- 2000 BUDGET PLAN PP 00215 OxyCon'tin? Tablets Pages 1?23 through 1-32 redacted ASSUMPTIONS A. Market Overview To date, the market for OxyContin Tablets consists of patients with both cancer pain and non? ?cancer hipain. The non-cancer pain market IS the srgm?cantly larger market - - p101ds 1n the OxyContin market wer - non- cancer pain compared to $261 million for cancer pain. Over 70% of OxyContin Tablets prescriptions are written for non-cancer pain. With the launch of Palladone XLTM capsules, the promotional focus will be OxyContin Tablets 1n non cancer pain. OxyContin Tablets will be a secondary promotion for cancer pain management. The classic model utilized .in the 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 WHO. are: Step I Use NSAIDS to treat mild pain, aSpirin (ASA), acetaminOphen (APAP), and non- -steroidal anti- ~in?ammatory agents (N SAIDS) Step 2: Use weak opioids to treat moderate pain, e. codeine, oxycodone, and hydrocodone combinations. Step 'Use strong opioids to treat severe pain, e. morphine, hydromorphone, fentanyl,? etc. Fixed Combination Opioids Prior to the introduction of OxyContin Tablets, opioid choices for 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: Percocet?). 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 short duration of action is also problematic for patients who need around-the-clock dosing of their pain medication. Dosing every four to six hours does not allow a patient" to sleep through the night, or participate easily in many normal activities. Even dosing every eight hours can interrupt activities or sleep. 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 1n Step 2 as well as the large dollar and prescription PP 00218 volume of this class of drugs, provide a continuing opporttmity for a single- -entity, long- -acting Oxycodone product, OxyContin Tablets. Single Entity Opioids Long-acting morphine and trans-dermal 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. Hovvever, these products possess 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. Hydromorphone 15 considered a potent Opioid analgesic, but has been limited 1n its use in chronic pain due to the need to close it at least every six hours for consistent around-the- clock pain relief. OxyContin Tablets are now being utilized for severe pain, as evidenced by an increase in the sales volume of the 40 mg'and 80 mg OxyContin Tablets dun'ng 1999. 0 MS Contin Tablets Generic Sustained Release Morphine MS Contin Tablets remains the gold standard for treating moderately severe to severe cancer pain (W.H.O. Step 3). In fact, some physicians, particularly oncologists, continue to switch patients with more severe pain from OxyContin Tablets to MS Contin Tablets?. 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 OxyContin Tablets of the perception of Percocet as a weaker Step 2 drug. Although faced with stiff competition from. Duragesic?, Oramorph OxyContin Tablets and generic sustained release morphine, MS Contin Tablets prescriptions have decreased only 4% (9,3 92) in 1999 year-to-date through March 1999 compared to the same time period in 1998. MS Contin prescriptions, plus our generic (ABG) prescriptions, have decreased 7. 6% (20, 052) 1999 year-to-date compared to the same period 1998. Generic sustained release morphine is now an alternative that decreases the cost of opioid therapy with (11% dosing. An AB-rated generic to MS Contin is produced by ENDO. When distribution is adequate, it is likely that a ?maximum allowable charge? (MAC) will be developed for MS Contin Tablets, increasing signi?cantly the rate of substitution. 00219 . . Duragesic Duragesic is another competitor to OxyContin Tablets. Janssen has been'targeting the moderate-to-moderately severe pain market for the past two to three years. Their progress has been slow but steady in obtaining patients coming directly from ?xed combination opioids, as they stress convenience, less side effects (particularly constipation), and increased quality of life. Field reports tell us that in 1999, anssen is seeking to replace Percocet, OxyContin Tablets and MS Contin Tablets prescriptions. anssen is expected to gain FDA approval for a. 12.5 patch, potentially by the end of 1999. It is expected to be targeted to the early treatment of non-cancer pain and pain in the more frail elderly patient. Janssen has a dedicated 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. Ultram is provided as a Step 1 to Step 2 analgesic, while Duragesic is promotedas a Step2 to Step 3 analgesic. Janssen has been stressing decreased side effects,-especially constipation, as well as patient quality of life, as supported by patient ratings compared to sustained release morphine. They have expanded their patient preference claims to oral opioids. Due to the above initiatives, it is probable that Janssen will continue to target primary care physicians (internists and selected family practice physicians), as well as oncologists. We estimate that their 1999 journal spend will be approximately four million dollars based on $1,041,000 injournal spend January?March 1999. This compares to $1,302,000 spent in 1998. Over 70% of the 1998 spend occurred during the fourth quarter of 1998. Market research from recent focus groups continues to show that Duragesic is perceived to be less effective than MS Contin Tablets and, in most cases, OxyContin Tablets. 