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.
Hi
I am Rahul Ranjan Rai, perusing MBA from Jaypee Business School and I have completed this Project under the supervision of Pro. Evan Costle (france). I hope this presentation will help you to understand the emerging concepts in Generic Industry
Thank you
Regards
Rahul
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.
Hi
I am Rahul Ranjan Rai, perusing MBA from Jaypee Business School and I have completed this Project under the supervision of Pro. Evan Costle (france). I hope this presentation will help you to understand the emerging concepts in Generic Industry
Thank you
Regards
Rahul
Originators and Princeps: How to face Biosimilars and Generics Joseph Pategou
Concerning the levers a originators producer can put in place to face the biosimilars competition and maintain his position, benchmarking on biosimilars, generics (13 companies from 2000 to 2015) and the results of our interview allow us to observe 10 levers:
Price Prescription
Patent Market saturation
Legal action New market
Cooperation Environmental strategy
Product Brand strategy
Presentation on marketing of medical devices in Europe (24.01.2012)Christian Dekoninck
Presentation on the legal implications & compliance in the sales & marketing of medical devices in Europe given at the 3rd annual Medical Device Reimbursement Conference in Brussels (Q1 Productions, January 24th, 2012)
BIOSIMILARS - Regulation and Market Trends Joseph Pategou
Nowadays patients and physicians can have access to three types of drugs: a originators, a generic or a biosimilar.
Those drugs have different regulatory systems that apply in Europe; moreover the biosimilars regulation is evolving and may change. Regulation is an important factor that can give more confidence to patients and healthcare professionals. As a consequence, biosimilaires will grow.
Comparison of medical device reimbursement policy between Korea and JapanSung Yoon Bae
Comparison of medical device reimbursement policy between Korea and Japan, and future challenges for sustainable innovation, presented at the 4th AMCHAM Health Care Innovation Seminar, which is held in Seoul, Korea, on June 28, 2013.
Speaker: Bae, Sung Yoon (Professor, Inje University)
Davenport Chiropractor, Dr. Clay, has prepared a presentation on proper shoveling posture and form. This presentation includes core stability exercises to help prevent injury during snow removal.
Originators and Princeps: How to face Biosimilars and Generics Joseph Pategou
Concerning the levers a originators producer can put in place to face the biosimilars competition and maintain his position, benchmarking on biosimilars, generics (13 companies from 2000 to 2015) and the results of our interview allow us to observe 10 levers:
Price Prescription
Patent Market saturation
Legal action New market
Cooperation Environmental strategy
Product Brand strategy
Presentation on marketing of medical devices in Europe (24.01.2012)Christian Dekoninck
Presentation on the legal implications & compliance in the sales & marketing of medical devices in Europe given at the 3rd annual Medical Device Reimbursement Conference in Brussels (Q1 Productions, January 24th, 2012)
BIOSIMILARS - Regulation and Market Trends Joseph Pategou
Nowadays patients and physicians can have access to three types of drugs: a originators, a generic or a biosimilar.
Those drugs have different regulatory systems that apply in Europe; moreover the biosimilars regulation is evolving and may change. Regulation is an important factor that can give more confidence to patients and healthcare professionals. As a consequence, biosimilaires will grow.
Comparison of medical device reimbursement policy between Korea and JapanSung Yoon Bae
Comparison of medical device reimbursement policy between Korea and Japan, and future challenges for sustainable innovation, presented at the 4th AMCHAM Health Care Innovation Seminar, which is held in Seoul, Korea, on June 28, 2013.
Speaker: Bae, Sung Yoon (Professor, Inje University)
Davenport Chiropractor, Dr. Clay, has prepared a presentation on proper shoveling posture and form. This presentation includes core stability exercises to help prevent injury during snow removal.
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Updated overview of all things Burufly, Indonesia's first Social Travel Site that focuses on travelers sharing their holiday & everyday moments. Burufly - the Trip you take before Traveling
Jan de Boer, Dura Vermeer. Spreker bij ‘Energietransitie: kansen voor bedrijfsleven en instellingen met Amsterdam Smart City’, 26-10-2011, georganiseerd door KennisKring Amsterdam.
This brochure explains Premier’s services, which encompass 3 core practice areas: Business Performance and Technology; Governance, Risk and Compliance; and Finance and Accounting.
Pictures from ECR 2011 taken by the Block Imaging team. Block exhibited this year to announce our new venture in Europe... http://info.blockimaging.com/news/press-releases/bid/41729/Block-Imaging-Announces-New-Venture-in-Europe
BioNeutral Group (OTCBB: BONU) is a specialty technology-based life science company which has developed a technology platform that neutralizes harmful environmental contaminants, toxins and dangerous micro-organisms including bacteria, viruses, mold, fungi and spores. BioNeutral's products, Ygiene™ and Ogiene™, kill germs and clean surfaces with a dramatic increase in speed and power over their rivals in the marketplace.
