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Sales, Marketing, and R&D Trends from Industry Analysts

Featured Briefs: Most Americans Want More Info on New Biotechnologies Sidebars: What Do You Think Synthetic Biology Is? Rating the Best Drivers of Attendance to speaker events Pharma Rebranding of Speaker Events Is Paying Off Japan Presents Opportunities, ­Challenges for Generic Manufacturers Sidebars: Blockbusters Expected to Come ­Off Patent in Japan, 2010-2012 Tips for Success in Japanese Generic Market R&D for ­Immunotherapies Expands to Alzheimer’s, Other Indications Market for ­Biomarker Analysis Expected to Boom Sidebars: Selected Companies Developing Immunotherapies (i.e., monoclonal antibodies, vaccines) for Alzheimer’s Disease Applications of Biomarkers Pharma ­Collaboration with Patient Advocacy Groups Can Boost Education Efforts Most Americans Want More Info on New Biotechnologies Nanotechnology and synthetic biology continue to develop as two of the most exciting areas of scientific discovery, but research has shown that the public is almost completely unaware of the science and its applications. A poll of 1,001 American adults conducted by Peter D. Hart Research Associates and the Project on Emerging Nanotechnologies (PEN) found that 90% think the public should be better informed about the development of cutting-edge technologies. “Historically, government and industry have done a poor job of informing and engaging the public about scientific developments that could have transformative impacts on society,” says David Rejeski, director of PEN. “The poll showed that better communication is needed and could be beneficial in securing the promise of our investments in science.” According to the poll, about 31% of respondents had heard a lot or some about nanotechnology, up from 24% in 2008 and about the same level measured in 2006. By contrast, about 22% had heard a lot or some about synthetic biology, a sharp increase from 9% a year earlier. “Public awareness of nanotechnology has barely moved in over four years of our project’s polling, despite billions of dollars of investment in research and a growing number of nano-enabled products in the marketplace,” observes Andrew Maynard, chief science advisor for PEN. “Clearly, the message about this new and important technology is not reaching the public.” The survey showed that the area of application is a decisive factor in shaping public attitudes toward synthetic biology. More than half of the respondents supported research in synthetic biology aimed at the development of more efficient biofuels even after being informed of the potential risks and benefits of this application. But poll respondents harbored concerns about potential risks associated with the development of synthetic biology, including its potential for creating what they perceive as artificial life. Two-thirds of the participants supported regulation of this emerging technology. For more information, visit nanotechproject.org. Pharma Rebranding of Speaker Events Is Paying Off In response to increased political and regulatory scrutiny, pharmaceutical companies are rebranding their promotional speaker programs as unparalleled opportunities for physicians to learn or remain current on the latest drug developments and to network with colleagues. According to Cutting Edge Information, the rebranding is helping to attract physicians who are more interested in learning than in getting a free meal, and is working to improve program ROI and lessen pressures from outside agencies that feel the meetings are payoffs for prescriptions. The report, Pharmaceutical Speaker Programs: Measuring ROI and Communicating Value, observes that companies have switched their focus from providing physicians with incentives for attending speaker events to making the program content itself the centerpiece for drawing prescribers. Because a range of perks can no longer serve as the attraction, companies must present the most knowledgeable speakers and informative content. Likewise, companies position speaker events as networking opportunities where physicians can communicate with other doctors in their field and communities. “Pharmaceutical companies know that speaker programs still hold great value as educational and promotional tools,” says Jason Richardson, president of Cutting Edge Information. The report notes that companies must work diligently to get the word out on their events and drive attendance to make programs successful. For more information, visit cuttingedgeinfo.com. Japan Presents Opportunities, ­Challenges for Generic Manufacturers According to a recent Thomson Reuters white paper, a combination of major drug patent expiries before 2012, a rapidly aging demographic, wide-ranging government initiatives to reduce healthcare spending, and comparatively high reimbursement prices are making the generic drug sector in Japan increasingly attractive to foreign manufacturers looking for a large, relatively untapped, and receptive market. Japan is the world’s second largest pharmaceutical market, commanding estimated annual sales of $64.5 billion; but only 6.6% of its prescription drug sales are contributed by generic drugs, the report says. “As Japan’s generic market is beginning to expand, market growth rates in established generic markets, such as Europe and the United States, are trending downward, sending generic drug companies seeking opportunities to enter new markets,” notes Mark Garlinghouse, senior VP, Asia-Pacific at Thomson Reuters. Thomson Reuters’ white paper, The Japanese generic drug market: opportunities and strategies for success, includes an exploration of the probable impact of the recent change in government in Japan on the generic industry. The incoming Democratic Party of Japan has signaled that it intends to continue to support the promotion of generic pharmaceuticals; however, in its July 2009 manifesto, the party claimed that even though generics are judged to be equivalent to the brand-name drug, the current tests for equivalence are insufficient, and it will promote the collection of additional information to be used in further evaluation of generics. For more information, visit go.thomsonreuters.com/jp_generic. R&D for ­Immunotherapies Expands to Alzheimer’s, Other Indications Applications of immunotherapies and vaccines for prevention and treatment of infectious diseases and cancer are well known; but clinical investigation of immunotherapies for other indications, while progressing for many years, has not received the same level of public attention. The use of immunotherapies for treatment of these diseases is a very promising field. The Insight Pharma Reports study, Immunotherapies and Vaccines for Nontraditional Indications, notes that while performance will vary with the different disease indications, some of these immunotherapies and vaccines have a potentially large market opportunity. For