1999 BUDGET PLAN OxyContin? Tablets PP 0016_7_ Pages 4-24 through 4-36 redacted RE DACTED pp 00169 REDACTED REDACTED PP 00171 .1 1 :1 -i REDACTED PP 00172 REDACTED PP. 4-29 REDACTED PP 00174 4-31 REDACTED pp 00175 '0 4?32 REDACTED PP (?176 . REDACTED REDACTED 4?35 RE DACTED 4-..3 RE DACTED .. PP 99.1.39 .. II. ASSUMPTIONS A. Market Overview The market for OxyContin Tablets consists of patients with both cancer pain and non-cancer pain. Thenno-n-cancer pain market is the signi?cantly larger market- Over 70% of OxyContin Tablets prescriptions are written for non-cancer pain. The classic model utilized in treatment of cancer pain is the World Health Organization (W.H.O.) Three Step Analgesic Ladder. While treatment of non- cancer pain often varies by the speci?c pain state, and the use of opioids is much more controversial compared to cancer pain, physicians often use the WHO. ladder as a guide for treatment of non?cancer pain. The recommendations of the- W.H.O. are: Step 1: Use NSAIDS to treat mild pain, aspirin (ASA), acetaminophen (APAP), and non-steroidal anti-in?ammatory agents (NSAIDS). Step 2: Use weak Opioids to treat moderate pain, codeine, oxycodone, and hydrocodone combinations. Step 3.: Use strong opioids to treat severe pain, morphine, . hydrornorphone, fentanyl, etc. Fixed Combination Opioids Prior to the introduction of .OxyContin, opioid choices in treating moderate-to- moderately severe pain in Step 2 had been limited to combination products containing oxycodone, hydrocodone, codeine, and either ASA (example: Percodan?) or APAP (example: Percocct?). The short duration of action of these products causes peaks and valleys in blood levels, which can contribute to increased'side effects and poor, inconsistent pain control. The combination of an opioid with APAP or ASA. limits the number of tablets that can be prescribed because of potential liver toxicity. The APAP or ASA component also has the potential to mask fever in cancer patients and other patients. with infections. All these factors, associated with the choice of Opioid analgesics in Step 2, as well as the large dollar and prescription volume of this class of drugs provide an Opportunity for a single-entity, long?acting oxycodone product, OxyContin Tablets. Single Entity Opioids Long?acting morphine and transdermal fentanyl provide physicians with tWo long?acting products to meet the needs of patients with moderately severe to severe pain as described in Step 3. However, these products possess v4" disadvantages such as the stigma that surrounds morphine and the reluctance of the physician, nurse, and pharmacist to use them. They are also considered ?potent? Opioids which physicians may be reluctant to prescribe until the pain is severe. Oxycontin is now being utilized for Step 3 as evidenced by an increase in the sales volume of the 40 and 80 mg. Oxy Contin Tablets during 1998. MS Contin Tablets MS Contin Tablets remain the gold standard for treating moderately severe to severe cancer pain (W. H. 0. Step 3) In fact, some physicians, particularly oncologists, will snitch patients with more severe pain from OxyContin Tablets to MS Contin? Tablwets Many health care providers continue to believe that MS Contin Tablets are more potent than OxyContin Tablets. This may be due in part to the carryover to OxyCo-ntin of the perception of Percocet as a Step 2 drug. Although faced 'with stiff competition from Duragesic?, Oram0rph and OxyConti'n, MS Contin Tablets prescriptions have increased approximately 2% in 1998 YTD through June compared to the same time period 1997 One of the OxyContin challenges is to gain additional physician support for treatment of more severe cancer pain.- Expected New Competitors A new competitor, Morphidexm, a combination of morphine and dexemethorphan is expected to be launched in 1999. This product is . expected to claim equally effective analgesia at a lower number of milligrams of morphine due to the analgesic effects of the dextromethorphan, as well as less deve10pment of tolerance, and possibly- less abuse potential. An additional promotional message will be geared to physicians" desire for a pain medication with the effectiveness of an Opioid with less-side e??ects- expressed in market research. A claim of less opioid side effects due to lower morphine milligram quantities is expected. Physicians reported that a decrease of 25% or more in opioid related side effects would be signi?cant enough for them to change their Opioid prescribing habits However, even a smaller percent difference is likely to have some impact on prescribing habits. Morphidex may claim a duration of action of approximately eight hours. At least one AB-rated generic controlled?release morphine sulfate tablet product is expected to be available within the next two years. Although neither of these products would be a direct competitor for OxyContin Tablets, since they would compete directly with MS Contin, they will likely be targeted against all long-acting opioids. If a genenc morphine product is priced considerably lower than OxyContin Tablets, it I PP 00133;; -- - will probably be positioned as a cost-effective alternative to OxyContin Tablets by managed care ?plans. Morphidex bene?ts may also be positioned against all opioid preparations vs. just morphine. One of the primary objectives for OxyContin promotion in 1999 will be to replace morphine as the product of choice for Step 3 pain management. This will decrease the size of the direct competitive market for future competitive morphine products, when launched. Duragesic Duragesic is another main competitor to OxyContin. Janssen has been targeting the moderate-to-moderately severe pain. market for the. past two-to-thre-e years. Their progress has been slow but steady in obtaining patients coming directly from ?xed combination opioids, as they promote Duragesic as the ?rst opioid to use when around-the-clock opioids are