New Healthcare-related Products, Services, and Companies
U.S. Subsidiaries Form Daiichi Sankyo New U.S.-based company expected to fuel growth. Sankyo Pharma Inc., Daiichi Pharmaceutical Corp., and Daiichi Medical Research have integrated their U.S. businesses, creating a new pharmaceutical company, Daiichi Sankyo Inc. The new company is the subsidiary of Daiichi Sankyo Co. Ltd., the second largest pharmaceutical company in Japan. Additionally, Daiichi Sankyo is the first of the global company’s three regions (United States, Japan, and Europe) to merge. The newly integrated company boasts an expanded product portfolio, global clinical research capabilities, and a promising pipeline. Also, as part of the integration, Daiichi Sankyo will combine its two salesforces. The company plans to launch three new products in the United States in the next three to five years, further fueling its already rapid growth. In preparation, the salesforce has been reorganized into two primary-care salesforces, as well as a hospital and an oncology salesforce. This integration builds on the momentum established by Daiichi Sankyo’s predecessors as we continually strive to innovate and provide new therapies for patients and physicians, says Joe Pieroni, President of Daiichi Sankyo Inc. New Peer-Review Service Ensures Unbiased CME A newly formed company, CME Peer Review LLC, is offering a turnkey service dedicated to independent evaluation of continuing-education activities for integrity and compliance. CME Peer Review was founded by veteran continuing education professional Jane M. Ruppenkamp and physician Rosemarie D. Rose, M.D., in response to the complex regulatory environment of continuing medical education. CME Peer Review’s service provides a solution for those CME providers who are challenged by the recent ACCME accreditation requirements, allowing accredited providers to validate their content before making it available to healthcare providers. CME Peer Review’s easy-to-use, secure Web portal makes it easy for users to upload the content and download the final report, improving efficiency and speeding turnaround. To ensure that CME content is valid and in the public interest, CME Peer Review’s network of physicians, pharmacists, and nurses are specifically trained to evaluate the content according to 15 key criteria (including scientific integrity, balance, and rigor) to verify compliance with regulatory and accreditation standards. All of the reviewers must meet rigorous qualification requirements and are thoroughly vetted for relevant financial relationships with commercial interests, ensuring independent content validation — without conflicts of interest. This service helps providers obtain educational grants by assuring grantors that CE content is free from commercial bias, says Jane Ruppenkamp, President and CEO of CME Peer Review. The Zitter Group Launches Services to Test Payer/Employer Markets As the influence of payers on pharmaceutical sales continues to rise, manufacturers are faced with the need to value test how their products will be received by managed care groups. The Zitter Group’s P&T Perspective meeting allows companies to see how payers will view their product, test the availability and understanding of supporting documentation and product economics, and gauge potential formulary restrictions. P&T Perspective is a pharmacy and therapeutics committee simulation, comprised of 15 active P&T members recruited from a variety of health plans of different sizes and types from across the country. Unlike traditional pharma-sponsored mock P&T meetings, the composition and management of P&T Perspective closely mirror the way that committees operate in the real world. The program uses Web-streaming technology to enable sponsors to watch and participate in the meeting anonymously, eliminating the bias inherent in a sponsored advisory board. P&T Perspective will be held four times in 2006, and will include reviews of categories with significant market dynamics, such as multiple sclerosis, asthma, statins, osteoporosis, diabetes, analgesics, rheumatoid arthritis, contraceptives, insomnia, and many more. The Zitter Group also has launched the Employer Resource Network Meeting (ERN), a new multiclient program that offers pharmaceutical marketers the opportunity to listen to and speak with some of America’s leading employers, benefits consultants, and coalition executives. The ERN, a semi-annual panel comprised of 20 to 25 of the largest employer segment representatives, offers marketers a cost-effective way to stay at the forefront of critical developments in the employer market. Pharma-oriented topics are covered in the general sessions of ERN meetings; sponsors also have the opportunity to explore proprietary issues during private two-hour sessions. ePharmaLearning Changes Name to ePharmaSolutions