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Transcript
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, antiinflammatory conditions
PDL’s Development Portfolio
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
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
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)
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
Diagnosed & Current Asthma
United States
2001
2011
Mild Intermittent
4,636,500
4,961,100
Mild Persistent
2,117,600
2,265,900
Moderate Persistent
2,273,700
2,432,800
Severe Persistent
2,117,600
2,265,900
11,145,400
11,925,700
Total
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
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
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
Allergen
IgE
Mast Cell
Daclizumab
Release of Factors
Allergic Reactions
Recruitment of T Cells
T Cells release more Factors
Amplification of Allergic reaction
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
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
Allergen
IgE
Xolair
Mast Cell
Daclizumab
Release of Factors
Allergic Reactions
Recruitment of T Cells
T Cells release more Factors
Amplification of Allergic reaction
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
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
Claims Data Statistics
Claims Data Results (Non-Medicare population)
N = 1402
Age
Mean
Median (50 %-ile)
Range
Std. Deviation
25
19
88
20.6
Source: HSI Network, LLC
Total Inpatient
Claims paid for
Patient
$ 7,275
$0
$ 553,000
$ 27,000
Total Physician
Claims paid for
Patient
$ 2,040
$ 863
$ 178,000
$ 5,800
Total Pharmacy
Claims paid for
Patient
$ 856
$ 323
$ 21,000
$ 1,600
Total Costs/
Patient (could
include nonasthma costs)
$ 10,200
$ 2,500
$ 569,000
$ 28,800
Claims Data Statistics
Claims Data Results—Fifty Patient Cases, calendar year 2002
N = 50
Age Range
Sex
Avg. Number of Asthma-Related ER visits
Avg. Number of Asthma-Related ER visits for patients visiting at least once
Avg. Hospitalization Claims paid
Avg. Physician Claims paid
Avg. Pharmacy Claims paid
Source: HSI Network, LLC
1 year-58 years
23 M, 27 F
0.84
2.10
$ 10,347
$ 1,624
$ 1,017
Cost Effectiveness Analysis
Change in Costs
Change in QALYs
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)
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!