needed. In 1998 Janssen is seeking to replace OxyContin prescriptions in. addition to'MS Contin prescriptions. Janssen is also currently involved in Phase trials for a 12.5 meg patch that is expected to be targeted to the early treatment of pain. In 1993 .Janssen hired a 'sales force targeted Speci?cally to the long-term care (LTC) market. In addition to marketing Duragesic, they are promoting Ultram for Ortho?McNeil in this market. mm is provided as a Step 1. to Step 2 analgesic while Duragesic is promoted as a Step 2 to Step 3 analgesic. l-ans'sen has beenstressing decreased side effects, eSpecially constipation, as well as patient quality of life as supported by patient ratings compared to sustained release morphine. Due to the above initiatives, we assume that Janssen will continue to target primary care physicians (internists and selected family practice physicians), as well as oncologists. In 1998 we estimate that their journal spend will be $560,000. This is equal to 1997. However, both 1997 and 1998 showed a signi?cant decrease ?'orn the $2.3 million spent in 1996.. Market research from recent focus groups shows that Duragesic is perceived to be less effective than MS Contin and, in most cases, Oxy-Contin. It is also perceived by physicians to have a Slow onset of action, lacks the ability to be titrated quickly, and is not considered cost effective. We will seek to take advantage of these Duragesic weaknesses in our 1999 OxyContin Tablets promotions. KadianT? In 1998 aulding began active promotion of Kadian with the launch of a US- sales force. The promotion of Kadian centers on its 24-hour dosing, its PP 00133 .fut sprinkle formulation, and cost effectiveness. Due to these feature-,s Kadian 13 being positioned as a better alternative to MS Contin. With the relaunch of. Kadian by Faulding, the Faulding sales representatives are stating that sales of Kadian did not do well during Zeneca? 5 promotion, since Zeneca did not give the product adequate attention. With the renewed promotion, prescriptions have remained ?at with less than 1,200 prescriptions per month through July 1993. It IS anticipated that, with continued promotion, Kadian will continue to slowly replace a small portion of MS Contin prescriptions and may reduce the available prescriptions for new patient starts on OxyContin Tablets. Faulding 15 also expected to promote Kadian as the next logical step when patients can no longer tolerate or receive adequate analgesia ?om OxyContin Tablets. Orarnogh SR Roxane is expected to obntinue promotion of Orarnorph SR by positioning it as a cost-effective alternative to MS Contin Tablets. Individual Roxane representatives are also promoting Oramorph SR as a cost effective alternative to OxyContin, utilizing a 1:1. conversion of morphine to oxycodone demonstrated. in pricing comparison charts that contain Oram0rph SR compared to both MS Contin and OxyContin. During 1- 998, Roxane began an Oramorph SR promotion that combines promotion of their pain products with other palliative care products under a Roxane Palliative Care Products umbrella. In 1998 Roxane prescription market share has stayed relatively ?at at below - 3. 0% through July 1998. PCA Pumps During 1997, sales ofinjectable morphine were $68,815,000. Recent market research at ASCO lists PC-A pumps as a form of cancer pain management used (along with MS Contin and Duragesic) when Oxy?Contin is perceived to be ineffective or no longer tolerated. While a percentage of the patients changed to PCA pumps may not be able to swallow, it is likely that a number of patients were switched to a PCA pump strictly due to lack of perceived OxyCon?n ef?cacy or reimbursement Issues MedtroniCs has been promoting their implantable pumps aggressively in the hospice market as well as for other chronic pain patients: For non-hospice patients, reimbursement issuescan play a role. Medicare W111 PP ooisar. .. .. g. . 90-11?, 4-43. pay for pump implantation as Well as the medication re?lls. Medicare does not reimburse for oral analgesics like OxyContin. In the postoperative patient, OxyContin is positioned for post-PCA pain management. A clinical study (Ginsberg) has supported OxyContin use in the post-operative patient. Abbott Pharmaceutical has the main responsibility for promotion in this?market. a PRODUCT INITIATIVES A. Objectives 0 To achieve $493 million in factory sales. 6 To prepare the market in anticipation of the Morphidex launch by emphasizing Q12 dosing, the bene?ts of a single agent product, and place tolerance in the proper perSpective. . To protect our market share from new competitors. 0 To continue to expand OxyContin Tablets use in the. non-malignant pain market by positioning it as the opioid to start with and stay with. To establish OxyContin Tablets as the Opioid of choice in Step 2 of the W.H.O. analgesic ladder by positioningit as the opioid to ?Start With.? 0 To continue to penetrate Step 3 of the W. H. O. analgesic ladder by replacing MS Contin Tablets and Duragesic and positioning OxyContin Tablets as the Opioid to ?Stay With.? 0 Due to proper dose titration of OxyContin from Step 2 to Step 3, MS Contin Tablets and Duragesic will become drugs of last resort as OxyContin Tablets IS used throughout the clinical progression for both non?cancer and cancer pain management. Once?a?day hydromorphone, once it becomes available, will be positioned after OxyContin Tablets and as a replacement for MS Contin Tablets and Duragesic for more severe cancer pain patiwents - Establish OxyFastT? and as the ideal medications for breakthrough - and/or incidental pain for patients on OxyContin. Launch OxyContin Tablets 160 mg. for high dose patients. 0 Enhance the acceptance of opioids for non-cancer pain. 0 Increase the use of OxyContin in the elderly patient, particularly in the long- term care market. . 0 Increase the use of OxyContin Tablets in acute and sub?acute conditions post-0p pain, where pain lasts more than a few days). 