1. Crossject aims to develop self-administered injectable medicines using its needle-free injection technology, ZENEO®, to optimize clinical benefits, patient compliance, and cost-effective health outcomes.
2. Crossject offers co-development of ZENEO® with biologics and vaccine companies, as well as turnkey "SuperGeneric" drug-device combination products for diseases like rheumatoid arthritis, migraine, and anaphylaxis.
3. Validation studies show ZENEO®'s ease of use, safety, and ability to facilitate self-injection, which can improve treatment compliance compared to traditional needles.
Three Roll Mill 101 - An introduction to a high shear blending and dispersion...torreyhillstech
A three roll mill has three horizontally positioned rollers. Each roller rotates in an opposite direction from the adjacent roller with a tiny gap between them, creating tremendous shear force that can finely disperse, mix, refine or homogenize viscous materials.
This presentation explains in detail the working mechanism, the structure, the application, the maintenance and the specification of popular models.
For more information about three roll mills, please visit our website at http://www.threerollmill.com
Unilife Corporation (NASDAQ:UNIS - News) is a U.S.-based developer, manufacturer and supplier of advanced drug delivery systems with state-of-the-art facilities in Pennsylvania. Established in 2002, Unilife works with pharmaceutical and biotechnology companies seeking innovative devices for use with their parenteral drugs and vaccines. Unilife has developed a broad, differentiated proprietary portfolio of its own injectable drug delivery products, including the Unifill® and Unitract® product lines of safety syringes with automatic, operator controlled needle retraction. Unifill represents the world's first prefilled syringe technology integrating safety within the primary drug container. The products are ideally positioned to help pharmaceutical companies maximize the lifecycle of their injectable drugs and enhance patient care. Unifill syringes, together with other devices that are part of the Unilife technology platform, can either be supplied to pharmaceutical customers ready for use, or customized to address the specific requirements of targeted novel drugs. For more information on Unilife, please visit www.unilife.com.
Since its founding in 1935, Morgan Stanley and its people have helped redefine the meaning of financial services. The firm has continually broken new ground in advising our clients on strategic transactions, in pioneering the global expansion of finance and capital markets, and in providing new opportunities for individual and institutional investors. Click below to see a timeline of Morgan Stanley's growth, which parallels the history of modern finance
Three Roll Mill 101 - An introduction to a high shear blending and dispersion...torreyhillstech
A three roll mill has three horizontally positioned rollers. Each roller rotates in an opposite direction from the adjacent roller with a tiny gap between them, creating tremendous shear force that can finely disperse, mix, refine or homogenize viscous materials.
This presentation explains in detail the working mechanism, the structure, the application, the maintenance and the specification of popular models.
For more information about three roll mills, please visit our website at http://www.threerollmill.com
Unilife Corporation (NASDAQ:UNIS - News) is a U.S.-based developer, manufacturer and supplier of advanced drug delivery systems with state-of-the-art facilities in Pennsylvania. Established in 2002, Unilife works with pharmaceutical and biotechnology companies seeking innovative devices for use with their parenteral drugs and vaccines. Unilife has developed a broad, differentiated proprietary portfolio of its own injectable drug delivery products, including the Unifill® and Unitract® product lines of safety syringes with automatic, operator controlled needle retraction. Unifill represents the world's first prefilled syringe technology integrating safety within the primary drug container. The products are ideally positioned to help pharmaceutical companies maximize the lifecycle of their injectable drugs and enhance patient care. Unifill syringes, together with other devices that are part of the Unilife technology platform, can either be supplied to pharmaceutical customers ready for use, or customized to address the specific requirements of targeted novel drugs. For more information on Unilife, please visit www.unilife.com.
Since its founding in 1935, Morgan Stanley and its people have helped redefine the meaning of financial services. The firm has continually broken new ground in advising our clients on strategic transactions, in pioneering the global expansion of finance and capital markets, and in providing new opportunities for individual and institutional investors. Click below to see a timeline of Morgan Stanley's growth, which parallels the history of modern finance
Unilife Corp. (NASDAQ: UNIS; Stock Twits: $UNIS) is a U.S.-based medical device company focused on the design, development, manufacture and supply of a proprietary range of retractable syringes. Primary target customers for Unilife products include pharmaceutical manufacturers, suppliers of medical equipment to healthcare facilities and patients who self-administer prescription medication.
Medical device industry 2014 - A Healthcare Sector AnalysisVikas Soni
Medical Device Industry and its impact on Healthcare Sector of India for FY2014 along with Current Scenario of Global, US, EU and Indian Medical device market.
Commercial considerations in early drug developmentSunil Ramkali
It is important in the drug development process that marketers and researchers collaborate early to ensure that products being developed are truly innovative and deliver brand value to the different end users in a way that the product and the subsequent brand messaging is relevant, compelling and differentiating compared to the competition. T
In the market place that is heavily cost constraint, innovation is no longer about a unique mode of action or a new formulation, but more about the incremental brand value offered by new pharmaceutical products over existing treatments (standard of care) and how much healthcare systems are prepared to pay for these incremental benefits. My lecture at the Department of Innovation, Lund University, Sweden explored the importance of R&D functions getter closer to external stakeholders to really understand their needs, how they define brand value and the importance of considering this early in the drug development process.