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 be taking advantage of these Duragesic weaknesses in our 2000 OxyContin Tablets promotions. Kadian? In 1999, Faulding continued active promotion of Kadian. The promotion of Kadian centers on its 24?hour dosing, its sprinkle formulation, and cost effectiveness. Due to these features, Kadian is being positioned as a better alternative to MS Contin Tablets. PP 00220 :j 1; i Faulding 3 main program to support Kadian has been the continuation of their ?sample? program with a free supply of Kadian at the retail pharmacy through use of a special. coupon and the patient? 3 prescription. While prescriptions have increased 77% 342) year-to-date 1999 through March compared to the same period 1n 1998, total prescriptions remain less than 1,200 prescriptions per month It is anticipated that, with continued promotion, Kadian will continue to have minimal impact on either MS Contin or OxyContin. Oramorph SR Roxane is expected to continue promotion of Orarnorph SR by positioning it as a cost-effective alternative to MS Conti-n and OxyContin Tablets. Individual Roxane representatives are also promoting Oramorph SR as a cost effective alternative to OxyContin Tablets, utilizing a conversion of morphine to oxycodone. During '1999, Roxane continues an Oramorph SR promotion that combines promotion of their pain preducts with other palliative care products under a Roxane Palliative Care Products umbrella. In 1999, Roxane? prescriptions increased 32% 742) YTD through March 1999 compared to the same period last year PCA Pumps During 1998, sales of injectable morphine were $68,000,000. Recent market research at ASCO "lists P-CA pumps as a form of cancer pain management used (along with MS Contin Tablets and Duragesic) when OxyContin Tablets 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 OxyContin Tablets ef?cacy, or reimbursement issues. Medtronics has been aggressively promoting their implantable pump in the hospice market, as well as for Other chronic pain patients. For non?hOSpice patients, reimbursement issues can play a role. Medicare will pay for pump implantation as well as the medication re?lls. Medicare does not reimburse for oral analgesics like OxyContin Tablets. In the postOperative patient, OxyContin Tablets are positioned for post-PCA pain management. A clinical study (Ginsberg) has supported OxyContin Tablets PP 00221 use in the post?operative. patient. Abbott Pharmaceutical has the main responsibility for promotion in this market. D. OxyContin Future Opportunities OxyContin 160 mg Tablet FDA approval of OxyContin 160 mg Tablets is expected late 1999 to early 2000. This will coincide very closely with the launch of Palladone Capsules. Currently, alinost 80% of OxyContin 80 mg Tablet prescriptions are for the management of non?cancer pain. The 160 mg tablets will also be positioned for the management of severe non-cancer pain. OxyConti?n Post-Operative SNDA It is expected that Purdue will ?le a supplemental NDA by the end of 1999 to eliminate the limitation placed on OxyContin- Tablets use during the first 12-24 hours post-operative. Approval of the SNDA would be expected by the end of June 2000. This will allow promotion of OxyContin Tablets use "by Purdue and" Abbott in the ambulatory surgery market. CAHO Pain Management Initiative In mid-1999, CAHO approved new requirements regarding appropriate pain assessment and management. These requirements have the potential to . revolutionize pain management in the hospital setting. New attention will. be paid to preper assessment and management of pain within all key departments of a hospital. This presents Purdue with the Opportunity to provide true value-added services as the ?pain experts? in this key area. B. Expected Entries 9 Anew competitor, Morphidex, a combination of morphine and dextromethorphan, was expected to be launched as early as Angust 1999. The FDA issued a nonapproval letter August 2, 1999. At best, a signi?cant delay is expected before the approval of this product. We will continue to monitor the status of this product. This product is expected to claim equally effective analgesia at a lower number of milligrams of morphine, due to the potentiating effects of the dextromethorphan. It appears unlikely that a claim of less development of tolerance to the analgesic effects, compared to morphine alone, will be given based on the clinical data we have seen to date. However, it isdexpectedthat Algos will discuss the research supporting PP 00222 NMDA inhibitor?s impact on the development of tolerance to analgesia and allow the health care practitioner to make the. transition to Morphidex and tolerance development. An additional promotional message will be geared to physicians? desire for a pain medication with the effectiveness of an opioid with less side effects. A claim. of less opioid side effects due to lower morphine milligram quantities may be expected. Physicians reported in market research 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. The dosing interval for Morphidex is likely to be q6h or q8h. This is not a sustained release product, but rather the expansion of duration of effect of the immediate release morphine by the dextromethorphan. Although Morphidex would not be a. direct competitor for OxyContin Tablets, since it would compete directly with MS Contin Tablets, this product will likely be targeted against all long-acting Opioids. . Roxicodone - Near the end of .1998, Roxane received an FDA ?approval? letter for their q12h Sustained release oxycodone product, Roxicodone SR. They currently have two mg and 30 mg tablets. To date, they have not launched this preduct. We have received reports that some Roxane representatives are discussing its future launch with health care professionals. The 10 mg strength has been assigned a rating with OxyContin . Tablets as the reference drug. The 30 mg strength remains unrated because there is no reference product. It is expected that this product will launch in late 1999 or early 2000 and will be positioned as a more affordable version of OxyContin Tablets. The 10 mg tablet creates the greatest risk to Oxycontin prescriptions, if - individual states andfor managed care plans accept Roxicodone SR as therapeutically'equivalent to OxyContin. We will position Roxicodone SR as not being therapeutically substitutable for OxyContin, due to the signi?cant increase in blood levels seen, when dosed with a high fat meal. .a PRODUCT INITIATIVES A. Objectives - 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.? 0 To establish OxyContin Tablets as the opioid of choice in Step 2 of the WHO. analgesic ladder by positioning it as the opioid to ?Start With? for non-cancer pain management. 0 Continue to establish and as the ideal medications for breakthrough andfor incident-a1 pain for patients on OxyContin Tablets. 0 Launch OxyContin Tablets 160 mg. for high dose non-cancer pain patients. - Enhance the acceptance of opioids for nan-cancer pain. I 0 Increase the use of OxyContin Tablets in the elderly patient, particularly in the long-term care market. 0 Increase the use of OxyContin Tablets in acute and sub-acute conditions- g, post-op pain, trauma, fractures where pain lasts more than 'a few days). - Increase the use of OxyContin Tablets in the ambulatory surgery setting following FDA approval of the SNDA. Positioning Statements . The analgesic efficacy of immediate-release oxycodone. The familiarity of physicians with oxycodone is 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 q12h dosing. Our market research indicates that the most important feature of OxyContin Tablets, beyond the familiarity of oxycodone, is the q12h dosing schedule - Onset Within one hour, comparable to immediate-release oxycodone. Recent market research focus groups, discussing product attributes, indicated OxyContin Tablets is perceived as being very effective, with a lower side effect pro?le than its competitors and with a favorable dosing schedule. In the ?rst half of 1998, OxyContin Tablets. were perceived to have a slow onset of action. This. perception has improved through the ?rst half of 1999, as shown in market research results. This onset of action message is very important in the. post- operative pain market. - . 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 through preper titration as the disease progresses. One to stay with. In 1999, OxyContin Tablets have been marketed for severe non-cancer pain. The primary strategy in the non-cancer pain market will be to establish OxyContin Tablets for a broader range of use thanis available to combination opioids. OxyContin Tablets will be positioned as an opioid physicians can initiate patients with and stay 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. By encouraging assessment of pain on a daily basis, we can prevent physicians from switching patients with more severe pain to MS Contin Tablets or Duragesi-c. . Effective in non-malignant pain states. In 2000, 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 efficacy and safety of combination 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 such as back pain, osteoarthritis, re?ex sympathetic trauma/injury, neuropathic type pains, etc. A single agent with no acetaminophen, aspirin or ibuprofen. OxyContin Tablets is a single entity Opioidlagent without the. limitations in dosing present in' products that are ?xed combinations of an opioid and a second agent like acetaminOphen, aspirin, ibuprofen, or dextrornethorphan. There is added dosing ?exibility with single agent, since a variety of co-analgesics and adjuvant medications can be used to enhance. the individual patient?s pain relief, while having the freedom to dose the OxyContin Tablets 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. No food effect. This attribute of OxyContin is particularly important in light of Roxicodone SR. OxyContin Will- be promoted as being able to be dosed without any need to limit or time food intake. This contrasts with Roxicodone SR, which must be taken One hour before a meal, or at least two hours after a meal. 4m Competition 0 Combination Opioids, (oxycodone, hydrocodone, codeine and prepoxephine with APAP, ibuprofen, or ASA): moderate-to?rnoderately severe pain (Step 2 of the ladder). 