0 Attach an emotional aspect to non?cancer pain so physicians treat it more seriously and aggressively. 0 Improve assessment of pain by physicians and increase Communications with patients. I - Utilize oncology and pain clinic nurses as a proactive advocates for OxyContin. Pesitioning Statements . The analgesic ef?cacy of immediate-release oxycodone. The familiarity of physicians with oxycodone 15 an important part of the message and has led to rapid acceptance. This familiarity is a principal factor that should lead to continued growth of OxyContin Tablets. 0 The ease of I 2 dosing. Our market research indicates that the most important feature of OxyContin Tablets, beyond the familiarity of oxycodone, is the .PP 00135;. ql2h dosing schedule. In all seven pre- launch market research projects condircted among 626 health care professionals this was the most compelling reason to prescribe OxyCoutin Tablets. Onset within one hour, comparable to IR oxycodone Recent market research focus groups discussing product attributes indicated Oxy Contin Tablets 15 perceived as being very effective with a lower side effect pro?le than its competitors, and with a favorable dosing schedule It has, however, received lower ratings as to its onset of pain relief and its cost effectiveness. Early onset of pain relief is important to physicians, especially when treating cancer pain. By highlighting the early onset of pain relief with OxyContin Tablets, we can enhance its use in cancer pain, as well as in acute non- cancer pain conditions (eg ., post-op pain, fractures/trauma, etc). It IS important that we position OxyContin Tablets for treatment of both acute and sub- acute pain- We will also position OxyContin Tablets as being cost effective versus other opioids. This can be accomplished by stressing the 2:1 potency compared to morphine, as well as the added administration costs associated with 4-6h opioid products in the institutional setting (hOSpital and nursing home). The bene?ts of q12 closing on patient functioning can also be stressed (better rested with a full night?s sleep, more productive). When ?an opioid naive patient needs an Opioid analgesic, physicians should prescribe OxyContin Tablets. The many bene?ts of OxyContin Tablets make it logical as the opioid to start with (for patients who would otherwise be started on Percocet, Lortab?, Vicodin?, Tylenol? #3 or Darvocet?; W.H.O. Step 2) and the opioid to stay with as the disease progresses through preper titration (when patients may otherwise be switched to MS CONTTN Tablets or Duragesic, W.H.O. Step 3). One to stayr with. In 1999, OxyContin Tablets will continue to be marketed for cancer. pain, as we have been successful in this area. The primary strategy in the cancer pain market will be to establish OxyContin Tablets for a broader range of use than isavailable to MS CONTIN Tablets. Oxycontin Tablets will be positioned as an opioid physicians can initiate patients with and st_ay with through the entire course of therapy Promoting ease of use? including one-to-two day titration and encouraging the use of higher dosage to reduce the number of tablets taken, plus an assessment of pain on a daily basis we can prevent physicians from switching patients with more severe pain to MS CONTTN Tablets or Duragesic Effective in non-malignant pain states, In 1999, OxyContin Tablets will be more aggressively promoted for use in 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. OxyContin Tablets will be positioned as providing the equivalent ef?cacy and safety of combinahon opioids, with early onset of pain relief and the bene?t Of a q12h dosing schedule. The promotional efforts will focus on speci?c disease pp 00137 .?uu C. D. such as back pain, osteoarthritis, reflex sympathetic trauma/injury, neuropathic type pains, etc . A single agent with no acetaminophen, aspirin or ibuprofen. OxyContin IS a single entity Opioid agent Without the limitations 1n desing present in products that are ?xed combination of an opioid and a second agent like acetaminophen, aspirin, 0r ibuprofen There IS added dosing ?exibility with a single agent since a variety of co- -analgesics and adjuvant medications can be used to enhance the individual patient 5 pain relief while having the freedom to dose the OxyContin as high as is clinically necessary There is also a decreased risk of side effects or organ toxicity compared to products containing acetaminOphen, aspirin or ibuprofen. Commtition 0 Combination opioids (oxycodOne, hydrocodone, cedeine and propoxephine with APAP or ASA) used for moderate- -to-moderately severe cancer pain (Step 2 of the W. 0. ladder) and non-malignant pain. Ultram 13 also used frequently for non- malignant pain. Long- -acting opioids (MS CONTIN Tablets, Duragesic, Kadian, and Gramorph SR) typically are used for moderately severe-to- ?severe cancer pain . (Step 3 ofthe W. H. O. ladder. 0 Market research as well as reports from the sales force indicates that methadone use is increasing in both the management of cancer pain and non- malignant pain due to its low cost. Clinical studies have also been published . over the last year regarding the e?ective use of methadone for cancer pain management. While not yet a serious competitor, this trend needs to be monitored. - Mogphidex x. as noted earlier, this product may become a competitor in 1999. Communication Objectives - To convince Mle to prescribe, as Well as RN 3 and appr0priate pharmacists to recommend OxyContin Tablets for opioid-naive or opioid-exposed patients with moderate-eto-severe pain lasting more than a few days instead of combination opioids and Ultrarn and, through proper dosing and titration, eliminate or delay the need for other long-acting opioids. Effective use of OxyContin Tablets for various pain cancer pain, back pain, osteoarthritis, neuropathic pain, post-operative pain, etc.) will be stressed. a To convince health care professionals (physicians, nurses, pharmacists, and managed health care professionals) to aggressively treat both non-cancer pain and cancer pain. The positive use of Opioids, and OxyContin Tablets 111 particular, will be emphasized. . To convince patients and their families to actively pursue effective pain treatment. The importance of patients assessing their own pain and commUnicating the status to the health caregiver will bestressed. 