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Sales, Marketing, and R&D Trends from Industry

Analysts Featured Briefs: Specialists More Likely to Open and Click Through Email Sidebar: Email Campaigns to Physicians by Type, July-December 2010 Branded Pharma Sites Help Drive Prospect, Patient Conversions Personalized Medicine Strategy Could Benefit Phase III Therapies Industry Collaboration Critical for Specialized Medicines Aggregate Spend Compliance Can Yield Strategic Advantage Combination Therapies Must Offer Clear Benefit to Succeed Sidebars: Q. What was the chief reason for ­pursuing FDC development? Therapeutic Market Fast Trax… Other market insights… R&D Budget Cuts On Horizon Monoclonal Antibodies a Strong Category China Presents Attractive Outsourcing Market Healthy Growth in U.S. Generic Market Contract Manufacturing Expect to Expand According to results from the second half of 2010 for SK&A’s Email Performance Archive (EPA), while family practitioners are consistently the most emailed physicians, specialty physicians are more likely to open emails and click to landing pages than family physicians and other general practitioners. EPA results show the three highest open rates were from trauma surgeons (13.4%), hepatologists (13.2%), and dermatopathologists (11.1%). Pediatric specialists also responded well to emails, with physicians in the areas of pediatric radiology, child neurology, pediatric surgery, pediatric pulmonology, pediatric cardiology, and neonatology ranking in the top 15 for open and click-through rates. By contrast, family practitioners, general practitioners, and internists did not make the top 15 for open and click-through rates, indicating that a more targeted audience approach may be necessary to increase email responsiveness. SK&A introduced the EPA in May 2010, giving readers a first-hand look at email campaign results across targeting, campaign type, and actual performance dimensions. “The Email Performance Archive provides a valuable baseline for email campaign activity targeting physicians, midlevel practitioners and other healthcare business professionals,” says Dave Escalante, VP and general manager, SK&A and OneKey. “Viewing the trends by campaign type, specialty, job title, and other metrics is useful for understanding the nuances of using the e-marketing channel.” { For more information, visit skainfo.com. Trend: Data show a more targeted audience approach, particularly by specialty, can result in a stronger response to physician email campaigns. Branded Pharma Sites Help Drive Prospect, Patient Conversions Exposure to online display advertising and branded websites provides a positive lift in awareness and favorability toward pharmaceutical brands. Results from comScore’s fifth annual Online Marketing Effectiveness Benchmarks for the Pharmaceutical Industry show that visits to branded websites continue to provide the most significant lifts in prospect conversion and patient refills. “With online marketing as an integral part of any comprehensive pharmaceutical marketing plan, it’s important to understand how various online channels affect consumers’ knowledge of a brand and propensity to use that brand,” explains John Mangano, VP of comScore health marketing solutions. “Our benchmarking data continue to show that branded websites have the greatest impact on conversions and also reinforce the significance of display and search advertising in increasing awareness and favorability toward a brand.” Supporting previous findings, the study found that visitation to a branded website generated the greatest positive lifts in conversion. Existing patients increased their refill rate 15.5 percentage points more than those who did not visit the site, the study found. The percentage of prospects beginning treatment after visiting a branded site was 8.8 percentage points higher than prospects with no exposure to the branded site. { For more information, visit comscore.com. Personalized Medicine Strategy Could Benefit Phase III Therapies The pharmaceutical industry’s investment in genetic biomarkers and personalized medicine (PM) is beginning to show valuable results; but that investment is unevenly distributed, with some companies demonstrating greater commitment and more structure in their approach than others. An estimated 46% of Phase III pipeline therapies could benefit from a personalized medicine strategy, according to the Diaceutics report, Pharma Readiness for Personalized Medicine. The report notes the groundwork for the future competitive landscape in PM for the entire pharmaceutical industry is currently being laid by select companies pursuing a range of approaches, and success in this space will be determined by how each company embraces PM, as measured both by how they restructure their internal R&D and external commercialization and launch behaviors. Diaceutics CEO Peter