ePharmaLearning Inc. has changed its name to ePharmaSolutions Inc. to better represent the company’s expanding portfolio of clinical services. ePharmaSolutions combines portal and e-learning technology with interactive adult-learning and clinical support services to help accelerate and improve study launches. “The ePharmaSolutions name better exemplifies the breadth and scope of the portfolio of services we have been providing over the last few years and supports our future growth initiatives,” says Lance Converse, CEO of ePharmaSolutions. ePharmaLearning remains as an operating unit of ePharmaSolutions and continues to deliver online training and e-collaboration services to the pharmaceutical industry. Most of our clients know us as an accelerated study-launch and patient-enrollment company, and it is important that our name reflects those offerings, says Lance Converse, CEO of ePharmaSolutions. M&A Activity Athenagen Inc., a privately held biopharmaceutical company based in South San Francisco, Calif., has acquired the assets of Osprey Pharmaceutical Co., a biotechnology company in Ponte Vedra Beach, Fla. The acquired assets include a lead clinical compound, GTS-21, targeting Alzheimer’s disease and a large library of related analogs. Additionally, Athenagen acquired intellectual property, preclinical and clinical data, and an active U.S. IND for GTS-21. The company plans to initiate Phase II studies in patients with Alzheimer’s disease in early 2007. For more information, visit athenagen.com. Discovery Partners International Inc. (DPI), a small-molecule and natural product-based drug-discovery company, and Infinity Pharmaceuticals Inc., a privately held company focused on oncology therapeutics, have agreed to merge to create a new company focused on cancer drug discovery and development. Under the terms of the agreement, San Diego-based DPI will issue shares of its common stock so that Infinity stockholders will own about 69% of the combined company on a pro forma basis, and DPI stockholders will own about 31%. The merged entity will operate as Infinity Pharmaceuticals Inc. and operations will be based out of Infinity’s headquarters in Cambridge, Mass. For more information,visit ipi.com. Dynavax Technologies Corp. has acquired biopharmaceutical and vaccine manufacturer Rhein Biotech GmbH, Maastricht, The Netherlands, for about $12.4 million in cash. Based in Berkeley, Calif., Dynavax discovers and develops innovative products to treat and prevent allergies, infectious diseases, and chronic inflammatory diseases. The company has acquired 100% of the outstanding capital stock of Rhein Biotech and assets including, manufacturing facilities, research and development stage products, an industrial R&D services business, and personnel. Rhein Biotech has become a wholly owned subsidiary, named Dynavax Dusseldorf. For more information, visit dynavax.com. Kendle, a global full-service clinical research organization (CRO), has agreed to acquire the Phase II-IV clinical services business of Charles River Laboratories International Inc., creating the world’s fourth largest provider of Phase II-IV clinical-development services. The transaction is expected to close in the third quarter of 2006, subject to customary conditions and regulatory approvals. The agreement provides for the purchase of 100% of the stock of the Phase II-IV clinical services business for about $215 million in cash. The acquisition adds about $103 million in unaudited net service revenue to Kendle’s 2005 performance. The acquired operations will operate under the Kendle name. The acquisition provides Kendle with a broadened strategic platform for growth to capitalize on the increasing demand for global clinical-development services. For more information, visit kendle.com. Millipore Corp., Billerica, Mass., has agreed to acquire Serologicals Corp., an Atlanta-based company that develops and commercializes consumable biological products. Millipore is a bioprocessing and bioscience products and services company. In an all cash transaction, Millipore will pay Serologicals shareholders $31.55 for each share of Serologicals common stock they hold. The deal is expected to close June 30, 2006, and is valued at about $1.4 billion, including the assumption of the projected debt at closing. The acquisition will transform Millipore into a company with estimated annual revenue of $1.4 billion, about 5,800 employees, and significantly expanded R&D capabilities. For more information, visit millipore.com. PharmaTech Solutions Inc. (PTS) has acquired Realinterface Expert Systems (RESI), Annapolis, Md., a specialized applications company focused on the clinical-trial and first-responder markets. PTS is an integrated clinical-development services company based in Wilmington, N.C. This acquisition brings together RESI, the developer