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US Neuropathic Pain

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					                                                                        Success Through Experience




                                                                        Providing an
This new EP Publications report:
                                                                        Enhanced Perspective...
s   Provides an epidemiological forecast
    for key conditions associated with
    neuropathic pain in the US market in
    2004, 2009, and 2014
                                                                        On
s   Forecasts the potential value of the
    neuropathic pain market for eight
                                                                        US Neuropathic
    indications through 2014
                                                                        Pain
s   Presents expert analysis of the
    commercial potential and key                                        Market Potential Through 2014
    differences among products in
    development for the treatment of
    neuropathic pain                                                    Authors:
                                                                        Sharon Grehan, Ph.D.
s   Incorporates interviews with thought-
    leading physicians regarding the
                                                                        Irina Fayngersh
    treatment of neuropathic pain
    in the US
                                                                        Contributor:
s   Describes the critical factors driving
                                                                        Tony Hung
    neuropathic pain market growth
    through 2014                                                        About WWMR, Inc.

                                                                        WWMR, Inc., is a leading marketing research and strategic consulting
New for 2004 report:
                                                                        firm with global capabilities. Since 1994, WWMR, Inc., has provided
                                                                        over 1,000 high-quality, insightful proprietary studies to clients in the
s   Report supplement addressing initial                                pharmaceutical, biotech, medical device, and diagnostics industries
    impact of the launch of generic
                                                                        worldwide. Using primary and secondary research methodologies,
    gabapentin
                                                                        WWMR, Inc., provides market opportunities and product assessments,
                                                                        competitive intelligence, forecasts, population projections, pre-launch
s   Supplement issue date approximately
                                                                        product planning, post-launch product monitoring, product pricing
    six months following generic
    gabapentin launch (est. early 2005)                                 strategy, database products, and on-site information center
                                                                        management. Enhanced Perspective Publications (EP Publications) is
                                                                        the multi-client service of WWMR, Inc.




                                                                                                                                                         USNP804P1




               2929 Campus Drive, Suite 200   s   San Mateo, CA 94403   s   Toll free (888)947-2339   s   Fax (650)312-1570   s   REPORTS@WWMR.com   s www.WWMR.com
                                                                               Providing an Enhanced Perspective...



    US NEUROPATHIC PAIN

A Complex Market of Diverse Needs
Neuropathic pain (NP) can have chronic, deblilitating impact on                         s    Complex regional pain syndrome
the lives of patients with a variety of conditions, including low-                      s    HIV/AIDS neuropathy
back pain, diabetes, herpes, trigeminal neuralgia, or HIV/AIDS.                         s    Post-herpetic neuralgia
Many patients and their physicians even fail to realize the                             s    Phantom limb pain
neuropathic nature of some patients’ pain, including severe                             s    Spinal cord injury
burning, stinging, and shooting pain. This general lack of                              s    Trigeminal neuralgia
awareness is largely due to the complicated nature of the onset
of NP, difficulty in confirming diagnoses, and the lack of                              Expert analysis and commentary describing the future NP market
effective treatments.                                                                   are based on:
An Opportunity to Meet Unmet Need for Therapy
                                                                                        s    Comprehensive analysis of prescriptions written for specific
By 2014, there will be over 2.6 million individuals in US                                    conditions, including estimations of prescription size, number
                                                                                             of refills, and cost
suffering from major NP conditions.
                                                                                        s    Evaluation of drugs in the NP drug pipeline, with conclusions
Given this substantial patient population, NP has received                                   on the future directions in treatment
particular attention in recent years due to its relative resistance to                  s    Interviews with leading US clinicians and researchers,
conventional analgesic therapies. Importantly, many analgesic                                including medical directors of selected pain centers and
drugs, from non-steroidal anti-inflammatory drugs to strong                                  clinicians treating NP
opiates, have proven to be either ineffective or to provide only                        s    In-depth analysis of the medical literature, including treatment
limited relief. In fact, few pharmacological therapies have been                             review articles, medical textbooks, epidemiology studies, and
approved specifically for the treatment of NP.                                               clinical studies
For these reasons, there is a critical need to develop novel
                                                                                        s    Thorough review of country-specific and overall trends
therapies that are safe and effective. Recent research elucidating                      Market and patient population forecasts are based on a
the mechanisms of NP has provided new targets for                                       consensus developed from industry experience, clinician input,
pharmacological interventions that have captured the attention of                       and analysis of secondary sources.
the pharmaceutical industry.
                                                                                        WWMR’s US Neuropathic Pain report will allow pharmaceutical
Report Objectives & Methodology                                                         and biotechnology executives to:
In this report WWMR, Inc., provides an overview for eight major                         s    Determine the initial effects of generic gabapentin on the US
conditions causing NP in the US market.                                                      neuropathic pain market and impact on the future market
This report also summarizes WWMR, Inc.’s current
                                                                                        s    Compare the epidemiology of neuropathic pain, including
understanding of NP mechanisms, and highlights promising                                     projected growth rates, by indication
targets for drug development. Also reviewed are new treatments
                                                                                        s    Recognize the specific conditions associated with neuropathic
already in development that offer the promise of improved pain                               pain that have high market potential in the next 10 years
management of NP in the near future.                                                    s    Target specific patient populations who will benefit most from
                                                                                             drugs in the neuropathic pain pipeline
Models representing patient populations and the commercial                              s    Anticipate upcoming competitors and product licensing
value (USD) of this market in 2004, 2009, and 2014 are                                       opportunities
reviewed. These models describe the important features of key                           s    Understand the type and level of unmet need in the US
conditions associated with NP:                                                               neuropathic pain market
s   Neuropathic back pain                                                               s    Recognize the impact of special market dynamics, including
s   Diabetic neuropathy                                                                      potential off-label usage, on product uptake forecasts


