DOCSLIB.ORG

Brixadi™In the US

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Brixadi™In the US Company presentation July 2020 2 Forward looking statements This presentation contains forward-looking statements that provide our expectations or forecasts of future events such as new product developments and regulatory approvals and financial performance. Camurus is providing the following cautionary statement. Such forward-looking statements are subject to risks, uncertainties and inaccurate assumptions. This may cause actual results to differ materially from expectations and it may cause any or all of our forward-looking statements here or in other publications to be wrong. Factors that may affect future results include currency exchange rate fluctuations, delay or failure of development projects, loss or expiry of patents, production problems, unexpected contract, patent, breaches or terminations, government-mandated or market-driven price decreases, introduction of competing products, Camurus‘ ability to successfully market products, exposure to product liability claims and other lawsuits, changes in reimbursement rules and governmental laws and interpretation thereof, and unexpected cost increases. Camurus undertakes no obligation to update forward-looking statements Long-acting medications addressing key healthcare challenges 4 Corporate highlights Rapidly growing commercial Broad late-stage pipeline stage company • 10 innovative clinical programs in • Fully operational commercial addiction, pain, oncology, endocrine infrastructure in Europe and Australia disorders and CV diseases • Buvidal® to date launched in 8 countries • Two ongoing Phase 3 studies • Strong growth of product • Advancing early stage opportunities Market approvals Unique FluidCrystal® Partnerships Positive 2020 outlook Weekly and monthly nanotechnologies R&D collaborations, Expected FY net revenues* ® Buvidal for opioid • New generation long-acting licensing and royalty SEK 340 - 380 million dependence depot technology arrangements with whereof product sales • Validated in +20 clinical trials pharma and biotech SEK 310 - 340 million companies and by approved products *excluding a $35 million milestone for final FDA approval of Brixadi™in the US LISTED ON NASDAQ STO; TICKER CAMX MARKET CAP ~ SEK 7.6 billion EMPLOYEES: 130 HQ: Lund, Sweden REGIONAL OFFICES: Cambridge, Mannheim, Sydney 5 Camurus‘ FluidCrystal® long-acting release technology has unique properties Easy and convenient administration Adopted to prefilled syringes and autoinjectors Rapid onset & long-acting release Manufacturing by standard processes Applicable across substance classes Strong intellectual property Injection of liquid . formulation Encapsulating Slow release Drug release and conc using prefilled H2O liquid crystal gel of drug biodegradation of syringe or triggered by blood gel matrix to full autoinjector water uptake drug resolution time Sources: Tiberg F, et al. Chapter in Long Acting Injections and Implants, Advances in Delivery Science and Technology 2012; Tiberg F, et al. OnDrugDelivery 2010; Tiberg F, et al. Drug Del. Sci. Tech., 21 (1) 101-109 2011. 6 FluidCrystal – Long-acting release Immediate release pasireotide (Signifor®) Pasireotide FluidCrystal® (CAM4071) 10 10 Pasireotide IR 600 ug (SC Pasireotide FluidCrystal 20 thigh, n = 94) mg (SC thigh, n = 12) 1 1 pasireotide plasma concentration (ng/mL) concentration plasma pasireotide pasireotide plasma concentration (ng/mL) concentration plasma pasireotide 0,1 0,1 0 7 14 21 28 0 7 14 21 28 Time (days) Time (days) 7 Opioid dependence – escalating global health crisis • Largest society burden of all drugs1 Mounting opioid overdose deaths2 1 64 30 • 35 million opioid users worldwide - Scotland • High need for better access to care 25 and new treatment alternatives USA 20 • Investment in treatment brings substantial value and saves lives 15 10 Australia • Significant limitation with current daily Sweden medications UK 5 Finland ‒ Diversion, misuse, overdosing, poor retention, Germany burdens and stigma of daily buprenorphine and 0 methadone medications Drug overdose deaths per 100,000, age group 15 #1 cause of death for people under 50 in the US2,3 Recent US life expectancy decline largely due to opioids4 Sources: 1UNODC, World Drug Report 2019; 2.EMCDDA 2018, National Records of Scotland, Centers for Disease Control and Prevention 3Frazier at al, 2017, Journal of the American Medical Association; 4Crow D. Financial