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Trends: Changing market forces and the trend toward more flexible business models have inspired the creation of dynamic companies better positioned to explore opportunities ­overlooked by larger life-sciences organizations.

NEW AMERICAN THERAPEUTICS, a specialty pharmaceutical company co-founded by two former Roche and Sanofi-Aventis executives, is focused on building a portfolio of products with the potential to improve outcomes for patients and provide more treatment options for physicians. “We saw an opportunity to create a new and agile business model that is flexible and versatile enough to navigate the challenges in today’s dynamic environment,” says President and CEO Alan Rubino, a former senior executive at Roche. Co-Founder Timothy Rothwell, former chairman, CEO, and president of Sanofi-Aventis U.S., serves as New American Therapeutics’ chairman. According to Mr. Rubino, the company’s acquisition of all U.S. rights to manufacture, market, and sell the topical antiviral drug Denavir to treat cold sores met very specific criteria. “It is an excellent therapeutic agent that, despite not receiving an adequate marketing investment, was still maintaining nearly a 50% prescription share of the topical antiviral market,” he explains. “We will be tapping into our deep relationships within many U.S. and international pharmaceutical companies to explore product acquisition opportunities and other collaborations,” Mr. Rubino says. { For more information, visit natxcorp.com. Dainippon Sumitomo ­Establishes Sunovion Japan’s Dainippon Sumitomo Pharma (DSP) has integrated its two U.S.-based operations, Sepracor and Dainippon Sumitomo Pharma America (DSPA), under the name Sunovion Pharmaceuticals. The company maintains U.S. sales and marketing efforts for DSP’s central nervous system and respiratory brands and remains with headquarters in Marlborough, Mass., and with critical R&D functions based in Marlborough and Fort Lee, N.J. President and Chief Operating Officer Mark Iwicki says his company’s name “combines the strength of the sun with innovation” and represents its focus to continue growing current brands and advancing pipeline candidates in the key United States market. “Sunovion Pharmaceuticals represents the combined value of our U.S. operations and allows us to focus our unified efforts on achieving our vision of becoming an internationally recognized global pharmaceutical company,” adds Masayo Tada, president and CEO of DSP. “Moreover, we intend to expand the Sunovion brand in certain strategic international locations,” he says. { For more information, visit sunovion.com. In other news… Alulim Pharma is a recently launched aerosol therapeutics company with a platform technology that allows drugs to be safely deposited throughout the respiratory tract, resulting in decreased toxicity and more rapid targeted drug distribution to treat cancers, asthma, organ transplantation, and various infections. George Noon, M.D., chief of the division of transplant surgery and assist devices in the surgery department at the Baylor College of Medicine, and director, transplant executive council for transplant services at Methodist Hospital in Houston, is serving as Alulim’s medical board chairman. { For more information, visit alulim.com. CytoGenix, a company developing biotechnology-derived products for vaccines and therapeutic applications, is moving its headquarters to New York as it prepares for its public listing on the Nasdaq Stock Market. “With our plan to have our company listed on the Nasdaq, we feel that being in the center of the financial world will enable CytoGenix to fully reach its goals of increasing shareholder value that much sooner,” says CEO Lex Cowsert, Ph.D. The company also has established a pharmaceutical research and testing facility in Middletown, Conn. { For more information, visit cytogenix.com. Health Strategies Group’s new service, Managed Care Complete, addresses an increasingly complex payer dynamic by providing critical knowledge for optimizing physician and patient access to branded medications in 10 drug categories. The service offers insights into the payer dynamic; identifies key influencers of brand access; and examines critical brand access decisions across major insurance plan types, including commercial, Medicare Part D, and Medicaid. Managed Care Complete also provides access to Health Strategies Group brand access experts, who help clients apply the market intelligence to their specific business objectives. “For more than 15 years, we’ve conducted ongoing analysis of the payer landscape to determine brand access issues in more than 30 drug categories,” says Susan Weber, director for brand access services. “Our new Managed Care Complete service takes a deeper dive into the complexities of brand access and provides a complete picture of the managed care commercial environment as well as