2001 BUDGET PLAN Dar/a ?7/2 "/?doi ?wa 2135/] 6&?44/ ?ax/V. 25c? PP 00252 Tablets Pages 4-28 through 4-37 reda?ted A. ASSUMPTIONS Market Over-View To date the market for OxyContin? Tablets consists of patients with both cancer pain and non-cancer pain. The non- cancer pain market is the signi?cantly larger market In 1999 sales of opioids were $1.7 billion for non-cancer pain compared to $261 million. for cancer pain. The primary promotional focus will continue to be for OxyContin Tablets 1n non-cancer pain- However, due to the delay of the launch of I-IHER Capsules, as well as the potential for new competitive threats 1n the treatment of cancer pain, a renewed focus on cancer pain will be essential for protection of the oncologyfcanCer pain franchise. in addition, we expect that new single agent and combination analgesics will expand their promotion to nonmalignant pain as well. The classic model utilized in the treatment of cancer pain is the World Health Organizatioan'l?lO) Three Step Analgesic Ladder. W'hile 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, some physicians use the WHO ladder as a guide for treatment of non-cancer pain. The rec?ommendations of the WHO are: Step I: Use NSAIDS to-?treat mild pain, aspirin (ASA), acetaminophen (APAP), and non-steroidal anti-in?ammatory agents (NSADDS). Step 2: Use weak Opioids to treat moderate pain, e. g. codeine, oxycodone, - - and hydrocodone combinations- Step 3: Use strong opioids to treat severe pain, e. morphine, hydromorphone, fentanyl, etc. OxyContin Tablets are recommended and promoted for Steps 2 and 3 of the WHO. analgesic ladder. In addition, OxyContin Tablets should be initiated after NSAIDS, Tramadol or Cox 2 fail in patients with persistent around?the-clock pain of a moderate to severe nature who require opioid therapy. Physicians? understanding of the utility and appropriateness of OxyContin Tablets therapy for persistent "pain lasting more than a few days will be essential to our efforts to compete with the Step 2 opioid combination products. Fixed Combination Opioids Prior to the introduction of OxyContin and MS Contin Tablets, oral opioid choices for treating moderate-to-moderately severe pain in Step 2 had been limited to combination products containing oxycodone, hydrocodone, codeine, and either (example: Percodan?) or APAP (example: Percocet?). The short duration ofacnon of these oral products causes peaks and valleys in blood levels, which can contribute to increased side effects and poor, inconsistent pain control. The short duration 0f 4?39 action is also problematic for patients who need aroun-d-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 may 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 or gastrointestinal toxicity. The APAP or ASA component also has the potential to mask fever in cancer patients and other patients with infections. All of 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 a continuing opportunity for a Single-entity, long-acting oxycodone product, OxyContin Tablets. - Percocet? E'ndo Pharmaceuticals launched three new product line eXtensions between November 1, 1999 and February 2000. Percocet 2.5/325 mg, 15/500 mg and 10/600 mg oxycodone/APAP Opioid combination products were launched to capitalize on the growing success of oxycodone made possible by OxyContin Tablets. Single Entity Opioids Long-acting morphine and transdennal 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 disadvantages such as. the stigma that surrounds morphine and the reluctance of physicians, nurses, and pharmacists to Use them. They are also considered ?potent? opioids, which physicians may be reluctant to prescribe until the pain is severe. Hydromorphone is considered a potent opioid analgesic, but has been limited in its use for chronic pain due to the need to dose it'at least every six hours for consistent around-the-cloclc pain relief. OxyContin Tablets is now being utilized for severe pain, as evidenced by an increase in the sales volume OxyContin Tablet during 2000. The availability of the 160 mg dosage strength represents a signi?cant opportunity for OxyContin Tablets to compete in the severe pain Step 3 analgesic ladder. The 160 mg tablet provides a competitive advantage relative to long-acting morphine and Duragesic, as well as being a barrier to entry for other long-acting opioids which may enter the market. MS Contin Tablets/Generic Sustained Release Morphine MS Contin Tablets remains the gold standard for treating moderately severe to severe cancer pain (WHO 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 who can treat cancer pain continue to believe that MS Contin Tablets is more potent than OxyContin Tablets. This may be due in part to the transfer to OxyContin Tablets of the perception of Percocet as. a weaker Step 2 drug. Faced with stiff competition from Duragesic?, Orarnorph OxyContin Tablets and generic sustained-release morphine (Endo?s AB rated generic), MS Contin Tablets prescriptions have decreased 15.6% (71,123) in. 2000 year-to-date (January through June 2000) compared to the same time period in 1999. MS Contin prescriptions, plus-our generic prescriptions, have-decreased 12.7% (60,681) 2000 year-to-date June compared. to the same period in 1999. Generic sustained release morphine continues to be an alternative that ldecreases the cost of opioid therapy with q12h 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. To date the MAC has not occurred; however, it was proposed and delayed in 2000. In addition, genericMSER has now captured approximately 23.4% of the prescription volume of the long-acting morphine category. All morphine sulfate distributed by ABG Labs was discontinued effective August 1, 2000:- D_u_ragesic Duragesic