Keeling observes that the industry’s standard definition of PM is narrow and should be broadened to consider any therapy directly benefiting from a new or reshaped diagnostic approach. “Most pharmaceutical companies say they are ready for personalized medicine, and their development pipelines are filling up with personalized medicine opportunities, but they may not fully understand the commercial ramifications of this technological shift,” Mr. Keeling says. { For more information, visit diaceutics.com. Industry Collaboration Critical for Specialized Medicines Cross-industry collaboration and uniformity are essential ingredients to successful implementation of the FDA-mandated risk evaluation and mitigation strategies (REMS) initiative, REMS?requires manufacturers to implement measures ensuring the benefits of a drug or biological product outweigh its risks. Assessing the Impact of Risk Evaluation and Mitigation Strategies (REMS) Requirements on the Pharmaceutical Supply Chain, a report produced by The Center for Healthcare Supply Chain Research in collaboration with the Campbell Alliance Group, found that two-thirds of REMS require only a medication guide, along with assessments mandated for all programs. But even these relatively simple strategies presented issues that may affect patient care, with at least one retail pharmacist interviewed noting that REMS overemphasis on risk may dissuade patients from taking a needed drug. This concern was also articulated independently by providers (physicians and patient advocates), who stated that communication regarding the benefits of medications requiring a REMS should not be unduly overshadowed by discussions of risk. In addition, pharmacists interviewed for the report indicated that more complex REMS — those often requiring training, certification, and registries to obtain access to the drug — can pose a challenge to the supply-chain flow, with the potential for unforeseen results on patients. “As today’s healthcare system faces the dual challenge to improve efficiency and patient care, our research defines the critical issues we all face in meeting the REMS requirements for specific medicines on the frontier of development,” says Karen Ribler, executive VP and chief operating officer of the Center for Healthcare Supply Chain Research. “It draws from experience and rigorous analysis showing how industrywide strategies can enable and speed the use of specialized medicines to treat serious diseases.” The Center for Healthcare Supply Chain Research is the nonprofit research foundation of the Healthcare Distribution Management Association (HDMA). { For more information, visit ­healthcaredistribution.org. Aggregate Spend Compliance Can Yield Strategic Advantage Aggregate spend compliance is one of the most disruptive forces affecting pharmaceutical sales and marketing today. Eric Newmark, research manager at IDC Health Insights, observes that state-by-state mandates have added significant complexity to sales operations by implementing strict promotional spending limits and banning several types of promotional activity, with their impact on pharmaceutical manufacturers continuing to increase as more states pass aggregate spend laws and a set of national regulations takes effect in 2013. According to the IDC Health Insights study, Business Strategy: Aggregate Spend Compliance The Next Frontier of Pharmaceutical Sales and Marketing, pharmaceutical companies that use this compliance initiative as an opportunity to optimize sales and marketing intelligence stand to gain a strategic advantage. The report recommends manufacturers implement a four-step process to achieve aggregate spend compliance: planning and identifying information to be aggregated; integrating data across the enterprise to create spend transparency; programming the required IT to track and report spend; and preventing noncompliant behavior. Also, by initiating a fifth step — optimizing and refining business processes based upon newfound visibility — companies can analyze how to best spend promotional dollars and maximize ROI, the report says. “While aggregate spend compliance will require much effort and investment, the results will provide pharmaceutical companies with an integrated, single view of HCP data, yielding many new analytical opportunities for sales and marketing,” explains Mr. Newmark. { For more information, visit idc-hi.com. Combination Therapies Must Offer Clear Benefit to Succeed One way in which pharma strategy and development executives are addressing the current wave of patent expirations and relatively lackluster pipeline is through the development of combination therapies with branded products to extend patent life. According to Best Practices, these fixed-dose combination products can extend a therapeutic advantage and become part of life-cycle management for companies, while addressing unmet