Currently worth a few million dollars, the emerging organs-on-chips market has the potential to become a multi-billion dollar market.
Organs-on-chips: the promise of solving one of the pharmaceutical industry’s major hurdles
Bringing a new drug to market is one of the longest and most costly paths any industry has to walk. Companies start with several thousands of compounds that may have positive effects against a disease or a human condition. More than twelve years and several billion dollars later, if they’re lucky they managed to get one of these compounds onto the market. All the others failed at one stage or another during the drug development process – and the later the failure, the more expensive it is. Current methods – cell culture in petri dishes and animal testing among others – are not predictive enough. Around 90% of drugs that have been validated on these models then fail during clinical trials because of toxicity or lack of efficacy. The pharmaceutical industry therefore needs more predictive tools to make drug candidates fail earlier and cheaper. Other industries where toxicity testing is a major concern, such as cosmetics, agro-food and consumer goods, also need such solutions, in particular because animal testing is now banned for these industries in certain geographical areas. Several options have been envisioned, the most promising of which is certainly organs-on-chips. These combinations of micro-technology and biology reconstitute the physiological and mechanical functions of human organs under the form of micro-engineered devices lined with living cells. Precisely controlled fluid flows combined with mechanical cues and tissue-tissue interfaces enable dynamic models, much more relevant than conventional static cell cultures. As a sign of confidence in this technology, significant funding has been allocated to organs-on-chips developers: DARPA and the NIH respectively awarded $140M and $76M over 5-year periods to support developments. In parallel, technology developers have raised more than $80M since 2012 with investors. In Yole Développement’s report, all the key elements to understand the organs-on-chips landscape are detailed.
For more information, please visit our website: https://www.i-micronews.com/reports.html
A Trust-Centric Healthcare Journey Part II | Full Presentation of PharmaLedge...PharmaLedger
In this presentation, you will find:
An introduction to the PharmaLedger project presented by Maria Eugenia (Xenia) Beltran | Project Coordinator / DRA and Use Case co-lead (Universidad Politécnica de Madrid)
Topic 1 | Clinical Trial eRecruitment | Despina Daliani (Onorach) and Ken Nessel (Pfizer)
Topic 2 | Clinical Trial eConsent | Hernando C. Giraldo (Boehringer Ingelheim) and Despina Daliani (Onorach)
Topic 3 | Health Data IoT Medical Device | Disa Lee Choun (UCB) and Francesca Rocchi (Bambino Gesù Children Hospital)
Topic 4 | Health Data Personalised Medicine | Beatriz Merino (Universidad Politécnica de Madrid) and Christos Kontogiorgis (Democritus University of Thrace)
You can also learn more about our #2 Open Webinar on Clinical Trials & Health Data by rewatching our video recording including the Q&A by clicking on the button below:
This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 853992. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.
Disclaimer: Any information on this presentation solely reflects the author’s view and neither IMI nor the European Union or EFPIA are responsible for any use that may be made of the information contained herein.
Pv day frankfurt june 2015 zittartz presentationpharmasol
Medical Devices and Pharmaceutical products have long been separate worlds with distinct regulations.
Advances in technology continue to create new opportunities by merging devices with drugs or biologics to provide previously impossible benefits to patients. As these combination products involve components that are normally regulated under different types of regulatory authorities, they raise several challenges to traditional pharmaceutical companies, not previously exposed to Device regulations.
Compared to drug regulations, device regulations are more diverse depending on the classification of the device. But the safety of Medical Devices has recently become the focus of regulatory activities in Europe following the scandal about industrial silicone breast implants in France, leading to changes in regulations that follow pharmacovigilance principles.
In this presentation Dr Marc Zittartz, Chief Quality Officer at pharmasol, provides an overview on drug-device combinations, the recent regulatory developments, and how this affects the traditional pharmacovigilance activities of pharmaceutical companies.
Regenerative Medicine: Impact of Convergence on Drug, Device, and Biologics D...MaRS Discovery District
Speaker Dr. Annemarie Moseley, CEO of Aggregate Therapeutics (Palo Alto) explores how drug-device combination products are altering the medical practice from development to regulation to treatment.
Part of the MaRS Emerging Technologies Event Series. More information on the series can be found here:
http://www.marsdd.com/emergingtech/
Unilife Corp. (NASDAQ: UNIS; Stock Twits: $UNIS) is a U.S.-based medical device company focused on the design, development, manufacture and supply of a proprietary range of retractable syringes. Primary target customers for Unilife products include pharmaceutical manufacturers, suppliers of medical equipment to healthcare facilities and patients who self-administer prescription medication.
Medical device industry 2014 - A Healthcare Sector AnalysisVikas Soni
Medical Device Industry and its impact on Healthcare Sector of India for FY2014 along with Current Scenario of Global, US, EU and Indian Medical device market.
