1997 BUDGET PLAN .OXYCONTINW The classic-model utilized in treatment of cancer pain is the World Health Organization (W.H.O.) Three Step Analgesic Ladder. The recommendations of the W.H.O. are: Step 1: Use NSAIDs to treat mild pain, aspirin, acetaminophen and NSAIDs. Step 2; Use weak opiOids to treat moderate pain, codeine, oxycodone and hydrocodone Step 3: Opioids to treat severe pain, - 1;:ine. Opioid c: . v. I .: treating moderate-to-moderately severe pain .n Ezep 2 have been limited by oxycodone, hydrocodone, and codeine combination products. Their short-acting duration of action provides peaks and vi. '_valleys in pain control. The combination of the opioid with APAP or ASA limits the maximum dosage because of potential lliver- toxicity. The APAP or .ASA component also has the potential to mask a fever in the cancer patient. All these problems associated with the choice of opioid analgesics in Step 2 provided an Opportunity for a single-entity, long?acting oxycodone product, OxyContin. Long-acting morphine and the transdermal fentanyl patch provide physicians with two long-acting products to meet the needs of moderately severe to severe pain in Step 3. Morphine and Fentanyl, available to treat Step 3, possess disadvantages such as the patient stigmas that surround morphine, "and the M.D., R.N., 'pharmacist reluctance to use them. .990 n. Fixed Combination Opioids Fixed combination opioids (oxycodone, hydrocodone, and codeine combined with APAP or ASA) have been the drugs of choice for treating moderate to moderately severe cancer pain Step 2). Because they contain APAP or? these jproducts are limited. by? a recommended _dosing ceiling, because the non?opioid can cause renal' or hepatic toxicities. Sales for generic combination opioids are expected to continue growing, while the branded products_will continue to decline. Combination opioids are considered. primary competition for OxyContin. MS CONTIN has become the gold standard for treating moderately severe to severe cancer pain (W.H.O. Step 3) Although faced with stiff competition from Duragesic? and Oramorph MS comm sales grew by 20% in 1995, to $113 million from $94 million in 1994;. It is expected an" that health care professionals will continue to support the use of MS CONTIN for severe pain in 1997 for patients who need morphine. Because a bioequivalent AB-rated generic controlled- release' morphine sulfate is expected to be available sOmetime in the near future, one of the primary objectives is to capture patients who would have been started on MS CONTIN to OxyContin, as quickly as possible. It is expected that Duragesic will continue to be heavily promoted. --for moderate to severe cancer pain. The patch' is ?mainly used for moderately severe to severe' pain;( but Janssen has been targeting the moderate to moderately severe market.for the past two? three years; Their progress has been slow but steady in obtaining patients coming straight off of" fixed combination opioids. qua JanSsen will continue to target primary care physicians '(namely' internists) as well as oncologists. In 1996, Janssen spent a significant amount of money ($1,008,519 through August) advertising-Duragesic in journals which target the internist and other primary care specialists. Because OxyContin is being positioned for patients who would.haye been started on fixed combination opioids, frown which. Duragesic draws approximately 25% of its sales, it is expected that Janssen will try to counter the OxyContin-position by stressing fewer side effects 'and easier_titration. A.recent market research survey revealed that a lack of efficacy, breakthrough pain and side_effects are the most common reasons why patients are switched .from leyContin to anOther* opioid? As a result, it will be critical that proper titration and treatment of side effects are stressed in the promotion of OxyContin. 2?27 Faulding 'received FDA approval to market Kadian (morphine sulfate extended release capsules) on July 3, 1996. Zeneca Pharmaceuticals, the company which has marketing rights to Kadian, .began promotion in September. Kadian can be dosed either q24h or q12h. Although not bioequivalent to MS CONTIN, IKadian is being positioned. as a "better alternative." In Australia the product was launched by Glaxo whose promotional focus has centered around' the inference that flatter plasma concentrations equate to better efficacy than MS CONTIN. It is unlikely that Kadian will be primary competition for OxyContin since the use of morphine for moderate to - moderately severe pain has not been an accepted practice among health care professionals.'Kadian will likely replace a portion of MS CONTIN prescriptions and reduce the available prescriptions for new patient starts on OxyContin instead of MS ?Contin. It iS Ianticipated, however, that Kadian will position itself as the logical next step as patients no longer tolerate or receive Hadequate analgesia from OxyContin. Just as with Duragesic, it will be critical that proper titration and treatment of side effects are stressed nhen selling OxyContin, thereby reducing the number? of patient failures. In addition, Kadian. will distract our field force as they focus on defensive actions to protect MS CONTIN rather than sales of OxyContin. Roxane is expected to continue promotion of Oramorph SR by positioning a cost effective alternative to MS CONTIN. _It is exper?