Si duhet ta shikojme/studjojme rrealisht nje statistike ne fushen e transportitAlbania Energy Association
Elementi baze ne ndertimin e nje projekti transporti eshte analiza e kerkes-ofert per transport. Kjo shpesh vjen nga verejtjet, ose pamjat direkte ne terren, nga menyra se si sillen ose levizin njerezit apo mallrat. Ashtu si dhe ne vleresimet e tjera per terrenin, edhe ketu kemi nje logjike te perafert, e dalluar, si me poshte:
1) Niveli i sherbimit mbi infrastrukturen ekzistuese, kjo ka te beje me grumbullimin e te dhenave rreale, statistikore mbi infrastrukturen ekzistuese, si dhe kerkesen per transport, apo sherbimet e transportit, si dhe pyetjet ose ceshtjet te tjera, qe lindin ne kete bashkeveprim kerkese-oferte
2) Modelimi simulues i nje sistemi, ne te cilen jane parashikuar vleresimet tekniko-ekonomike, nder te tjerat dhe demografike, social-ekonomike, urbanistike, etj. Si kane ndikuar ose vijuar keto elemente, gjate shfrytezimit ?
3) Treguesit Financiare, si kane qene dhe si eshte bilanci financiare i ketij sherbimi, dinamika e tij, si dhe ndonje alternative e tij, ne pasqyren e kostove e te rendimentit
Medgenics (NYSE AMEX: MDGN) - Nomura Code Securities Limited, London Medgenics, Inc. (NYSE AMEX: MDGN; Stock Twits: $MDGN) is developing and commercializing Biopump, a proprietary tissue-based platform technology for the sustained production and delivery of therapeutic proteins using the patient's own skin biopsy for the treatment of a range of chronic diseases including anemia, hepatitis C and hemophilia. Medgenics believes this approach has multiple benefits compared with current treatments, which include regular and costly injections of therapeutic proteins.
Si duhet ta shikojme/studjojme rrealisht nje statistike ne fushen e transportitAlbania Energy Association
Elementi baze ne ndertimin e nje projekti transporti eshte analiza e kerkes-ofert per transport. Kjo shpesh vjen nga verejtjet, ose pamjat direkte ne terren, nga menyra se si sillen ose levizin njerezit apo mallrat. Ashtu si dhe ne vleresimet e tjera per terrenin, edhe ketu kemi nje logjike te perafert, e dalluar, si me poshte:
1) Niveli i sherbimit mbi infrastrukturen ekzistuese, kjo ka te beje me grumbullimin e te dhenave rreale, statistikore mbi infrastrukturen ekzistuese, si dhe kerkesen per transport, apo sherbimet e transportit, si dhe pyetjet ose ceshtjet te tjera, qe lindin ne kete bashkeveprim kerkese-oferte
2) Modelimi simulues i nje sistemi, ne te cilen jane parashikuar vleresimet tekniko-ekonomike, nder te tjerat dhe demografike, social-ekonomike, urbanistike, etj. Si kane ndikuar ose vijuar keto elemente, gjate shfrytezimit ?
3) Treguesit Financiare, si kane qene dhe si eshte bilanci financiare i ketij sherbimi, dinamika e tij, si dhe ndonje alternative e tij, ne pasqyren e kostove e te rendimentit
Medgenics (NYSE AMEX: MDGN) - Nomura Code Securities Limited, London Medgenics, Inc. (NYSE AMEX: MDGN; Stock Twits: $MDGN) is developing and commercializing Biopump, a proprietary tissue-based platform technology for the sustained production and delivery of therapeutic proteins using the patient's own skin biopsy for the treatment of a range of chronic diseases including anemia, hepatitis C and hemophilia. Medgenics believes this approach has multiple benefits compared with current treatments, which include regular and costly injections of therapeutic proteins.
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.
