SPECIAL REPORT DECEMBER 2011 DRUG DELIVERY REVIEW AND OUTLOOK INDUSTRY GROWTH TO CONTINUE THROUGH NEW TECHNOLOGIES The worldwide drug-delivery arena is growing each year as the increasing aging population is in need of improved methods of administration for products and therapies. Drug-delivery industry growth is being led by the United States as well as emerging markets. Oral forms remain the preferred method of drug-delivery administration. Gaining in popularity are parenteral, inhalation and implantable systems. Elements impacting the development of drug-delivery systems include reimbursement, environmental factors, and regulatory processes. Product developers are coming up with better ways to improve therapy performance and safety as patients become more involved in their treatments in an effort to cut down on costs. New electronic technologies for reusable systems and disposable devices are leading to improved sales of auto-injectors. Microneedle technology is on the rise so that medicine can be precisely delivered to areas in need of treatment. UBM CANON DATA PRODUCTS TABLE OF CONTENTS 828B Newtown-Yardley Road, Suite B Drug-Delivery Industry Overview . Page 3 Newtown, PA 18940 Drug-Delivery Company Overview . 8 United States Phone: +1 .215 .944 .9800 Drug-Delivery Prescription Products Fax: +1 .215 .867 .0053 Website: PharmaLive .com Awaiting Approval . 26 Steve Corrick Phase III . 29 VP and Executive Director UBM Canon Publishing Phase II/III . 36 steve .corrick@ubm .com Phase II . 37 Roger Burg Phase I/II . 46 VP, Operations Publications Division Phase I . 47 roger .burg@ubm .com +1 .310 .445 .4221 Preclinical Development . 50 Glenn Glasberg Companies . 52 Circulation and Marketing Director glenn .glasberg@ubm .com Drug-Delivery Medical Devices +1 .215 .944 .9810 Class I Devices – General Controls – 510(k) Exempt . 61 Sandra Baker Class II Devices – General Controls and Special Controls – 510(k) . 66 Data Products Manager sandra .baker@ubm .com Class III Devices – General Controls and Special Controls – 510(k) . 78 +1 .215 .944 .9836 Unclassified Devices – 510(k) . 79 Amanda Wells Assistant Marketing Manager Companies . 80 amanda .wells@ubm .com +1 .215 .944 .9840 Brandon Materazzi Marketing Assistant brandon .materazzi@ubm .com Review the most recent Special Reports at: www .PharmaLive .com/SpecialReports +1 .215 .944 .9809 Andrew Humphreys See these and other topics: Editor In Chief, Data Products andrew .humphreys@ubm .com POM Quarterly +1 .215 .944 .9812 Top 50 Specialty Companies Stefanie Fedder Global Contract Manufacturing Companies: Pharmaceutical and Biotechnology Manager, Data and Content stefanie .fedder@ubm .com Nutraceuticals and Vitamins Review and Outlook +1 .215 .944 .9807 Top 50 Pharmaceutical Companies and Their Pipelines John King Market Analyst/Editor john .king@ubm .com +1 .215 .944 .9820 eKnowledgeBase - searchable pipeline and business-information database for the world’s pharma & biotech companies . Request a trial at: www .PharmaLive .com/newEKB Silvia Arriola Data Specialist silvia .arriola@ubm .com +1 .215 .944 .9803 MDRWeb.com - searchable database of global medical device companies and Diane Strohm their products . Learn more at: www .MDRWeb .com - enter promo code SRTRIAL for Data Specialist diane .strohm@ubm .com free two-week trial access . +1 .215 .944 .9828 Andrew Ellison For more information on these products contact: Data Specialist andrew .ellison@ubm .com Sandra .Baker@ubm .com or call: +1-215-944-9836 +1 .215 .944 .9826 Stacey Miller Contributing editor EDITORIAL ADVISORS FOR SPECIAL REPOrtS Kim Stannard Jay Carter, SVP Director of Strategy Services, AbelsonTaylor Production assistant Sander Flaum, President, Flaum Partners Mark Havenhand, MBA, Ph .D ., Novartis Pharma AG, Global Head, UBM Ltd. Corporate Head Office Ludgate House Business Strategy & Planning Clinical Medical Services 245 Blackfriars Road Boaz Mendzelevski, VP of Cardiology & Chief Medical Officer, London, SE1 9UY, United Kingdom Medifacts International Phone: +44 (0) 20 7921 5000 Website: ubm .com Steven Michaelson, Managing Partner, RosettaWishbone Mike Myers, President, Palio UBM Canon Headquarters 11444 W . Olympic Blvd . David M. Oakley, R .Ph ., Ph .D ., Director of Technical Development, Los Angeles, CA 90064 AAIPharma United States Deborah Schnell, President, Sales and Strategic Planning, Phone: +1 .310 .445 .4200 Fax: +1 .310 .445 .4299 Healthy Advice Networks Website: ubmcanon .com Marc Weiner, Managing Partner, Ogilvy CommonHealth Worldwide 2 DruG DELIVERY REVIEW AND OUTLOOK The global drug-delivery market is ex- “There can be a cost benefit when health informatics in new patient-cen- periencing annual growth in the mid-to- transitioning health-care provision from tered systems,” he adds. high