Times.com, accessed on March 13, 2018, https://www.ft.com/content/d22e742c-e65c-11e7-97e2-916d4fbac0da 8 Buvidal® – flexible long-acting treatment of opioid dependence Flexible-dose, weekly and monthly, subcutaneous buprenorphine for treatment of opioid dependence within a framework of medical, social and psychological treatment in adults and adolescents 16 years or over1 Launch initiated in Europe and Australia in 2019 Source: 1Buvidal Summary of Product Characteristics (SmPC), 2018 9 Buvidal provides significant benefits to patients and society • Improved treatment outcomes and patient satisfaction1,2 • Reduced treatment burden and stigma3 • Diminished diversion, misuse and pediatric exposure4 • Reduced treatment costs in the criminal justice system5 “CAM2038 compared to my previously prescribed sublingual buprenorphine treatment” “For me, Buvidal is a Much better 83% revelation. I know that as Slightly better POSITIVE long as I stay on Buvidal 1 I’ve got a chance” About the same N=133 Sophie, Buvidal patient in Wales Slightly worse Much worse 1. Frost et al, Addiction, 2019;114(8):1416-1426; 4. EPAR 10 Accelerating uptake of Buvidal •Launched in 8 markets since 2019 •Increasing product sales 7,500 patients in treatment with MSEK Buvidal at the end of March 2020 60 Market leader in Finland and Norway* Rapid growth in Australia with an 50 48.6 estimated 3,000 patients on Buvidal Accelerating uptake in Sweden, 40 +60% Germany, UK and Denmark 30.3 Covid-19 highlights Buvidal 30 advantages 19.5 Expanding use in the criminal justice 20 setting 11.0 11.3 10 Wide media coverage of Buvidal 0 Q1 Q2 Q3 Q4 Q1 Quarterly product sales 2019 2020 * Measured by product sales 11 Key access limitations addressed in 2020 Norway Sweden Outreach services started to Reimbursement of Buvidal facilitate patient access and approved by TLV4 mitigate risk of spreading Covid-191 Germany Scotland Physician remuneration Government announced system modified balancing £1.9m budget to support reimbursement for different people in prison on OST to treatment modalities5 switch to Buvidal2 Austria Wales Law changed allowing Wales’ Health Minister injectable treatments 6 supports treatment with Australia for opioid dependence long-acting buprenorphine GPs allowed to during the ongoing prescribe Buvidal Covid-19 crisis3 from 1 April 2020 1. https://sykepleien.no/2020/04/leverer-lar-medisiner-pa-dora?cid=sm7786262328 ; 2. https://news.gov.scot/news/supporting-people-affected-by-drug-use; 3. https://gov.wales/wales-roll-out-once-month-injection-recovering-heroin-addicts-help- protect-nhs-staff; 4. https://www.tlv.se/beslut/beslut-lakemedel/begransad-subvention/arkiv/2020-05-19-buvidal-ingar-i-hogkostnadsskyddet-med-begransning.html; 5. https://www.kbv.de/html/1150_45794.php; 6. Federal law for Austria issued 18 May 2020 Part II 215th regulation: Amendment of the drug regulation 12 Market expansion in Wave 2 countries Benelux >22,000 patients in opioid Austria 1 dependence treatment >18,000 patients in opioid Preparation for launch dependence treatment1 Launched 19 May 2020 France >179,000 patients in opioid dependence treatment1 Final regulatory Italy discussion with ~70,000 patients in opioid 1 authorities dependence treatment Pricing and reimbursement Spain discussions >58,000 patients in opioid dependence 1 Launch sequence treatment Wave 1 markets Wave 3 markets Preparation for launch Wave 2 markets Wave 4 markets 1. European Drug Report 2019, EMCDDA 13 Global strategy for Buvidal (Brixadi) REGION PARTNER NO OF PATIENTS PEAK MARKET POTENTIAL EU ~1.3 million ~€300 million2 Australia HIGH-RISK OPIOID USERS1 North >2 million $0.6-1.2 billion4, 5 America DIAGNOSED WITH OPIOID USE DISORDER IN THE US3 Middle East 5 & North >300,000 €25-75 million 6 Africa (Israel) WITH OPIOID DEPENDENCE Source: 1European Drug Report 2019; 2Camurus estimate; 3SAMHSA, Results from the 2017 National Survey on Drug Use and Health, Sep. 2018; 4Opioid Use Disorder: Opportunity Analysis and Forecasts to 2027, GlobalData 2018; 5Camurus estimates; 6World Drug Report and NewBridge estimate 14 Regulatory progress with Buvidal® (Brixadi™) •New regulatory filings •Braeburn preparing for US launch CAM2038 Chronic pain Market authorization application Clear path to final market approval, Pre-submission meeting submitted to the Swiss Agency for after FDA granting Citizen Petition in held with EMA Therapeutic Products (Swissmedic) Nov. 2019 Rapporteurs Market authorization application Request for final FDA approval of the under review in New Zealand NDA for Brixadi accepted by FDA Product positioning & pricing studies under with PDUFA date 1 Dec. 2020 completion All product requirements in place for a Availability of Buvidal in MENA successful launch (Braeburn) Planned 2020 regulatory • submission to EMA region Arbitration proceedings started in England after Camurus issuance of a Early access programs and regulatory material breach notice on Braeburn1 filings initiated with collaboration partner NewBridge Pharmaceuticals FDA final approval of Brixadi expected 1 Dec 2020 – triggering a First patients treated with Buvidal $35 million milestone