    About EP Publications
    Enhance your perspective through EP Publications, a service of WWMR, Inc. Each report pinpoints and evaluates
    key trends and markets, enabling clients to identify opportunities and augment strategic decisions. In-house
    consultants with industry experience use qualitative and quantitative research methodologies to provide the most
    comprehensive and insightful business intelligence available in the life sciences industry.
                                                                                                                                                                USNP804P2




                      2929 Campus Drive, Suite 200   s   San Mateo, CA 94403   s   Toll free (888)947-2339   s   Fax (650)312-1570   s   REPORTS@WWMR.com   s www.WWMR.com
                                                                                        Providing an Enhanced Perspective...



    TABLE OF CONTENTS                     s   US NEUROPATHIC PAIN
     NEW IN 2004                                                           6.  Basis of target population projections                C.   Limitations of Current Treatment
s    A supplement addressing the initial impact of the                     7.  US HIV/AIDS neuropathy population                     D.   Promising New Approaches
     launch of generic gabapentin will be issued                               projections                                           E.   Future Trends
     approximately 6 months following the launch (est.                 D. Neuropathic Back Pain                                      F.   Drugs in Clinical Development to Treat
     mid-2005).                                                           1. Low-back pain                                                Neuropathic Pain
s    The supplement will carefully examine the relative use               2. Low-back pain incidence and prevalence                       1. Recent changes in the pipeline
     of generic gabapentin in its first few months post-                  3. Chronic low-back pain prevalence                                  1.1 Recent launches
     launch _ the period over which the launch is                         4. Neuropathic, chronic low-back pain                                1.2 Drugs recently entering clinical trials
     expected to have its most dramatic impact.                                prevalence                                                      1.3 Discontinued or suspended drugs
                                                                          5. Basis of target population                                   2. Phase III, Preregistration, and Registration
    I. EXECUTIVE SUMMARY
                                                                          6. US neuropathic, chronic low-back pain                             2.1 Ion channel antagonists
    II. INTRODUCTION AND METHODOLOGY                                           population projections
    III. PHYSIOLOGY OF PAIN                                                                                                                    2.2 Glutamate receptor antagonists
                                                                       E. Trigeminal Neuralgia
         A. Definition of Neuropathic Pain                                                                                                     2.3 Neuromuscular blocking agents
                                                                          1. Trigeminal neuralgia
            1. Nerve injury                                                                                                                    2.4 Cannabinoid receptor agonists
                                                                          2. Incidence
            2. Long duration                                                                                                                   2.5 Growth factor agonist
                                                                          3. Basis for target population
            3. Abnormal sensations                                                                                                             2.6 Alpha Adrenoreceptor agonists
                                                                          4. US trigeminal neuralgia population
            4. Aggravation by physiological processes                          projections                                                3. Phase II
            5. Cellular mechanisms of neuropathic pain                 F. Complex Regional Pain Syndrome                                       3.1 Glutamate/NMDA receptor
         A. Definition of Neuropathic Pain States                                                                                                   antagonists
                                                                          1. Complex regional pain syndrome
            1. Diabetic neuropathy                                                                                                             3.2 Growth factor agonists
                                                                          2. Complex regional pain syndrome
            2. Post-herpetic neuralgia                                         prevalence                                                      3.3 Undefined mechanisms
            3. Peripheral neuropathy in HIV/AIDS                          3. Complex regional pain syndrome severity                           3.4 Ion channel antagonists
            4. Neuropathic low-back pain                                  4. Basis of target population estimation                             3.5 GABA receptor agonists
            5. Trigeminal neuralgia (tic douloureux)                      5. US CRPS population projections                                    3.6 Cannabinoid receptor agonists
            6. Complex regional pain syndrome (CRPS)                   G. Phantom Limb Pain                                                    3.7 Nicotinic acetylcholine receptor
                                                                                                                                                    agonists
            7. Phantom limb pain                                          1. Phantom limb pain
                                                                                                                                               3.8 Prostaglandin antagonists
            8. Spinal cord injury                                         2. Amputation incidence and prevalence
                                                                                                                                               3.9 Cholecystokinin antagonists
    IV. MEASUREMENT OF PAINFUL CONDITIONS                                 3. Phantom limb pain incidence and
                                                                               prevalence                                                      3.10 Cyclo-oxygenase inhibitors
         A. Pain Measurement Scales
                                                                          4. Basis of target population estimation                        4. Phase I
            1. Qualitative assessments
                                                                          5. US phantom limb pain population                                   4.1 NMDA antagonists