0- Ultram: non-cancer pain. . Duragesic: non-cancer pain. Methadone: Market research, as well as reports from the sales force, indicate 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 effective use of methadone for cancer pain management. While not yet a serious ?cernpetitor, this trend needs to be monitored. - Morphidex: as noted earlier, this product may become a competitor in the future, although its future is quite uncertain at this time." - Roxicodone SR: This second entrant into the sustained-release oxy'codone market will compete for the ?start with? patient and for patients with stable pain where a 30 mg q12h dose'is appropriate (one pill vs. three OxyContin 10 mg tablets per dose). Communication Objectives 0 Convince MDs to prescribe, (as well as RNs and appropriate pharmacists to recommend), OxyContin Tablets instead of combination opioids or Ultram for opioid-naive or opioid-exposed patients with moderate-to-severe pain lasting more than a few days. Through proper dosing and titration, eliminate or delay the need for other long-acting opioids. - Broader OxyContin Tablets usage among various pain back pain, Osteoarthritis, neuropathic pain, post-operative pain, etc.) will be stressed. Convince health care professionals (physicians, nurses, pharmacists, and managed health care professionals) to aggressively assess and treat both non? cancer pain and cancer pain. The positive use of Opioids, and? OxyContin Tablets in particular,?will be emphasized. - Convince patients and their families to aetively- pursue e?fective pain relief. The importance of patients assessing their own pain and communicating the status to the health care giver will be stressed. 0 Put into perspective issues that the introduction of Morphidex may highlight: tolerance, Opioid side effects, the convenience of 12?hour vs. eight hour (or six hour) dosing, and ?exible vs. ?xed combinations of products in pain management. - Emphasize BX rating ofRoxicodone SR 10 mg tablets to OxyContin 10 mg Tablets as well as food effect for Roxicodone SR. Selling Points The One to Start it}! The logical ?next step? for patients no longer tolerating or responding to non- opioids conforms to the three- -step H. O. analgesic ladder. The analgesic ef?cacy of immediate-release oxycodone? with the convenience ofq12h dosing. Rapid onset of action (similar to short-acting opioids). Pain control lasts 12 hours; two?to-three times longer than each dose of short? acting products such as Percocet, Percodan, Tylox?, Vicod'in, Lortab, Lorcet, Ultram, and Tylenol with codeine. OxyContin Tablets should only'be dosed every twelve hours, as it is not an eight-hour drug. Convenient q12h schedule won ?t interfere with patient?s daytime activities, or nighttime rest and encourages compliance. - Even q8h dosing interferes with activities and a good night? 5 sleep Q12h closing 15 the most frequent acceptable dosing schedule for chronic pain. Patient is less likely to anxiously ?clock Watch? when pain control is sustained. over long periods. Single-entity agent avoids adding the potential toxicities of products containing aspirin or acetaminophen, as well as allowing ?exibility in prescribing concomitant NSAIDS. our dosage bioequivalent and dose-proportional, are appropriate for a broad range of pain. A ?fth dosage strength, 160 mg tablets, is expected to be approved in late 1999. I Small color-coded tablets are easy to identify and swallow an important bene?t for elderly patients and those on multiple medications. In studies of patients With non-malignant pain: Rapid reductionin 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, interact with others, and enjoy life May be titrated every one to two days. The One to'Sray With 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 PercoceL 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?ectiveness with increasing doses is not limited by a Patients avoid the added risk of gastric/hepaticfrenal toxicity that can occur with products containing aspirin or acetaminophen. . Excellent compliance, high degree of patient acceptability during clinical trials. Multiple dose are available to accommodate patients with severe pain. Fewer pills to take and for physicians to prescribe. The introduction of the 160 mg OxyContin Tablets will increase the dosing ?exibility. Idea! for Long-Term Therapy A single-entity oral agent, contains no APAP or ASA allows ?exibility of independent coadrninistration and dosage adjustments with non-opioids of choice. No deVeIOpmentof analgesic tolerance seen over 18 months of therapy in osteoarthritis patients. - - Q12h dosing convenience for both patients and staff. 1 2h increases the probability of a full night?s rest. Eng to Live ith The Delivery System Aliows Both Rapid and Prolonged . Effective pain control may allow many patients teachieve the goal of functioning as close as possible to the way they did prior to having pain. Convenient ql2h schedule won?t interfere with patient?s daytime activities er nighttime rest and encourages compliance. The? ql2h desing schedule will make life easier for both the patient and caregiver, as their days and nights will not be interrupted ?'equently 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 dothings for them. It may also result in more patients being able to be treated in the home environment. Breakthrough medications and available for incident or breakthrough pain. Polypharmacy can be avoided. 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. 25.9%, was seen between the ?rst and last weeks of a cancer study even as daily doses increased. Absorption Over a 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 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 period. 100% of patients in clinical trials were dosed q12h. ?00223 . 1-43 a 1-44 0' 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? assures" .minimal effect of stomach contents on absorption bioavailability unaffected by food or ingestion of other medications. E35210 Titrare - Steady state achieved 111 24-48 hours and remains constant thereafter. If needed, pain assessment and titration are possible every one to two days. 0 In cancer studies: Titration enhanced efficacy of therapy only 3.5% of cancer patients discontinued, (due to inadequate pain control), when allowed to titrate and use rescue medications. Patients were titrated as quickly and easily with OxyContin Tablets as with immediate-release oxycodone. 