Maxim Group research coverage on Medgenics (NYSE AMEX: MDGN), which is developing and commercializing Biopump, a proprietary tissue-based platform technology for the sustained production and delivery of therapeutic proteins using the patient's own skin biopsy for the treatment of a range of chronic diseases including anemia, hepatitis C and hemophilia. Medgenics believes this approach has multiple benefits compared with current treatments, which include regular and costly injections of therapeutic proteins.
Caprock: "We are initiating coverage on Pegasi Energy Resources Corporation with a
STRONG BUY rating and with a 12-month price target of $1.50. We believe PGSI’s shares offer investors a unique and favorable risk/reward profile."
María montessori. la formacion del hombreAna Otalora
El niño tiene el impulso natural de crecer y perfeccionarse por sí mismo. Por lo tanto, educar es guiar el desarrollo de la vida del hombre y del medio ambiente que lo rodea.
Este es el último libro que publicó Maria Montessori
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
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
LEARN MORE
https://www.disposablebiomanufacturingonline.com/?&shownewswindow=1&utm_source=PharmaIQ&utm_medium=SMO&mac=PMIQ_Slideshare&utm_campaign=Slideshare&utm_term=pdf
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.
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.
Maxim Group research coverage on Medgenics (NYSE AMEX: MDGN), which is developing and commercializing Biopump, a proprietary tissue-based platform technology for the sustained production and delivery of therapeutic proteins using the patient's own skin biopsy for the treatment of a range of chronic diseases including anemia, hepatitis C and hemophilia. Medgenics believes this approach has multiple benefits compared with current treatments, which include regular and costly injections of therapeutic proteins.
Caprock: "We are initiating coverage on Pegasi Energy Resources Corporation with a
STRONG BUY rating and with a 12-month price target of $1.50. We believe PGSI’s shares offer investors a unique and favorable risk/reward profile."
María montessori. la formacion del hombreAna Otalora
El niño tiene el impulso natural de crecer y perfeccionarse por sí mismo. Por lo tanto, educar es guiar el desarrollo de la vida del hombre y del medio ambiente que lo rodea.
Este es el último libro que publicó Maria Montessori
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
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
LEARN MORE
https://www.disposablebiomanufacturingonline.com/?&shownewswindow=1&utm_source=PharmaIQ&utm_medium=SMO&mac=PMIQ_Slideshare&utm_campaign=Slideshare&utm_term=pdf
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.
How Patent and Regulatory Exclusivity can Protect Your Medical Device BusinessMichael Weickert, Ph.D
Medical Device patents are the principal asset around which business transactions are structured. They can help establish a monopoly around the invention or product. Patents should be structured to protect the Business; solving the problem, not just the invention. Regulatory barriers can also protect the business by extending the duration a product dominates a market. Some Combination products (drug plus device, like EpiPen or asthma inhalers) may have access to several important Regulatory exclusivity programs like Orphan, Clinical Investigation exclusivity and QDIP. The goal is to have Regulatory and Patents strategies that work together to strengthen your business by protecting your innovative products from competitors.
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
TransPacific Energy, Inc., a U.S.-based company that
designs and sells energy systems which maximize heat
recovery and convert waste heat into electrical energy.
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.
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
Basavarajeeyam is an important text for ayurvedic physician belonging to andhra pradehs. It is a popular compendium in various parts of our country as well as in andhra pradesh. The content of the text was presented in sanskrit and telugu language (Bilingual). One of the most famous book in ayurvedic pharmaceutics and therapeutics. This book contains 25 chapters called as prakaranas. Many rasaoushadis were explained, pioneer of dhatu druti, nadi pareeksha, mutra pareeksha etc. Belongs to the period of 15-16 century. New diseases like upadamsha, phiranga rogas are explained.
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
The Gram stain is a fundamental technique in microbiology used to classify bacteria based on their cell wall structure. It provides a quick and simple method to distinguish between Gram-positive and Gram-negative bacteria, which have different susceptibilities to antibiotics
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
CDSCO and Phamacovigilance {Regulatory body in India}NEHA GUPTA
The Central Drugs Standard Control Organization (CDSCO) is India's national regulatory body for pharmaceuticals and medical devices. Operating under the Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India, the CDSCO is responsible for approving new drugs, conducting clinical trials, setting standards for drugs, controlling the quality of imported drugs, and coordinating the activities of State Drug Control Organizations by providing expert advice.