Commercial considerations in early drug developmentSunil Ramkali
It is important in the drug development process that marketers and researchers collaborate early to ensure that products being developed are truly innovative and deliver brand value to the different end users in a way that the product and the subsequent brand messaging is relevant, compelling and differentiating compared to the competition. T
In the market place that is heavily cost constraint, innovation is no longer about a unique mode of action or a new formulation, but more about the incremental brand value offered by new pharmaceutical products over existing treatments (standard of care) and how much healthcare systems are prepared to pay for these incremental benefits. My lecture at the Department of Innovation, Lund University, Sweden explored the importance of R&D functions getter closer to external stakeholders to really understand their needs, how they define brand value and the importance of considering this early in the drug development process.
Currently worth a few million dollars, the emerging organs-on-chips market has the potential to become a multi-billion dollar market.
Organs-on-chips: the promise of solving one of the pharmaceutical industry’s major hurdles
Bringing a new drug to market is one of the longest and most costly paths any industry has to walk. Companies start with several thousands of compounds that may have positive effects against a disease or a human condition. More than twelve years and several billion dollars later, if they’re lucky they managed to get one of these compounds onto the market. All the others failed at one stage or another during the drug development process – and the later the failure, the more expensive it is. Current methods – cell culture in petri dishes and animal testing among others – are not predictive enough. Around 90% of drugs that have been validated on these models then fail during clinical trials because of toxicity or lack of efficacy. The pharmaceutical industry therefore needs more predictive tools to make drug candidates fail earlier and cheaper. Other industries where toxicity testing is a major concern, such as cosmetics, agro-food and consumer goods, also need such solutions, in particular because animal testing is now banned for these industries in certain geographical areas. Several options have been envisioned, the most promising of which is certainly organs-on-chips. These combinations of micro-technology and biology reconstitute the physiological and mechanical functions of human organs under the form of micro-engineered devices lined with living cells. Precisely controlled fluid flows combined with mechanical cues and tissue-tissue interfaces enable dynamic models, much more relevant than conventional static cell cultures. As a sign of confidence in this technology, significant funding has been allocated to organs-on-chips developers: DARPA and the NIH respectively awarded $140M and $76M over 5-year periods to support developments. In parallel, technology developers have raised more than $80M since 2012 with investors. In Yole Développement’s report, all the key elements to understand the organs-on-chips landscape are detailed.
For more information, please visit our website: https://www.i-micronews.com/reports.html
A Trust-Centric Healthcare Journey Part II | Full Presentation of PharmaLedge...PharmaLedger
In this presentation, you will find:
An introduction to the PharmaLedger project presented by Maria Eugenia (Xenia) Beltran | Project Coordinator / DRA and Use Case co-lead (Universidad Politécnica de Madrid)
Topic 1 | Clinical Trial eRecruitment | Despina Daliani (Onorach) and Ken Nessel (Pfizer)
Topic 2 | Clinical Trial eConsent | Hernando C. Giraldo (Boehringer Ingelheim) and Despina Daliani (Onorach)
Topic 3 | Health Data IoT Medical Device | Disa Lee Choun (UCB) and Francesca Rocchi (Bambino Gesù Children Hospital)
Topic 4 | Health Data Personalised Medicine | Beatriz Merino (Universidad Politécnica de Madrid) and Christos Kontogiorgis (Democritus University of Thrace)
You can also learn more about our #2 Open Webinar on Clinical Trials & Health Data by rewatching our video recording including the Q&A by clicking on the button below:
This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 853992. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.
Disclaimer: Any information on this presentation solely reflects the author’s view and neither IMI nor the European Union or EFPIA are responsible for any use that may be made of the information contained herein.
Pv day frankfurt june 2015 zittartz presentationpharmasol
Medical Devices and Pharmaceutical products have long been separate worlds with distinct regulations.
Advances in technology continue to create new opportunities by merging devices with drugs or biologics to provide previously impossible benefits to patients. As these combination products involve components that are normally regulated under different types of regulatory authorities, they raise several challenges to traditional pharmaceutical companies, not previously exposed to Device regulations.
Compared to drug regulations, device regulations are more diverse depending on the classification of the device. But the safety of Medical Devices has recently become the focus of regulatory activities in Europe following the scandal about industrial silicone breast implants in France, leading to changes in regulations that follow pharmacovigilance principles.
In this presentation Dr Marc Zittartz, Chief Quality Officer at pharmasol, provides an overview on drug-device combinations, the recent regulatory developments, and how this affects the traditional pharmacovigilance activities of pharmaceutical companies.
Regenerative Medicine: Impact of Convergence on Drug, Device, and Biologics D...MaRS Discovery District
Speaker Dr. Annemarie Moseley, CEO of Aggregate Therapeutics (Palo Alto) explores how drug-device combination products are altering the medical practice from development to regulation to treatment.
Part of the MaRS Emerging Technologies Event Series. More information on the series can be found here:
http://www.marsdd.com/emergingtech/
Explore our most comprehensive guide on lookback analysis at SafePaaS, covering access governance and how it can transform modern ERP audits. Browse now!