-; that Roxane will continue to spend a significant .- .12. of promotional money for journal advertising .-: -E.:ect mail. Their marketing and Isales promotion convincing formulary decision makers for hos;;t and state formulary committees that Oramorph :1 expenSive, but just as effective replacement 'As with Kadian, this product reduces Ch: available for switches to OxyContin. Generic Morphine Sulfate Controlled?Release It is possible that Ia generic -morphine sulfate controlled-release product that is bioequivalent to Ms CONTIN will be approved by FDA sometime in the next two years. This product will not be considered primary competition for OxyContin since it will compete mainly with MS CONTIN. However, since it will be a day, long?acting Opioid, if ii: is priced considerably lower than OxyContin. it will likely be positioned as a cost?effective alternative to OxyContin. As' with Kadian, _th;si product. reduces the . prescriptions available for switches to OxyContin. During 19?5, of injectable morphine was flat. PCA Pumps are considered primary or secondary competition for OxyContin since a large majority' of Ithese-patients can no longer swallow. gun . Clinical Support/Dates Study: Date of Completion: Date.of Marketing Usage: Marketing Usage: Study: Date of-Completion: . Date of Marketing Usage: Marketing Usage: Study: Date of Completion: 'Date of Marketing-Usage: Marketing Usage: .efficacy, Naive and Opioid ?-Fixed Combination (PRN) Patients First Quarter, 1997 Second Quarter, 1997 To demonstrate that] OxyContin can be an effeCtive analgesic in opioid naive patients or in patients currently taking fixed Combination opioids. OxyContin vs. Percocet? vs. Placebo 7 in? Patients Fourth Quarter, 1996 First Quarter, 1997 A. head-to?head comparative study to .measure the safety, and quality of life of OxyContin vs. Percocet in osteoarthritis patients. OxyContin vs. Percocet in Cancer Pain patients who are opioid naive or on low dose fixed combinations. (OC95-0304) Fourth Quarter, 1997 First Quarter, 1998 -To prove that OxyContin is as safe and effective as Percocet in cancer_ patients but provides a better quality ?Df life because of its _q12h administration. gun Osteoarthritis Study: Date of Completion: Date of Marketing Usage: Marketing Usage: Study: Date of Completion: Date of Marketing USage: Marketing Usage: Study: Date of Completion: Date of-Marketing Usage: 'Marketing Usage: Open label extension. of OxyContin in osteoarthritis Fourth Quarter, 1996 First Quarter, 1997 To prove that OxyContin is safe and effective in osteoarthritis pain OxyContin vs. Placebo Outcomes in Osteoarthritis Patients ?Second Quarter, 1998 Third Quarter,_1998 Designed to demonstrate that OxyContin is safe and effective in patients '-with osteoarthritis and can provide outcomes benefits. Post?Op PCA Conversion to OxyContin Second Quarter, 1997 Third Quarter, 1997 A multi? study with anesthesiologists to measure ?pain ratings, quality of sleep, acceptability and optimal dosing when converting patients from PCA to OxyContin post?op. Study: Date of Completion: Date of Marketing Usage: Marketing Usage: Study: Date of Completion: Date oflMarketing Usage: Marketing Usage: _Study: Date of Completion: Date of Marketing Usage: Marketing Usage: Post?Op multi~center QED study (OC96-O701) Third Quarter, 1997 Fourth_Quarter, 1997 An open label? study? with 50 surgeons measuring patient acceptability and optimal dosing in patients with various post?operative pain Post?operative Epidural Conversion Fourth Quarter, 1997 First Quarter, 1998 A multi?center trial measuring pain ratings PCA rescue use, quality of sleep and global acceptability of OxyContin 20 mg or 40 mg q12h. Open label follow up of.cancer and noncancer patients Fourth Quarter, 1996 First Quarter, 1997 To prove the effectiveness and safety of OxyContin PP. 00979.. w" -10. ll. Study: Date of Completion: Date of Marketing Usage: Marketing Usage: Study: Date of Completion: Date of Marketing Usage: Marketing Usage: Initiation of Post-operative Patients Within 24 Hours After Surgery and OC96- 0302). Second Quarter, 1998 Fourth_Quarter, 1998 This is a double blind multi- center study measuring pain