Pharmacovigilance, on the other hand, is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. The primary aim of pharmacovigilance is to ensure the safety and efficacy of medicines, thereby protecting public health.
In India, pharmacovigilance activities are monitored by the Pharmacovigilance Programme of India (PvPI), which works closely with CDSCO to collect, analyze, and act upon data regarding adverse drug reactions (ADRs). Together, they play a critical role in ensuring that the benefits of drugs outweigh their risks, maintaining high standards of patient safety, and promoting the rational use of medicines.
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 release and our SEC filings for more information regarding the use of forward looking statements. 03/10/11
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8. Developing a Full Proprietary Portfolio Unifill ® Ready-to-Fill syringes (glass barrel filled by pharma) Commercial release 2011 Development Pipeline Development Pipeline Development Pipeline Approved and launched Development Pipeline Staked needle (Subcutaneous) Attachable needle (IM) 3, 5mL - used with standard luer needles Staked needle (Insulin / TB) Project Taipan Project Liger Unifill syringe Unifill Select Unitract 1mL Unitract Clinical Confidential Projects Unitract ® Clinical syringes (for use with vials) 03/10/11
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12. Potential Drug Candidates for Unifill Syringe 83 approved and pipeline drugs from 19 pharmaceutical companies across more than 20 therapeutic classes now available or potentially suitable for use in a prefilled syringe designated for subcutaneous injections 03/10/11
Investing in Unilife offers a broad investment in healthcare, it is not just a syringe story We are at the forefront of the convergence between therapeutic drugs and innovative delivery devices We are in the unique position whereby we can help pharmaceutical companies protect billions of dollars of revenue, and at the same time: Protect healthcare workers, Improve patient care, Reduce healthcare costs, Enhance the brand differentiation and product lifecycles of drugs in competitive therapeutic markets and…. drive commensurate revenue & profits for shareholders. Sanofi-aventis - the world’s largest purchaser of prefilled syringes - approached us in 2003 after a global review of all safety syringe technologies. They have since provided almost $40m to help develop the Unifill ready to fill syringe, and to have the exclusive right to negotiate its purchase within two main drug classes until 2014. We are now at various stages of discussions with many other pharmaceutical leaders We are not just a one product company. Our first product line is already FDA-approved, and we have a very strong and exciting pipeline We have the operational capabilities to meet projected pharmaceutical demand for our products, and We have a have a highly qualified Board and management team with an average of 23 years experience
Before Unilife can be a preferred and trusted supplier of primary drug containers to some of the world’s largest pharmaceutical companies, we must first demonstrate we have the industrial resources and operational capabilities to meet projected demand. Like a gold mine... The gold is worth nothing until you have the capacity to dig it out of the ground and supply it to the customer. We must demonstrate that we have the production facilities, assembly systems and quality assurance systems in place to earn the responsibility to have our devices contain the drugs of our pharmaceutical partners. The last few years have been focused on building these operational capabilities to meet projected demand. We are now reaching a point where we will be ready to supply our devices to pharmaceutical customers. Unilife has earned its reputation for meeting its key business milestones Best example is the development of our new $31 million state-of-the-art facility in York, PA - Ground turning of the site began on December 8, 2009. We moved into the completed facility on December 17, 2010. Fully on-schedule and on budget Designed by leading pharmaceutical architects to meet stringent pharmaceutical requirements for primary drug containers The facility includes eleven 8 clean rooms, a Water for Injection system, laboratories, product development centers and a fully segregated warehouse. Today, Unilife employs approximately 150 staff at the facility. Facility has been designed to accommodate our near and long-term growth requirements Stage one has the facility to manufacture up to 400 million units per year A 100,000sqf Stage Two extension is already pre-approved from local authorities, and would increase capacity to up to 1 billion units per year
