Confronting Influenza 2006 A Tamiflu Update

Confronting Influenza 2006 A Tamiflu Update

Confronting Influenza 2006 Confronting Influenza 2006 A Tamiflu Update A Tamiflu Update Dominick A. Iacuzio, PhD Dominick A. Iacuzio, PhD Medical Director Medical Director

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

D. Release From D. Release From Cell Cell B. Entering Cell B. Entering Cell C. Replication C. Replication A. Binding to Sialic A. Binding to Sialic Acid Acid Pathology of Influenza Infection Pathology of Influenza Infection

Tamiflu Tamiflu™ ™ Relenza Relenza® ® (oseltamivir phosphate) (oseltamivir phosphate) (zanamivir) (zanamivir) Indication Indication Treatment Treatment in adults, in adults, Treatment in Treatment in adults, adults, adolescents and adolescents and adolescents and adolescents and children children ≥ ≥1 yr 1 yr children children ≥ ≥7 yrs 7 yrs Prophylaxis Prophylaxis in adults in adults and children and children ≥ ≥1 yr old 1 yr old Spectrum Spectrum Type A, type B Type A, type B Type A, type B Type A, type B Administration Administration Oral Oral Inhaled Inhaled Selective Neuraminidase Inhibitors Selective Neuraminidase Inhibitors

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

TAMIFLU TAMIFLU TM TM z z Indicated for Indicated for treatment treatment of influenza A and B in of influenza A and B in adults and children older than 1 year adults and children older than 1 year z z Indicated for the Indicated for the prevention prevention of influenza A and of influenza A and B for adults and children older than 1 year* B for adults and children older than 1 year* z z Available in Capsules and suspension Available in Capsules and suspension z z Licensed since 1999 Licensed since 1999 – – over 30 million treated over 30 million treated * New FDA expanded indicated for the * New FDA expanded indicated for the prevention prevention of influenza A and B of influenza A and B for adults and children older than 1 year old _ December 2005 for adults and children older than 1 year old _ December 2005

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

Active ingredient (API) Capsule Finished medicine Epoxide Ep. Azide Azide step 1 step 2 step 3 step 4 step 5 Shikimic Acid (fermentation) SA Establishment of an Establishment of an “ “end end- -to to- -end end” ” supply supply chain on US soil progressing ahead of chain on US soil progressing ahead of schedule schedule z z Today: ~15 Mio. treatments per year capacity on Today: ~15 Mio. treatments per year capacity on US soil US soil - - except for step 1 except for step 1 z z Activities to establish full supply chain and expand Activities to establish full supply chain and expand capacity moving full steam ahead capacity moving full steam ahead z z Capacity of ~86 Mio.

treatments per year by Capacity of ~86 Mio. treatments per year by September 2006 September 2006

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

10 Update on Roche Update on Roche’ ’s Planned Studies for s Planned Studies for Tamiflu Tamiflu z z Support of the NIH trial examining standard dose vs high dose (1 Support of the NIH trial examining standard dose vs high dose (150 50 mg bid) in severe hospitalized influenza, including H5N1 in SE A mg bid) in severe hospitalized influenza, including H5N1 in SE Asia/ sia/ NIH (US) NIH (US) z z Support of a clinical trial in UK using oseltamivir treatment of Support of a clinical trial in UK using oseltamivir treatment of children (1 children (1- -12 yrs) 12 yrs) – – examining resistance following approved unit examining resistance following approved unit dose administration dose administration z z Roche continues to support the efforts of NISN to monitor the gl Roche continues to support the efforts of NISN to monitor the global obal emergence of resistance to Tamiflu emergence of resistance to Tamiflu z z Roche established the oseltamivir expert working group to discus Roche established the oseltamivir expert working group to discuss s the design & conduct of pre the design & conduct of pre- -clinical experiments on H5N1, including clinical experiments on H5N1, including examining different dosing schedules/combinations with other examining different dosing schedules/combinations with other antivirals in ferrets/mice/monkeys and bridge this knowledge to antivirals in ferrets/mice/monkeys and bridge this knowledge to what what is known clinically with H5N1 is known clinically with H5N1 z z In collaboration with several groups, collecting clinical data, In collaboration with several groups, collecting clinical data, PK data, PK data, virological virological data on H5N1 infections to better understand the nature data on H5N1 infections to better understand the nature of the disease and Tamiflu outcomes of the disease and Tamiflu outcomes z z Designing protocols for studies to examine Tamiflu in Designing protocols for studies to examine Tamiflu in immunocompromised patients for both treatment and prevention immunocompromised patients for both treatment and prevention