Load more

Recommended publications
  • CAM2038 Weekly Opioid Dependence
    Cowen & Co. Annual Health Care Conference 2017 Camurus Advancing late stage pipeline with high market potential Company Presentation, 7 March 2017 Forward-looking statements This presentation contains forward-looking statements that provide our expectations or forecasts of future events such as new product developments and regulatory approvals and financial performance. Camurus is providing the following cautionary statement. Such forward-looking statements are subject to risks, uncertainties and inaccurate assumptions. This may cause actual results to differ materially from expectations and it may cause any or all of our forward-looking statements here or in other publications to be wrong. Factors that may affect future results include currency exchange rate fluctuations, delay or failure of development projects, loss or expiry of patents, production problems, unexpected contract, patent, breaches or terminations, government-mandated or market-driven price decreases, introduction of competing products, Camurus‘ ability to successfully market products, exposure to product liability claims and other lawsuits, changes in reimbursement rules and governmental laws and interpretation thereof, and unexpected cost increases. Camurus undertakes no obligation to update forward-looking statements 2 Camurus overview LISTED ON NASDAQ STOCKHOLM • Innovation that delivers 3rd DEC, 2015 − Proprietary FluidCrystal® technology used in 10 clinical programs − Preclinical to NDA/MAA enabling MARKET CAP pipeline programs − Expansive and rewarding pharma partnerships
    [Show full text]
  • Camurus Company Presentation
    Corporate presentation Updated 15 July 2021 2 Forward looking statements This presentation contains forward-looking statements that provide our expectations or forecasts of future events such as new product developments and regulatory approvals and financial performance. Camurus is providing the following cautionary statement. Such forward-looking statements are subject to risks, uncertainties and inaccurate assumptions. This may cause actual results to differ materially from expectations and it may cause any or all of our forward-looking statements here or in other publications to be wrong. Factors that may affect future results include currency exchange rate fluctuations, delay or failure of development projects, loss or expiry of patents, production problems, unexpected contract, patent, breaches or terminations, government-mandated or market-driven price decreases, introduction of competing products, Camurus‘ ability to successfully market products, exposure to product liability claims and other lawsuits, changes in reimbursement rules and governmental laws and interpretation thereof, and unexpected cost increases. Camurus undertakes no obligation to update forward-looking statements 3 Long-acting medications addressing key healthcare challenges 4 Camurus snapshot Rapidly growing commercial Broad late-stage pipeline stage company • +10 innovative clinical programs in addiction, • Fully operational infrastructure in Europe pain, endocrine disorders and oncology and Australia • Three Phase 3 programs • Buvidal® to date available in
    [Show full text]
  • Company Presentation