More than 1.3 million lives lost each year as a result of unsafe injection practices Two key problems The reuse and sharing of syringes (mostly in developing countries or by injecting drug users); and Needlestick injuries to healthcare workers – 600,000 injuries in US each year US was the first country to introduce legislation in 2000 mandating the mandatory use of safety syringes in all healthcare facilities Legislation being strongly enforced by OSHA However as this graph from Massachusetts shows - rates of reported needlestick injuries caused by syringes have not declined since 2002 Only difference is that safety syringes are now causing the majority of all reported needlestick injuries. This is because current safety products are either being used incorrectly by healthcare workers, or not at all. OSHA, the FDA and many healthcare workers have expressed a preference for the use of products with passive and integrated safety features. Rarely however are such products available. The market continues to await the arrival of products of choice that can meet the safety and functionality needs of healthcare workers and patients. Europe and other international regions are now following the US towards the adoption of similar laws
Prefilled market is the most profitable, least congested and fastest growing market (removed “s”) for syringes. Made of glass - materials in fluid path must be biocompatible with drug for a two year shelf life. More than 2.4 billion prefilled syringes used a year, with the market valued at $1.5 billion. Convenient, accurate, fast and easy to use - Popular with healthcare workers and patients. There are more than 20 pharmaceutical companies with drugs in a prefilled syringe format More than 50 drugs are now available in a prefilled syringe format These are being marketed across 12 highly competitive therapeutic drug classes. More than 100 drugs in the pipeline expected to be launched in prefilled syringe format. However there is no prefilled syringe with safety features integrated within the glass barrel. To comply with needlestick prevention laws, pharmaceutical companies are required to attach ancillary safety products onto a regular prefilled syringe. This has several drawbacks Cost of attaching the safety product onto the prefilled syringe – risk of product loss Increases packaging, shipping and storage volumes by up to 70% Bulky size for operator handling and disposal A small number of ancillary safety devices on the market. See photo - All look similar, and share similar steps of use. Current ancillary safety devices are commodity items – they offer little opportunity for differentiation within these competitive therapeutic classes. Unifill syringe on the far right does not just provide high level of safety – it is different... By partnering with Unilife, pharmaceutical companies can generate powerful brand differentiation and optimize the lifecycles of their drug products.
Unilife has a market-driven approach to product development. All of our proprietary products share a unique technology platform that allows operators to control the speed of automatic needle retraction directly from the body into the barrel. The risk of infection from needlestick injuries or splatter is virtually eliminated. The needle is then locked inside the barrel to prevent reuse or re-exposure. All these safety features are fully integrated within the barrel of the syringe.
Our goal is to develop the first full range of prefilled and clinical use syringes that share a common technological platform of passively activated and fully integrated safety features. Our Unitract range of syringes are designed for use with drugs that are supplied in a vial or ampoule form. The range includes the Unitract 1mL safety syringes that are already approved for use and currently being sold across the U.S. Our Unifill range of prefilled syringes are designed for supply directly to pharmaceutical companies for filling an injectable drug or vaccine. All of Unilife’s prefilled and clinical use safety syringes will be used and activated in a similar way. We believe that by standardizing injection procedures with one technology platform, we can help to set a new standard for the safe, simple and routine injection of therapeutic drugs. In addition, we are also working on other confidential pipeline projects that will complement our current proprietary portfolio, and help to further expand the scope of our relationships with pharmaceutical companies.