            2. Standard quantitative pain
                 measurement scales                                            projections                                                     4.2 Adenosine A1 receptor antagonists
                 2.1 Visual analog scale (VAS)                         H. Spinal Cord Injury                                                   4.3 Unknown mechanisms
                 2.2 McGill Pain Questionnaire (MPQ)                      1. Spinal cord injury                                           5. No recent development reported
                 2.3 The neuropathic pain scale (NPS)                     2. Spinal cord injury incidence                          VII. MARKET FORECASTS AND ESTIMATES,
                                                                          3. Spinal cord injury prevalence                             CURRENT AND FUTURE
         B. Clinical Assessment of Neuropathic Pain
                                                                          4. Spinal cord injury chronic pain prevalence                A. Current Sales of Pharmaceutical Products,
    V. EPIDEMIOLOGY - CURRENT AND FUTURE                                                                                                  By Condition
         A. Diabetic Neuropathy                                           5. Basis of target population estimation
                                                                                                                                          1. 2004 US market: Summary by drug class
            1. Diabetic neuropathy                                        6. US spinal cord injury population
                                                                               projections                                                2. 2004 US market: Summary by
            2. Diabetic prevalence                                                                                                             neuropathic pain condition
                                                                    VI. APPROACHES TO TREATMENT OF
            3. Diabetic neuropathy prevalence                           NEUROPATHIC PAIN                                                       2.1 Clinician views
            4. Symptomatic diabetic neuropathy                         A. Actual Clinical Practice                                        3. 2004 US market: Details by pain
                 prevalence                                                                                                                    condition
                                                                          1. Antidepressants
            5. Diabetic neuropathic pain prevalence                                                                                            3.1 Diabetic neuropathic pain
                                                                          2. Anticonvulsants
            6. Basis of target population projections                                                                                          3.2 HIV/AIDS neuropathic pain
                                                                          3. Local anesthetics, regional nerve blocks,
            7. US diabetic neuropathy population                               and sympathetic nerve blocks                                    3.3 Post-herpetic neuralgia
                 projections                                                                                                                   3.4 Neuropathic back pain
                                                                          4. Antiarrhythmics
         B. Post-Herpetic Neuralgia                                                                                                            3.5 Trigeminal neuralgia
                                                                          5. Non-narcotic synthetic opioids
            1. Post-herpetic neuralgia                                                                                                         3.6 Complex regional pain syndrome
                                                                          6. Opioids and semi-synthetic narcotics
            2. Herpes zoster incidence                                                                                                              (CRPS)
                                                                          7. Muscle relaxants
            3. Post-herpetic neuralgia incidence                                                                                               3.7 Phantom limb pain
                                                                          8. NMDA receptor antagonists
            4. Post-herpetic neuralgia prevalence                                                                                              3.8 Spinal cord injury
                                                                          9. Steroids
            5. Basis of target population projections                                                                                  B. Market Forecasts for Neuropathic Pain
                                                                          10. VR-1 receptor agonists                                      Treatment, 2009 and 2014
            6. US post-herpetic neuralgia population
                 projections                                              11. Non-steroidal anti-inflammatory agents                      1. Anticonvulsants
                                                                               (NSAIDS)
         C. HIV/AIDS Neuropathic Pain                                                                                                     2. Antidepressants
                                                                          12. Non-pharmacologic treatments
            1. HIV/AIDS Pain                                                                                                              3. Oral opioids
                                                                               12.1 Electrical nerve stimulation
            2. HIV/AIDS incidence and prevalence                                                                                          4. Pregabalin
                                                                               12.2 Acupuncture
            3. AIDS incidence and prevalence                                                                                              5. Ziconotide
                                                                               12.3 Hypnosis and psychological
            4. HIV/AIDS pain prevalence                                              approaches                                           6. Other
            5. HIV/AIDS neuropathic pain prevalence                    B. Clinical Practice Guidelines
                                                                                                                                                                                HPC103P3
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                          2929 Campus Drive, Suite 200        s   San Mateo, CA 94403   s   Toll free (888)947-2339   s   Fax (650)312-1570   s   REPORTS@WWMR.com      s www.WWMR.com

				
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