92% of patients were titrated to stable pain control With OxyContin Tablets, compared with 79% for immediate-release oxycodone. 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. to Dose 0 Small, color-coded tablets are easy to identify and swallow an important bene?t for patients on multiple medications. Vanety of permitSprecise titration to an effective dose. Breakthrough or incident pain. can be managed with or avoiding polypharmacy. PP 00229 1-45 F. Target Audiences 1. Primary Audiences Audiences .., Site Targets Comments . A. Physicians. (Primary) O?ice and 13,000 Target List IA 0 IMS Hospital Decile 8, 9, or 10 for "strong" . Opioids who are also Decile for ?combo" opioids ANS . . Sur Target List 18 . . 7,600 Decile 10 for combo only but not 0 h/ledtcme on Target List IA - Neurologists . Rhemnatologists 33,000 Target List 2 - Other Decile 9 and 10 for "Strong" Opioids only B. Physicians/Nurses . Hospice 27,000 . . 1 (Secondary) . . 0 Home Care . a - ONCs . Of? -- Hem/Ono's - cc Rad/Ones Hospital - . ONC RNs o. . Nurse Practitioners C. ManagedICare 348312.33de Care TBD PBMs Organizations Fac111t1es . . 1P AS .- . Directors of . Sta?? Models i Pharmacy -- - i a Clinical I I Pharmacists . Case Managers 0 Quality Assurance Managers . - I Other - D. - Long-Tenn 6,000 In?uential decision?makers a . Consultant . Care Facilities 10,000 LTC fac111t1es 1' Pharmacists - i 0 Nursing Home I - MDs and RNs 1-46 2. Secondary Audiences Secondary Audiences - 9 I 51?? - Targets Comments A. Patients and Caregivers . I B. Residents/Fellows Teaching 6 TBD Provides the ability to in?uence I Hospitals . physicians still in training. Chief - residents can be eSpeeially in?uential in . . teaching facilities. C. Wholesalers . - 150 . I D, Pharmacies . . Hospital 6,000 To assure appropriate stocking of the ?ve . Retail - 60,000 dosage i !i i PP 00231 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 in the opioid market. OxyContin will remain the primary product in calls on physicians who predominately treat non?cancer pain. It will. be the second promoted product on calls to physicians who predominately ?treat cancer pain. Sales force allocation to OxyContin Tablets will continue at 70% of primary sales calls in 1999. - . B. Representative Delivered Promotional Materials Wholesalers/Chain Headquarters (National Accounts Managers) Contacts will be made with wholesalers to ensure that there are appropriate inventory levelsmg, and, when appr0priate, the 160 mg strength tablets. Adequate inventory levels of and will also be ?ensured. -- . Pharmacies Representatives will call on chain and independent retail stores to make sure there is adequate stocking of the OxyContin Tablets with particular emphasis on increasing distribution of the 40 mg, 80 mg, and,lwhen appr0priate, the 160 mg strength. Representatives will also continue to increase the distribution of . and at the retail level. Hospitals In an effort to continue gaining hospital fonnulary acceptance of OxyContin Tablets, representatives will work with their Abbott counterparts to make calls on 1 all Pharmacy and Therapeutic committees. The hospital formulary kit and product data brochure will be utilized by the sales force to provide the apprOpriate clinical data necessary to continue to add OxyCo-ntin Tablets to hospital formularies. In addition, representatives will continue to use the OxyContin Tablets tabletOp hospital diSplay pane-Is. Speakers? Bureau lectures will be conducted during grand rounds, tumor board's, etc. The focus of these presentations will be the addition of OxyContin Tablets to the 1 analgesic treatment annamentarium?. 1 The OxyContin Tablets post-Operative SNDA will add the ability to actively 1 promote OxyContin Tablets in the ambulatory surgery market. This will include 1 hospital-based same day surgery units. This will be a major initiative in 2000. 1-48' 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 JCAHO requirements in this area through the development of pain assessment and pain management materials geared to the hospital setting Managed Care Organizations Managed Care Account Executives will target all major PBMs and IPA plans where OxyContin Tablets are not on formulary. They will also promote the formulary inclusion of and as well as adding the 160 mg strength of. OxyContin Tablets when available committee members will be provided with fonnulary 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 Mailin insg A number of mailings are planned to support OxyContin Tablets in 2000. With the launch of the 160 mg tablets, announcement mailings will be sent to appropriate health care professionals announcing the availability of this line extension. Additional mailings will be done to support key OxyContin Tablets messages following the launch of Morphidex as well as to support the use of OxyContin in the post-operative pain area following SNDA approval. Representative Follow-up Mailings- Representatives will be able to send follow-up mailings to MDs and RNs after making a call. This will be accomplished through the Quest system. Journal Advertising The journal ad for OxyContin Tablets will continue to contain the ?Keep It Simple? message begun in 1999, as well as the patient pro?le campaign for non-cancer pain management. This humane, quality of life look, with pictures of patients with their pain under control with OxyContin Tablets will discuss Speci?c pain states. 