Memorandum Of Association Constitution of Company.pptseri bangash
www.seribangash.com
A Memorandum of Association (MOA) is a legal document that outlines the fundamental principles and objectives upon which a company operates. It serves as the company's charter or constitution and defines the scope of its activities. Here's a detailed note on the MOA:
Contents of Memorandum of Association:
Name Clause: This clause states the name of the company, which should end with words like "Limited" or "Ltd." for a public limited company and "Private Limited" or "Pvt. Ltd." for a private limited company.
https://seribangash.com/article-of-association-is-legal-doc-of-company/
Registered Office Clause: It specifies the location where the company's registered office is situated. This office is where all official communications and notices are sent.
Objective Clause: This clause delineates the main objectives for which the company is formed. It's important to define these objectives clearly, as the company cannot undertake activities beyond those mentioned in this clause.
www.seribangash.com
Liability Clause: It outlines the extent of liability of the company's members. In the case of companies limited by shares, the liability of members is limited to the amount unpaid on their shares. For companies limited by guarantee, members' liability is limited to the amount they undertake to contribute if the company is wound up.
https://seribangash.com/promotors-is-person-conceived-formation-company/
Capital Clause: This clause specifies the authorized capital of the company, i.e., the maximum amount of share capital the company is authorized to issue. It also mentions the division of this capital into shares and their respective nominal value.
Association Clause: It simply states that the subscribers wish to form a company and agree to become members of it, in accordance with the terms of the MOA.
Importance of Memorandum of Association:
Legal Requirement: The MOA is a legal requirement for the formation of a company. It must be filed with the Registrar of Companies during the incorporation process.
Constitutional Document: It serves as the company's constitutional document, defining its scope, powers, and limitations.
Protection of Members: It protects the interests of the company's members by clearly defining the objectives and limiting their liability.
External Communication: It provides clarity to external parties, such as investors, creditors, and regulatory authorities, regarding the company's objectives and powers.
https://seribangash.com/difference-public-and-private-company-law/
Binding Authority: The company and its members are bound by the provisions of the MOA. Any action taken beyond its scope may be considered ultra vires (beyond the powers) of the company and therefore void.
Amendment of MOA:
While the MOA lays down the company's fundamental principles, it is not entirely immutable. It can be amended, but only under specific circumstances and in compliance with legal procedures. Amendments typically require shareholder
Premium MEAN Stack Development Solutions for Modern BusinessesSynapseIndia
Stay ahead of the curve with our premium MEAN Stack Development Solutions. Our expert developers utilize MongoDB, Express.js, AngularJS, and Node.js to create modern and responsive web applications. Trust us for cutting-edge solutions that drive your business growth and success.
Know more: https://www.synapseindia.com/technology/mean-stack-development-company.html
Discover the innovative and creative projects that highlight my journey throu...dylandmeas
Discover the innovative and creative projects that highlight my journey through Full Sail University. Below, you’ll find a collection of my work showcasing my skills and expertise in digital marketing, event planning, and media production.
"𝑩𝑬𝑮𝑼𝑵 𝑾𝑰𝑻𝑯 𝑻𝑱 𝑰𝑺 𝑯𝑨𝑳𝑭 𝑫𝑶𝑵𝑬"
𝐓𝐉 𝐂𝐨𝐦𝐬 (𝐓𝐉 𝐂𝐨𝐦𝐦𝐮𝐧𝐢𝐜𝐚𝐭𝐢𝐨𝐧𝐬) is a professional event agency that includes experts in the event-organizing market in Vietnam, Korea, and ASEAN countries. We provide unlimited types of events from Music concerts, Fan meetings, and Culture festivals to Corporate events, Internal company events, Golf tournaments, MICE events, and Exhibitions.
𝐓𝐉 𝐂𝐨𝐦𝐬 provides unlimited package services including such as Event organizing, Event planning, Event production, Manpower, PR marketing, Design 2D/3D, VIP protocols, Interpreter agency, etc.
Sports events - Golf competitions/billiards competitions/company sports events: dynamic and challenging
⭐ 𝐅𝐞𝐚𝐭𝐮𝐫𝐞𝐝 𝐩𝐫𝐨𝐣𝐞𝐜𝐭𝐬:
➢ 2024 BAEKHYUN [Lonsdaleite] IN HO CHI MINH
➢ SUPER JUNIOR-L.S.S. THE SHOW : Th3ee Guys in HO CHI MINH
➢FreenBecky 1st Fan Meeting in Vietnam
➢CHILDREN ART EXHIBITION 2024: BEYOND BARRIERS
➢ WOW K-Music Festival 2023
➢ Winner [CROSS] Tour in HCM
➢ Super Show 9 in HCM with Super Junior
➢ HCMC - Gyeongsangbuk-do Culture and Tourism Festival
➢ Korean Vietnam Partnership - Fair with LG
➢ Korean President visits Samsung Electronics R&D Center
➢ Vietnam Food Expo with Lotte Wellfood
"𝐄𝐯𝐞𝐫𝐲 𝐞𝐯𝐞𝐧𝐭 𝐢𝐬 𝐚 𝐬𝐭𝐨𝐫𝐲, 𝐚 𝐬𝐩𝐞𝐜𝐢𝐚𝐥 𝐣𝐨𝐮𝐫𝐧𝐞𝐲. 𝐖𝐞 𝐚𝐥𝐰𝐚𝐲𝐬 𝐛𝐞𝐥𝐢𝐞𝐯𝐞 𝐭𝐡𝐚𝐭 𝐬𝐡𝐨𝐫𝐭𝐥𝐲 𝐲𝐨𝐮 𝐰𝐢𝐥𝐥 𝐛𝐞 𝐚 𝐩𝐚𝐫𝐭 𝐨𝐟 𝐨𝐮𝐫 𝐬𝐭𝐨𝐫𝐢𝐞𝐬."