0 To put into perspective issues that the introduction of Morphidex may highlight: tolerance, Opioid side effects, the convenience of 12-hour vs. 8-hour dosing and rational vs. ?xed combinations of products in pain management. Selling Points - The One to Start ith" a The logical ?next step? for patients no longer tolerating or responding to non- opioids conforms to the three-step W.H.O. analgesic ladder. . The analgesic ef?cacy of immediate-release oxycodone with the convenience of q1'2h dosing. Rapid onset of action (similar to short-acting o-pioids). . a Pain control lasts 12 hours; two-to-three times longer than each dose of short- acting products such as Percocet, Percodan, Tylox?, Vicodin, Lort-ab, Lorcet, Ultram, and Tylenol with codeine. OxyContin Tablets should be only dosed every twelve hours as it is not an eight-hour drug.? - Convenient quh schedule won?t interfere with patient?s daytime activities or nighttime rest and encourages compliancej a Patient is less likely to anxiously ?clock watch? When pain control is sustained over long periods. I - Single-entity agent avoids adding the potential toxicities of products containing aSpirin or acetaminophen. Does not mask fever in patients with infections. a Four dosage bioequivalent and dose-proportional, are appropriate for a broad range of pain. A ?fth dosage strength, 160mg tablets, is expected to be approved in 1999. . . 0 Small color-coded tablets are easy to identify andswallow an important bene?t for elderly patients and those on multiple medications. . In studies of patients with non?malignant pain: Rapid reduction in-pain intensity over the ?rst 24 hours By day three, patients achieved 94% of their total 'pain reduction Patients reported improved ability to sleep, walk, perform normal work, get along with other people, and. enjoy life The One to Stay z'r?h quh dosing provides smooth and sustained blood levels - fewer peaks and valleys than with immediate-release oxycodone a Smooth and reliable pain control less ?equent closing than with Percocet, Vicodin, or Tylenol with codeine - No maximum daily dose or ?ceiling? to analgesic ef?cacy - may be titrated. upward as necessary. With full agonists, such as oxycodone, "'e?ectz?veness with increasing doses is not limited by a "ceiling 0 Patients avoid the added risk of gastricfhepatic/renal toxicity that can occUI with products containing aspirin or acetaminophen . 0 Excellent compliance, high degree of patient acceptability during clinical trials PP 00139 . . Ideolfor Long-Term Therapy A single-entity oral agent, contains no APAP or ASA allows ?exibility of independent coadministration and dosage adjustments with non-opioids of choice. Eng to Live With Effective pain control may allow many patients to achieve the goal of functioning as close as possible to the way they did prior to having pain. Convenient q12h schedule won interfere with patient? 3 daytime activities or - nighttime rest, and encourages complianCe. The q12h dosing schedule will make life easier for both the patient and caregiver as their days and nights will not be interrupted frequently by dif?cult dosing schedules. Improved control of the pain may allow for greater patient independence, as patients will not have to depend on others to do things for them. It may also result in more patients being able to be treated in the home environment Common opioid side effects may be anticipated and effectively managed or prevented. . A signi?cant decrease in the percentage of patients reporting adverse events (56,5% vs. 25 was seen between the ?rst and last weeks of a cancer study even as daily doses increased. The 12- Hour A 0C ONT Delivery System Allows Both Rapid and Prolonged Absorption Over 0 12-Hour Period Bi-phasic absorption in the Acrocontin Delivery system allows for early onset of pain relief? similar to short?acting opioids, as well as a long?acting (12 hour) component similar to other controlled?release Opioids g. MS Contin Tablets). - Rapid absorption? pain relief begins within one hour. Prolonged absorption? pain control Continues as tablet matrix slowly releases oxycodone granules at a constant rate over a 12 hour penod. Special acrylic coating renders oxycodone granule? ?pH independent,? allowing uniform release within an acid environment (the stomach), or an alkaline environment (the intestines). ?pl-I ind'ependence?_ assures. . .minimal effect of stomach contents on absorption bioavailability unaffected by food or ingestion of other medications. to Titrate Steady state achieved In 24-48 hours and remains constant thereafter If needed, pain assessment and titration are possible every one to two days In cancer studies: Titration enhanced ef?cacy of therapy? only 3. 5% of cancer patients discontinued (due to inadequate pain control) when allowed to titrate and use rescue medications. pp 00190 . Patients were titrated as quickly and easily with OxyContin Tablets as with immediate-release okycodone. 