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Daclizumab for Asthma: A Business Opportunity Assessment

Explore the business potential of Daclizumab for various indications like asthma, multiple sclerosis, and ulcerative colitis. Learn about the development portfolio, global initiatives, pharmacotherapy, and unmet medical needs for asthma treatment. Dive into the efficacy comparison with Xolair, pricing, claims data statistics, and regulatory factors.

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Daclizumab for Asthma: A Business Opportunity Assessment

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  1. Daclizumab for Asthma:A Business Opportunity Assessment

  2. PDL’s Line of Business • Humanizing antibodies from animal populations (mice) • Non-exclusive out-licensing of patents • Development of humanized MAbs as therapeutic agents • Asthma, cancer, autoimmune disorders, anti-inflammatory conditions

  3. Monoclonal Antibody Indication(s) Daclizumab Asthma Multiple sclerosis Type 1 diabetes Ulcerative colitis Nuvion Ulcerative colitis HuZAF (anti-gamma interferon) Crohn’s Disease Anti-51 Integrin Solid tumors Anti-51 Integrin Fab Age-related macular degeneration PDL’s Development Portfolio

  4. Asthma • Chronic inflammatory disorder of airways • Coughing, wheezing, airway constriction • Genetic and environmental factors • Occur, regress, recur at any age • Hypersensitivity to allergens • Inappropriate immune response

  5. Asthma Severity Groupings • Mild Intermittent (41.6 %) • Mild Persistent (19 %) • Moderate Persistent (20.4 %) • Symptom episode every day for 12 months • Severe Persistent (19 %) • 21 Symptom episodes in a typical week Global Initiatives for Asthma (GINA)

  6. Asthma Pharmaco Therapy • Controller (maintenance) therapy • Inhaled corticosteriods • Long-acting beta2 agonist (inhaled/oral) • Leukotriene antagonists (oral) • Sustained-release theophyline (oral) • Oral corticosteriod (severe cases only) • Reliever therapy • Short-acting beta2 agonist

  7. Diagnosed & Current Asthma

  8. Most Accessible Segment - • Refractory severe persistent asthma • 2 to 3 % of diagnosed AND current population • Poorly controlled by inhaled corticosteriods (ICS) • Potential population of • 223,000 to 334,000 • 0.076% to 0.114% of US population

  9. Unmet Medical Needs • Agents for refractory severe persistent asthma • Anti-inflammatory controller agents as effective as corticosteriods w/o side effects • More convenient dosage forms • depot, once daily inhaler, once daily tablet

  10. Daclizumab for Asthma • Humanized monoclonal antibody • Pharmacology • IL-2 receptor antagonist (immunosuppressive) • Inhibits T-cell migration and a cascade of events that increase severity of asthma • Dosage form • Concentrated solution diluted prior to injection • Patient administered drug at specialty pharmacies • Administered every two weeks • Marketed as Zenapax (H. La Roche) • Acute kidney transplant rejection drug

  11. Daclizumab

  12. Daclizumab for Asthma • Development status • Completed Phase II trial • 114 patients • Clinical study patient population • Chronic persistent asthma • Poorly controlled by inhaled corticosteriods • Results will be compared to Xolair efficacy

  13. Reference Technology: Xolair • Genentech • Approved June 2003 • First biotech for asthma • Moderate-to-severe persistent asthma • Same population as Daclizumab • Sub-cutaneous injection every 2 to 4 wks • Same administration as Daclizumab • Higher concentration of drug • In some instances, 5X higher

  14. Xolair Daclizumab

  15. Efficacy Comparison • Xolair: • Improved Fev1 by 3% • This decreased asthma exacerbations by about 30% • Daclizumab • Improved Fev1 by 2.9% • No measurement of exacerbation change, but can assume it’s similar • Same efficacy! • PDL Choices • Alter phase III to attain better efficacy • More frequent administration • Higher concentrations • Create a me-too drug • Alter phase III trials to test an easier form of administration • Self-administration • Longer time lengths between administrations

  16. Reference Technology: Xolair • Pricing • AWP of $541.25 per 150 mg vial • $8,000 to $12,000 per patient per year • Market penetration • Jan 2004 – 923 total Rx, $1.82 MM • Feb 2004 – 1,090 total Rx, $2.08 MM • March 2004 - 1,462 total Rx, not available

  17. Claims Data Statistics

  18. Claims Data Statistics

  19. Cost Effectiveness Analysis Change in Costs Change in QALYs

  20. Cost Effectiveness Analysis Assumptions: • Improved QALY score with Zenapax • Less costly than Hospitalization (on a per incident basis) • More costly than Hospitalization considering the numbers of patients treated in order to capture those most at risk. (consider treating 50 patients to capture 20)

  21. Regulatory Factors • Predicate product (Xolair) [+] • New cGMP bio-manufactuing facility [+] • 2nd indication for approved product [+] • Zenapax for acute kidney transplant rejection • Predicate product reimbursed [+] Good regulatory position!

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