medical needs and patients’ dosing burdens. The Best Practices report, Fixed Dose Combination Products: Successful Strategies for Developing and Bringing FDC Products to Market, found it takes between five and eight years and an average of $80 million to bring an FDC product to market. Almost two-thirds of respondents told Best Practices their company pursued FDC development as part of a life-cycle management strategy geared to extend therapeutic as well as commercial advantage, while the remaining one-third said FDC development addressed an unmet medical need. But to successfully commercialize an FDC therapy, the company must create a differentiated product with a clear therapeutic benefit. Critical product-shaping strategies such as positioning and value were identified by veteran FDC leaders as the most valuable tactics for a successful launch of an FDC product, according to the report. { For more information, visit best-in-class.com. AUTISM Some medical and behavioral treatments show promise for reducing certain behaviors in children with autism spectrum disorders (ASDs), but more research is needed to assess the potential benefits and harms. Two commonly used medications — risperidone and aripiprazole — show benefit in reducing some behaviors, including emotional distress, aggression, hyperactivity, and self-injury. But these medicines are also associated with significant side effects, such as rapid weight gain and drowsiness. Source: The U.S. Department of Health and Human Services’ Agency for Healthcare Research and Quality, Comparative Effectiveness of Therapies for Children with Autism Spectrum Disorders. { For more information, visit ­effectivehealthcare.ahrq.gov. CANCER Surveyed U.S. oncologists estimate that 67% of patients with advanced non-small cell lung cancer (NSCLC) who complete first-line induction therapy receive maintenance therapy. Currently, continuation maintenance therapies such as Lilly’s Alimta, Genentech/Roche/Chugai’s Avastin, off-label use of ImClone Systems/Merck Serono/Bristol-Myers Squibb’s Erbitux, and Lilly’s Gemzar receive more use compared with switch maintenance therapies such as Genentech/OSI Pharmaceuticals/Roche/Chugai’s Tarceva and Sanofi-Aventis’s Taxotere among NSCLC patients. This is likely due to the fact that oncologists want to suppress disease progression after first-line induction therapy but do not wish to exhaust a patient’s treatment options prematurely. Source: Decision Resources, U.S. Physician & Payer Forum report, Maintenance Treatment of Non-Small-Cell Lung Cancer (NSCLC) in the United States: Will Payers and Prescribers Support a Paradigm Shift? { For more information, visit ­decisionresources.com. GASTROINTESTINAL The market for Crohn’s disease therapies is projected to experience modest growth over the next decade, increasing from about $3.2 billion in 2009 to $4.2 billion in 2019 in the United States, France, Germany, Italy, Spain, the United Kingdom, and Japan. Source: Decision Resources, Robust Market Forecast and Opportunities Analysis of Crohn’s Disease Market. { For more information, visit ­decisionresources.com. INFECTIOUS DISEASE To date, the most successful anti-infective drugs in terms of sales target HIV, the herpes virus (HSV-1 and HSV-2), bacterial infections, and hepatitis C (HCV). The anti-infective drugs market is expected to climb to $66 billion by 2013. Source: TriMarkPublications.com, Anti-Infective Drugs Markets. { For more information, visit ­trimarkpublications.com. NEUROPATHIC BACK PAIN For the treatment of neuropathic back pain, the highest percentages of surveyed neurologists (53%) and surveyed managed care organizations’ (MCO) pharmacy directors (40%) chose Pfizer’s Lyrica (pregabalin) as the most efficacious therapy when compared with other currently available agents. Surveyed neurologists who chose Lyrica indicated high satisfaction with the percentage of patients responding to treatment, reduction in pain intensity, and reduction of disability. Source: Decision Resources, DecisionBase 2011 report, Neuropathic Back Pain: Could an Emerging Therapy Obtain Commercial Success by Targeting this Untapped Patient Population? { For more information, visit ­decisionresources.com. RHEUMATOID ARTHRITIS Rheumatologists are initiating biologics, particularly the established TNF-alpha inhibitors, earlier in the rheumatoid arthritis (RA) treatment continuum compared with one year ago. Usage of the newer TNF-alpha inhibitors (UCB’s Cimzia and Centocor Ortho Biotech’s Simponi) and biologics with alternative mechanisms of action (Bristol Myers Squibb’s Orencia and Genentech-Roche’s Actemra and Rituxan) continues to expand at the expense of the established TNF-alpha inhibitors. Source: BioTrends Research Group, TreatmentTrends: Rheumatoid Arthritis. { For more information, visit ­­bio-trends.com. UROLOGY About 57% of surveyed U.S. urologists selected