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 non-cancer pain. pp 00233 Conventions The OxyContin Tablets exhibit structure will feature graphic panels of the OxyContin Tablets core creative concept as seen in our journal ads and visual aids. 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 Tablets 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 00234 qt" OXYCONTIN Tablets Promotional Plan First Quarter Second Quarter Third Quarter Fourth Quarter . Total Cost I . Program .2000 Jan Feb Mar Apr May Jun July Aug Sept Oct Nov Dec Promotional Materials I 100 mg Tablets Launch $755,000 ?Taking Control oi Your Pain? $300,000 Booklets Promotionai Materiais $2,005,000 'x Reprintiseorders . I I New Reprints $000,000 . Educa?onal Slide Kit for $450,000 x: x. Representatives Primary Care Expansion . 1 Primary Care Physician $00,000 5 Visual Aid on Pain I -- OxyCon?n vs. Combo $150,000 Analgesic Slim Jim 2000 Prescribing Guide - $70,000 Guidelines for use of opioids $100,000 i inlnon-rnaiignant pain OxyContin Annotated $150,000 Prescribing Information - - i . . - . 1 Pain Terms De?nition Tear $100,000 Primary Care crinioa $150,000 i Background - OxyContin in Low Back Pain PP. 00235 I I i i OXYCONTIN Tablets Promotional Plan First Quarter Second Quarter Third Quarter- Fourth Quarter Total Cost. Program .2000 Jan Feb Mar Apr May Jun July Aug Sept Oct Nov Dec New Patient Pro?les Regional Highlights in Pain $100,000 Management - Pain Clinic Focus CME Critical Pathways $50,000 workbook Men-sana Diagnostic $100,000 - Program PCA Conversion to $50,000 I OxyContin Quick Reference - Wail Chart OxyContin Clinical Highlights $100,000 -Review Manage the $50,000 the Recovery Post-Op SNDA $100,000 x- Patient Education OxyContin Patient Instruction $200,000 - Booklets JCAHO OxyContin Scroll Pens $300,000 .x x- .x JCAHO Resource Binder $225,000 with Tabbed Section Pain: The Fifth We] Sign - $240,000 ,cnpboard . . . i 91-52 OXYCONTIN Tablets Promotional Plan First Quarter Second Quarter Third Quarter Fourth Quarter Totat Cost Program .2000. Jan Feb Mar Apr May Jun July Aug Sept Oct Nov Dec .Pain: The Fifth Vital Sign 550,000 Wail Chart Wisconsin Pain. Initiative $500,000 .X Resource 'Buitding an Institutional Commitment to Pain Management? Premium items OxyContin Canvas Tote $250,000 'x 5.395 OxyContin Mag Light $125,000 New Competition Fact Sheets $80,000 Reminder" Post Cards $15,000 Managed Care OxyConti'n Template $100,000 Package (MC) Template Binder (LTC) $75,000 .I Journal Advertising $4,000,000 Journal Ad Production NewJoumalAds 050,000 ?Post-op -PHN ?Fibro PP 00237 I . 1-53 . I. OXYCONTIN Tablets Promotional Plan First Quarter Second Quarter Third Quarter Fourth Quarter Total Cost Program '2000 Jan Feb Mar Apr May Jun July Aug Sept Oct Nov Dec Sgecial Programs OxyContinStarterPakwim $6,000,000 x. x. PCS Card Relaunch orParmersAgainsl $975,000 Pain (induding materials) . . . Regulatory Environment $750,000 Program - - Direct Mail Case Study Direct'Maii $300,000 combines existing pro?les with reminder points to PCPs JCAHO Direct Mail $50,000 - Osteoar?lritis Direct Mail: $300,000 - . - - PCP Audience . - Power Pak - Phannacy $30,000 - . Education'Ma'iling PAINP Mailer $100,000 Mailer $100,000 .x Representative Follow-up $385,000 .X I Letters a I Keep it Simple Mailers $300,000 PP 00238 Q-I itil-54 oxrcomin Tablets Promotional Plan . - New or 2nd Qtr. 3rd Qtr. 4th Qtr. 1st Qtr. 2nd Qtr. 3rd Qtr. 4th Qtr. Total Cost Program Usage Repeat No.Pleces No.Pleces No.Pieces .2000], Cost . Cost Cost Cost 2000 i Prom tlonal Materials 160 mg Tablets. Launch To support printing and New 2,000 TBD TBD $50,000 . $357,500 $357,500 $765,000 promotional materials - revisions for the 160 mg - . tablet. "Taking Control of Your Patientbooklets on pain New 100,000 100,000 $300,000 - $300,000 Pain' Booklets developed with Tufts - I: I - University Hospital (in five languages). Reprints/Reorders successful materials based on 1999 utilization and ?eld force expansion. Includes purchase of outserts used in promotion. PromotionatMaterlais To provide reprints of Repeat. . NM NM MA MA tannin $606,250 $666,250 $656,250 $666,250 $2,665,600 New Reprints Reprints tor OxyContin New 75,000 75,000 75,000 75,000 300,000 $75,000 $75,000 $75,000 $75,000 $300,000 Educational Slide Kit for Acomprehensivein-service New 250 250 250 250*_ 1,000 $115,000 $115,000 $115,000 $115,000 .. $460,000 Representatives slide kit on pain . managementto educate key . - customers. PP 00239 . .. . w" OXYCONTIN Tablets Promotional Plan Program Usage New or Repeat Qtr. No. Pieces 2nd Qtr. No. Pieces 3rd Qtr. No. Pteces Total Pieces 2000 Qtr. Cost 2nd Qtr. Cost 3rd Qtr. Cost 4th Qtr. Cost Total Cost 2000 Primary Care Expansion Primary Care Physician Visual Aid on Pain OxyConlin vs. Combo Analgesic Slim Jim 2000 Prescribing Guide Guidelines for use of opioids in non-malignant pain OxyConlin Annotated Prescribing Information A visual aid which will address the issues faced by PCPs in the treatment of pain. A slim Jim visual which focuses on combo vs. single entity, IR vs. CR and bene?ts of q1 2h dosing. A combined program (Senokot and OxyContin) with