92% of patients were titrated to stablepain control with OxyContin Tablet-s, compared with 79% for IR oxycodone. I Average time to stable pain Control was 1.6 days. The goal of titration to effectively control pain with two or fewer rescue doses per day. I Eng to Dose Small, color-coded tablets are easy to identify and swallow an important bene?t for patients on multiple medications. .. a Variety of permits precise titration to an effective dose. Breakthrough or incident pain can be managed with 01-:le or OxyFast, avoiding polypharmacy. .. qua: '4-48 1:11: Target Audiences 1. Primary Audiences Primary Audiences Site Targets Comments - A. Physicians . O?ice and. 13,000 Target List 1A - IMS Hospital Decile 8, 9, or .10 for "strong" I, opioids who are also Decile 8, 9, - D05 or 10 for "combo" opioids - ANS . Surg Target List 1B . Physical Medicine 7,500 Decile 9 and 10 for "Strong" - Neurologists op101ds only I 33,000 Tar et List No. 2 - ONCS Dec?e 10 for combo only but not Hem/Ones . tL' 1A Rad/Ones 1n arge Other B. ONC RNs - Heepice 27,000 Oncology Nurses Home Care Of?ce Hos?pita! . c. Managed Care . Managed TBD . PBMS organizations Care IPAS - 0 Directors of Facilities - Staff Models Pharmacy 0 Clinical Pharmacists - Case Managers . Quality Assurance Managers In Other . D. Co.n3u]tant Long-Term Care [36,000 . In?uential decision makers at Phanrlamsts Facditres 010,000 LTC Nursmg Home N035 and RNs PP 00192 . 2. Secondary Audiences Secondary Audiences Site Targets Comments A. Patients and spa-Fever: - 1.2 million new cancer cases annually Caregivers m] ion cancer patients 35 million back pain patients B. Residents/Fellows Teaching TBD Provides the'ability to in?uence physicians - Hospitals while still in their training. Chief residents can be especially in?uential in teaching facilities. - . C- ?11101653138 15 0' National Accounts reSponsibility 0 Prescription Sales Force responsibility 5 200 i D. Pharmacies . . HOSpital 6,000" 0 To assure appropriate stocking of the . Retail 60,000 four dosage val 131300193 - .. - VI. TACTICS A. Sales Force Allocation The deployment of our most valuable resource, the sales force, is critical to the continued success of OxyContin Tablets. Heavy promotional support will continue in order to ensure appropriate awareness of OxyContin Tablets 1n the Opioid market. Sales force allocation to OxyContin Tablets will continue at 70% of pnmary sales calls 1n 1999 Representative Delivered Promotional Materials Wholesalers Contacts will be made with wholesalers to ensure that there are appropriate inventory levels for the mg, and when appropriate, the 160 mg strength tablets. Adequate inVentory levels of $01:le and OxyFast will also be ensured. Pharmacies . Representatives will call on chain and independent retail stores to make sure there is adequate stocking of the OxyContin Tablet with particular emphasis on increasing distribution of the 40 mg, 80 mg, and when appropriate, the. 160 mg strength. Representatives will also continue to increase the distribution of 011le and OxyFast at the retail level. Ho?1 ital In an effort to continue gaining hospital fonnulary acceptance of OxyContin Tablets, representatives will work with their Abbott counterparts to make calls on all committees. - The hospital formulary kit and preduct data bro?Chure will be utilized by the sales force to provide the appropriate clinical data necessary to add OxyContin Tablets to hospital formularies In addition, representatives will continue to use the .OxyContin Tablets tabletop hospital display panels. Speakers Bureau lectures will be conducted during grand rounds, tumor boards, etc. The focus of these presentations will be the addition of OxyContin Tablets to the analgesic treatment . annamentariurn. JCAHO (Joint Commission Agency that accredits hospitals) is beginning a major emphasis on pain assessment and treatment We have an Opportunity to be seen as a leader in helping hOSpitals meet the CAI-IO requirements in this area through the deveIOpment of pain assessment materials geared to the hospital setting. Managed Care Organizations Managed Care Account Executives will target all major PBMs and IPA plans where OxyContin Tablets is not. on the formulary. They will also promote the inclusion of and OxyFast formulary inclusion, as well as the addition of the 160 mg strength of OxyContin when available. committee members will be provided with formulary kits and product data brochures. The Partners Against Pain program will continue to be expanded for the managed care market, providing customized materials to meet their needs. Educational materials will be offered to managed care organizations with their plan ?indicia? printed on them. Consultations with pain management specialists, etc. are being explored as a possible value-added service offered through the Partners Against Pain. program. Direct Mail Mailings . A number of mailings are planned to support OxyContin in 1999. With the launch of the. 160 mg, announcement mailings will be sent to apprOpriate health care professionals announcing the availability of this line extension. Reinforcement of the availability and proper" uSe of OxyFast will be provided through mailings Supporting Purdue?s oxycodone ?family of products.? This will provide continued support to the fourth quarter 1998 launch of OxyFast. A three-wave mailing will also stress the efficacy of OxyContin in the management of next-cancer pain by focusing on the use of OxyC-ontin in managing the pain of arthritis. Additional mailings are outlined in the addendum outlining the program to prepare the market for the expected launch of Morphidex. - Representative ollow?up Mailings Representatives will be able to send follow?up mailings to M133 and RN 3 after making a call. This willbe accomplished through the Precise system.? Journal Advertising The journal ad for OxyContin Tablets will continue to contain the core creative concept of 24-hour oxycodone the (six dosing cups) vs. the (two dosing cups). It will also take on a humane, quality of life look, with . pictures of patients with their pain under control with OxyContin Tablets. This will be a component of our Patients? Pro?les campaign that highlights speci?c pain states such as osteoarthritis and low back pain. The journal schedule and publications used will be chosen based on important Specialties for treating both cancer and non?cancer pain. Additional advertising initiatives to