Business Valuation Principles for EntrepreneursBen Wann
This insightful presentation is designed to equip entrepreneurs with the essential knowledge and tools needed to accurately value their businesses. Understanding business valuation is crucial for making informed decisions, whether you're seeking investment, planning to sell, or simply want to gauge your company's worth.
Improving profitability for small businessBen Wann
In this comprehensive presentation, we will explore strategies and practical tips for enhancing profitability in small businesses. Tailored to meet the unique challenges faced by small enterprises, this session covers various aspects that directly impact the bottom line. Attendees will learn how to optimize operational efficiency, manage expenses, and increase revenue through innovative marketing and customer engagement techniques.
Accpac to QuickBooks Conversion Navigating the Transition with Online Account...PaulBryant58
This article provides a comprehensive guide on how to
effectively manage the convert Accpac to QuickBooks , with a particular focus on utilizing online accounting services to streamline the process.
Enterprise Excellence is Inclusive Excellence.pdfKaiNexus
Enterprise excellence and inclusive excellence are closely linked, and real-world challenges have shown that both are essential to the success of any organization. To achieve enterprise excellence, organizations must focus on improving their operations and processes while creating an inclusive environment that engages everyone. In this interactive session, the facilitator will highlight commonly established business practices and how they limit our ability to engage everyone every day. More importantly, though, participants will likely gain increased awareness of what we can do differently to maximize enterprise excellence through deliberate inclusion.
What is Enterprise Excellence?
Enterprise Excellence is a holistic approach that's aimed at achieving world-class performance across all aspects of the organization.
What might I learn?
A way to engage all in creating Inclusive Excellence. Lessons from the US military and their parallels to the story of Harry Potter. How belt systems and CI teams can destroy inclusive practices. How leadership language invites people to the party. There are three things leaders can do to engage everyone every day: maximizing psychological safety to create environments where folks learn, contribute, and challenge the status quo.
Who might benefit? Anyone and everyone leading folks from the shop floor to top floor.
Dr. William Harvey is a seasoned Operations Leader with extensive experience in chemical processing, manufacturing, and operations management. At Michelman, he currently oversees multiple sites, leading teams in strategic planning and coaching/practicing continuous improvement. William is set to start his eighth year of teaching at the University of Cincinnati where he teaches marketing, finance, and management. William holds various certifications in change management, quality, leadership, operational excellence, team building, and DiSC, among others.
3.0 Project 2_ Developing My Brand Identity Kit.pptxtanyjahb
A personal brand exploration presentation summarizes an individual's unique qualities and goals, covering strengths, values, passions, and target audience. It helps individuals understand what makes them stand out, their desired image, and how they aim to achieve it.
What is the TDS Return Filing Due Date for FY 2024-25.pdfseoforlegalpillers
It is crucial for the taxpayers to understand about the TDS Return Filing Due Date, so that they can fulfill your TDS obligations efficiently. Taxpayers can avoid penalties by sticking to the deadlines and by accurate filing of TDS. Timely filing of TDS will make sure about the availability of tax credits. You can also seek the professional guidance of experts like Legal Pillers for timely filing of the TDS Return.
What is the TDS Return Filing Due Date for FY 2024-25.pdf
Crossject self & safe needle-free auto-injectors sc im & id - partnering offer april 2013
1. page 1
OUR GOAL IS TO DEVELOP SELF - ADMINISTERED PARENTERAL
MEDICINES BASED ON OUR TRUE IM, SC & ID NEEDLE-FREE AUTO-
INJECTORS THAT OPTIMIZE CLINICAL BENEFITS , PATIENTS
COMPLIANCE WITH ENHANCED COST EFFECTIVE HEALTH OUTCOMES
2. page 2
SUMMARY
THE DEVICE
Full prescribed dose delivered in <1/10s 3
CROSSJECT OFFER
Biologics & Super-Generics 11
APPENDICES 20
ZENEO® & Anaphylactic Shock 27
ZENEO® & Migraine 31
ZENEO® & Arthritis 35
Future development for ZENEO 40
Market segments for ZENEO 43
CONTACT 50
PRESS RELEASE ON LAST PARTNERING DEAL 51
3. 1. The device – ZENEO®
Superior patented devices for
the needle-free injection of drugs
Easy – Fast & Safe
4. page 4
“Poor adherence to long-term treatment of chronic diseases is a worldwide
problem” (according to WHO):
Adherence in developed countries averages 50%
Better adherence can produce better health outcomes and limit health
care expenditures
Reducing hospital admissions and caring for people more appropriately
outside of hospital is key.
Outpatient pharmacotherapy of chronic diseases relies on drug self
administration at home
Needs Increase with Ageing Population
Self Administration : An Inevitable Evolution
5. page 5
Zeneo® advantage: ease & safety of use
Ease of use facilitates self-injection,
particularly for populations requiring chronic
treatment.