a focus'on pain medications which cause cons?pauon. A compendium of current references which support the use of Opioids in the treatment of non-malignant pain. A graphic visual which calls out the key inform alien from the OxyContin prescribing information. New New Repeat New New 20,000 50,000 50,000 50,000 50,000 PP 0.0240 50.000 4 sopoo 50,000 50,000 $80,000 $150,000 $70,000 $100,000 $150,000 $00,000 $150,000 $70,000 $100,000 $150,000 1?55 OXYCONTIN Tablets Promotional Plan Program Usage New or Repeat Qtr. No. Pieces 2nd Qtr. No. Pieces 3rd Qtr. No. Places 4th Qtr. No. Pieces Total Pieces 2000- ist Qtr. Cost 2nd Qtr. Cost 3rd Qtr. Cost 4th Qtr. Cost Total Cost Pain Terms Definition Tear Pad Primary Care Clinical Background - OxyContin in Low Back Pain New Patient Protlles Regional Highlights in Pain Management Pain Clinic Focus CME Critical Pathways Workbook Mensana Diagnostic Program pain physician. A tear pad Version of the terminology visual. To expand the results of OxyConlln studies into the primary care audience. Regional testimonials on pain management success stories which will be compiled into new pro?les to expand acceptance or' optolds in treatment of non- malignant pain. A case study format designed to challenge the A third party reference for physicians to utilize when diagnosing ?problem? patients. New New New New 50,000 10,000 TBD - PP 00241 50,000 TBD TBD- 50.000 50.000 TBD 10,000 Tee $100,000 $50,000 $50,000 $150,000 $50,000 $100,000 . . $150000 $000,000 2000 - $100,000 $50,000 $100,000 OXYCONTIN Tablets Promotional Plan Program Usage New or Repeat Qin- No. Pieces 20d Qtr. No. Pieces 3rd Qtr. No. Pieces 4th Qtr. No. Pieces Total Pieces ist Qtr. Cost 2nd Qtr. Cost 3rd Qtr. Cost 4th Qtr. Cost Total Cost PCA Conversion to Wall Chart OxyContin Clinical . Highlights - Review Manage the the Recovery Post-0p SNDA Patient Education OxyContin Patient Instruction Booklets Designed to be a quick OxyConiin Quick Reference reference for clinicals based on most popular parenteral opioids to OxyConlin conversions. A clinical review of current 0xyContin data. A quick reference card which focuses on OxyContin bene?ts in post-operative setting. New materials to support expanded indication in post- operative market. Small booklets which can be read by patients to outline preper administration of OxyContin Tablets. New New New new New 50,000 50.000 200,000 50.000 PP- 00242 TBD - 2000 . 1:50.009 50,000 Top 200,000 $50,000 $50,000 $200,000 $100,000 $100,000 $100,000 2000 - $50,000 3100.000 $200,000 OXYCONTIN Tablets Promotional Plan I 1?58 New or 'an Qtr. 0rd Qtr. -4th Qtr. 2nd Qtr. 3rd Qtr. 4th Qtr. Total Cost Program Usage Repeat No.Plecas No.Pleces N_o.Pieces N.o.Pieces-? 2000 Cost Cost Cost Cost 20% JCAHO OxyContin Scroll Pens A pen with OxyContin ?New 50,000 I . 50,000 50.000 150.000 . $100,000 $100,000 5100.000 5300.000 conversion and titration - .. information. JCAHO Resource Binder A binder which will outline New 20,000 20.000 $225,000 with Tabbed Section the tools from Purdue lo . . help aid in JCAHO compliance as well as provide template examples of tools currently being used for assessment. etc. . - Contains CDIROM which will - allowaccounts to customize examples of resource tools. 0225.000 Pain?Thethwm?S?Q" Apainassessmenlc'ipboard New 20.000 20.000 20.000 20.000 00.000 $60,000 $60,000 360000 36000010240000 Clipboard which is targeted to hospital . a . . and outpatient setting. Pain: The Fifth Vital Sign Awaitbhartassessmenliool New . 50,000 550.000 $501000 Wall Chart ioruse as well . . - - asiheomceseiingio - - assess pain. 1, - . OXYCONTIN Tablets Promotional Plan New or 1st Qtr. 2nd Otr. '3rd Qtr. 4th Qtr. Total-Pieces 2nd Qtr. 3rd Qtr. 4th Q'tr. Total Cost i Program Usage Repeat No.Pleces No.Pleces No. Pieces No. Pieces 2000 Cost Cost Cost Cost 2000 Wisconsin Pain initiative Aresource which?can be New TBD TBD TBD TBD TBD $125,000 $125,000 $125,000 $125,000 $500,000 Resource ?Building an offered by the representative - - - Institutional Commitment to to key institutions who are Pain Management? gearing up for JCAHO review regarding pain Standards. Premium Items OxyContin Canvas Tote Quality denier nylon tote bag New 251000 . 25?000 - 32501000 32501100 Bags embossed with OxyContin. .- - - . OxyContin Mag Light A mini ?ashlight of high New 25.000 . - 25,000 $125,000 $125,000 quality embossed with .. .. . . . OxyContin logo. New Competition Fact Sheets Afaotsheetcornparison New TBD TBD TBD TBD 410,000 $20,000 $20,000 $20,000 $20,000 $80,000 - piece to highlightOxyContin . . advantages over future competition. PP 00244 OXYCONTIN Tablets Promotional Plan New or 2nd Qtr. 3rd Qtr. 4th Qtr. Total'Pi-eces 1st Qtr. 2nd Qtr. 3rd Qtr. 4th Qtr. Total Cost Program Usage Repeat No.Pleces No.Pieces No. Pieces No. Pieces 2000 Cost Cost Cost Cost 2000 Reminder Post Cards Leave-behind versions of New 50.000 "50.000 $15,000 - $15,000 our Keep It Simple direct - -. -. - mail or other creative direction focusing on OxyContln features and bene?ts. - Managed Care . . a OxyContln Template Atemplate package to - New . TBD I TBD 540300 540.000 $20,000 P3911309 (MC) support promotional efforts . . . . . in managed care. Template Binder (LTC) A template binder to support New TB 0 . $751000 $751000 Promotional eiiorts In leng- - term care. Expanded focus for 2000 to Repeat . TBD. TBD TBD TBD . $1,000,000 $1,000,000 $1,000,000 31.000300541000000 tnctude primary care. - . orthopedic