    Company presentation November 2020 2 Forward looking statements This presentation contains forward-looking statements that provide our expectations or forecasts of future events such as new product developments and regulatory approvals and financial performance. Camurus is providing the following cautionary statement. Such forward-looking statements are subject to risks, uncertainties and inaccurate assumptions. This may cause actual results to differ materially from expectations and it may cause any or all of our forward-looking statements here or in other publications to be wrong. Factors that may affect future results include currency exchange rate fluctuations, delay or failure of development projects, loss or expiry of patents, production problems, unexpected contract, patent, breaches or terminations, government-mandated or market-driven price decreases, introduction of competing products, Camurus‘ ability to successfully market products, exposure to product liability claims and other lawsuits, changes in reimbursement rules and governmental laws and interpretation thereof, and unexpected cost increases. Camurus undertakes no obligation to update forward-looking statements Long-acting medications addressing key healthcare challenges 4 Corporate highlights Rapidly growing commercial Broad late-stage pipeline stage company • +10 innovative clinical programs in • Fully operational infrastructure in Europe addiction, pain, oncology, endocrine and Australia disorders and CV diseases • Buvidal® to date launched in 9 countries • Two ongoing
    [Show full text]
  • Camurus Company Presentation Cowen 2020
    Company Presentation Cowen & Co. 40th Annual Health Care Conference 2 March 2020, Boston, MA Forward looking statements This presentation contains forward-looking statements that provide our expectations or forecasts of future events such as new product developments and regulatory approvals and financial performance. Camurus is providing the following cautionary statement. Such forward-looking statements are subject to risks, uncertainties and inaccurate assumptions. This may cause actual results to differ materially from expectations and it may cause any or all of our forward-looking statements here or in other publications to be wrong. Factors that may affect future results include currency exchange rate fluctuations, delay or failure of development projects, loss or expiry of patents, production problems, unexpected contract, patent, breaches or terminations, government-mandated or market-driven price decreases, introduction of competing products, Camurus‘ ability to successfully market products, exposure to product liability claims and other lawsuits, changes in reimbursement rules and governmental laws and interpretation thereof, and unexpected cost increases. Camurus undertakes no obligation to update forward-looking statements 2 LISTED ON NASDAQ STO; TICKER CAMX MARKET CAP Camurus in brief ~ SEK 4.5 billion EMPLOYEES: 130 HQ: Lund, Sweden REG. OFFICES: Cambridge, Mannheim, Sydney, Paris ® Unique FluidCrystal Two Phase 3 programs nanotechnologies • Late-stage pipeline with 10 innovative • In-house developed with strong IP clinical
    [Show full text]
  • Invitation to Subscribe for Shares in Camurus AB
    Invitation to subscribe for shares in Camurus AB Please note that the subscription rights are expected to have an economic value. In order to not lose the value of the subscription rights, holders must either: • Exercise the subscription rights received and subscribe for new shares no later than 25 March 2019, or • Sell the subscription rights received, but not exercised, no later than 21 March 2019. Please note that shareholders with nominee-registered shareholdings subscribe for new shares through their custodian/nominee. The distribution of this prospectus and the subscription for new shares are subject to restrictions in certain jurisdictions (see “Selling and transfer restrictions”). FINANCIAL ADVISORS IMPORTANT INFORMATION For certain definitions used in this prospectus, see “Certain definitions” on the next page. A Swedish version of this prospectus has been approved and registered by the Swedish Financial Supervisory Authority (the “SFSA”) in accordance with Chapter 2, sections 25 and 26 of the Swedish Financial Instruments Trading Act (lagen (1991:980) om handel med finansiella instrument). Approval and registration does not imply that the SFSA guarantees that the information in the prospectus is accurate or complete. The prospectus and the offering hereunder are governed by Swedish law. Disputes arising in connection with this prospectus, the offering and related legal matters shall be settled exclusively by Swedish courts. The prospectus has been prepared in both Swedish and English language versions. In the event of any conflict between the versions, the Swedish version shall prevail. Camurus has not taken, and will not take any actions to allow a public offering in any jurisdiction other than Sweden.