The Unifill ready-to-fill (prefilled) syringe (“s” removed) is our lead product and our most significant near term commercial opportunity. It is designed to be integrated into (removed “the”) current industrial systems used by pharmaceutical customers to fill an equivalent standard prefilled syringe with an injectable drug or vaccine. World’s first and only known prefilled syringe with automatic safety features that are fully integrated within the glass barrel. Similar in size to an equivalent prefilled syringe. And it is one-third smaller than prefilled syringes attached with an ancillary safety product. As a primary container, all components within the fluid path utilize materials that are USP compliant, and sourced from established pharmaceutical suppliers. The handling and administration of the Unifill syringe is the same as per typical subcutaneous injections undertaken with an equivalent prefilled syringe. Upon the delivery of a full dose by the operator, a passive retraction mechanism is activated. Operators can then be in full control of the speed at which the needle withdraws directly from the body into the barrel of the syringe. This virtually eliminates the risk of needlestick injury or aerosolization (splatter). The plunger is then automatically locked in place to prevent re-exposure, and facilitate compact, convenient disposal. Unifill is ideally positioned to help pharmaceutical customers minimize industrial, packaging and storage costs; extend product lifecycles and enhance brand differentiation within competitive therapeutic markets.
Late last year, Unilife conducted independent evaluations of the Unifill syringe with 66 experienced healthcare workers in San Francisco, Philadelphia and Chicago. These healthcare workers use prefilled syringes with ancillary safety products on a daily basis. We asked them to compare the Unifill syringe against two leading prefilled syringe products with clip-on safety features that are used in the market today. Suffice to say, we got the WOW factor from them. Our product was strongly preferred across all five surveyed areas of functionality, safety, ease-of-use, performance and appearance. Of those 66 healthcare workers, 100% preferred the Unifill syringe against the largest selling prefilled ancillary safety device in the U.S. And more than 80% preferred the Unifill syringe against another less used prefilled safety product. Most of those who preferred the other product liked its comparably larger size because they had large hands. However 50% of those who chose the Unifill syringe liked it because of its relatively small size for easy handling, compact disposal and ability to minimize patient discomfort. It just goes to show you can’t please everyone. Additional market-based evaluations of the Unifill syringe by both Unilife and pharmaceutical companies are currently underway. To-date, the results have been equally favorable.
Unifill syringes offer pharmaceutical companies with truly Unique Selling Proposition. It is not a commodity product. You can only get them from one source…us. This is very important when you consider that the strength of our IP position, with patents scheduled in most countries, including the United States, to expire between 2026 and 2030. They thus offer far more than optimal healthcare worker protection and enhanced patient care. The commercial opportunities that can be generated through the effective use of innovative devices have led to the start of a new ‘arms race’ amongst pharmaceutical companies. Today, the convergence of therapeutic drugs and delivery devices into unique combination products represents one of the fastest-growing and highly sought-after prizes. Conversion of prefilled drugs to our Unifill products, which can be controlled within a particular therapeutic class and thus restricted to generic or branded competitors, can provide a unique opportunity to enhance, and even extend, the lifecycle of the drug product. There are more than seven prefilled drugs that will expire over the six years that have combined annual revenues of more than $20 billion. The upgrading of drugs approaching patent expiration to the Unifill syringe can create especially compelling lifecycle opportunities. White papers developed for interested pharmaceutical companies with prefilled drugs approaching patent expiration indicate that their conversion to Unifill could help protect or regain revenues of around 20% that would otherwise be lost to generics. As a unique primary drug container, it may even help improve claims for the drug device combination product, thus obstructing the entry of competitor products by reducing the likelihood of substitution.
In total, we are tracking more than 80 marketed and pipeline drugs and vaccines from more than 20 pharmaceutical companies that are deemed suitable for potential use with the Unifill™ syringe. This includes not only drugs that are currently indicated for use across more than a dozen broad therapeutic classes, but a number of new areas. This includes a number of blockbuster drugs approaching patent expiration or under threat from generic or biosimilar competition.
As I said earlier, our primary pharmaceutical customer sanofi-aventis has committed approximately $40 million in exclusivity fees and industrialization payments for the Unifill™ syringe. We have a great relationship with sanofi-aventis and are fortunate and proud to have them as a partner. Earlier this year, we agreed to a list of therapeutic drug classes where they have the exclusive right to negotiate the right to purchase the product. They have secured the full therapeutic drug classes of antithrombotic agents and vaccines, where they are market leaders, until June 2014. They have also secured an additional four sub-classes where prefilled syringes are not currently used by any pharmaceutical company.