prepare the market for the expected launch of Morphid-ex are outlined in the addendum section. Conventions The OxyContin Tablets eXhibit structure will'feat'ure graphic panels of the OxyContin Table-ts core creative Concept as seen in our journal ads and visual aids, pp 00195 3l a i it EASY depicting am. and pm. dosing represented by two dosing cups. In addition, panels highlighting speci?c pain states from our Patients? Pro?les campaigns will be utilized at appropriate conventions. For example, a panel. highlighting the use of OxyContin for osteoarthritis will be utilized at primary care conventions, as well as the rheumatology and consultant pharmacist conventions. Various promotional activities will be conducted at the booth to draw attendees into a discussion with our representatives about OxyContin Tablets. PP 00196 11-" Tablets Promotional Plan First Quarter Second Quarter Third Quarter Fourth Quarter Total Cost .Program 1999 Jan I.F.eb Mar Apr May Jun July Aug Sept Oct Nov Dec Promotional Materials 1999 Pain Management $50,000 - Guide Promotional Materials . IX Repn'n tsIReorders . xi xi OxyContin 160 me Launch I Materials OxyConlin 150 mg Tablets . $10,230 . .AWP Sell Sheet i -- OxyCon?n 160 mg Tablets xi ?$300 Wholesale Speci?cation - . Sheet OxyCon?n160rng?No $36,000 Cl'aims' Sell Sheet i' 160 mg Tablet . $15000 Press Release OxyCon?n 160 mg F: 545.000 X. Flashcard . Expansion of Patient Pro?les Program Post-operative Pain . . $30,000 Management Reprint Carrier Flashcard Visual Post? $210390 operative Pain Management - PP 00197 I *4?54 OXYCONTIN Tablets Promotional Plan First Quarter Second Quarter Third Quarter Fourth Quarter - Totall'Cosf . Program - 1999 . Jan 'Fe.b Mar Apr May Jun July Aug Sept Oct Nov Dec Flashcard Visual - Post- $90,000 herpetic Neuralgia Case Study Revise Patient Pro?le Visual $90,000 . Fibeimyalgia Case Study A $50,000 Visual (5.53.. HlVlAlds Case Studies with 3 5130000 0_x?iContin vs. Combination Analgesics OxyContin vs. Combination 5120.000 I Analgesics Wsual j? Post-Operative Pain :9 $50,000 AssessmentScale More Than a Few Days $60,000 Wsual 1? Professional Education NurselCase Manager $50999 Audiotape . l: sanguine Audiotape Pain Management $100,000 I Algorithms Management of Non-Cancer $350,000 'x . Pain Guidelines 0-5 Pain $15,000 PR 00198 Assessmenlmh?a?on Scale - i ?he! OXYCONTIN Tablets Promotional Plan First Quarter Second Quarter Third Quarter Fourth Quarter 'Total Cost 1999 Jan .- Feb Mar Apr May Jun July Aug Sept Oct Nov Dec Program Side Effect Management Guide (Partners Against Pain) OxyContin PCA Conversion Wall Chart OxyContin Oral Drug Conversion Wail Chart Titration Guide Wall Chart Addiction. Physical Dependence, Tolerance Terminology Visual Slate Guideline andior Concensus Statements Regarding Opioid Use in Cancer and Non-Cancer Pain Management Pharmacy 'Consultant Spotlight Patient Education Spanos Patient-to?Patient Video - Spanish Version OxyContin Patient Instruction Sheet - English and Spanish Reminder items Clocks Universal Penhoiders OxyContinlele! OxyFast $90,000 . $45000 $6.095?) $061060 sienna $30,000 $200,000 $140,000 $20000 $55,000. ar-l - OXYCONTIN Tablets Promotional Plan upon First Quarter Second Quarter Third Quarter Fourth Quarter _TotaIC;ost - Program ?2.199997 Jan? Feb Mar Apr May? Jun July Aug Sept Oct Nov Dec ?199913-monti10xy0ontin Calendar OxyContin 1.50 mg Tablets List-tattoo Announcement Mailings - . Osteoarthritis Three-Wave $137,000 . Mailing - OxyContin Family of ?mantle xw Products Three-Wave Mailing Representative Follow-up $350300 it all Mai?ngs in the Precise System New Representative Letter .13, Journal Advertising Journal Ad Production $100000 -JournalAdvertising. Sgeclal Programs Patient Evaluation Initiative (3.1455530? .x :61 Patient Evaluation Initiative $1,650,000 ?t Relaunch ofPartners 5 #497,500 "x Against Pain (including materials) Regulatory Environment 3:750,qu X. oxvcomm Tablets Promotional Plan I New or 2nd Qtr. 3rd Qtr. _4th Qtr. - 1st Qtr. 2nd on. 3rd 00. 4th on. rotor Cost Program Usage Repeat No.Pieces No.P_leces No. Pieces No. Pieces Cost Cost Cost Cost 1999 otionat Materials $50,000 - $50,000 1999 Pain Management A combined program with Repeat 30,000 ulde Senokot-S and MS Contln that lists pain medications which cause constipation and includes advertisements for OxyContln, MS Contin, and Senokot-S. 1 Promotional Materials A fund to provide reprints 01 Repeat . MA NM NM ReprintsIReorders successful materials based on 1990 utilization and field force expansion. $400,000 $400,000 $400,000 $400,000 $1,000,000 New Reprints Reprints tor OxyConlin New- 60,000 40,000 40,000 - 40,000 resulting from publication in ?5 fall 1998 of OxyContin . cliniceis and additional new articles regarding OxyConiln and/or pain management principles during $45,000 $45,000 $45,000 $45,000 $100,000 .191? 00201 . OXYCONTIN Tablets Promotional Plan Program Usage New or Repeat 1st Qtr. No. Pieces 2nd Qtr. No. Pieces 3rd Qtr. No. Pieces Qtr. Cost 2nd Qtr. Cost 3rd Qtr. Cost 4th Qtr. Cost Total Cost 1999 0x Contin 160m Launch Materials OxyContt'n 160 mg Tablets AWP Sell Sheet OxyContin 160 mg Tablets Wholesale Speci?cation Sheet . OxyContin 160 mg 'No Ctalms' Sell Sheet 4- OxyContin 160 mg Tablet Press Release OxyContln 160 mg Flashcard For retail pharmacy promotion of OxyConiin 160 mg tablets. For wholesale and chain account promotion of OxyContln 160 mg tablets. An initial sell sheet, with no setting claims. to utilize while the FDA reviews the updated setting materials. Press release with artwork for medical and trade media An Introductory sales piece for the OxyConlln 160 mg tablets. . New New New New New 55,000 100,000 30,000 . PP 00202 $16,250 $300 $36,000 $1,000 $45,000 $16,250 $300 $36,000 $1,000 $45,000 F?e Tablets Promotional Plan . -. Newer 1et0tr. 2nd Qtr. 3rd Qtr. 4th Qtr. tet'Qtr. 2nd on. 3rd Qtr. 4th on. Total Cost Program - Usage Repeat No.P .eces No.Ptecee N0.Ple'cee No.Pleces i 1 Cost Cost Cost Cost 1999 Ex anslon of Patte Profiles-Pro ram Post-operative Pain Reprint carrier for Ginsberg New 530.000 I $30300 - Management Reprint Carrier study of OxyContin In past operative pain as a part of the Patients Pro?le program. Flashcard Visual - Post Expansion of the Patient New . 