    [Show full text]
  • Camurus Had an Excellent Start of 2021 with Strong Revenue Growth, New Regulatory Approvals and Progress in the Pipeline”
    INTERIM REPORT FOR THE FIRST QUARTER 2021 “Camurus had an excellent start of 2021 with strong revenue growth, new regulatory approvals and progress in the pipeline” Camurus is an international science-led biopharmaceutical company committed to developing and commercializing innovative medicines for the treatment of severe and chronic conditions. New drug products with best-in-class potential are conceived based on the unique proprietary FluidCrystal® drug delivery technologies and its extensive R&D and sales expertise. Camurus’ clinical pipeline includes product candidates for the treatment of cancer, endocrine diseases, pain and addiction, which are developed in-house and in collaboration with international pharmaceutical companies. Camurus’ share is listed on Nasdaq Stockholm under the ticker CAMX. For more information, visit camurus.com First quarter summary Q1 • Total revenue amounted to SEK 126 (49) million, an increase of 155% (161% at CER1) • Product sales were SEK 124 (49) million, an increase of 156% (162% at CER) • Sales growth was 20% (18% at CER) compared to the previous quarter Total revenue • Market approval for Buvidal in New Zealand SEK 126 million • CHMP recommended approval of a new 160mg dose of Buvidal in the EU +155% • Buvidal launched in Spain and the first hundred patients received treatment • Positive decision from health economic evaluation of Buvidal by Haute Autorité de Santé in France Product sales • FDA issued Safe to Proceed letter for the start of a Phase 3 study of CAM2029 for the treatment of SEK 124 million neuroendocrine tumors +156% • Scientific advice with FDA regarding the clinical program for CAM2029 for polycystic liver disease • New patent issued for CAM2038 Weekly in the US with patent term until July 2032 Operating result • The financial outlook for 2021 is unchanged; total revenue SEK 680 – 750 million2, SEK -26 million whereof product sales SEK 620 – 680 million, and the operating result SEK -120 – 0 million2 +66% 1) At constant exchange rates in January 2021.
    [Show full text]
  • Solasia Acquires Exclusive License and Distribution Rights from Camurus for Episil® Oral Liquid in Japan and China
    Camurus AB Press release Ideon Science Park SE-223 70 Lund, Sweden www.camurus.com Phone: +46 46 286 57 30 Solasia acquires exclusive license and distribution rights from Camurus for episil® oral liquid in Japan and China Lund, Sweden, and Tokyo, Japan — March 30, 2015 — Camurus AB (“Camurus”) and Solasia Pharma K.K. (“Solasia”) jointly announced today that they have entered into a license and distribution agreement for episil® oral liquid, a unique and effective treatment for the pain of oral mucositis, a treatment-limiting side effect of some cancer therapies, as well as other oral lesions. As part of the agreement Solasia receives exclusive commercialization rights to episil® in Japan and China, where it has ongoing operations and is building a specialty pharmaceutical infrastructure in the area of oncology and cancer supportive care. Solasia plans to first launch episil® in China followed by Japan. “We are pleased to enter into this collaboration with Camurus, and for the opportunity to commercialize episil® in Japan and China” said Yoshihiro Arai, President and Representative Director of Solasia. “Solasia specializes in innovative oncology treatments, and episil® will take its place as one of the core products in our oncology pipeline”, he continued, noting that episil® fills an important unmet need in daily pain management associated with cancer care, and will contribute to improved quality of life for cancer patients in Japan and China. “The new partnership with Solasia expands Camurus’ distributor network for episil® oral liquid in two of the key markets in Asia”, said Fredrik Tiberg, President and CEO of Camurus.