single digits. The rising global popu- the hospital environment to the home In the field of auto-injectors, sophisti- lation and the need for more convenient environment or other health-care facili- cated use of electronics in reusable sys- drug-administration methods have creat- ties,” he states. “Effective drug-delivery tems and disposable devices is causing ed more opportunities for manufacturers devices and systems that enable a patient growth, Mr. Reynolds says. to produce additional drug-delivery sys- to self-inject can aid this transition. For “There are also trends toward en- tems and therapies. example, it is now possible to transition hanced manual systems, including er- The U.S. drug-delivery market is an- from hospital IV to home-administered gonomic features designed to improve ticipated to generate 10 percent yearly subcutaneous injection through the use an impaired patient’s ability to deliv- growth during 2011 and 2012, according of an electronic patch injector or auto- er a dose from a prefilled syringe,” he to industry experts. injector.” states. “There are several well-estab- The worldwide pharma market was Auto-injectors are becoming more lished companies in this space offering projected to grow about 5-7% during commonly used to deliver medications device technologies, and increasing em- 2011 compared to 4-5% growth generat- that treat a variety of therapeutic areas phasis on new and merging players offer- ed in 2010. U.S. pharma sales were pre- such as rheumatoid arthritis, oncology, ing improved patient convenience, and dicted to be up slightly during 2011 com- diabetes, and multiple sclerosis. As a re- integration between the device and the pared to 2010. sult, mass production will be required to container.” The industry will continue to grow support the demand for auto-injectors through more sophisticated drug-deliv- and in turn stimulate various industrial MICRONEEDLE TECHNOLOGY ery systems, says Graham Reynolds, VP activities to support the manufacturing of Marketing/Innovation, Pharmaceutical processes required for development. In the realm of new technologies, a small Delivery Systems, West Pharmaceutical Worldwide sales of advanced drug-de- band of device-development companies Services Inc. “There will be an increase livery systems – inhalers, injections and have been attempting to commercialize in self-administration of therapies,” he infusion pumps – are projected to grow drug-delivery products based on arrays shares. “For novel devices, look for con- from a value of $139 billion in 2009 to of microneedles. By establishing chan- tinued trends toward safety and a strong $197 billion in 2014, according to Cam- nels in the outer most layer of the epi- focus on the needs of the patient.” bridge Design Partnership LLP experts. dermis, these devices were expected to West Pharmaceutical has developed Cambridge Design Partnership is a con- deliver therapeutic drugs across the skin innovative delivery systems such as the sulting company that develops drug-de- and into the dermal layers, according to ConfiDose auto-injector system and livery devices in the United Kingdom. Greystone Research Associates. the SmartDose electronic patch injec- Matt Schuman, senior partner at Cam- Greystone analysts say after years of tor. These systems offer a range of op- bridge Design Partnership, advises man- prototyping unique array designs, a few tions for dose volume, injection time and ufacturers to learn from other industries development programs have migrated electronic control/feedback. They are de- that focus on creating differentiation and toward improving the performance of signed to meet the challenges of innova- gaining competitive advantage through existing delivery methods. The market tive drug products. innovations in branding, usability and availability of microneedle drug-delivery Oral forms are expected to remain the shelf appeal. devices such as the Sanofi Pasteur’s In- largest drug-delivery category. Parenter- “We think, in the future, patients are tanza influenza vaccine, which is based al, inhalation and implantable systems going to be much more involved in their on Becton, Dickinson and Co.’s (BD) are on the quickest growth pace. Indus- own treatments to reduce costs and Soluvia syringe-mounted microneedle try analysts expect parenteral formula- smart drug-delivery technologies are part array device, is considered a milestone tions will eventually surpass oral dosag- of what is going to enable this change in the transition of microneedle drug de- es as the largest segment. safely,” says Tom Oakley, Head of Drug livery from development to market. Influencing drug-delivery systems de- Delivery at Cambridge Design Partner- Microneedle technology is anticipated velopment will be reimbursement,