intensity in the first six hours of pain intensity/pain relief during the first six hours post surgery and safety for 48 hours. The purpose of this study is-to remove the 'precaution on the use of OxyContin-within the first 12 to 24 hours post-operatively. Pediatric Pharmacokinetic Trial (OC96-0602) Fourth Quarter, 1997 First Quarter, 1998 This is an open label randomized trial measuring the bio-equivalence of OxyContin compared to Oxycodone IR in pediatric patients. PRODUCT STRATEGY To adhieve million in factory sales. To generate -To roll out OxyContin into the non?malignant pain market by. positioning rit' as. an alternative to shorter.acting opioids. I To establish OxyContin as the opioid of choice in step 2-of the W.H.O. analgesic stepladder.- ITO displaCe MS CONTIN and Duragesic in Step 3 of the W.H.O. analgesic stepladder, by positioning OxyContin -as~'the- opioid: toi start ?with; and stay -Wif??v-therehy expanding the usage of Step .2. Hence, Step 3 'products, .MS CONTIN, Duragesic, ?will Ibecome drugs of last resort, as OxyContin is used throughout the clinical progression of the_cancer pain. All 'the analgesic efficacy- of immediate-release oxycodone. The importance of the familiarity of physicians with oxycodone cannot be overstated. This familiarity is a principal factor that should lead to the continued growth of OxyContin. All the ease of quh dosing. All of our market research indicates that the most important feature of 'OxyCon-tin beyond oxycodone is the quh' dosing schedule? In all seven prelaunch market research projects conducted among 626- health care professirni;s. this-was the most compelling reason to OxyContin. when naive patient needs an opioid analg- . Irrysicians are reluctant to begin the:4:; - YE CONTIN. Therefore, OxyContin is the .. ::art with (for patients who would otherU..o :zarted on Percocet, Lortab, Vicodin or 32-; W.H.O. Step 2) and the opioid to stay with as'the disease progresses (when patients PP Qua may otherwise be switched to MS CONTIN or Duragesic; W.H.O. Step 3). In 1997, QxyContin will continue to be marketed for cancer Ipain. The Iprimary strategy in the cancer pain market will be to establish OxyContin for a broader range of use than is available to MS CONTIN. In 1997 OxyContin will be launched into the non- malignant pain market. The most common. diagnoses for? - non-malignant, pain are back pain; osteoarthritis, injury and trauma pain. The major competitors for these diagnoses will be oxycodone and hydrocodone combination products, as-well as Ultram. nytontin will be positioned as providing the eq;;va;ent efficacy and safety of combination opic;dr. v.1b the benefit of a quh_ dosing sched-;~ Winn Combinatzc: opioids (oxycodone, hydrocodone and codeine with APAP or ASA) used for moderate to 9-1 . OxyContin for' opioid naive or moderately severe cancer pain (Step 2 of W.H.O. ladder) and non-cancer. Ultram 'which is used for non-malignant pain will be a competitor in 1997. Long-acting opioids (MS Duragesic and- Kadian) used for moderately severe to severe cancer pain (Step 3 of the WQH.O. analgesic ladder). .. Q1 . To conyince MDs to prescribe and RNs to recommend opioid ?exposed patients with moderate to severe cancer pain instead of combination opioids and Ultram, and thereby eliminate or delay the need for .other long-acting opioids. the 3 11' . . E. The logical "next step" for' patients no longer tolerating or responding to non-opioids - conforms to the three?step analgesic ladder All the analgesic efficacy? of 'immediate-release oxycodone a all the con?enience of q12h dosing Pain relief begins within one hour Rapid onset of action Rapidly effective upon initiation, most patients can expect relief within one hour Pain control lasts 12 hours; two to three times longer than each dose of short-acting products such Has -Percocet?, Percodan?, Tylox?, Vicodin@, and Tylenol? with Codeine. 'Convenient _q12h schedule won't interfere with patients' daytime activities or nighttime rest, and encourages compliance Patients less likely to anxiously' "clocki watch" .when pain control is suStained over long periods 2-39 Single4entity agent - avoids adding the potential toxicities of products containing aspirin or acetaminophen Three dosage bioequivalent and dose~ proportional, are appropriate for a broad_range of pain Small color-coded tablets are easy to identify and swallow - 'an important benefit for elderly patients and those on multiple medications In Studies of patients with non?malignant Rapid. reduction in. pain intensity' over the first 24 hours - By day three, patients had achieved 94% of- their total pain reduction Patients reported improved ability to sleep, walk,' perform normal work, get along' with other people, enjoy life gnu . Q12h. dosing' provides smooth and 