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Research and Markets: Target Product Profiles 2009: Physician Insights on Key Attributes: Attention-Deficit/Hyperactivity Disorder

Attention-Deficit/Hyperactivity Disorder: A nonstimulant therapy approved for adult ADHD with no risk of suicidal ideation

Using Target Product Profiles in Your Market Strategy

Our Target Product Profiles qualitatively predict the market potential of a drug fulfilling a key unmet need. This information is critical for evaluating the impact of clinical attributes on physician prescribing of emerging agents, whether the emerging drug is your own or a competitors. Examples of how to use the information you will find in this report are highlighted below:

For companies who are developing a drug with some of the characteristics we are testing, our survey results reveal the standards that surveyed physicians expect the remainder of the drugs clinical profile to meet. Our analysis begins to uncover physician-expected drug attributes as well as acceptable trade-offs in emerging therapies. Our primary research with practicing physicians includes this emerging therapys anticipated patient share, projected use by line of therapy, and forecasted sales.

For companies that already have a drug launched for the indication in question, our data and analysis show the impact an emerging drug would have on their brands market. Not only does our research reveal which existing brands would be replaced by a drug meeting the Target Product Profile, but it also clearly outlines whether any drugs in the pipeline will meet the criteria laid out by physicians to challenge the existing sales leader. This knowledge gives existing brands the information they need to protect their share, either through new clinical trials aimed at end points physicians say are critical differentiators or by aggressive marketing of brand attributes that emerging agents will not be able to beat.

For companies looking to enter a disease through licensing or acquisition, the challenge of sifting through tens or hundreds of early-stage candidates can be daunting. Our Target Product Profiles can quickly show business development teams the clinical attributes that are unique versus products already on the market, and our primary research with physicians quickly identifies likely share and market potential to give a first glimpse at valuation. Because all of our Target Product Profiles are designed to be attainable within the next decade, our research can be a fast and efficient way to whittle the field of potential licensing candidates down to the most valuable few.

The Target Product Profile reports are divided into two sections. The first section, Etiology and Pathophysiology, offers a high-level view of the genetic and environmental causes of the disease under study, as well as the subsequent symptoms and clinical effects that result. This section is intended to give the reader a clear view of the physical and biochemical pathways that are known, or suspected, to be causative to disease onset or progression. These pathways, therefore, are common targets for drug therapy; where possible, we identify the molecular targets against which current or emerging drugs act.

The second section, Target Product Profile Summary, begins with an overview of the drug development landscape and the attributes on which investigators are focusing. Based on this analysis, as well as the clinical end points that practicing physicians say are most influential in their prescribing decision, our analysts define a key unmet need that could be addressed within the next ten years. Our Target Product Profiles are a set of quantified performance measures against key clinical end points and attributes that physicians build themselves. Our analysis of physician-desired attributes identifies areas of potential trade-offs versus those attributes that are either expected in new agents or are fully satisfied by current therapies. This section concludes with an analysis of high-profile agents currently in the pipeline (Competitors to Watch and Emerging Product Profiles). Using surveyed physicians estimates of these agents usage as inputs, our analysis integrates our extensive knowledge of the competitive landscape and non-clinical market hurdles to determine the market potential of these agents and their threat to current brands.

Key Topics Covered:

• Introduction
• Using Target Product Profiles in Your Market Strategy
• Report Contents
• Target Product Profile Methodology
• Etiology and Pathophysiology
• Overview
• Etiology
• Environmental Risk Factors
• Genetic Predisposition
• Pathophysiology
• Abnormal Brain Regions in ADHD Patients
• Dysfunctional Neurotransmitter Systems
• Target Product Profile Discussion Adult Attention-Deficit/Hyperactivity Disorder
• Target Product Profile Summary for Adult Attention-Deficit/Hyperactivity Disorder 2012
• Assessing Drug Development Opportunities
• Target Product Profile Methodology
• Physician Survey Results
• Efficacy
• Safety and Tolerability
• Delivery
• Estimated Patient Share
• Pricing Potential
• Forecasted 2017 Pricing Environment
• Competitors to Watch
• Emerging Product Profiles

Methodology:

Target Product Profile Methodology

Our Target Product Profiles are made up of two physician-defined profiles that highlight physicians expectations of emerging therapies in terms of how much better or worse the therapy performs relative to a comparator drug on key measures of efficacy, safety and tolerability, and delivery. The profiles also provide physician insight on estimated uptake and use (i.e., patient share) of drugs matching the Target Product Profiles as well as key drugs already in the pipeline.

Interviews with key thought leaders are used to identify a key drug development opportunity that is realistic and obtainable within the next ten years. To complete the profile of a product that is able to fulfill the key drug development opportunity and determine the products potential uptake, we conduct two surveys for every disease we cover, involving approximately 60 U.S. and 30 European (France, Germany, and the United Kingdom) physicians who have large clinical practices.

The first survey asks U.S. physicians how they would expect a therapy fulfilling the key drug development opportunity to perform on various measures of efficacy, safety, and delivery. To qualify physicians willingness to accept varying trade-offs in efficacy, safety, or delivery, price points above and below a comparator therapy (generally the sales-leading agent in the disease) are used. Price is used to force physicians to make choices between must-have drug attributes and acceptable tradeoffs. These prices do not necessarily reflect the potential cost or reimbursement of a novel agent fulfilling the key drug development opportunity. With these price points in mind, physicians are asked to profile two theoretical therapies:

• Minimal Acceptable, defined as a therapy that satisfies the key drug development opportunity being tested and is priced lower than the comparator drug.
• Major Achievement, defined as a therapy that satisfies the key drug development opportunity being tested and is priced higher than the comparator drug.

All physician survey responses are averaged together to create the two final Target Product Profiles, each of which has clearly quantified performance measures against efficacy, safety, and delivery end points.

The second survey presents these two Target Product Profiles to a new set of approximately 60 U.S. physicians and to approximately 30 European physicians and asks for their opinion on the market potential of each profile. Survey results reveal both Target Product Profiles market potential in terms of prescription patterns (how many patients physicians would consider prescribing the theoretical product profiles), the line of therapy such theoretical products would be used, and which current drug(s) the theoretical products would replace.

The results of each of these surveys are presented and analyzed in the Target Product Profiles section of this report.

For more information visit http://www.researchandmarkets.com/research/3434cb/target_product_pro

Research and Markets
Laura Wood, Senior Manager,
press@researchandmarkets.com
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716