Phase 1 OXyContin? Tablets Team To: Distribution Frorn: E. Chickering/L. Harrison Reviewed By.- E. Lockhart Subject: Phase IV OxyContinD Tablets Date: June 16, 1997 Team Meeting Minutes June 13, 3997 S. Aron*, E. Chickering, M. Cullen, R. Davis?, L. Harrison, E. ingber*, B. Kennedy, M. Laszek?, H. Lazarus, E. Lockhart, M. Shi absent Marketing and Sales Update Mike Cullen discussed in detail Marketing's positioning of OxyContin. He explained that we want to expand extensively in the noncancer market segment, while promoting OxyContin as "the one to start with" in cancer pain {instead of Percocet/Vicodtn, etc.) and "the one to stay with" through proper titration. We can show that we areas "effective" as morphine, but do not want to say. OxyContin is as "powen?ul" as morphine. Words such as "powerful" may make some people think the drug is dangerous and should be reserved for the more severe pain. This could have a negative effect in the much larger noncancer pain market. Mike reminded the team that we should keep this positioning in mind as we develop future marketing programs, symposia, clinical study manuscripts, and any other items that discuss the use of OxyContin. Mike also reviewed the recent attribute grid market research that was conducted at the Purdue ?Train the Trainer" Symposium held in San Antonio with physicians from the South Central Region. The grid results show us which attributes are important to physicians for treating cancer pain as well as noncancer pain and how OxyContin is perceived versus the competitive products in meeting these attributes. Medical Education Program Update H. Lazarus reported on the Purdue-sponsored pain management symposia in May/lune. CME Regional Meeting - Dallas, TX 5/31-6/1 Attendees: 90 primary care physicians Drs. R. Scott, M. Cone, S. Nadier, and D. Manning, spoke on ?Meeting the Chronic Pain Challenge" 97min8.doc Page i PDD1701807664 HIGHLY CONFIDENTIAL ACCESS RESTRICTED BY COURT ORDER ?3 North Central Regiori Pain Management/Speakers? Bureau Mtg. New Orleans, LA - 5/30-6/1 Attendees: 150 physicians Speakers included Drs. M. Levy, E. Narcessian, N. Irick, A. Lipman, A. Spanos, and two of patients of Dr. Spanos Surveys were distributed and are being analyzed. Scienti?c Writing Update Double?Blind Trial vs. IR Oxycodone in Low Back Pain (OC92-1201) manuscript is in internal review. Double?Blind Trial vs. Placebo in Osteoarthritis (OC92-1 102 - Roth) manuscript is expected to be in internal review by week of 6/16. Study report Percocet and Placebo in Osteoarthritis) comments have been incorporated and draft report will begin peer review during week of 6/16; final signoff expected 7/15. (Relative Potency Study vs, MS Contin) - draft manuscript is being written by a contract writer; expect first draft in-house by end of June. OxyContin Ciinicai Program Update Completed 1) 2) 3) 4i Placebo-Controlled vs. Percocet in Osteoarthritis - 167 Status: Data has been preliminarily analyzed. Both actives separate from placebo for pain relief. OxyContin has superior sleep quality over Percocet. Timeline: Final study report preparation and sign off by 7/15 00312-1101 Open Label Clinical Testing - n=247 Status: All outside data clarification forms have been answered. Timeline: BCDM stat tables to Sci Comm by 7/30 0033?0506 Opioid Naive I Fixed Combo Dosing Guidelines - =68 . Status: Data clarification forms have been answered and will be sent to outside data entry. Timeline: BCDM stat tables to Sci Comm - end of 3rd 0C93-0704 - Open Label Dosing Guidelines - :131 Status: Data analysis will be hand tallied Timeline: To be determined OC95-0203 - Cancer