100,000 - 2.100.000 $20,000 - . 520.000 operative Pain Management Pro?le program to Include 7 the use otOxyContin tor a postoperative patient. gum Flashcard Wsual - Post? Expansion of the Patient New 100.000 herpellc Neuralgla Case Profile program to include Study the use of OxyContin in post- herpetlc neuralgia. $20000 $20,000 Revise Patient Pro?le Visual Update visual to include New 30.000 Intermatlon regarding pesto operative and post-herpetic neuralgia pain management .- and the 100 mg tablets. - $90,000 $90,000 OXYCONTIN Tablets Pror'notlonai Plan - - . New or 2nd Qtr. 3rd Qtr. 4th Qtr. i?tat?lecee 2nd Qtr. 3rd Qtr. 4th Qtr. Total Cost Program Usage Repeat No.Plece_s No.P_ieces No. Pieces No.Pleces ?121999Lw= Cast Cast Cost Cost 1999 Fibermyatgla Case Study Expansion of the Patient New . 50,000 Visual - Pro?le Program to Include basic information regarding ?bennyalgla and Its treatment. Including an OxyContln case study. . $50,000 $50,000 Case Studies with Case study tonne! of three New 60.000 y: 5100.000 $180,000 Carriers patients utilizing OxyContln. with a carrier listing the basic advantages of 0xyCentln. 4n PP00204 I I . up" OXYCONTIN Tablets Promotional Plan - -. - . Newer 2nd0tr. 3rd Qtr. 4th Qtr. 2nd Qtr. 3rd.Qtr. 4th Qtr. Total Cost Program Usage Repeat N0.Pleces No.Pleces. N0.Pleces No.Pleces Cost Cost Cost Cost 1999 OyContln us. .-, Combination Analgesics . 0xyContin vs. Combination Designed tostress the New 60000 Analgesics Visual advantages of Oxy?Conlln vs. combination products by stressing a number of variables: (1) no maximum analgesic dose, (2) smaller number of pills per day. what is a rational combination discussion, comparison to qlh. q6h. and qiih dosing regimens. (5) OxyContln blood levels vs. frequent peaks and troughs of short-acting medications. $120,000 $120,000 Post-operative Pain A tool to address initiation of New 60.000 Assessment Scale 0xyContln and conversion from morphine IV or i combination analgesics. $60,000 - $00,000 PP 00205 OXYCONTIN Tablets Promotional Plan Program Usage New or Repeat 1st Qtr. No. Pieces 2nd Qtr. No. Pieces 3rd Qtr. No. Places 4th Qtr. i6! . No.Pleces - Qtr. Cost 2nd Qtr. Cost 3rd Qtr. Cost 4th Qt'r. Cost Total Cost 1999 - Visual '0 Audiotape More Than a Few Days Professional Education NurseICase Manager . Audlotape PhysicianiPharmaclst Pain Management Algorithms visual will emphasize that'around-the-ctock' - dosing of a 'Iong-acting' medication can be eliectlve even when the medication to only needed for a few days; Educate nurses and case managers on proper pain management (costs to cover completion of program begun In 1998). Educate physicians and pharmacists regarding proper pain management principles (costs to complete program begun in 1998). Algorithms regarding the management of non-cancer pain based on the Philadelphia College guidelines. New Repeat Repeat New TBD TBD TBD 20,000 TBD PP 002 06 $50,000 $50,000 $100,000 $60,000 $50,ch $60,000 $50,000 $100,000 OXYCONTIN Tablets Promotional Plan . I 1 Newor 2nd Citr. 3rd Qtr. 4th Otr. 2nd on. 3rd on. 4th on, Total Cost Program Usage Repeat No. Pieces No. Pieces No.Plec-es No. Pieces 3 Cost Cost Cost Cost 199!) Management of Non-Cancer Reproduction oi the New 60,000 00,000 Pain Guldeilnes complete Philadelphia College non-cancar?pain guidelines. $180,000 $180,000 $360,000 05 Pain - A second version of the pain New 50,000 1.4-. 50,000 - $15,000 $15,000 AssessmenliTiiraiion Scale assessment scale (original Is - 0-10) to accommodate that - utilize a 0-5 scale. Side Effect Management A variation of 0P034A New 1 60,000 . {30,000 $90,000 Guide (Partners Against only the professional 3 Pain) education piece based on . . Dr. Michael Levy's protocols for managing opioid related side ettects. $90,000 OxyContin PCA Conversion 9-1i2'x11'wall chart for 20,000 -: 90,000 $20,000 $20,000 Wall Chan hospital use to aid proper conversion of patients irom PCA to OxyConiin. OxyContinOIalDrug B-ti2'x11'wallchartof New 45.000 457,060 $45,000 $45,000 Conversion Wail Chart conversion otoraiopioids to OxyConiIn. . . PP00207 .- . - i oxrcomm Tablets Promotional Plan Program Usage New or Repeat 1st Qtr. No . Pieces 2nd 'Qtr. No. Pieces 3rd Qtr. No. Pieces 4th Qtr. No. Pieces Total :Piepes 1st Qtr. Cost 2nd Qtr. Cost 3rd Qtr. Cost 4th Qtr. Cost Total Cost - .5 1999 0xyContinI0xyiRiOxyFast Titration Guide Wall Chart Addiction, Physical Dependence. Tolerance Terminology Vlsual State Guideline andlor Concensus Statements Regarding Oplold Use in I Cancer and Non-Cancer Pain Management Pharmacy ?Consultant Spotlight? 8-112? 1: 11? version of OxyContin Tllratlon Guide to encourage proper dose adjustments. Visual to clarify terminology for health care professionals and stress how rare true addiction to oplolds used for pain management really ls. Statements supportive of the use of opioids for the management of cancer and non-cancer pain to continue to Increase the acceptance of the preper use of oplolds. Pharmacist education program on appropriate use oi oplolds ln non-cancer pain. New New New 60.000 45,000 Jon dis 50,000 48,000 for field. plus mat tributlon PP 00208 .. $60,000 $00,000 $60,000 $90,000 $20,000 $20,000 $65,000 $65,000 (a OXYCONTIN Tablets Promotional Plan . '9 New or 2001 on. 3rd 00, 4th on. marine?; 1st on; 2nd on. 3rd 00. 4th Qtr. Total Cost Program Usage Repeat N0.Pleces N0.Pteces No.Pieces No.Ptei:es_ - Cost Cost Cost Cost 1999 Pal Education il SpanosPattent-to-Patient Spanish version ofSpanos 3,000 -, $30,000 - 530.000- Video- Spanish Version Patient Education video - OxyConttn Patient Tear-off pad or patient New 100,000 1 000,000 - - $200,000 $200,000 Instruction Sheet - English instructions to aid in patient and Spanish understanding of proper OxyContin use. Reminder items 4.