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Daclizumab for Asthma: A Business Opportunity Assessment

Daclizumab for Asthma: A Business Opportunity Assessment. 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.

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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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