No needle-phobia; no needle-stick risk
Increased compliance
Safety
Reliability
Decreased « Social stigma »
of the injectable chronic treatments, allowing a
broader acceptance.
Self-Injection by “place and push” in <0.1
second : a warranty on dose administration
6. page 6
Zeneo® - superior device: characteristics
Needle-free auto injector for a better compliance
Intramuscular,
Subcutaneous,
Intra dermal.
1/10s auto-injection : improving medical benefit
for acute care and emergency uses = a warranty on dose
Pre-filled & Single-use (disposable)
Drug volume range: 0.1–0.6ml
User-friendly, not syringe-like design, just “place & push”
Convenient size, very fast, very easy
Clinically proven, well-established technology
Adapted from air bag/seat belt systems technology
Adaptable to product viscosity
7. page 7
Zeneo® Ensures Delivery of Full Prescribed Dose
Open ZENEO®
ZENEO is ready for injection
Apply on Injection Site & Push
Arm, Stomach, Thigh…
Automatic injection process (no button)
Just Hear the Click
Injection is completed in less than 0.1s
Either you inject, or you do not inject…
but you can not miss you injection!
8. page 8
Clinically proven: >10 000 tests on human skin & >300 on patients
Different injection routes : SQ, IM, ID
Different injection sites: shoulder, tight, abdomen
Different viscosities (including very high viscous gels)
Different molecules, including DNA, therapeutic proteins, suspensions...
High preference to ZENEO for self injection
Standard materials in pharmaceutical sub-assembly
Minimised regulatory burden – comparability with original syringes
Use conventional syringe/cartridge automated filling technologies
Easy to customize
No need for drug reformulation
Shorter Pharmaceutical & regulatory route
Robust supply chain
Expert industrial partners
Broad & Strong IP protection
380 + patents worldwide in 26 families with life up to 2026
Zeneo® - an advanced proprietary platform
A combination
of technologies
for patient care
9. page 9
“End-user” validation: perfect for self-administration
3 studies independently conducted by 3 big Pharma partners
Health care staff (Dermatologists, rheumatologists, nurses) & patients.
France (Paris, Lille), Germany, Spain, UK, USA (New York)
“Crossject device meets expectations and is close to the ideal
device”
Ease of handling
minimized training requirements,
high level of comfort,
highly effective in reducing needle-stick injury,
extremely safe device to use.
“ Physicians confirm that Zeneo® device would positively
influence their prescription of a biologic product ”
12. page 12
As a combination product (drug + device), prefilled and single
use, ZENEO is registered as a drug
Each drug combined with ZENEO will need an approval
For Drugs already registered
Registration process similar to generic products
Only demonstrating:
• Equivalence to needle/syringe (bioequivalence)
• Safety with the device
No risks
• Everything from the drug is already well known from us and from the
authorities
Similar procedures world-wide
Especially for SuperGenerics
A straightforward regulatory process
14. page 14
3 Market segments for ZENEO
1. Biologics and Vaccines
Self-administration
Avoids needle-phobia
Avoids viral cross contamination
Intra-dermal a practical possibility
No need for adjuvant (intra dermal)
Avoids needle-phobia
2. Biosimilars
As above, co-developed only
Customers: innovator companies: life-cycle management. Generics
majors.
3. SuperGenerics
CJ development – ‘turnkey’ offerings are possible
The device adds the value (IP)
Self-administration
Preferred injectable version of previously oral drugs
Wide variety of possible customers
15. page 15
Crossject
French Company founded in 2001, based in Dijon
Spin-Off from Fournier Laboratories
Crossject Staff: 14 people + partners
Key competencies:
Research, Mechanical Design & Engineering, Testing,
Industrial development,
Biopharmaceuticals
QA
Long development history; well-characterised device
Strong Industrial partnerships
Solid mastering of COG
High potential but focus on turn key SuperGenerics
Distribution licences
16. page 16
The ZENEO™ devices : needle free self injector
A pharmaceutical sub-assembly
An actuator
Casing
Gas generator
Trigger
Body
Cap
Membrane
Drug container
Nozzle
17. page 17
Customisable device : unique versatility
Injection nozzle:
number and size of orifice(s)
Drug container:
Type I glass or polymer (COC/COP)
Gas generator: customisable
pressure profile
Standard rubber stoppers
(formulation chosen by customer)
• Simple adaptations for route of administration
(SQ IM ID), volume and drug characteristics
• Primary packaging materials specified by
customer to reduce risks of drug/container issues
18. page 18
Industrial Flow: extended company
Full preparation
Aseptic Filling
Assembly
(secondary packaging)
Mechanical assembly
19. page 19
Biologics, Biosimilars & Vaccines:
Co-development with pharmaceutical companies
Licence for use with their drugs
• Therapeutic Area / Worldwide exclusivity
Sales of devices
Filling/Packaging services purchased to RECIPHARM
Service Products (SuperGenerics)
Development by CROSSJECT
Or with partner
Distribution licences
Turnkey product (device + drug)
Sales price including royalties
CROSSJECT Offers
20. page 20