Efficacy in Mexico - =41 Status: DCFs to be completed at the end of June Timeline: Stat report due by 7/15 97min8.doc Page 2 andESUsaes PDD1701807665 HIGH LY CONFIDENTIAL ACCESS RESTRICTED BY COURT ORDER IN COMMONWEALTH OF KENTUCKY, EX REL. JACK CONWAY, ATTORNEY GENERAL v. PURDUE PHARMA L.P., ET AL., CIVIL ACTION NO. 303 (PIKE COUNTY CIRCUIT COURT) Ongoing 1) IN) 5) 6) OC96-0204 - Postop Within Labeling Conversion from PCA - 200 (planned) Status: Enrollment: 180. Preliminary report shows that conversion of I to 1.5 from IV morphine OxyContin has very good efficacy and good side effect profile. Abstract to be submitted to APS Annual Meeting. Timeline: Study completion in field 6/15 Gals-0304 vs. Percocet in Opioid-Naive Cancer Patients - 100 (planned) Status: Enrollment: 78. Timeline: Study will end in the field in August - Postop Inpatient Safety/Dose Finding Study to Expand Indications - n=120 (planned) Status: Twenty~one patients completed. All sites are initiated. Anticipate 12 patients per month. ?inging: Study completion 1? 0036-0602 - Pharmacokinetic Study in Children 25 FDA required Status: Three patients have completed. Dr. Peter Davis of the University of Pittsburgh is submitting budget. Protocol sent to University of Utah. - Timeline: Completion 3'd 0C96-0703 - Postop Within Labeling Conversion from Epidural - 120 (planned) Status: Study initiated. Timeline: Study completion (2/97 Postop Ambulatory Study to Expand Indications - 120 (planned) Status: Study initiated at three sites in Salt Lake City area. Timeline: Completion by is anticipated - Placebo Controlled Osteoarthritis - n= 100 (planned) Status: Two sites initiated; other 8 sites to follow over the next few weeks. Timeline: Completion 3"d Protocols Under Development or for Second and Third Quarter 1997 initiation 1) 2) 0036-0701 Postop 60?Center Surgeon Study - n: 300 (planned) Status: First teleconference has taken place. Abbott has sent out its sales force to continue to recruit surgeons. Timeline: Next teleconference with surgeons scheduled for june 18. Completion in the field (2/97 0036-1002 - Placebo Controlled/ Back Pain =100 (planned) Status: Protocol to be signed off. Plan to use Pharmacy Gold HMO as site. Timeline: Initiation end of 3'd COmpletion in field 4?h 0/98 97min8.doc Page 3 euonansi?if PDD1701807666 HIGHLY CONFIDENTIAL ACCESS RESTRICTED BY COURT ORDER IN COMMONWEALTH OF KENTUCKY, EX REL. JACK CONWAY, ATTORNEY GENERAL V. PURDUE PHAR MA L.P., ET AL., ACTION NO. (PIKE COUNTY CIRCUIT COURT) 3] 0095-0202 - Open Label Outcomes vs. lR Oxycodone/APAP in Osteoarthritis - n=200 (planned) Status: Protocol being developed. Timeline: initiation 3rd Completion in the field (2/98 4) 0C95-0202A - Pharmacoeconomic Cost-Effectiveness Analysis (associated with 0035?0202) Status: Developing timelines for pilot and main study. Timeline: Pilot study to start with OC96-1003. Report at end of 5) 0C97-0302 - Long Term Open Log of Noncancer Patients Status: Synopsis submitted for executive review. Timeline: Initiate Status: Protocol is in final review, awaiting FDA response. Timeline: Initiation is projected for July. Miscellaneous F, Presentation to IPS scheduled for June 24. A. Labrosciano joined the team as CRA. cc: Team l. Conover P. Coldenheim J. Komorowski R. Reder M. Alfonso R. Fitzmartin W. Herlihy J. Lang K. Sackler R. Burch M. Friedman R. Kaiko W. Mallin R. Sackler 97min8.doc Page 4 90130303288 PDD1701807667 HIGHLY CONFIDENTIAL - ACCESS RESTRICTED BY COURT ORDER lN COMMONWEALTH OF KENTUCKY, EX REL. JACK CONWAY, ATTORNEY GENERAL v. PURDUE PHARMA L.P., ET AL., CIVIL ACTION NO. 07~Cl~01303 (PIKE COUNTY CIRCUIT COURT)