of the InClinix software system with PTS, the developer of a novel technology for automatic patient identification at a medical practice or through multiple, clinical investigator locations. Under the terms of the agreement, Chris Sleat, founder and chairman of RESI, will join the PTS board of directors and serve as chief technology officer of the combined entity. Existing offices will be maintained in Wilmington and Annapolis, with the combined sales staff positioned throughout the United States. For more information, visit pharmatechsolutions.com. YM BioSciences Inc., a cancer product development company, has agreed to acquire Eximias Pharmaceutical Corp., Berwyn, Pa., a privately held pharmaceutical company that acquires, develops, and commercializes products for the treatment of cancer and cancer-related disorders. The deal was expected to close in early May, making Eximias a wholly owned subsidiary of YM, Mississauga, Ontario. Upon completion of the agreement, the new unit is expected to operate under the name YM BioSciences USA Inc. and serve as YM’s U.S. headquarters. For more information, visit ymbiosciences.com. New Consulting Firm Offers Solutions for CME Administrators A new consulting firm, PTR Educational Consultants LLC, is helping continuing medical education (CME) providers navigate the increasingly complex regulatory environment. Led by a team of veteran CME professionals, PTR offers practical services, educational tools, and critical resources that support CME program administrators’ efforts to attain robust compliance on regulatory issues while delivering effective education. PTR’s presentations provide real-world explanations and expert insights to ensure participants grasp the information — delivered with the candor that only an independent party can offer. The presentations allow for a variety of formats, such as facilitated discussions, lectures, and Q&A sessions, that can be tailored to faculty, staff, and grantors according to each provider’s needs. Our principals have accumulated more than 50 years of experience, with consulting services offered across the continuum of CME providers, says Jacqueline Parochka, Ed.D., Partner, PTR Educational Consultants LLC. What’s New on the Shelves FDA Investigations Operations Manual (IOM), 2006 Edition, published by the National Technical Information Service, is the primary source regarding U.S. Food and Drug Administration policies and procedures for field investigators and inspectors. The 2006 IOM has been significantly revised, incorporating a new numbering system used by international standards organizations, reorganizing content, expanding the index, and making the manual more user friendly. Content has been reorganized into shorter, more readable sections, offering better searchability. Many of the IOM’s exhibits have been revised, improving their readability. For more information, visit ntis.gov. The Executive Bookshelf, available from the Pharmaceutical Institute (PI), is a collection of 12 titles that have been handpicked as essential reading material for pharma and biotech professionals. Book topics fall into seven key categories, including discovery, drug development, managed markets, marketing and brand management, the pharmaceutical industry in general, and reference materials. The Executive Bookshelf can be purchased in its entirety, or any individual book or combination of books in the collection can be purchased at significant discounts from list prices. For more information, visit pharmainstitute.com. Good Clinical Practice, published by Barnett International and available from Piribo Ltd., is a pocket guide to Good Clinical Practice (GCP) requirements in drug, biologics, and device clinical trials. Presented in question-and-answer format, the guide covers 400 frequently asked questions about the conduct of clinical trials and offers an accessible introduction to the regulations governing clinical trials. For more information, visit piribo.com. Marketing and PR in Clinical Research, by Faiz Kermani, Ph.D., tackles some of the ethical dilemmas that the pharmaceutical industry currently faces in working across the world and addresses how and why pharma companies must be mindful of the way their promotional work is perceived. The book details trends in R&D and case studies to help pharma professionals better understand the importance of marketing and public relations in R&D and business development. Marketing and PR in Clinical Research will be available in July from the Institute of Clinical Research. For more information, visit icr-global.org. Medical Marvels: The 100 Greatest Advances in Medicine, by Eugene W. Straus, M.D., and Alex Straus, celebrates the noble science and art of medicine by highlighting the 100 greatest medical advances. The book emphasizes the importance of committed individuals who