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Bipolar Disorder: Can Competitive Advantage Be Established in a Challenging Market


Description: A poorly understood, complex disease that involves a number of neurotransmitters, bipolar disorder presents several challenges for pharmaceutical companies seeking to develop new treatments. While lithium and several antiepileptic and antipsychotic agents are currently used to treat either manic or mixed episodes of BPD, only Eli Lilly’s Symbyax and AstraZeneca’s Seroquel have received FDA approval for treatment of bipolar depression. The numerous unmet therapeutic needs resulting from the incomplete understanding of BPD create significant opportunities within the competitive BPD market.

Get the Answers You Need to Shape Your Strategy

Bipolar disorder represents a market with significant opportunity, but few drug companies are actively developing new agents. What obstacles are currently deterring companies from entering the BPD market? What challenges need to be addressed, and what therapeutic needs remain unmet?

The treatment of depression associated with BPD has not been as extensively studied as the treatment of either unipolar depression or bipolar mania. What strategies does treatment of bipolar depression rely upon? Which classes of antidepressants appear to be the most effective for treating bipolar depression?

Several agents have received specific approval for treating BPD; other agents are commonly used off-label. Which agents are most frequently used as off-label treatments for BPD? What competitive advantages, if any, does FDA approval provide? Which companies are specifically pursuing FDA approval for their BPD agents?

Scope

- BPD background: Symptoms, pathophysiology, and etiology.
- Treatment options: Current therapies for the four common types of episodes associated with bipolar I disorder and bipolar II disorder.
- Market dynamics: Sales growth statistics for BPD-approved agents versus non-BPD-approved agents; sales and prescriptions of antipsychotics and antiepileptics in the United States.
- Emerging therapies: Antipsychotics and sodium- and calcium-channel blockers currently in development, along with novel approaches.
- Market outlook: Limitations of current BPD agents; challenges still remaining; and the likelihood that any one agent will dominate the BPD market.


Contents: Executive Summary
Strategic Considerations
Stakeholder Implications
Introduction
Overview of Bipolar Disorder
Symptoms, Pathophysiology, and Etiology
Types of Bipolar Disorder
Diagnosis, Epidemiology, and Impact of Bipolar Disorder
Current Pharmacological Therapies for Bipolar Disorder
Lithium
Antiepileptic Agents
Antipsychotic Agents
Antidepressants
Does Approval Aid Adoption?
Emerging Therapies for Treatment of Bipolar Disorder
Emerging Antipsychotic Agents
Janssen’s Invega Extended-Release Tablets
Organon’s Asenapine
Solvay’s/Wyeth’s/Lundbeck’s Bifeprunox
Vanda Pharmaceuticals’ Iloperidone
Sodium- and Calcium-Channel Modulators in Development for Bipolar Disorder
Novartis’s Licarbazepine (LIC-477)
Memory Pharmaceuticals’ MEM-1003
Novel Approaches to the Treatment of Bipolar Disorder
Outlook for the Bipolar Disorder Market

Tables:
1. Agents Commonly Used to Treat Bipolar Disorder, 2006
2. Emerging Agents for the Treatment of Bipolar Disorder
3. Sales of Leading Agents to Treat Bipolar Disorder, 2006

Figures:
1. Prevalent Cases of Bipolar Disorder by Type in the Major Markets, 2006
2. U.S. Sales of Antipsychotics Used in the Treatment of Bipolar Disorder
3. U.S. Prescriptions of Antipsychotics Used in the Treatment of Bipolar Disorder
4. U.S. Sales of Antiepileptics Used in the Treatment of Bipolar Disorder
5. U.S. Prescriptions of Antiepileptics Used in the Treatment of Bipolar Disorder
6. Regional Shares of Bipolar Disorder Treatment Sales in the Major Markets, 2006


Companies Mentioned Abbott Laboratories AstraZeneca Bristol-Myers Squibb Dainippon D-Pharm Eli Lilly Forest Laboratories Gedeon Richter GlaxoSmithKline Hoechst Marion Roussel Janssen Janssen-Cilag International Johnson & Johnson Kyowa Hakko H. Lundbeck Marinus Pharmaceuticals McNeil Memory Pharmaceuticals Novartis Organon Ortho-McNeil Otsuka Pharmaceutical Pfizer Repligen Sanofi -Aventis Shire Pharmaceutical Solvay Pharmaceuticals Taisho Titan Pharmaceuticals Vanda Pharmaceuticals Wyeth


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