solifenacin (Astellas’s Vesicare/Vesikur) as the most efficacious drug for the treatment of overactive bladder when compared with other available therapies. But only 25% of surveyed managed care organizations’ (MCOs) pharmacy directors chose solifenacin as the most efficacious therapy for the indication, suggesting low awareness among them regarding the results of a head-to-head trial between ER tolterodine and solifenacin in which solifenacin demonstrated statistically significant superiority to ER tolterodine on a number of efficacy measures. Source: Decision Resources, DecisionBase 2011 report, Overactive Bladder: Will Advantages in Tolerability Be Sufficient to Give Emerging Agents an Edge Over Currently Marketed Anticholinergics? { For more information, visit ­decisionresources.com. VACCINES It is estimated that at least 2 million children die each year from diseases that could have been prevented by existing vaccines. More than 1.2 million of these deaths, 90% of which occur in the developing world, are a result of pneumococcal diseases, according to the World Health Organization. Pneumococcal conjugate vaccines (PCV) are taking aim at these diseases, and PCV revenue in Asia grew 18.1% annually since 2006 to reach $442 million in 2010. Source: Kalorama Information, Asian Vaccine Markets. { For more information, visit ­kaloramainformation.com. R&D Budget Cuts On Horizon According to Industrial Info Resources’ 2011 Pharmaceutical & Biotech Industry Outlook, all major pharmaceutical companies have announced cuts to their research and development budgets for 2011 and beyond. For example, company officials at Pfizer announced plans to reduce the company’s R&D budget by almost $3 million to $8.5 million by 2012. Meanwhile, GlaxoSmithKline has said it wants to cut the $6 billion it spent on R&D in 2010, and AstraZeneca expects to trim $1 billion from its R&D budget by 2014. Entire therapeutic areas are being cut as companies tighten their therapeutic focus and shed dry pipelines, the report says. { For more information, visit industrialinfo.com. Monoclonal Antibodies a Strong Category According to Insight Pharma Reports’ Monoclonal Antibodies Pipeline: A Segment of Major Growth, global revenues from monoclonal antibody products will have moved significantly past the $40 billion level in 2010 and are poised to continue growing steadily through to 2015. About 286 monoclonal antibodies are in various stages of clinical development, roughly 150 of which are in the clinic for cancer indications. Monoclonal antibodies in clinical development for other indications include an estimated 70 for treatment of inflammatory and autoimmune diseases 15 products for treatment of various metabolic disorders, 16 for CNS disorders, and 25 for infectious diseases. A further 10 are in development for treatment of cardiovascular diseases or transplant rejection. { For more information, visit insightpharmareports.com. China Presents Attractive Outsourcing Market China is regarded as a lucrative market able to help pharmaceutical companies to improve drug discovery at a reasonable cost. New analysis from Frost & Sullivan, Drug Discovery Outsourcing Market in China, finds that the market reached $315 million in 2009 and is expected to grow at a compound annual growth rate (CAGR) of 23% from 2009 to 2016. “Expired patents and the rise in diseases are expected to fuel the growth of the Chinese drug discovery market,” says Frost & Sullivan Research Analyst Amritpall Singh. “China offers a large talent pool in the field of pharmaceutical research and development, including an increasing number of Western-educated graduates or researchers having international working experience.” { For more information, visit pharma.frost.com. Healthy Growth in U.S. Generic Market The RNCOS report, Booming US Generic Drug Market, says the robust growth of the generic drugs market in the United States is being driven by factors such as demand for cost-effective medications, patent expiration of blockbuster drugs, and government support. The U.S. generics market is anticipated to grow at a CAGR of around 10% during the 2010-to-2013 period, the report projects. { For more information, visit rncos.com. Contract Manufacturing Expect to Expand Contract manufacturing is helping pharmaceutical companies to meet growing demand for new drugs and improve their core competencies. These factors helped the contract manufacturing market to generate revenue worth an estimated $22.5 billion at the end of 2009, according to the RNCOS report, Global Contract Manufacturing Market Analysis. With the changing economic scenario and the pressure to reduce the cost of manufacturing drugs, the global contract manufacturing market is expected to grow at a CAGR of around 11% during the 2011 to 2013 period. { For more information, visit rncos.com.

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