Single Use & Disposable Technology in BiomanufacturingPharma IQ
Single Use & Disposable Technology in Biomanufacturing
Pharma IQ Sector Report & Resources June 2011
Downloadable guide to latest developments in this field
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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/
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.
Global Patient Monitoring Equipment Market Size, Insights and Strategies, 201...Hexa Reports
The patient monitoring platform is modular, integrating various components. Modular systems are developed in the context of consideration of probable specifications for the interaction of system components.
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.
Medistein is a new startup for portable medical devices. Our vision is to improve the health outcomes of mobile and home-based patients. We propose to achieve this vision by building a world-‐class consumer medical devices company that develops portable, user-friendly and state of the art healthcare products.
Caprock: "We are initiating coverage on Pegasi Energy Resources Corporation with a
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FORM 8-K. Filed 05/07/12 for the Period Ending 05/07/12. A PowerPoint presentation that Ventrus Biosciences, Inc. will present at the 37th Annual Deutsche Bank Health Care Conference in Boston, MA on Monday, May 7, 2012.
Sections include: Company Overview --- Focus on Fibromyalgia and Post-Traumatic Stress Disorder. Large Markets with Unmet Need --- Novel Formulation Technology Applied to Known Ingredients = Better Drugs --- Robust Product Pipeline with Nearterm Milestones, and more.
Early this morning, SunSi announced it is acquiring 51% of
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APDN sells patented DNA security solutions to protect products, brands and intellectual property from counterfeiting and diversion. SigNature DNA is a botanical mark used to authenticate products in a unique manner that essentially cannot be copied. Our mark provides a forensic chain of evidence that can be used to prosecute perpetrators. To learn more, go to www.adnas.com where APDN routinely posts all press releases.
2. Cautionary Note Regarding Forward-Looking Statements
This presentation contains forward looking statements under the safe
harbor provisions of the US securities laws. These forward-looking
statements are based on management’s beliefs and assumptions and on
information currently available to our management.
Our management believes that these forward-looking statements are
reasonable as and when made. However you should not place undue
reliance on any such forward looking statements as these are subject to
risks and uncertainties. Please refer to our press releases and our SEC
filings for more information regarding the use of forward looking
statements.
3. About Unilife
Emerging Leader for Advanced Drug Delivery Systems
Redefining $10 B+ injectable drug delivery device market
Innovative, differentiated devices that can enable, enhance and extend
commercial lifecycles for brand-name, generic or biosimilar drugs
Targeting fastest-growing, most profitable market sectors
Diversified device portfolio driven by unmet customer needs
Backed by pharmaceutical partners with long-term, high-value contracts
Unifill: World’s only prefilled syringes with integrated safety
Sanofi paid $40MM for access in two classes, sales underway
4. About Unilife
Development and Commercial Supply Partner
State-of-the-art
facility in York,
PA
Operational capabilities and expertise in place to respond to
pharmaceutical customers with speed, agility and reliability
5. About Unilife
World-Class High-Performing Team
Name Title Previous Employment
Alan Shortall CEO, Executive Director Founder of Unilife
Dr. Ramin Mojdeh COO BD (Head of Pharma Systems & Product Development)
Rich Wieland CFO Cytochroma, Advanced Life Sci.
Dr. Jack Kelley VP, Strategic Marketing BD, Medtronic
Mike Ratigan VP, Commercial Development BD, Stryker
Dr. Masoud Samandi VP, R&D BD
Ian Hanson Director, Advanced Delivery Medtronic Diabetes
Mark Hassett VP, Sales Safety Syringes Inc.
Dennis Pyers Financial Controller KPMG
Chris Naftzger General Counsel Chesapeake Corporation, Koch Industries
Managers of Advanced Drug Delivery Systems include: Dr. Ashley Palmer (BD), Dr. Jyoti Gupta (BD),
Dr. Gautam Shetty (BD) and Dr. Molly Miller (BD)
6. Injectable Drug Delivery Device Market
Targeting the fastest-growing, highest value sectors
Global Injectable Drug Delivery
Prefilled syringes Device Market ($U.SM) 2010-2015
2.5 B prefilled units sold in 2010
A $15.8 B
$4.8 B in 2015 (13.5% CAGR) market by 2015
Handful of component suppliers
Self-injection systems
Auto-Injectors / Auto-Infusors
$1.2 B in 2015 (14.5% CAGR)
Fragmented market, no leader
Source: MarketsandMarkets. 2010.
