition Beyond the Nasal Valve with Excellent Reproducibility
Initial deposition (0-2minut
OptiNose powder device
• >90% of dose is deposited beyond the nasal valve
• >70% of dose deposited in the upper posterior 2/3 of the nasal cavity
• High reproducibility of deposition beyond the nasal valve
• No lung deposition
• Fulfils the ideal requirements for nasal delivery
ConfidentialNot to be distributed without the written consent of the Company 1111
OptiNose Prevents Drug Deposition in Lungs
Nasal inhalation OptiNose
27% of dosein lungs
No radioactivityabove backgr.
Inhalation of 2-5 micron particles from
PARI Nebulizer
Djupesland PG et al. JAM 2004; 17(3); 249-59.
ConfidentialNot to be distributed without the written consent of the Company 12
Pipeline Status
Preclinical Phase I Phase II Phase IIIRespiratory
Nasal polyposis OptiNose Liquid
Chronic rhinosinusitis OptiNose Liquid
Neurology
Migraine OptiNose Powder
Sedation Collaboration Liquid
Sedation Collaboration Powder
Breakthrough Pain OptiNose Liquid
Vaccine
Influenza Collaboration Liquid
Diphtheria Collaboration Liquid
Undisclosed Collaboration Powder
Other
Peptide OptiNose Powder
Undisclosed Collaboration Liquid
ConfidentialNot to be distributed without the written consent of the Company 1313
Migraine: First disease target for PowderDelivery Therapy
28 million people in US suffer withmigraine
• Overall prevalence 18.2% among females and 6.5% among males
• Frost and Sullivan report: US migraine market $2.39 billion; 13.9% growth
• Sumatriptan succinate is gold standard
Triptans administered with existingnasal sprays have pharmacokinetics andonset of action comparable to oraltablets
OptiNose can deliver to posterior twothirds of nose providing opportunity for:
• faster onset of action• greater effect at lower dose• reduced side effects
ConfidentialNot to be distributed without the written consent of the Company 14
Epidemiology data shows very large unmet market need
• Chronic rhinosinusitis (CRS) is the most common chronic disease in the US today
• More than 32 million US residents report CRS
• Up to 18 million US residents are diagnosed by health professionals*
• Estimated 2-4 million US residents develop nasal polyps
• More than 500,000 sinus surgeries are performed annually in the US
• Intranasal steroids already a $3 billion market
• No pharmaceutical product is approved for the treatment of CRS
*EPOS 2007
OptiNose selected Chronic Rhinosinusitis & Nasal Polyposis as disease targets for topical therapy
OptiNose AS Oslo Innovation CenterGaustadalléen 21 N-0349 Oslo, Norway
hkd@optinose.noPhone: +47 22 95 80 17 Fax: +47 22 95 80 98 Mobile: +47 90 88 56 43Web: www.optinose.no
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