Short term: Super Generic is the value added strategy
for ZENEO in a life cycle management process
21. page 21
3 SuperGenerics under development
Combination products developed by CROSSJECT
Distribution licenses proposed to pharmaceutical companies
Country/country or Region/Region or Worldwide
METHOTREXATE (rheumatoid arthritis)
SQ
7,5mg, 10mg, 15mg, 20mg & 25mg
EPINEPHRINE (anaphylactic shock)
IM
0,15mg and 0,3mg (0,5mg)
SUMATRIPTAN (acute migraine)
SQ
6mg
24. page 24
Zeneo® advantage: no needle-stick injury
High exposure:
12 billion injections/year worldwide
2 million infections in 35 million Health Care
Workers annually
800 000 needle-stick injuries are reported
in the US each year, inducing an average cost
of $ 1000 per injury (excl. contamination)
Safety devices for the injections mandated
in the US
Through use of needles, unsafe injections cause
millions infections per year in particular:
Hepatitis B
Hepatitis C
HIV
Source: ISIPS 2004
25. page 25
Zeneo® advantage: no needle phobia
Needle phobia is a defined condition that affects
more than 10% (7-22%) of the general population*
More than 15 million American adults and 5
million children suffer from high discomfort with
injections
Needle phobia leads to avoidance which may
have severe medical consequences including
death
Roche says that of patients not receiving Fuzeon despite being
eligible, 4 out of 5 cite fear of injection as the main reason
(Scrip, 2004)
Source: * American Psychiatric Association
26. page 26
Ease of use:
Safety & reliability for professional and patient
Suitable for self-injection, particularly for populations with
chronic treatments
0,1 second self-injection by “place & push” ensuring
the right dose for acute care and emergency case
Elimination of risk of needle-stick injury
2 million infections in 35 million Health Care Workers
annually
Through use of needles, unsafe injections cause millions
infections per year in particular Hepatitis B, Hepatitis C,
HIV
Zeneo® advantages
Elimination of needle phobia
Needle phobia is a defined condition that affects more than 10% (7-22%) of
the general population (up to 30% if discomfort with needles)
Needle phobia leads to avoidance which may have severe medical consequences
including death
Source: ISIPS 2004
Source: * American Psychiatric Association
27. page 27
Zeneo® advantages
Accuracy of dosing:
Compliance assured (if the injection is made…)
Many classical syringe injections are thought
to be inappropriate dose and/or injected
at the wrong depth
ID particularly difficult to achieve correctly
with needles
Shorter duration of pain and user-
friendly device improve prospects of
injections being made
87 % of subjects would prefer ZENEO®
over needle for self injection in chronic
treatments
28. page 28
ZENEO compatible with many drugs, incl. biologics
The integrity of a wide range of drugs has been
checked successfully though “Stress Tests”:
Therapeutic proteins : 2 MABs tested, Calcitonin*
Low molecular weight heparins*
Several vaccines **
• with and without alum adjuvant (suspensions)
DNA vaccine
Others (Sumatriptan*, ...)
* Includes successful PK or PD on pigs
** Successful clinical test with flu vaccine
30. page 30
Reference Product for IM adm. of Epinephrin
Alternatives (all needle based)
Anapen (Lincoln)
E-Cue (Sanofi)
Vibec (Antares)
MYLAN
Epipen
(needle-based)
Worldwide leader
>$500M sales expected for 2012
31. page 31
Key drawbacks of existing solutions (with needles)
IM injection not guarantied into tie
ZENEO demonstrated true IM injections clinically
Injection time is too long (prep & injection)
ZENEO injects within less than 50ms
Preparation time for ZENEO very short (just remove cap & push onto
injection site)
Others
Needle Phobia
Risk of needle-stick injury
References
Self-Injectable Adrenaline for Anaphylactic Emergencies: effectiveness of Epipen and Anapen...
Ram J Allergy & Therapy 2012 3:1
Adequacy of the Epinephrine Auto injectors needle length in delivering epinephrine to the
muscular tissues – Ann Allergy Asthma Immunol 2005 May; 94(5):539-42
Anaphylaxis: past, present, future – Allergy 66 (2011) 1-14
What are the “ideal” features of an adrenaline auto-injector in the treatment of anaphylaxis –
Allergy 66 (2011) 15-24
Comparison of the robustness and functionality of 3 adrenaline auto-injectors – Journal of
Asthma & Allergy 2012:5 39-49
32. page 32
Direct comparison ZENEO®/Needle Auto-Injectors
IM Injection of blue coloured water through a piece of jeans
Muscle shown on photos below (cross section near the injection site)
½ inch needle ZENEO
34. page 34
Reference Product for Needle-free adm. of Sumatriptan
ZOGENIX launched DOSEPRO in 2011
$30M Sales in 2011
$40M Sales expected for 2012
Sales Price = 105$
83% prescriptions conversions from oral form
ZOGENIX (ZGNX)
DosePro
(needle-free 0,5ml/SQ)
Approved in US and EU
Regulatory path cleared
Generic Path
Fast
No Risk
35. page 35
Clinical validation of the injection (SQ)
Arm Thigh Abdomen
0.5 ml 0.8 ml 0.8 ml
87 % of subjects would prefer ZENEO® over needle
for self injection in chronic treatments
Source: Internal Crossject clinical research
37. page 37
RA requires highly ergonomic drug delivery system
RA patients need life-long treatment
Home treatment, with frequent injections.