surgery. general surgery. long-term care,- anesthesia and rheumatology. PP 00245 . In: .. .9 1-60 OXYCONTIN Tablets Promotional Plan Program Usage New or Repeat Qtr. No. Pieces 2nd Qtr. No. Pieces 3rd Qtr. No. Pieces 4th Qtr. No. Pieces Total Pieces 2000 Qtr. Cost 2nd Qtr. Cost 3rd Qtr. Cost 4th Qtr. Cost Total Cost 2000 Journal Ad Production New ads to Primary Care Journals - Post-op PHN - Fibre eciai Pro rams OxyContln Starter Pair with PCS Card Relaunch oi Partners Against Pain (including materials) Regulatory Environment Program . . Creation of new OxyContin ads which incorporate new focus of ?keep it simple.? A PCS program with ?exibility targeted at high potential prescribers oi OxyContin to initiate trial therapy in non-cancer pain. Program through Porter Novelli pain survey. To expand the in?uence of Partners Against Pain and build brand equity. To monitor and in?uence policy and public information related to pain. New New New New TBD NIA TBD 50,000 730 NM TBD 50,000 TBD NIA PP 00246 50,000 TBD NIA 730 150.000 TED NIA $243,750 $187,500 $25,000 $2,000,000 $243,750 $187,500 $25,000 $2,000,000 $243,750 $187,500 $50,000 $2,000,000 $6,000,000 $243,750 $975,000 $107,500 $750,000 . OXYCONTIN Tablets Promotional Plan . 1?62 Program Usage New or Repeat 1 st Qtr. No. Pieces 20d Qtr. No. Places 3rd Qtr. No. Pieces 4th Qtr. No. Pieces Total Pieces 2000 1st Qtr. Cost 200 Qtr. Cost 3rd Qtr. Cost 4th Qtr. Cost Total Cost 2000 Direct Mail Case Study Direct Mail combines existing pro?les with reminder points to PCPs. JCAHO Direct Mail OsteoarthriUs Direct Mail: PCP Audience Power Pak - Pharmacy Education Mailing 'k WW- I Direct mail compaign targeted to hospital administration and EVA personnel for JCAHO pain standards to support representative efforts regarding JCAHO. A direct mail program targeted to primary care physicians on the effectiveness of Ox'yContin in osteoarthritis. Focuses on quality of life. A cooperative mailer containing information to educate pharmacists on terminology of pain (is. . addictionipseudo-addictlon) -. New New New New 50,000 50,000 5,000 65,000 5,000 50,000 . 4. 50,000 100.090 10.000 100.000 $150,000 $150,000 $300,000 $25,000 $25,000 $50,000 $150,000 $150,000 $300,000 $30,000 $30,000 oxvcourm Tablets Promotional Plan New or Q-tr. 2nd Qtr. 3rd Qtr. 4th Qtr. . . 1st Qtr. .2nd Qtr. 3rd Qtr. 4th Qtr. Total Cost Program Usage Repeat No.Pleces -No.Pleces No.Pleces No.Pleces C-os-t' Cost Cost Cost f- 2000. PNNP Mailer A direct mail program New 20.000 focused on the value of PAINP in diagnosing and treating pain; $130,000 $100,000 OBIGYN Mailer - A direct mail program New '3 - 10.000 - focusing on quality of pain management after operative gynecological procedures. 5100.000 ??51009?? Representative Follow-up Quest system letters which Repeat 70,000 70,000 70.000 70.000 Letters will be sent by . representatives following a sales call. $06,250 $96,250 596.250 $96,250 $385,000 Keep it Simple Mailers A direct mail campaign on Repeat TBD TBD TBD early adoptions of new technology in light of future competition. 375.000 $75,000 $5,000 575.000 PP 00248 eat." ?Mr-mammal" . .- v. Total sap Overview (0003) 1998 2000 Change of Sales 99196 00199 100% 116.1% 41.5% 1999 0f I Sales Est. 100% $659,455 Of Sales 1 00% Actual $305.143 Proj. Sales $933,000 Marketing Promotion Promotional Materials Direct Mail Journal Advertising $3,872 $308 $1,906 1.3% 0.1% 0.6% $7,996 $885 . $2,526. 1.2% 0.1% $8,623 $1,729 0.9% 0.2% 106.5% 187.3% 32.5% 95.4% 62.6% 0.4% $4,107 0.4% Total Direct Advertising $2,214 Samples $3 Agency Fee $813 Special Promotions $220 Co-op Advertising $24 Conventions $821 Abbott Commission $20,122 0.5% $5,836 0.0% $0 0.7% $3,411. 0.0% $0 0.3% $1,075 0.1 $6,545 0.0% $0 0.3% $1,077 6.6% $49,282 0.6% 54.1% 71.1% 0.0% 400.0% NA 0.2% $1,387 0.1% 32.2% 29.0% 1.0% $9,171 1.0% 40.1% 0.0% $0 0.0% 400.0% NA 0.2% $1,051 . 0.1% 31.2% 2.4% 7.5% $71,576 7.7% 144.9% 45.2% Total Marketing Premotion $28,089 9.2% $69,386 10.5% $97,646 10.5% 147.0% 40.7% TOtal Allocatlon $79,605 26.1% $114,730 17.4% - $104,116 11.2% 44.1% Total $107,694 35.3% I $184,116 27.9% $201,762 21.6% 71.0% Includes MHC and LTC PP 00249 Sales Marketing 8. Promotion Promotional Materials Direct Mail Journal Advertising Total Direct MalIlJoumal Advertising Samples Agency Fee Special Promotions Co-op Advertising Conventions Sales Agent Commission Total Marketing 8. Promotion Total Allocation. Total Includes MHC and LTC MSC 1999 of Actual Sales $109,199 100% $1,260 1.2% $511 0.5% $0 0.0% $511 0.5% $0 0.0% $0 0.0% $498 0.5% $0 0.0% $85 0.1% $0 - 0.0% $2,362 2.2% $14,384 13.2% $16,746 15.3% V. Total Overview (0005) MS I MSC 2000 OXY 1999 of of Est. Sales I Est. Sale: $90,000 100% $059,455. 100% $1.270 1.4% $7.996 1.2% $391 0.4% $885 0.1% $0 0.0% $2,525. 0.4% $391 0.4% $3.411 0.5% $0 -1 0.0% $0 0.0% $0 0.0% $0 0.0% - $0,545 1.0% $0 0.0% $0 0.0% $0 0.0% $1,077 0.2% $0 0.0% .661 1.8% $69.386 10.5% $16,191 18.0% $114,730 17.4% $17,852 19.8% $184,116 27.9% PP 00250 $1.075 0.2% $49,262 7.5% OXY 2000 Combined of - of Pro]. Sales OXY 2000 Sales $933,000 100% $1,023,000 100.0% $8,623 0.9% $9,993 1.0% $1,729 0.2% $2,120 0.2% $4,107 0.4% $4,107 0.4% $5,636 0.6% $6,227 0.6% $0 0.0% 0.0% $1,387 0.1% $1,387 0.1% $9,171 1.0% $9,171 0.9% $0 0.0% $0 0.0% $1,051 0.1% $1,051 0.1% $71,578 7.7% $71,578 7.0% $97,646 10.5% $99,307 9.7% $104,116 - 11.2% $120,307 11.8% $201,762 21.6% $219,614 21.5% . .1 1?65 I MS Contin? Tablets PP 00951 .