    [Show full text]
  • Pipeline Progress
    Second quarter results 2020 Audiocast presentation 16 July 2020 2 Forward looking statements This presentation contains forward-looking statements that provide our expectations or forecasts of future events such as new product developments and regulatory approvals and financial performance. Camurus is providing the following cautionary statement. Such forward-looking statements are subject to risks, uncertainties and inaccurate assumptions. This may cause actual results to differ materially from expectations and it may cause any or all of our forward-looking statements here or in other publications to be wrong. Factors that may affect future results include currency exchange rate fluctuations, delay or failure of development projects, loss or expiry of patents, production problems, unexpected contract, patent, breaches or terminations, government-mandated or market-driven price decreases, introduction of competing products, Camurus‘ ability to successfully market products, exposure to product liability claims and other lawsuits, changes in reimbursement rules and governmental laws and interpretation thereof, and unexpected cost increases. Camurus undertakes no obligation to update forward-looking statements 3 Agenda • Second quarter 2020 overview Company participants • Buvidal progress in EU & Australia Fredrik Tiberg, PhD President & CEO, Head R&D • Pipeline update • Key take-aways Eva Pinotti Lindqvist • Revised Outlook 2020 Chief Financial Officer • Q&A Richard Jameson Chief Commercial Officer 4 Continued strong performance in the second
    [Show full text]
  • Fourth Quarter & Full Year Results 2019
    Fourth quarter & full year results 2019 12 February 2020 Forward looking statements This presentation contains forward-looking statements that provide our expectations or forecasts of future events such as new product developments and regulatory approvals and financial performance. Camurus is providing the following cautionary statement. Such forward-looking statements are subject to risks, uncertainties and inaccurate assumptions. This may cause actual results to differ materially from expectations and it may cause any or all of our forward-looking statements here or in other publications to be wrong. Factors that may affect future results include currency exchange rate fluctuations, delay or failure of development projects, loss or expiry of patents, production problems, unexpected contract, patent, breaches or terminations, government-mandated or market-driven price decreases, introduction of competing products, Camurus‘ ability to successfully market products, exposure to product liability claims and other lawsuits, changes in reimbursement rules and governmental laws and interpretation thereof, and unexpected cost increases. Camurus undertakes no obligation to update forward-looking statements 2 Agenda • Fourth quarter 2019 overview Participants • Buvidal progress in EU & Australia Fredrik Tiberg, PhD • US approval and launch status President & CEO, Head R&D • R&D pipeline update • Key take-aways Eva Pinotti Lindqvist Chief Financial Officer • Q&A 3 Financial overview Financials Q4 2019 FY 2019 2019 Product sales 2020 Guidance FY 2020 MSEK MSEK MSEK 80 72.1 *) Net revenue 35.0 (7.8) 105.6 (49.3) 70 Total revenues 290 – 330 60 – product sales 240 – 280 – product sales 30.3 (5.1) 72.1 (11.3) 50 41.9 OPEX 570 – 610 Operating 40 result -88.4 (-103.2) -360.0 (-287.2) MSEK *) 30 excl.