We have retained the right to negotiate with other pharmaceutical companies seeking to utilize the Unifill™ syringe across more than 10 therapeutic classes that fall outside of those areas exclusively retained by sanofi-aventis This means we are strongly positioned to maximize the commercial opportunity of this device, which is poised to significantly disrupt the pharmaceutical market for prefilled syringes. Over the past year, we have held senior-level discussions with 20 pharmaceutical companies – most of which are already active in the prefilled syringe market. Discussions with many of these interested parties are now accelerating. As commercial production and supply of the Unifill syringe begins, we also expect to start formalizing a number of pharmaceutical discussions that are now underway. These agreements may take any number of forms, including a development or collaboration agreements, or industrialization and exclusivity agreements for pipeline products similar to what we have done with sanofi-aventis. Whilst supply agreements for the Unifill syringe could come at any time, I believe that most are likely to be secured only after commercial sales have commenced.
Our supply chain strategy seeks to minimize risk, maximize customer choice and complement standard pharmaceutical handling systems for prefilled syringes. We recognize that many of our pharmaceutical customers may have specific material preferences for the Unifill syringe. We have thus engineered the product so that it can accommodate a wide variety of materials that are already used with prefilled syringes and vials. Pharmaceutical customers will ideally be able specify a preferred source or component materials. Indeed, it is our focus that we will have a dual to triple source strategy for the supply of all of our components and essential services wherever possible. More than a dozen established suppliers of pharmaceutical materials have already been qualified by Unilife. These suppliers cover all of the components used in the production of the Unifill syringe. We expect that additional suppliers will be added to our list as production ramps up, and we consolidate relationships with pharmaceutical companies. The first automated assembly line that has been developed for us will have the capacity to manufacture up to 60 million units of the Unifill syringe per year. To help de-risk our production ramp strategy, additional high-volume assembly lines to be added moving forward will essentially be larger scale variants of this initial line. The expected annual capacity of these future lines will be 150 million units per year. Preparations for the Factory Acceptance Testing and qualification of our first Mikron line are currently taking place. We expect initial production to commence out of our York facility towards the end of this month. We are thus confident that the initial commercial supply and sales of the Unifill syringe will commence towards the middle of the 2011 calendar year once internal qualification and validation tests have been completed.
In summary, we now have all key elements of our business in place and ready for execution. Our focus is on fast-growing, low congestion and profitable sectors of pharmaceutical and healthcare markets being driven by legislation towards the mandatory use. These markets continue to seek products of choice because their injection safety needs are not being adequately addressed at present. We have developed a full portfolio of syringes with best-in-class safety features that are custom-designed to meet the specific safety and functionality needs of each target market. In particular, the Unifill prefilled syringe is (remove “ have”) the first and only known prefilled syringe with safety integrated inside glass barrel. This non-commodity product can offer help optimize drug lifecycles and deliver powerful brand differentiation in competitive therapeutic markets. To validate its commercial potential, we have a $40 million partnership with sanofi-aventis – who are the world’s largest consumer of prefilled syringes. We are also in active discussions with many other pharmaceutical companies , many of which are now beginning to accelerate rapidly. So that we can be a strong and reliable supplier to pharmaceutical companies, we have built upfront the operational capabilities to meet projected demand. In particular, our new state-of-the-art production facility in Pennsylvania is designed to meet the stringent pharmaceutical standards for primary drug containers. To back this up, we have built a highly experienced team with deep industry expertise. Given our strong commercial position, Unilife has created a number of significant opportunities to generate sustainable revenue growth with attractive margins and minimal go-to-market costs. We look forward to delivering on our key upcoming milestones including the initial production and sale of the Unifill syringe, as well as the signing of agreements with other pharmaceutical industry leaders….Questions