'sustained 'blood levels - fewer peaks and valleys than with immediate-release oxycodone - Smooth and reliable pain control - less frequent dosing than with PercocetQ, Vicodin?; or Tylenol? with Codeine 6 No "ceiling"- to analgesic efficacy may be titrated'upward.as necessary With full agonists, such as oxycodone, "effectiveness with_increasing doses is not limited by a ?ceiling'." - Patients .avoid the added risk of gastric/hepatic/renal toricity that can occur with products containing aspirin or acetaminOphen - Excellent compliance, high degree of patient acceptability during clinical trialsp pp 00037 Ideal for Long-Term Therapx- _41 A single-entity'oral agent, contains no APAP or ASA allows independent coadministration and dosage adjustments with non-opioid of choice ?Easy to-Live Convenient q12h schedule won't interfere with patients' daytime activities or nighttime Irest, and encourages compliance Side effects may be anticipated and effectively managed Or prevented 0 A significant decrease in the persent of patients reporting adverse events (5675%' vs. 25.9%, was_ seen between the first and last weeks of 1a cancer study even as daily doses increased The 12-Hour Delivery System Allows Both Rapid and Absorption Over a 12-Hour Period 0 Rapid absorption. - ?pain relief begins within one hour PP 0008.8 1 1 w" Prolonged absorption - pain control continues as tablet natrix slowly releases oxycodone granules at a constant rate over a 12-hour period Special'acrylic coating renders oxycodone granule "pH independent;" allowing uniform release within an acid environment (the stomach) or an alkaline environment (the intestines). "pH independence" effect of stomach contents cx1 absorption 1. bioavailability unaffected by' food. or ingestion of other medications F, ?a Steady state achieved in 24 48 hours and remains constan: thereafter - if needed, pain assessment 0 enhanced efficacy of therapy - only 3.51 cf cancer patients discontinued (due to inadequate pain control) when allowed to titrate and use rescue medication in" Patients were titrated as quickly and easily with OxyContin' as with immediateQrelease ?oxycodone - ?92% of patients were titrated to stable pain control with OxyContin, compared with 79% f0r IR oxycodone 0 Average time to stable pain control was 1.6 days 0 The goal .of titration - to effectively control pain with two or fewer rescue doses per day 0 Small. color-coded tablets are easy' to identify and swallow an important benefit'for patients on ?vizcations permit precise titration to an eff? dose. Breakthrough or incident pain can be rinazed with - avoids polypharmacy 4v" 1. Primary Audiences Nursing.Home MDs and RNs _Primary Audiences Site Targets Comments A. physicians . Office and 13,000 Iarget; m3; :0 Hospital Decile 8, 9, or 10 for ONCs I ."StrongV opioids who Hem/Ones are also Decile 8, 9, Rad/Oncs or 10 for "Combo" IMS . OpiOidS 7,600 DOS Decile 9 and 10 for ANS "Strong" opioids only {Surg 33,000 Iazg?LiLiaii?Z Other? DeCile 10 for combo only but not in Target List non-malignant market ONC RNs 0 Hospice 27,000- Oncology NurSes 0 Home Care 0 Office 0 Hospital Managed Care TBD 0 PBMs Organizations 0 IPAs 0 Staff Models Consultant Long-term 25,000 Influential decision Pharmacists Care makers at Facilities facilities 210,000 PP00091 2. Secondary Audiences 'Secondary . - AudienCes Site Targets Comments A. Patients and . 0 1.2 million new cancer Caregivers million cases annually - cancer patients 35 million back pain patients B. Teaching Residents/Fellows Hospitals Wholesalers 15 I National Accounts responsibility 200 0 Ethical Sales Force responsibility D. Pharmacies 0 Hospital 6,000 0 Retail 20,000 0 Stock OxyContin 40,000 0 Stock combos/not OxyContin *hl I Irv. TACTICS A. Saleei?orcelsllocation The deployment of our most valuable'resource, the sales force, is critical to the success of OxyContin. Heavy promotional support during the first three years of launch will ensure appropriate awareness of Oxy'Contin in the opioid market. Sales_ ?force allocation should be implemented. as follows: 36 OF PRIMARY SALES . YEAR . . CALLS 1996 70% 67,221 1997 709' 79;424 1st Quarter was lower as physician selling did not - begin until-March. I: - ?wo Representative Delivered Promotional Materials ?hnlesalers In an effort to ensure fast and-adequate distribution of. 80 Img? OryContinu Tablet, National .Account Managers will begin making pre-launch sales calls. during_ November, 1996. The objective of these sales calls is to obtain EPIC numbers for the 80 mg tablet and have the product downloaded into computer systems. A pre- launch wholesaler sell sheet will be developed for the 80 mg: tablet, supplying all appropriate information NDC numbers, package sizes, pricing, etc.). A launch sell sheet will be developed for the 80 