example, the current market for therapies to treat the symptoms of Alzheimer’s disease already exceeds $4 billion annually worldwide. This market is likely to grow significantly if more effective therapies that actually treat the disease itself become available. For more information, visit insightpharmareports.com. Market for ­Biomarker Analysis Expected to Boom The biomarker analysis market has excellent growth potential, and the field of biomarker research will test the frontiers of biomedical research in the coming years, according to analysts at Frost and Sullivan. A biomarker is a characteristic objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention. According to the Frost & Sullivan report, An insight into the active and high growth Biomarker Market, at present there is a huge lag between the time that a biomarker is discovered in the laboratory and when it is actually commercialized. This is because of the various challenges faced in the biomarker validation and assay development, including the emerging status of its constituent companies, which are mostly startups. Frost & Sullivan research has shown that the biomarker analysis market is in the early growth phase and is expected to continue in this phase for at least the next four to five years, during which time many new biomarker panels are expected to be approved by the regulatory authorities for mainstream testing during preclinical and clinical drug development. By 2015, the biomarker analysis market is expected to complete its late-growth stage and attain maturity, the report says. Feedback has indicated that while the United States is the current leader in the biomarker market, some of the world-class biomarker companies are found in Europe, and that the western European region is not far behind the United States in terms of market size and growth rate. Asian countries including Japan are almost on par with Europe, and South Korea is also testing the frontiers of biomarker research and development. For more information, visit frost.com. Pharma ­Collaboration with Patient Advocacy Groups Can Boost Education Efforts Patient and professional advocacy groups are trusted resources for consumers seeking information on new and novel therapies and are an integral part of educating the marketplace on new medicines. For pharmaceutical companies that are bringing new therapies to market, collaborating with advocacy groups is fundamental as a way to educate the public on treatment options and is especially critical for socially sensitive conditions or therapies. Respondents to a recent study from Best Practices, Collaborating with Patient Advocacy Groups to Educate the Marketplace, note that the management of relationships with advocacy groups benefits from clarity of the relationship, ownership, role, and responsibility, as well as standardized processes. According to the study, pharma companies should assess the landscape of advocacy and community-interest groups to understand the broad spectrum of players, special interests, and possible collaborators. Different groups may prove to be more valuable collaborators at different stages of the product and disease life cycle, study respondents observed. The report also advises pharmaceutical companies to develop an expertise structure to support rapid response to external special interest groups — both positive and negative — and allow rapid resolution of issues and ongoing intelligence gathering. Other recommendations include centralization of information management and response; staying informed through rapid global updates on hostile group activities; and responding locally to attacks to avoid global issue spread. For more information, visit best-in-class.com. While the market for generics in Japan offers opportunity, foreign drug companies seeking to enter it face significant challenges. Thomson Reuters offers the following ­recommendations to those ­opportunity-seekers: n Don’t go it alone. In-country experience, brand reputation, and personal relationships offered by domestic partners are vital to success. n Reach out to physicians to promote the value of generic drugs. While public awareness of generic drugs is increasing in Japan, many patients are still reluctant to ask physicians to prescribe generics, and many physicians continue to be suspicious of generic drugs. n Have a spotless quality record. The Japanese market’s focus on quality will make it difficult for those generic companies that have run afoul overseas to make inroads in Japan. Source: Thomson Reuters, The Japanese generic drug market: opportunities and strategies for success. For more information, visit go.thomsonreuters.com/jp_generic. Year Active ingredient Sponsor in Japan 2010 insulin aspart Novo Nordisk risedronate sodium Ajinomoto salmeterol xinofoate GlaxoSmithKline tacrolimus Astellas Pharma 2011 atorvastatin calcium Astellas Pharma pioglitazone hydrochloride Takeda pramipexole dihydrochloride Nippon Boehringer Ingelheim 2012 anastrozole AstraZeneca losartan potassium Banyu Pharmaceutical quetiapine fumarate Astellas Pharma, AstraZeneca rabeprazole sodium Eisai Co Ltd raloxifene hydrochloride Chugai Pharmaceutical Co., Eli Lilly Japan KK telmisartan Nippon Boehringer Ingelheim, Astellas Pharma zoledronic acid Novartis Source: Thomson Reuters, The Japanese generic drug market: opportunities and strategies for success. ­For more­ ­information, visit go.thomsonreuters.com/jp_generic. Biomarkers have several applications in four main areas: discovery, preclinical, clinical, and diagnostics. Some of the disciplines in which they currently play an active role include: n Early disease identification. Detection of certain biomarker molecules can help predict the presence of diseases such as cancer, Alzheimer’s, and Parkinson’s at an early stage. n Identifying potential drug targets. Currently, researchers use very advanced techniques such as proteomics to find proteins specific to various disorders, which may offer a potential target for drug treatment. Biomarkers help researchers understand the disease process at the protein expression level. n Predicting the response of patients to medications. Biomarkers can help physicians monitor the response to medication administered to patients suffering from serious ailments and judge the efficacy of a particular drug regimen in terms of cure rate. n Accelerating clinical trials. Biomarkers play a major role in reducing trial duration by predicting drug efficacy in animal models and human trials by acting as surrogate primary endpoints. n Personalized medicine. Biomarkers could help physicians prescribe the right medication to the right patient. This could help reduce side effects, as patients would be prescribed a drug after determining the particular pathway that is playing an active role in the progression of disease in the patient in question.

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