proposed conceptual breakthroughs that made a telling difference to the human condition. Emphasizing that medicine should be founded on ethical integrity, compassion, and the encouragement of unfettered scientific research, the authors warn that powerful forces in contemporary society are in danger of seriously neglecting these fundamental principles. The book offers a new appreciation for the achievements and future promise of medicine. For more information, visit prometheusbooks.com. Patient Compliance: Sweetening the Pill, edited by Madhu Davies and Faiz Kermani, Ph.D., explores the key factors that drive compliance and the part that healthcare professionals can play in improving this — with the underlying goal of improving public health in its broadest sense. The book’s multifaceted discussions offer readers greater understanding of the key issues impacting compliance. For more information, visit gowerpub.com. Wishbone Launches Backbone — a New Med ed company Wishbone-ITP Inc. has formed a new medical-education company called Backbone. According to Steven Michaelson, founder and CEO of Wishbone, this move represents a natural expansion into the more clinical, educational side of the same basic philosophy that guides Wishbone — big ad agency experience without the bureaucracy. Diana Freed, managing director — chief science officer, heads up the new company. Ms. Freed, formerly executive VP, chief science officer at Wishbone has been replaced by James Christodoulou, M.D., a practicing cardiologist. Specifically targeting biotechnology companies, Backbon ’s mission is to address the needs of analyzing data, Phase IV development, publication planning, and strategic medical education. The strategy is to create a highly academic environment coupled with strategic insights to develop solutions for clients’ educational objectives. Two Industry Veterans Create New Med Ed Agency Long-time medical-education professionals Lenny LaManna, DPM, and Adam Margolis have opened a new medical-education agency, L&M Healthcare Communications LLC. Dr. LaManna and Mr. Margolis, who have almost 30 years of combined experience in pharmaceutical marketing and medical education, are dedicated to developing highly strategic and medically accurate content for pharmaceutical, biotechnology, and medical-device companies. L&M’s team of experts provide core project offerings include: thought-leader development, custom speakers’ bureau management, speaker training, consultant activities, traditional and Web-based educational programs, slide kit development, and product publications. Additionally, L&M’s experts are highly experienced in many therapeutic areas, including central nervous system, dermatology, wound care, autoimmune diseases, gastroenterology, and cardiology. “Medical education is one of the most important aspects of the pharmaceutical marketing mix,” Mr. Margolis says. “We believe that targeted and credible medical education can successfully impact the launch of new products.” Lenny LaManna (left) and Adam Margolis, Founding Partners of L&M Healthcare Communications LLC, have put together a team of customer-focused experts to partner with clients in the prelaunch, launch, and postlaunch phases of pharmaceutical product marketing. Partnering for Patient Education Harvard Medical School and M|C Communications are launching an initiative to expand the role of patient education in primary-care medical practices. The venture, Pri-Med Patient Education Center, introduces multimedia education systems into physicians’ waiting rooms throughout the United States. Through this partnership, Harvard Medical School provides educational content that is written for the general public and addresses a broad spectrum of conditions and disease states, as well as preventive medicine and healthy lifestyle. Pri-Med’s patient-education centers were first launched in 2005 through a partnership with the Medical Group Management Association (MGMA). To date, more than 2,000 large-group practices have patient-education centers installed in their waiting rooms. The network is slated to expand to 5,000 practices this year and reach 10,000 by the end of 2007. Harvard’s stature and the quality of content provided by its faculty will underscore the value and credibility of the Pri-Med Patient Education Center in the eyes of both doctors and patients, says John Mooney, CEO of M|C Communications. imc2 Helps Pharma Target NPs and PAs imc2 has created a comprehensive marketing program focused specifically on physician assistants (PAs) and nurse practitioners (NPs). The company’s new offering allows pharmaceutical clients to understand the growing role this audience plays in treating and educating patients. The agency helps pharmaceutical companies design specific communication programs to meet their target audiences’ needs. “This segment