mg OxyContin tablet.? It will carry' promotional messages Iabout OxyContin and explain the level of marketing and Sales support that the brand will receive. Ehamanies Representatives will be provided. with a launch sell sheet for the 80 mg OxyContin tablet. Initial targets will be pharmacies where the 40 mg Oxycontin tablet is P1399094 no" stocked. Representatives will be provided. with lists showing all stores purchasing the 40 mg tablet within the last 6'to i2 months. Hospitals-1 In an effort 'to continue gaining hospital formulary acceptance of OxyContin, representatives will make calls on all committees. .The hospital formulary kit and product data brochure will be utilised. by the sales force to ?provide the appropriate clinical data necessary to add OxyContin to hospital formularies. In addition, representatives will continue to use the OxyContin tabletop hospital display panels. Speakers' Bureau- lect?res will- be 'conducted durimg grand rounds, tumor boards, etc. The focus of these--preSentations will be. the addition of a new, opioid'~ (OXYContin) to the' analgesic.? treatment armamentarium. d? Managed Care Organizations Managed Care Account Erecutives will continue targeting all major PBMs and IPA plans where_OxyContin is not on the formulary. committee members will be provided with formulary kits and product data brochures. The PartnerSa Against' Pain? program='will- be expanded Significantly *for ?the ?managedl care ?market, providing customized materials to ?eet their needs. Educational materials such as a. continuing .education video and monograph, patient education video, waiting' room will be offered to managed care organizations with Itheir plan's indicia printed on them. In addi:;on, various educational programs such as regional; phys;:;an. and :nurse educators, consultations with pain management specialists, etc. are being explored as .;.ss;ble value-added serviceS' offered through the iaztnv:s Against Pain program. .pre-launch. ?mailings will be sent to 'wholesalers announcing that the. 80 mg OXyCo-ntin tablet is coining soon ftom Purdue. The objective of these mailings is to ensure that_EPIC numbers are assigned to OxyContin by each wholesaler. This will speed up the distribution' prooess, since it takes apptoximately 60 days to complete this task. Approval As soon as orgasms retail distribution?of the 80 'mg tablet is announcements will be sent to MDs, RNs, RPHS. '..hospitals and hospices. The objective of these :5 to build awareneSs of the 80 mg OxyContL: an" .1. The focus of mailings after the 80 mg launch will be on HARD versus EASY of pain control. The graphic of two cups representing a.m. and p.m. dosing will be the main message that is conveyed. These mailings- will have the objective of creating brand awareness of OxyContin and also campaign awareness that carries the. most important .benefit OxyContin has to offer; q12h dosing. Representatiyg Hollow-up Mailings Representatives will be able to send follow?up mailings to MDs and after making a call. This will be 'accomplished through the Precise System. 1 E3 .. The journal ad for ?OxyContin. will contain the core creative concept of 24 hr. oxycodone the (6 dosing cups) vs. the (2 dosing cupS). This ad will be a four?page insert placed in journals. The PP 00098 . journal schedule-and publications used will be picked based on opioid prescribing habits of the readers[ anventiQns A new exhibit structure has been constructed specifically for OxyContin. The OxyContin exhibit structure will feature graphic panels of the OxyContin core creative concept, EASY depicting a.m. and p.m. dosing repreSented by two dosing cups. Various- Ipromotional activities will be conducted at.the booth to draw attendees into a discussion with our representatives about OxyContin. ~53 Wanna: Patient Profile Visual Aid Partners Against Pain Opioid Documentation Kit Partners Against Pain Side Effect Management Reference Non?Malignant Pain Consensus Guidelines Partners Against Pain Call the Expert Hotline 80 mg Tablet Slim Jim Revised Titration Guideline Card 80 mg ?Cross?" Pen OxyCOntin 80 mg Tablet Wholesaler/Chain Sell Sheet OxyContin 80 mg Tablet Retail _Pharmacy Sell Sheet Disposable Camera Premium Photo Card Visual Aids Clinical Study Reprint Series OxyContin/OxyIR Slim Jim . Reprint Fund OxyContin In?Servioe Slide Module File Card Case Studies Brochure Partners How to Talk to Your Patients About? Opioids Pamphlet Patient Profile Video Over and Over Visual Aid/Premium Slim Jim Partners Against Pain In-Service Board Game Case Studies Video PAP Professional Newsletter If You Could Control Pain the ?Easy Way? Wouldn?t You? Visual Aid Launch Visual Aid File Card Conversion Reference Chart PP 09.191. PROMOTIONAL MATERIALS cont: Tabletop DisplaYs Product Data Brochure Phone Message Pads Physician Reminders' Rep Follow- -up Mailings in the Precise System 80 mg Wholesaler/Chain Launch Announcement- 80 mg Pharmacy Power Pack Mailing (2 waves) 80 mg Managed Care Launch Mailer 80 mg Managed Care Approval Announcement 80 mg Hospital Approval Announcement 80 mg Consultant Approval Announcement 80 mg Hospice Approval Announcement 80 mg MD Approval Announcement ?Iv- PP 00102 . . . . 