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1 2016-06-07 Klaria Confidential Rescue of opioid overdose NALOXONE
Transcript of 5HVFXHRIRSLRLGRYHUGRVH 1$/2;21(...õ • µ v v ] } v ] v } r ] ] } v u l ] o } Á U } v o Ç î 9 }...
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1 2016-06-07 Klaria Confidential
Rescue of opioid overdoseNALOXONE
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Two Separate Markets: Community Use vs Co-Prescription
• Provided in pharmacy together with opioid medications
• Insurance against catastrophic event
• Typically administered by person with relation to patient
• Size of Naloxone preparation is very relevant
• Price of Naloxone preparation is very relevant
• First-reponders, public transport etc
• Acute treatment of ongoing over-dose
• Typically administered by person with no relation to patient
• Size and price of Naloxone Formulation less relevant
Community Use Co- Prescription
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Naloxone Alginate Film is Perfectly Suited for Co-Prescription
Community Use Co- Prescription
FilmNasal Spray
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Naloxone Co-Prescription is Recommended by HHS
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Naloxone Co-Prescription Levels Are Very Low
2016-06-07 Klaria Confidential
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Opiod Rx Volume Will Remain High Going Forward
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• 168 million opioid prescriptions written in US in 20181
• 21 to 29 % of patients prescribed opioids for chronic pain actually misuse them2, an equal number of patients have the potential to misuse them
Approximately 50% of opioid Rxs are written to patients at higher risk of opioid complications, where opioid co-Rx is recommended by HHS
84 million prescriptions/year are written to at-risk patients in US where co-prescription is recommended
• Today, co-prescription of Naloxone to at-risk patients is less than 2% of patients3
Naloxone Co-Prescription is a Large Market
1: Centers for Disease Control; U.S. Opioid Prescribing Rate Maps; https://www.cdc.gov/drugoverdose/maps/rxrate-maps.html
2: Vowles KE et al. Rates of opioid misuse, abuse, and addiction in chronic pain. Pain. 2015;156(4):569-576
3: Lin, L.(., Brummett, C.M., Waljee, J.F. et al. Association of Opioid Overdose Risk Factors and Naloxone Prescribing in US Adults. J GEN INTERN MED 35, 420–427 (2020). https://doi.org/10.1007/s11606-019-05423-7
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• 84 million Rx/year is the addressable market
• Average US retail price of Narcan Nasal Spray is $142 for package of 2 units 1
• US pharmacies make own preparations of Naloxone nasal spray, retail at $60-70 for package of 2 units 1
• Assumed US retail price of Klaria Naloxone Film is $23 for package of 2 units
• 1/6 of the Narcan price
• 1/3 of the in-pharmacy made naloxone preparation price
$1.9 billion/year addressable market opportunity in US
Naloxone Co-Prescription is a Large Market Continued
1: Jiang T, Dec 17-18, 2018: Clinical and Regulatory Overview of Naloxone Products Intended for Use in the Community; Joint Meeting of the FDA Anesthetic and Analgesic Drug Products Advisory Committee and the FDA Drug Safety and Risk Management Advisory Committee
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• Current penetration in co-prescription market is low, only 2% of opioid using patients have received an Rx of Naloxone1
• Klaria projects a 33% penetration of the addressable market with a product developed specifically for the co-prescription indication that is well suited for the purpose
$633 million/year in projected annual sales for Naloxone Alginate Film in US
• Significant commercial opportunity also in Europe and RoW
Naloxone Alginate Film for Opiod Co-Prescription has Blockbuster Potential
1: Lin, L.(., Brummett, C.M., Waljee, J.F. et al. Association of Opioid Overdose Risk Factors and Naloxone Prescribing in US Adults. J GEN INTERN MED 35, 420–427 (2020). https://doi.org/10.1007/s11606-019-05423-7
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Pre-Clinical
Naloxone
Klaria Confidential
Naloxone Alginate Film: EU and US Approval in 2024
Clinical Dose Finding Pivotal Studies File for Approval
Complete in 2022
• Manufacture of clinical material scheduled to be completed in 2020• Clinical Dose finding studies to start in 2020, complete in 2021• Pivotal studies to start in 2021, complete in 2022• Filing for approval with FDA and EMA scheduled for 2023• Approval in EU and US scheduled for 2024
2023Complete in 2021Completed
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