public payers in 10 specialized drug categories.” { For more information, visit healthstrategies.com. Community ­Connections to Aging Well (CCAW) — a pilot program launched by the National Council on Aging (NCOA) in partnership with Sanofi-Aventis U.S., the Baltimore County Department of Aging (BCDA), and the John A. Hartford Foundation — is helping physicians connect older patients with diabetes to evidence-based education and wellness support in their local communities. As part of Sanofi-Aventis’ role in the partnership, the company’s U.S. field representatives are providing physicians and staff with information on how to link their patients to CCAW programs. Patients can be referred to eight of the BCDA’s 20 senior centers to participate in an evidence-based chronic disease self-management workshop, as well as educational seminars, fitness, nutrition, and medication management workshops. NCOA is coordinating the launch and evaluating the pilot program’s effectiveness; if successful, NCOA and Sanofi-Aventis plan to expand the program in several other U.S. cities. “CCAW is helping to address one of the largest and fastest-growing health problems in the United States,” says Annette Schmidt, director, external affairs for Sanofi-Aventis U.S. “Through this partnership, we can link Baltimore County Medicare patients with diabetes or pre-diabetes to helpful programming right in their community.” “CCAW provides a unique link to community resources that can help older adults be more effective partners in their care,” says James Firman, Ph.D., president and CEO of NCOA. “We hope that success in Baltimore will lead to opportunities to empower older adults across the county to share in the management of their health care.” { For more information, visit ncoa.org or sanofi-aventis.us. Novartis has unveiled plans to invest $600 million over the next five years to expand its global research headquarters in Cambridge, Mass. The plans include the addition of 300 new jobs and the expansion of the existing campus by more than 400,000 square feet. “The constellation of talent and environment in the Cambridge area is unmatched,” says Mark Fishman, president of the Novartis Institutes for BioMedical Research. “We look forward to the next wave of new medicines coming from this center.” { For more information, visit novartis.com. Worldwide Clinical Trials has changed the name of its Cedra division to Worldwide Clinical Trials Drug Development Solutions. The division continues to offer bioanalytical sciences and early-stage clinical research services, as well as specialized studies to determine the effects of dose, formulation, drug interactions, and other factors on pharmacokinetics. “We chose to change the name of our company to reflect the relationship and corporate identity of the Worldwide Clinical Trials brand,” says Anthony Busa Jr., CEO of Worldwide Clinical Trials Drug Development Solutions. { For more information, visit ctrials.com. The Barnett International guide, EXPEDITING DRUG AND BIOLOGICS DEVELOPMENT: A STRATEGIC APPROACH, includes insights from dozens of leading experts on different techniques to drive and improve each aspect of a drug and biologic product development program’s design and implementation. The book provides templates, forms, and tools to support pharmaceutical developers in the trenches of new drug and biologic development and assist them in conducting safe, efficient, and cost-effective clinical programs that lead to the rapid submission and approval of marketing applications. { For more information, visit barnettinternational.com. PHARMACEUTICAL AND BIOMEDICAL PROJECT MANAGEMENT IN A CHANGING GLOBAL ENVIRONMENT offers novices and professionals a road map to current best practices in life-sciences project management, as well as how to meet tomorrow’s challenges. Edited by Scott Babler of Integrated Project Management (IPM), the primer includes contributions from professionals at global giants such as Pfizer, Bayer Schering, and Genentech, as well as from emerging companies and consulting firms. The authors share real-world experiences that illustrate in practical terms how effective project management can help drive successful outcomes on time and on budget, even under adverse conditions. { For more information, visit ipmcinc.com. Outcome Sciences has announced the release of the second edition of REGISTRIES FOR EVALUATING PATIENT OUTCOMES: A USER’S GUIDE, a federal publication by the Agency for Healthcare Research and Quality (AHRQ) that offers information on designing, implementing, and evaluating patient registries. The updated edition features four new sections and includes new methodological developments; emerging topics in registry science, including updates on safety; technological advances; and operational examples and case studies from around the world. { For more information, visit outcome.com.

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