80 mg RN Approval Announcement 80 mg PDR Addendum OxyContin High Prescriber Mailings Patient Profiles Direct Mail Series (3 wavesf, I OncOlogy Nurse Direct Nazi Series: Features Benefzts (3 waves) Journal Advertising Push Monies for Dru; WholeSaler Incentiv-. Rebates on Initial Drugstore Orders .Drug Wholesaler AdvertiSing_Programs qua 001.93. in" NEW OR IIEM QUARTER Eromotional_Materials: Patient Profile Visual hi! New Partners Against Pain? Opioid New Documentation Kit Partners Against Pain? Side New Effect Management Reference NO.IOF 10.000 60,000 100:000 QQSI iESIil IUSAGE $60,000 $125,000 $95,000_ Isuffering from back pain, A sales aid demonstrating the quality of life benefits that OxyContin offers to patients osteoarthritis, cancer and post? surgical pain. A kit providing tools for progress notes in patient charts. This kit will help physicians identify and document the reason for giving an opioid to avoid any complications with the DEA for prescribing a Class II narcotic. This will be a value-added service tool through L?Partners Against Pain." EA handy reference guide for *physicians and nurses to use when treating opioid side effects. This piece will emphasize the aggressive and prophylactic treatment of side effects caused by all opioids. IIEM FIRST QUARTER cont. EerQLiQnal Materials QQDL: Non-Malignant Pain Consensus Guidelines Partners Against Pain Call the Expert Hotline PPOOHB NEW OR New New NOLOF 100,000 CQSILJESILJ. USAGE $250,000 $200,000 A fund used to provide an educational grant to a panel of experts to develOp a consensus guideline for the use of opioids in non?malignant pain. This _fund will also be used to.print these guidelines and distribute them through the field force. Experts such as Steven LOng MD and/or Daniel Carr MD would be the chairmen of the committee. A fund used to set up a 1-800 number for physicians to call a pain management expert, such as Dr. Michael Levy, Dr. Richard Payne, etc. for a consult on pain management. This program would be especially attractive to managed care organizations as a value added service for Partners-Against Pain. ITEM FIRST QUARTER cont. EerQLiQnal Materials 80 mg Tablet Slim Jim Revised Titration Guideline Card 780 mg ?Crossm? Pen OxyContin 80 mg Tablet Wholesaler/Chain Sell Sheet NEW OR New New New New PPOOKM 100,000 300,000 3,000 10,000 MW $75,000 $80,000 $60,000 $30,000 A simple visual aid to announce the launch of the 80 mg tablet. It will be designed to fit in the back pdcket of the patient profile visual. Updated to include the 80 mg tablet, a two sided flash card explaining the TIME principles of titration to ensure appropriate titration is carried out with OxyCo ntin. A premium pen for the highest OxyContin prescribers} To be used wit wholesalers/ chains to stock OxyContin 80 mg and offer terms of sale- IIEM FIRST QUARTER cont. . . .: OxyContin 80 mg Tablet Retail Pharmacy Sell Sheet (300,000 for Power Pack Mailing - 50,000 for sales force) Disposable Camera Premium mum; 'Rep Follow-Up Mailings in the Precise-System RPOOHW NEW OR New New Repeat OF 350,000 15,000 150 ltrs/ rep/qtr USAGE $50,000 $100,000 $50,000 To be used when stoCking retail pharmacies with OxyContin 80 mg tablets. It will offer a rebate . on the initial order. A?mailing_ of 200,000 of the sell sheets will be made to all retail pharmacies across the country through Pharmacy Power Pack. A disposable photo camera to coincide with the patient profile visual aid. The first photo will be of the new ad campaign. A series of letters that representatives can send to NUS, RNs and as a follow?up to their sales call. This program is administered through the Precise system. 2?61' IIEM FIRST QUARTER cont. Direct Mail cont: 80 mg WholeSaler/Chain Launch Announcement 80 mg Pharmacy Power Pack Mailing (2 waves) (Retail, Hospital, Consultant Pharmacies) 80 mg Managed Care Launch Mailer . 