Confronting Influenza 2006 A Tamiflu Update

Confronting Influenza 2006
    A Tamiflu Update
   Dominick A. Iacuzio, PhD
       Medical Director
Roche’s Continued Development of
 Tamiflu
z  An update of the new US Label for Tamiflu
z  Roche’s increased production capacity:
    -      US manufacturing capacity
    -      Worldwide production capacity
z    Update of ongoing and future planned studies:
    - Preclinical / clinical /seasonal viruses / H5N1
    -       Monitoring resistance of annual influenza
            viruses (NISN)
z       Patient-level data from the Medstat Marketscan
        claims database

                                                         2
Pathology of Influenza Infection
A. Binding to Sialic   B. Entering Cell   C. Replication   D. Release From
       Acid                                                      Cell
Selective Neuraminidase Inhibitors
                       Tamiflu™               Relenza®
                  (oseltamivir phosphate)    (zanamivir)
 Indication       Treatment in adults,      Treatment in
 adults,
                  adolescents and           adolescents and
                  children ≥1 yr            children ≥7 yrs
                  Prophylaxis in adults
                  and children ≥1 yr old
 Spectrum         Type A, type B            Type A, type B
 Administration   Oral                      Inhaled
Roche’s Continued Development of
 Tamiflu
z  An update of the new US Label for Tamiflu
z  Roche’s increased production capacity:
    -      US manufacturing capacity
    -      Worldwide production capacity
z    Update of ongoing and future planned studies:
    - Preclinical / clinical /seasonal viruses / H5N1
    -       Monitoring resistance of annual influenza
            viruses (NISN)
z       Patient-level data from the Medstat Marketscan
        claims database

                                                         5
TAMIFLU TM
 z   Indicated for treatment of influenza A and B in
     adults and children older than 1 year
 z   Indicated for the prevention of influenza A and
     B for adults and children older than 1 year*
 z   Available in Capsules and suspension
 z   Licensed since 1999 – over 30 million treated


* New FDA expanded indicated for the prevention of influenza A and B
for adults and children older than 1 year old _ December 2005
Roche’s Continued Development of
 Tamiflu
z  An update of the new US Label for Tamiflu
z  Roche’s increased production capacity:
    -      US manufacturing capacity
    -      Worldwide production capacity
z    Update of ongoing and future planned studies:
    - Preclinical / clinical /seasonal viruses / H5N1
    -       Monitoring resistance of annual influenza
            viruses (NISN)
z       Patient-level data from the Medstat Marketscan
        claims database

                                                         7
Establishment of an “end-to-end” supply
chain on US soil progressing ahead of
schedule
Shikimic
                   SA            Ep.        Azide
Acid
(fermentation)                                           Active                  Finished
                           Epoxide         Azide    ingredient (API)   Capsule   medicine
          step 1        step 2         step 3          step 4          step 5


z     Today: ~15 Mio. treatments per year capacity on
      US soil - except for step 1
z     Activities to establish full supply chain and expand
      capacity moving full steam ahead
z     Capacity of ~86 Mio. treatments per year by
      September 2006
Roche’s Continued Development of
 Tamiflu
z  An update of the new US Label for Tamiflu
z  Roche’s increased production capacity:
    -      US manufacturing capacity
    -      Worldwide production capacity
z    Update of ongoing and future planned studies:
    - Preclinical / clinical /seasonal viruses / H5N1
    -       Monitoring resistance of annual influenza
            viruses (NISN)
z       Patient-level data from the Medstat Marketscan
        claims database

                                                         9
Update on Roche’s Planned Studies for
    Tamiflu
z     Support of the NIH trial examining standard dose vs high dose (150
      mg bid) in severe hospitalized influenza, including H5N1 in SE Asia/
      NIH (US)
z     Support of a clinical trial in UK using oseltamivir treatment of
      children (1-12 yrs) – examining resistance following approved unit
      dose administration
z     Roche continues to support the efforts of NISN to monitor the global
      emergence of resistance to Tamiflu
z     Roche established the oseltamivir expert working group to discuss
      the design & conduct of pre-clinical experiments on H5N1, including
      examining different dosing schedules/combinations with other
      antivirals in ferrets/mice/monkeys and bridge this knowledge to what
      is known clinically with H5N1
z     In collaboration with several groups, collecting clinical data, PK data,
      virological data on H5N1 infections to better understand the nature
      of the disease and Tamiflu outcomes
z     Designing protocols for studies to examine Tamiflu in
      immunocompromised patients for both treatment and prevention
                                                                                 10
Roche’s Continued Development of
 Tamiflu
z  An update of the new US Label for Tamiflu
z  Roche’s increased production capacity:
    -      US manufacturing capacity
    -      Worldwide production capacity
z    Update of ongoing and future planned studies:
    - Preclinical / clinical /seasonal viruses / H5N1
    -       Monitoring resistance of annual influenza
            viruses (NISN)
z       Patient-level data from the Medstat Marketscan
        claims database

                                                         11
Medstat Marketscan
    Database
 Manuscript in process
Methodology
z   Anonymous patient-level data from the
    Medstat Marketscan claims database was
    collected between 2000 and 2004
z   Used to identify children with influenza, aged
    between 1 and 12 years
z   Patients who received a prescription for
    oseltamivir were compared against those who
    received no antiviral therapy
z   Primary and secondary endpoints included
    frequencies of pneumonia and rates of
    hospitalization, numbers of health care
    services utilized and health care expenditures
Results
z   28,854 children were identified as having an episode of influenza
    during the influenza seasons (October-March)
     - Of these 4,447 (17.9%) received a prescription for oseltamivir
       the they were diagnosed with influenza
     - The remaining [patients (20,407) received no anti-viral
       treatment
z   Oseltamivir use increased during the 4 years under evaluation,
    rising from 9.8% during the 200/2001 season to 31.9% during the
    2003/2004 season
z   Pneumonia
     - Patients receiving oseltamivir had a 51.7%* reduction in
       pneumonia
     - Children aged 6-12 experience the largest reduction in
       pneumonia risk, 64.1%*
     - Children between 1-5 experienced a 37.1% reduction in
       pneumonia risk
    *P
Results
z   Frequency of Hospitalization
     - Hospitalization for pneumonia occurred infrequently in both the
       intervention and control groups
     - A 25.7% relative risk reduction (95% CI: 0.227, 1.996) was
       observed for the oseltamivir group, the low rates limited the
       ability to display statistical significance
z   Use of Antibiotics
     - Patients in the oseltamivir group were significantly less likely
       (25.9%*) to receive a prescription for antibiotics
z   Health Care Utilization and Expenditures
     - Medical expenses were reduced by 17.9% among the oseltamivir
       group compared to the control group
     - A savings of $10 per patient for inpatient services and $29 per
       patient for outpatient services for those receiving oseltamivir
       compared to those receiving no antiviral treatment, respectively
     - These cost-saving were offset by a higher pharmaceutical
       expenditures ($65) while overall net expenditures were 6.5%
       ((5% CI: -1$12.80, $39.57) higher for the oseltamivir group
                                                              *P
THANK You!


Questions?
You can also read
Next part ... Cancel