    [Show full text]
  • Covid-19 Causing Spike in Opioid Overdoses
    Company presentation November 2020 2 Forward looking statements This presentation contains forward-looking statements that provide our expectations or forecasts of future events such as new product developments and regulatory approvals and financial performance. Camurus is providing the following cautionary statement. Such forward-looking statements are subject to risks, uncertainties and inaccurate assumptions. This may cause actual results to differ materially from expectations and it may cause any or all of our forward-looking statements here or in other publications to be wrong. Factors that may affect future results include currency exchange rate fluctuations, delay or failure of development projects, loss or expiry of patents, production problems, unexpected contract, patent, breaches or terminations, government-mandated or market-driven price decreases, introduction of competing products, Camurus‘ ability to successfully market products, exposure to product liability claims and other lawsuits, changes in reimbursement rules and governmental laws and interpretation thereof, and unexpected cost increases. Camurus undertakes no obligation to update forward-looking statements Long-acting medications addressing key healthcare challenges 4 Corporate highlights Rapidly growing commercial Broad late-stage pipeline stage company • +10 innovative clinical programs in • Fully operational infrastructure in Europe addiction, pain, oncology, endocrine and Australia disorders and CV diseases • Buvidal® to date launched in 10 countries • Two ongoing
    [Show full text]
  • Annual Report 2015 Contents This Is Camurus
    INNOVATIVE NANOSCALE THERAPEUTICS ANNUAL REPORT 2015 CONTENTS THIS IS CAMURUS This is Camurus ................................................................................................ 1 Leading innovation Key performance indicators ............................................................. 2 • FluidCrystal® – award-winning drug delivery technology 2015 In brief ......................................................................................................... 3 • Broad and advanced product pipeline Statement from the CEO ...................................................................... 4 • More than 400 patents and patent applications Operating environment........................................................................ 6 Strategy..................................................................................................................... 7 The patient in focus Technology platforms ..........................................................................10 • Simple and flexible administration Our development portfolio ..........................................................14 • Long-acting formulations for improved compliance Marketing organisation ......................................................................18 • Improved treatment outcomes and quality of life Employee portraits ..................................................................................20 Our development portfolio, cont. .........................................21 Strategic partnerships Early R&D projects ....................................................................................26
    [Show full text]
  • 2018 Otte, Liquid Crystalline Drug Delivery Vehicles for Oral and IV
    International Journal of Pharmaceutics 539 (2018) 175–183 Contents lists available at ScienceDirect International Journal of Pharmaceutics journal homepage: www.elsevier.com/locate/ijpharm Liquid crystalline drug delivery vehicles for oral and IV/subcutaneous T administration of poorly soluble (and soluble) drugs ⁎ Andrew Ottea, , Bong-Kwan Sohb, Gwangheum Yoonb, Kinam Parka,c a Purdue University, Weldon School of Biomedical Engineering, West Lafayette, IN 47907, USA b Chong Kun Dang Research Institute, 315-20, Dongbaekjukjeondaero, Giheung-gu, Youngin-si, Gyeonggi-do 16995, South Korea c Purdue University, Department of Industrial and Physical Pharmacy, West Lafayette, IN 47907, USA ARTICLE INFO ABSTRACT Keywords: Poorly soluble drug molecules often have low bioavailability issues and absorption problems in the clinical Liquid crystal setting. As the number of poorly soluble drugs increases from discovery, developing technologies to enhance Drug delivery their solubility, while also controlling their release is one of the many challenges facing the pharmaceutical Cubosome industry today. Liquid crystalline systems, nanoparticulate or macro-matrix, self-assemble in the presence of an Hexosome aqueous environment and can provide a solubility enhancement, while also controlling the drug release rate. Poorly soluble drug This review examines the fundamentals of liquid crystalline systems through the representative literature, concluding with examples of liquid crystalline systems in clinical trials development. The review focus is on the potential of utilizing liquid crystalline systems for poorly soluble drugs, in the areas of oral delivery and IV/ subcutaneous, followed by water soluble molecules. Key considerations in utilizing liquid crystalline systems advantages while also discussing potential areas of key research that may be needed will be highlighted.
    [Show full text]