80 mg Managed Care Approval Announcement NEW OR NO. OF EIECES New 300 New 100,000 (each wave} New 15,000 New 12,000 PP 00108.. $500 $20,000 $11,250 $9,000 ?2 -6 2 Once FDA approval is attained, a launch announcement will be sent to all wholesalers/chain pharmaceutical buyers announcing the availability of the OxyContin 80 mg tablet: A mailing of our sell sheet to all retail, hospital, consultant pharmacies announcing the availability of the OxyContin 80 mg tablet. A mailing sent to managed care administrators explaining the features and benefits of the. OxyContin_80 mg tabletr Once adequate retail distribution is attained, a one- page letter will be sent to all members of Managed Care Committees announcing the launch of the OxyContin 80 mg tablet. IIEM FIRST QUARTER cont. Direct Mail 80 mg Hospital Approval Announcement 80 mg Consultant Approval Announcement 80 mg HOSpice Approval Announcement PPOOHD NEW OR New New New 20,000 6,000 2,000 COST USAGE $15,000 $4,500 $1,500 Once wholesaler distribution is . attained, a one?page letter will be sent to all members of I Hospital Committees announcing the launch of the OxyContin 86 mg tablet. Once adequate retail 9 distribution is attained, a one- page letter will be sent to all vmembers of the American Society of Consultant Pharmacists announcing the launch of the OxyContin 80 mg tablet. Once adequate retail distribution is attained, a one? page letter will be sent to all hospice directors announcing the launch of the OxyContin.80 mg tabletr IIEM FIRST QUARTER cont. Direct Mail ant: 80 mg MD Approval Announcement 80 mg RN Approval Announcement 80 mg PDR Addendum New? NEW OR ?uw New New N0.10F BIECES 10,000 25,000 25,000 PPOOHD USAGE $22,500 .$18'750 $18,750 Once adequate retail distribution is attained, a one?' page letter will be sent to all high prescribers of opioids announcing the launch of the OxyContin 80 mg tablet. Once adequate retail distribution is attained, a one# page letter will be sent to all members of the Oncology Nursing Society announcing the launch of the OxyContin 80 mg tablet. Once adequate retail distribution is attained, a mailing will be sent to? physicians announcing the launch of OxyContin 80 mg tablet, and providing them with a package insert to be inserted into their Physicians' Desk Reference manual. IIEM FIRST QUARTER cont. Journal Advertising: Journal Advertisinu BO mg Tablet I. .: Push Monies for Drug Wholesaler Incentives Rebates on Initial Retail Drugstore Orders Drug Wholesaler_Advertising Programs Now New New - New PPOOLH $250,000 $10,000 $7,000 $10,000 Budget used to advertise OxyContin in journals. A budget used to provide wholesalers with an incentive for stocking OxyContin 80 mg into pharmacies. I A fund used to pay rebates to retail pharmacies on their initial order of 80 mg OxyContin. Budget used to advertise 80 mg OxyContin in wholesaler advertising booklets and computer programs. IIEM SECOND QUARTER -Ernmotional_Material: Photo Card Visual Aids Clinical Study Reprint Series OxyContin/OxyIR Slim Jim Reprint Fund NEW OR New 100,000 New 3 Reprints 30,000 each New 100,000 New $100,000 $90,000 $125,000 $50,000 A series of flashcard visual aids highlighting case histories of patients with various non? malignant pain A follow up to the patient.profile visual aid..? Reprint carriers for non- malignant pain clinical studies, one each for low back pain, osteoarthritis and post surgical pain. A simple two~sided flash card used to explain the benefits of using OxyContin and together. A_fund used to purchase reprints as OxyCOntin manuscripts are published. IIEM SECOND QUARTER cont. EerQtiQnal Material? QQDL: OxyContin In~Service Slide Module File Card Mail: Rep Follow~Up Mailings in the Precise System OxyContin High Prescriber Mailings NEW OR Repeat Repeat Repeat New PP 00113 NO.COF 500 100;000 150 ltrs/ rep/qtr TED CQSILJEEHLJ. USAGE $15,000 $50,000 $50,000 $75,000 A set of 20 slides to be used by representatives for in?services on OxyContin. A mini visual/file card used as a leave-behind for A series of letters that representatives can send to NUS, RNs and as a follow-up to their sales call. This program is administered through the Precise system, A fund used to send frequent E3 i00 mailings to high prescribers of OxyContin-throughout the course of the year. The objective of these mailings is to keep in touch with our best customers for OxyContin to ensure they continue prescribing itL" 7 ITEM SECOND QUARTER cont. 1 .1 I Patient Profiles Direct Mail Series (3 waves) Oncology Nurse Direct Mail "Series: Features Benefits (3 waves) Journal_Adrertiaing: Journal Advertising . I My!? NEW OR New New New EIECES 25,000 '25,000 PPOGUA u. $300,000 $150,000 $250,000 A three?wave, threerdimensional mailing to high-prescribing opioid physicians promoting OxyContin for various pain (back, osteoarthritis, post-surgery). A three?wave mailing to all members of the Oncology Nursing Society explaining the unique features and benefits of OxyContin. Budget used to advertise OxyContin in journals. a" 142-68 Qua ITEM THIRD QUARTER . . Case Studies Brochure Partners Against Pain? How to Talk to Your Patients About Opioids Pamphlet Patient Profile Video Over and Over Visual Aid/Premium NEW OR NO. OF REBEAI New 50,000 New 150,000 New 10,000 New 15,000 USAGE $50,000 $75,000 $100,000 $125,000 A brOChure presenting patient case studies in both malignant and non~malignant_pain describing the benefits of OxyContin therapy. A patient education pamphlet used to alleviate the fear of taking opioids. An educational videotape designed in conjunction with Dr Liz Narcessian-to provide patient testimonials about OxyContin in various pain A picture frame reminder item to position OxyContin as the ?Easy Way" to treat moderate to- severe pain NEW OR IIEM THIRD QUARTER cont. Bromotional Materials Cont: Slim Jim Repeat Partners Against Pain In-Service Board Game New Case Studies Video New -. 