is looking for help in selecting appropriate treatment for patients in ensuring regimen compliance,” says Doug Levy, president of imc2. “We created a comprehensive marketing program focused specifically on the PA and NP audiences.” Recognizing the increasing role and value of PAs and NPs in the healthcare arena — as well as the lack of sustained marketing programs directed at them — imc2 conducted a pair of surveys to gain insight into the PA and NP market. The surveys — Nurse Practitioners and Physician Assistants’ Patient Compliance Opinion Poll and Physician Extenders and Their Impact on Pharmaceutical Marketing — revealed the growing importance of this segment in driving more effective patient education and improving regimen patient compliance. According to this research, 80% of PAs and NPs reported that physicians encourage them to make recommendations about which medications are best for patients. The studies further revealed that 88% of PAs and 94% of NPs spend more time educating their patients than the average physician. Physician assistants and nurse practitioners are looking for help in selecting appropriate treatment for patients in ensuring regimen compliance, says Doug Levy, President of imc2. Around the Globe Baxter International Inc., a medical products and services company based in Deerfield, Ill., will invest about $60 million in the next five years to expand production capacity at its four manufacturing facilities in China. This investment will support sales growth in the company’s medication delivery and renal businesses. Baxter’s sales in China, which were about $100 million last year, are expected to more than double by 2010, given the anticipated increase in demand for the company’s intravenous solutions and peritoneal dialysis products. For more information, visit baxter.com. Cato Research Ltd., a full-service contract research organization (CRO) based in Durham, N.C., and JSW-Research Forschungslabor GmbH, Graz, Austria, a CRO specializing in central nervous system therapeutics, have formed a strategic business development collaboration focused on expanding both companies’ operations throughout the European Union and Eastern Europe. The deal follows a successful long-term relationship between the two CROs, involving numerous large-scale clinical-trial programs in the European Union. Under the agreement, Cato and JSW will share their proprietary CRO know-how, leverage their business development capabilities, and extend the reach of their preclinical and clinical development capabilities and regulatory expertise to pharmaceutical and biotechnology companies seeking to introduce new medicines in the United States, Canada, the European Union, Eastern Europe, Israel, and South Africa. Separately, Cato BioVentures, the venture capital affiliate of Cato Research, purchased an undisclosed equity interest in JSW-Research. For more information, visit cato.com. Follow up Backbone, New York, a division of Wishbone/ITP Inc., is a medical education company specializing in the biotechnology sector with a focus on providing high- quality, high-level scientific products. For more information, visit wishbone-itp.com. CME Peer Review LLC, Alexandria, Va., provides independent, third-party evaluation of continuing education activities. For more information, visit cmepeerreview.com. Daiichi Sankyo Inc., Parsippany, N.J., is the U.S. subsidiary of Japanese pharmaceutical company Daiichi Sankyo Co. Ltd. and has a strategic focus is on cardiovascular diseases. For more information, visit daiichisankyo-us.com. ePharmaSolutions Inc., Philadelphia, provides technology-based clinical services that improve the way investigator sites are selected, trained, and activated to commence clinical trials and enroll patients. For more information, visit epharmasolutions.com. Harvard Medical School, Boston, is committed to creating and nurturing a community of people committed to leadership in alleviating human suffering caused by disease. For more information, visit hms.harvard.edu. imc2, New York, is an independent digital marketing agency. For more information, visit imc2.com. L&M Healthcare Communications LLC, Scotch Plains, N.J., is an independent, full-service medical-education company. For more information, visit lmhcare.com. M|C Communications LLC, Boston, produces more than 200 educational programs each year through live, print, and online channels. For more information, visit mc-comm.com. PTR Educational Consultants LLC, Bristow, Va., offers practical services, educational tools, and critical resources to support CME program administrators. For more information, visit ptreducationalconsultants.com. The Zitter Group, Millburn, N.J., helps pharmaceutical, biotechnology, and medical-device companies work more effectively within managed markets. For more information, visit zitter.com.