Global Injectable Drug Device Market
7. Complex Drugs, Specific Device Needs
Transition of clinical pipelines to large-molecule drugs
Large-molecule drug market
More than 1,000
(ie. biologics) $180 B in 2015 large-molecule drugs
such as biologics in
20% of total market value (2015) development pipeline
Almost all require injection
Liquid stable or lyophilized form
Specific molecular, formulation
and patient needs for delivery
High-value drugs (hundreds or
thousands of dollars a dose) Small molecule Biologics
8. Generating Strong Brand Differentiation
Market Demand for Innovative, Differentiated Devices
Innovative devices can deliver strong brand differentiation
Growing competition in therapeutic classes (novel, generic, biosimilar)
Potential to increase / protect market share for new or approved drugs
Patent Cliff - 30 biologics with $51 B sales to expire by
2015
Transition into superior devices can help to extend product lifecycles
Collaborations during clinical development can create unique
drug-device combination products
Unique device-related claims may obstruct generic or biosimilar entry
9. Patient Self-Administration
Self-Injection Market to Double in Size to $1.2B in 2015
Increasingly used to treat a range
of acute and chronic diseases
Reduced burden on hospitals
Reduced healthcare costs
Improves patient quality of life
Superior devices can help to:
Improve therapy compliance
Increased opportunities for
prescription and drug reimbursement
10. Mandatory Use of Safety Syringes
Risk of Harm Remains Despite Strong Enforcement
Needlestick Injuries Caused by Syringes Among Hospital Workers in Massachusetts
Sharps Injuries among Hospital Workers in Massachusetts 2002 - 2009. Massachusetts Sharps Injury Surveillance System
11. The Unifill Syringe
The Leading Edge of our Portfolio
Only prefilled with integrated safety
Automatic, user-controlled retraction
USP compliant materials in fluid path
Integration into fill-finish systems
Similar size to standard prefilled syringe
60-70% less packaging, transport and
storage costs to clipon safety products
Intuitive use by either healthcare
workers or patients
12. The Unifill Syringe
Received $40MM in payments from Sanofi since 2008
Sanofi has exclusive right to
negotiate access in two drug
classes until mid-2014
Initial production, sales underway
Initial annual capacity 60MM units
Additional lines 150MM capacity
Initial sales for drug stability test
Accelerating discussions with
multiple interested parties
13. Customer-Driven Technology Pipeline
Most Complete Injectable Device Portfolio on the Market
Rapid diversification of portfolio
enabled by success with Unifill
Primary drug containers with
integrated safety features
Patient self-injection
Target organ delivery
Driven by unmet market needs
Liquid stable or lyophilized drugs
Differentiated delivery systems
Can be customized to drug needs
14. Unifill Select
Only prefilled with attachable needles and integrated safety
Suitable for filling with either the liquid stable or a diluent for
use with lyophilized drugs supplied in a vial
Attachable needles up to 1 ½” in length
15. Unifill EZMix
Only prefilled reconstitution syringe with integrated safety
Dual or multiple drug containers in single glass barrel
Leverages materials and proven technology of Unifill® syringe
Addresses unmet patient safety needs
Half the steps of use as conventional reconstitution systems
(left) and fewer steps than prefilled syringe with diluent (right)
Traditional Prefilled
Reconstitution Syringe and
Vial Adapter
16. Patient Self-Injection Systems
Unifill Auto-Injector
Unifill syringe gives compact size relative to conventional auto-injectors
True end-of-dose indicator (audible, tactile click, plus visual window)
Patient never sees the needle during any stage of use
17. Patient Self-Injection Systems
AutoInfusor™
Only infusion pump system for drugs 5mL or larger in volume
Single-use, disposable system worn by patient.
Automatic drug infusion into subcutaneous tissue at push of button
Can be pre-set for infusion times from minutes to hours in duration
18. Novel Devices for Target Organ Delivery
Specialized high-value devices delivering drug to target organ
Target organs may include brain, ear and eye
Pharmaceutical collaborations to develop unique drug-device
combination products
Device developed in parallel the pipeline drug
Can help to enable the commercialization of a pipeline drug
First organ delivery device scheduled to enter into clinical
trials with pharmaceutical partner later this year
19. Upcoming Milestones
Unifill Syringe
Sales to current and additional pharmaceutical customers
Placement of Unifill syringe onto drug stability studies
Expanded syringe portfolio
Clinical development agreements (EZMix, Select, Auto-Injector)
Commencement of initial sales
Other Advanced Drug Delivery Systems
Clinical development agreements (ie. organ delivery devices)
Commencement of sales
Continued expansion of proprietary portfolio
20. Summary
Advanced operational capabilities and expertise now in place
Unifill – world’s only prefilled syringes with integrated safety
$40MM in payments from Sanofi, initial sales underway
Diversified product portfolio in direct response to unmet needs
Discussions with multiple customers across multiple areas
Attractive model with long-term contracts and strong margins
Redefining fast-growing $10 billion injectable device market
Targeting fastest-growing, highest-value device sectors
Becoming intertwined with global injectable drug market