1. awe-r EIECES 100,000 1,000 10,000? PPIXHIG c931 (ESI. 113395 $125,000 $90,000 $125,000 Reduced version of the OxyContin retained viSual in slim jim size for reps to use in a stand? up selling situation and .as a leave- behind piece. Board game designed to be used by representatives during in? services to test the knowledge of physicians and nurses about pain _management. This educational tool would be used to teach proper pain management techniques while providing an .interesting in- service presentation. .Dr. Spanos has patients who have done extremely well on OxyContin and would like to develop case studies around these patients He is willing to allow us to interview these patients to put tOgether a video that shows vignettes of patient case studies and how OxyContin has improved their quality of life. Tamnrum_m__am.- .- IIEM THIRD QUARTER cont. Hiram: Rep Follow?Up Mailinqs in Precise System Adxertiaing: Journal Advertising NEW OR OF Repeat 150 ltrs/ rnp/qtr New PP 00117 USAGE $50,000 $250,000 A series of letters that representatives can send to NUS, RNs and as a follow? ?up to 'their sales call. This program is administered through the Precise system. Budget used to advertise OxyContin in journals. ~71- ITEM FOURTH QUARTER Promotional Material: PAP Professional If You Could Control Pain the ?Easy Way? Wouldn't You? Visual Aid Launch Visual_Aid File Card Conversion Reference Chart NEW OR New New Repeat Repeat_ Repeat 40,000/Qtr 50,000 5,000 300,000 200,000 pp 00118 $200,000 $100,000' $45,000 $100,000 $225,000' A newsletter for health care professiOnals updating them on the latest advances in pain management. This newsletter will be geared as an educational tool to teach them the most . appropriate ways to manage pain. -A visual aid comparing OxyContin to combination opioids. A 20?page retained visual that will be the cornerstone sales aid for the representatives. A mini visual/file card to be used as a package insert. - A conversion chart providing appropriate conversions from other opioids ?9 NEW OR IIEM FOURTH QUARTER cont. EerQLiQnal Tabletop Displays New Product Data Brochure Repeat Phone Message Pads Repeat Physician Reminders Repeat NO.ZOF 1,000 50,000 100,000 TBD FPOOLE) '$15,000 Display panels used by representatives when exhibiting at hOSpitals, hospices, etc. A brochure summarizing all and clinical studies $50,000 $35,000 Pads given to the receptionist for recording phone messages for physicians. Because it bears the OxyContin logo, physicians will _constantly be reminded of OxyContin ever ry time they get a phone message. $200,000 Reorders of various premiums (pens, post-it notes, etc.) to constantly remind the physician of the availability of ql2h OxyContin. 2-73 at" ITEM FOURTH QUARTER cont. Rep Follow?Up Mailings in the Precise System ?Qurnal Adyertiaing: Journal Advertising NEW 0R Repeat New 150 ltrs/ rep/qtr PP 00120 $50,000 $250,000 A series of letters that representatives can send to NUS, RNs and as a follow-up to their sales call. This program is administered through the Precise system. Budget used to advertise OxyContin in journals. s?ht?e74 Sales Marketing a Promotion use 1996 of Actual Sales $116,666 Promotional Materials Direct Mail Journal Advertising Journal Production Total Direct Mail/ Journal Advertising garlic Relations Samples Agency Fee Special Promotions (Devoted to wholesalers) Conventions Other Programs Incremental Bonus (OxyContin) Total Marketing a Promotion Total Allocation Total 8 8 $1,167 1.0% 778 0.7% 135 0.1% $2.309 $10.838 2.0% 9.3% $13.147 11.3% v. a 'Inooaf us CONTINQ MSC 1997 of Sales OXY 1996 of Est. Sales Proj. $115,744 .$4S,Bll $836 0.7% $2,731 628 0.5% 775 210 0.2% 710 1.5% 25_ 0.1% so 0.1% 863 0.7% 1.535? 3.4% 600 1.3% 210 0.5% 224 0.2% 395 0.9% - 0 0.0% 2,400 5.2% 1.6% $7,871 . $1,923 17.2% $14,858 12.7% $31,937 69.7% $16,781 $39,808 14.4% 86.9% PP 00121 1.71' OXY 1997 of Proj. Sales $77,930 3,230 4.1% 851. 1.1% 1,000 1.3% 0 0% 1.851 2.4 '000 1.0% 207 0.1% 384 0.5% $6.472 8.3% 543.174 55.4% 549.646 63.7% Combined use OXY of 1997 Sale $194,674 $4,066 2.1% 1,479 0.01 1,210 0.6% 25 0.1% 2,714 1.4% i 300 I 0.4% 207 0.1% $50,012 29.3% $66,420 - PP 00122