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

Medstat Marketscan Medstat Marketscan Database Database Manuscript in process Manuscript in process

Methodology Methodology z z Anonymous patient Anonymous patient- -level data from the level data from the Medstat Marketscan claims database was Medstat Marketscan claims database was collected between 2000 and 2004 collected between 2000 and 2004 z z Used to identify children with influenza, aged Used to identify children with influenza, aged between 1 and 12 years between 1 and 12 years z z Patients who received a prescription for Patients who received a prescription for oseltamivir were compared against those who oseltamivir were compared against those who received no antiviral therapy received no antiviral therapy z z Primary and secondary endpoints included Primary and secondary endpoints included frequencies of pneumonia and rates of frequencies of pneumonia and rates of hospitalization, numbers of health care hospitalization, numbers of health care services utilized and health care expenditures services utilized and health care expenditures

Results Results z z 28,854 children were identified as having an episode of influenz 28,854 children were identified as having an episode of influenza a during the influenza seasons (October during the influenza seasons (October- -March) March) - - Of these 4,447 (17.9%) received a prescription for oseltamivir Of these 4,447 (17.9%) received a prescription for oseltamivir the they were diagnosed with influenza the they were diagnosed with influenza - - The remaining [patients (20,407) received no anti The remaining [patients (20,407) received no anti- -viral viral treatment treatment z z Oseltamivir use increased during the 4 years under evaluation, Oseltamivir use increased during the 4 years under evaluation, rising from 9.8% during the 200/2001 season to 31.9% during the rising from 9.8% during the 200/2001 season to 31.9% during the 2003/2004 season 2003/2004 season z z Pneumonia Pneumonia - - Patients receiving oseltamivir had a 51.7%* reduction in Patients receiving oseltamivir had a 51.7%* reduction in pneumonia pneumonia - - Children aged 6 Children aged 6- -12 experience the largest reduction in 12 experience the largest reduction in pneumonia risk, 64.1%* pneumonia risk, 64.1%* - - Children between 1 Children between 1- -5 experienced a 37.1% reduction in 5 experienced a 37.1% reduction in pneumonia risk pneumonia risk *P

Results Results z z Frequency of Hospitalization Frequency of Hospitalization - - Hospitalization for pneumonia occurred infrequently in both the Hospitalization for pneumonia occurred infrequently in both the intervention and control groups intervention and control groups - - A 25.7% relative risk reduction (95% CI: 0.227, 1.996) was A 25.7% relative risk reduction (95% CI: 0.227, 1.996) was observed for the oseltamivir group, the low rates limited the observed for the oseltamivir group, the low rates limited the ability to display statistical significance ability to display statistical significance z z Use of Antibiotics Use of Antibiotics - - Patients in the oseltamivir group were significantly less likely Patients in the oseltamivir group were significantly less likely (25.9%*) to receive a prescription for antibiotics (25.9%*) to receive a prescription for antibiotics z z Health Care Utilization and Expenditures Health Care Utilization and Expenditures - - Medical expenses were reduced by 17.9% among the oseltamivir Medical expenses were reduced by 17.9% among the oseltamivir group compared to the control group group compared to the control group - - A savings of $10 per patient for inpatient services and $29 per A savings of $10 per patient for inpatient services and $29 per patient for outpatient services for those receiving oseltamivir patient for outpatient services for those receiving oseltamivir compared to those receiving no antiviral treatment, respectively compared to those receiving no antiviral treatment, respectively - - These cost These cost- -saving were offset by a higher pharmaceutical saving were offset by a higher pharmaceutical expenditures ($65) while overall net expenditures were 6.5% expenditures ($65) while overall net expenditures were 6.5% ((5% CI: ((5% CI: - -1$12.80, $39.57) higher for the oseltamivir group 1$12.80, $39.57) higher for the oseltamivir group *P

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