Handling syringes is a challenge.
Crossject contributes to improve the
patient care in this specific disabled
population:
Ease of use facilitates self-injection
Compliance, safety and reliability of
the injection.
Rheumatoid Arthritis (RA) is
an auto-immune disease
(mainly in young women)
The auto-immune drugs
market represents $10bn.
38. page 38
Reference Product self administration of Methotrexate
MEDAC
Metoject
METHOTREXATE is a first line
treatment in RA:
72% in first intention
SQ injection of MTX gives better
response than oral MTX
Injection often performed by a
nurse
39. page 39
“End-user” validation: perfect for self-administration
3 studies independently conducted by 3 big Pharma partners
Health care staff (Dermatologists, rheumatologists, nurses) & patients.
France (Paris, Lille), Germany, Spain, UK, USA (New York)
“Crossject device meets expectations and is close to the ideal
device”
Ease of handling
minimized training requirements,
high level of comfort,
highly effective in reducing needle-stick injury,
extremely safe device to use.
“ Physicians confirm that Zeneo® device would positively
influence their prescription of a biologic product ”
40. page 40
Clinical validation of the injection (SQ)
Arm Thigh Abdomen
0.5 ml 0.8 ml 0.8 ml
87 % of subjects would prefer ZENEO® over needle
for self injection in chronic treatments
Source: Internal Crossject clinical research
42. page 42
Other applications for ZENEO technology
Intravitreal injections
For retinopathies, glaucoma, allergies, etc.
Injection of very small injection volumes (<0,1ml)
• Precision
• Reduced risks of eye damaging
Ex vivo results already available with ZENEO
• Proof of concept : passed
Ergonomics will need to be adapted to eye
Co-development on-going with pharmaceutical company
• Therapeutic areas available for partnering
(26G Needle) (ZENEO)
43. page 43
Other applications for ZENEO technology
Ready to Fill & Polymer Drug Container
Allowing customers to manufacture with
their own equipment
High Injection Volumes (1ml and over)
Suited for modern biological products
Specific galenic forms of drugs (ZENEO
compatible)
Suspensions, emulsions, gels…
• Perfectly suitable for fragile or poorly soluble
biologics
• Allow sustained/controlled release
Specific ergonomics
Animal health
Cosmetics
46. page 46
2.2 Biosimilars
Fast growing market – $3.7bn by 2014 (70%CAGR
2009–2015)*
30+ branded bio products off-patent 2011-2015
Sales of $51bn will lose their patent exclusivity
Regulatory pathway relatively recently defined
Several major Bio-pharma companies and generics
specialists active in this new field
Product differentiation will be a key advantage
Products hard to copy – more expensive than small
molecule generics
Partnered, not Crossject own development
* USA and 5 major EU markets. Source: Datamonitor published on 23 February 2011
47. page 47
2.3 SuperGenerics
Premium prices up to x50 compared to basic syringe
or vial presentation
Selection
o rheumatoid arthritis (methotrexate):
o acute migraine (triptan) :
o Anaphylactic shock (epinephrine) :
And many other potential drugs: LMWH, Type 2
diabetes, Fertility, Erectile Dysfunction, Acute Pain
Relief, Inflammatory Burden, Psychiatry, Local
Analgesia, B12 vitamin, Testosterone, etc.
SuperGeneric product : the added-value comes from the device
- safe, convenient, no phobia, patented, differentiated
48. page 48
MARKET DRIVERS
Obvious medical needs
Needle-free systems will be reference for emergency needs:
anaphylaxis, inflammatory burden, acute pain ...
Pharmacoeconomy trends
Self injection at home for chronic disease (reduces disease
cost management for health care agencies)
49. page 49
Unmet needs Self Administration (1)
“Poor adherence to long-term treatment of chronic
diseases is a worldwide problem”
“Adherence to long-term therapy for chronic illnesses in developed
countries averages 50%”.
“Better adherence can produce better health outcomes and limit health
care expenditures”
Source World Health Organization
“NHS reforms have for the first time given real incentives
for NHS hospitals to reduce the length of time their
patients spend in hospital”.
“Reducing hospital admissions and caring for people more appropriately
outside of hospital is key”.
“When hospital care is needed, the NHS needs to minimise that time,
whilst not undermining patient safety or quality of care”.
50. page 50
Unmet needs Self Administration (2)
“Outpatient pharmacotherapy of chronic
diseases relies on drug self
administration at home”
The EIP Strategic Implementation Plan
identifies 14 priorities
N°1: identifying innovative solutions to ensure
better adherence to treatment
N°4; promoting integrated care models for chronic
diseases, including the use of remote monitoring
51. page 51
Contact for partnering
Tim MULLER, Chief Business Officer & Executive Board Member
emails : tm@scientex.eu or t.muller@crossject.com
Mobile : +33 (0) 645 523 540 (main) or +33 (0) 602 510 791 (secondary) -
Office phone : +33 (0)977 1956 79