- 0xyConttn Clocks Reminder Item for targeted New 20,000 key physicians with OxyConttn logo. $140,000 $140,000 Universal Penholders Penhotder on a rope for New 60,000 $55,000 $55,000 nurses. 199910-month0xyContin 10-month reminder calendar Repeat 100,000 . 100,000 . $45,000 $45,000 Calendar with OxyContln OxyFast, or Oxth=0raI PCA - - . . message. i - PP 00209 4-65 OXYCONTIN Tablets Promotional Plan I . New or 2nd Cttr. 3rd Qtr. 4th Qtr. TotatPieces 1st0tr. 2nd Qtr. 3rd Ctr. 401 Qtr. Total Cost Program Usage Repeat No. Pieces _No.Pieces No.Pioc-es No.Pieces Cost Cost Cost Cost 1999 DirectMall OxyContin 160 mg Tabtets to New 321,960 57,900 379940 $07,000 $30,000 5117.000 Announbement Mailings att appropriate health care professionals announcing . . . the availabilityofOxyContin 160 mg tablet. Osteoarthritis Three-Wave Mailing to reinforce the use New 11,600 023,200 6 Mailing - of OxyContin in osteoarthritis. $100,000 $79,000. $167,000 do" OxyContin Famiiy of To reinforce availability and New 57,900 115,960 Products Three-Wave proper use of OxyFast and . . . Mailing 0;:le with OxyContin. 5&3" $66,333 $111,667 $180,000 Representative Follow-up - Letters representatives can Repeat 67,500 67,500 67,500 67,500 Mailings in the Precise send to their audiences as a System . follow-up to their sates caits. 2312.70.000 $00,000 $104,000 $104,700 $00,000 $300,700 New Representative Letter Letters from new sates Repeat 5,000 - 5,000 5,000 - 5,000 Program - representatives to - physicians In their territories 3 Introducing themselves and our products. $660 $660 $660 $660 $2,720 PP 00210 . I i . oxvcourm Tablets Promotional Plan Program New or 1etQtr. 2nd Qtr. 3rd Qtr. 4th Qtr. Totatgl?tecee tstotr. 2nd Cttr. 3rd Qtr. 4th Qtr. Total Cost Usage Repeat No. Pieces No.Pleces No.Pleces No.PIece-s '19997 Cost Cast Cast Cost 1999 Journal Journal Ad Production *nu Journal Advertising Patient Evaluation lnltiattve (PEI) 2 Production of added Pal-lent Repeat NIA MA MA I NIA Pro?le Journal ads for post- herpeltc neuralgia and post- . operative pain management "9 050.000 550.000 .0 $100,000 with OxyContin. as wellas- - an physical dependence, etc. . . Emphasis on both cancer Repeat NIA NIA NIA N10 $600,000 $600,000 $600,000 $600,000 $2,400,000 and non-cancerpaln. 1 Specific ads for different pain states such as . . . osteoarthritis and low back pain. Program to encourage Repeat 10,000 kits patient trials with OxyContln by physicians who would normally prescribe a competitive product. $1,650,000- $1,650.000 PP 00211 .m oxvcomm Tablets Promotional Plan New or Repeat 1st Qtr. No. Pleces? 3rd Qtr. No. Pieces Total Places -'1999- 2nd Qtr. No. Pieces 4th Qtr. Program No.'Pleces Usage 1st Qtr. Cost 2nd ctr. Cost 3rd Qtr. Cost .4th 00. Total Cost Patient Evaluation lnilialive (PEI) 3 9 Program to encourage patient trials with OxyContin by physicians who would normally prescribe a competitive product. Repeat 12,000 kits 12.000005 Relaunch of Partners Against Pain (including materials} Public relations program including survey, press - conferences, andongolng support. New TBD TBD TBD TBD Regulatory Environment Program to impact the New TBD TBD TBD TBD Program regulatory envlronment for I 3:3, .9 opioid prescribing In triplicate slates. . . s' ,y?i $60,000 $100,000 $100,000 $200,000 $1,650,000 . $150,000 $200,000 Cost $187,500 $250,000 1999 $1,050,000 $497,500 $750,000 1b" Sales Marketing Promotion Promotional Materials Direct Mail Journal Advertising Total Direct Advertising Samples Agency Fee Special Promotions? Co-op Advertising Conventions Abbott Commission Total Marketing 8. Promotion Total Allocation ETotal sap I Includes MHC and LTC increased budget for PEI programs, PAP initiative, and regulatory environment program v. Total sap Overview (0003) 1997 1.1/0 Of Sales Est. 100% $326,705 1998 1999 Change (yo Of Sales 100% Of Sales 100% Actual $144,827 Pro]. $493,223 - 98197 125.6% 99190 51.0% a $2,352 1.6% NA NA NA - NA $3,861 $859 $1,896 1.2% 0.3% 0.5% 29.4% 3.0% 33.2% $4,996 $885 $2,526 1.0% 64.2% 0.2% -. NA 0.5% NA .1 0.7% 0.0% 0.2% 1.1% 0.0% 0.2% 7.7% 0.0% $3,411 0.0% $0 0.3% $1,075 0.1% $5,305 0.0% - $0 0.2% $1,027 $30,003 46.9% 0.0% 19.4% 6100.0% -66.7% 11.9% 178.4% 23.8% 0.0% 30.5% 1640.3% - -100.0% 55.6% 70.9% $1,070 1.3% $2.755 $0 0.0% $0 $090 0.5% $024 $5 0.0% $310 $3 0.0% $1 $590 0.4% $000 $7,900 5.5% $22,241 $13,504 10.9% 9.3% $30,652 9.4% $53,907 127.0% 75.9% $56,765 39.2% $78,411 24.0% $100,098 20.3% 36.1% 27.7% 40.5% 334% $154,005 $109,063 31.2% $70,269 55.2% 41.2% pp 00213 53? Sales Marketing 8; Promotion Promo-llonal Materials Direct Mail Journal Advertising Total Direct Advertising Samples Agency Fee Special Promotions Co-op Advertising Conventions Sales Agent Commisslon Total Marketing 81 Promotion Total Allocation Total Includes MHC and LTC MSC 1999 of Sales 100% Actual $126,458 $607 0.5% $9 0.0% $2 0.0% $11 0.0% $0 0.0% $0 0.0% $6 0.0% $2 0.0% $55 0.0% $0 0.0% $761 0.6% $10,157 9.0% $10,919 9.6% V. Total Overview (0005) MS CONTIN I OXY199B 0/0 Of Sales 100% M30 1999 of Est. Sales Est. $123,642 100% $326,705 OXY 1999 V0 Of Sales 100% Combined OXY of 1999 Sales $616,865 100.0% Pro]. $493,223 $1,268 1.0% $511 0.4% $0 0.0% $3,861 $859 $1,896 1.2% 0.3% 0.6% $4,996 $885 $2,526 1.0% 0.2% 0.5% 0.7% $3.922 0.0% $0 0.2% $1,075 1.1% $5.993 0.0% $0 0.2% $1,112 7.7% $39003 $6,264 $1,396 $2,526 1.0% 0.2% 04%) $511 0.4% $2,755 $0 0.0% $0 $0 0.0% $824 $499 0.4% $310 $0 0.0% $1 $95 0.1% $660 $0 0.0% . $22,241 0.9% $3,411 0.0% $0 0.3% $1,075 0.1% $5,395 0.0% $0 1. 0.2% $1,027. 6.8% $38,003 0.6% 0.0% .. 0.2% 1.0% 0.0% 0.2% - 6.2% $2,362 1.9% $30,652 :2 9.4% $53,907 10.9% $56,269 9.1% $13,163 10.6% $78,411 24.0% $100,098 20.3% $113,261 18.4% $15,525 12.6% $109,063 33.4% $154,005 31.2% $169,530 PP 00214 27.5%' 4*?0