is another competitor to OxyContin Tablets. anssen 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. In 2000 anssen is seeking to replace Percocet, OxyContin Tablets and MS Contin Tablets prescriptions. Janssen is expected to gain FDA approval for a 12.5 2000/early 2001. It is expected to be targeted to the early treatment of non?cancer pain and pain in the ?'ailer elderly patient- Field reports have revealed at least one direct head-to?head study of Duragesic and OxyContin Tablets in nonmalignant pain. In addition, Janssen was asked by the PP 00257 FDA in 2000 to remove Prepulsid?, a GI. motility drug with sales in excess of $1 billion US, from the market. This has produced a renewed focus on Duragesic by anssen, and the weekly prescription volume for Duragesic continues to reach new records. anssen 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 promoted as a Step 2 to Step 3- analgesic. anssen 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. We do not have such data to support the OxyContin promotion. They have expanded their patient preference claims to oral opioids. In addition, Ianssen has been using the ?start with. . .stay with? message in promotion of Duragesic for nonc'ancer pain. 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 2000 journal spend will be approximately $680,000 based on $170,000 in journal Spend anuary?March 2000. This compares to $2,210,000 Spent in 1999. - Market Research 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, lacking the ability to be titrated quickly, and not considered cost effective. We will be taking advantage of these Duragesic weaknesses in our 2001 OxyContin Tablets promotions. Kadian? In 2000 Faulding continued active promotion of Kadian. The promotion of Kadian centers on its 24-hour dosing, its sprinkle formulation, and cost effectiveness. In addition, Kadian added the'indication for use in NG tubes and began promotion in 2000. Due to these features Kadian is being positioned as a better alternative to MS Contin Tablets. Faulding?s 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?s prescription. Kadian prescriptions have increased 53% 616) year-to- -date 2000 through an? June compared to the same period in 1999 On average, Kadian prescriptions remain at 2,715 per month for the time period July 1999 through June 2000. Recent weekly data indicate a sharp increase in Kadian prescriptions. This rs due mainly to the introduction of color-coded capsules- Orarnogph SR Roxane rs expected to continue promotion of Orarnorph SR by positioning it as a cost-effective alternative to MS Contin and OxyContin Tablets. Individual Roxane representatives are also promoting Oramorph SR as a cost effective alternative to OxyContin Tablets, utilizing a 1:1 conversion of morphine to oxycodone . During 2000 Roxane continues an Oramorph SR promotion that combines promotion of their pain products with other palliative care products under a Roxane Palliative Care Products umbrella. As a result of the continued promotion of Orarnorph SR versus MS Contin, Oramorph SR prescriptions increased 22.4% (+24,008) YTD through June 2000, compared to the same period last year. It is important to note that the absolute numbers for the category are growing in 2000. PCA Pumps During 1999 sales of injectable morphine were $73,119,000. The 2000 year sales of injectable morphine are forecasted for $78,441,000, an increase of approximately Market research lists PCA pumps as a form of cancer pain management used (31mg 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. Medic-are will pay for pump implantation as well as the medication re?lls. Medicare does not reimburse for oral analgesics like OxyContin Tablets; however the debate regarding a Medicare drug bene?t in Congress has heated up in 2000. In the post-operative patient OxyContin' Tablets are positioned for post?PCA pain management. A clinical study (Ginsberg) has supported OxyContin Tablets use in the post-operative patient. However, the planned program to capitalize on the addition of postOperative use to the Pl. has not been launChed because D. E. delay in the project. Abbott. Phannaceutical has the main responsibility for promotion in this market. Recently, Abbott signed an agreement with Knoll Laboratories to promote Vic0profen? for acute postOperative pain. OxvContin Future Opportunities OxvContin 160 mg Tablet FDA approval of OxyContin 160 mg Tablets was received in March of 2000. Currently, almost 46% of OxyContin 80 mg Tablet prescriptions are for the management of non-cancer pain. Although the targeted promotion of the 160 mg OkyContin Tablet will be in non-cancer pain, this new strength provides an opportunity to protect the cancer pain market for OxyContin. The 160 mg tablet also provides an entry barrier for irnpending competition in the cancer market, as well as the severe non-cancer pain market based on the ability to ?stay with? OxyContin Tablets for escalating pain. JCAHO Pain Management Initiative In June 2000 JCAHO (Joint "Commission for the Accreditation of Health Organizations) approved the ?nal phase of the proposed pain standards. Scoring related to the pain standards will begin in January 2001. Purdue- supported the educational e?orts of the JCAHO in an exclusive agreement throughout 2000 by supporting two pain summits and three educational efforts, including a video on the ?Continuum of Care,? a pain education book, and a media education campaign for the CAHO pain standards with unrestricted educational grants. Another signi?cant opportunity presents itself in 2001 for Purdue to support the efforts of CAHO. This initiative represents an opportunity to provide true value-added education on pain management and, at the same time, continue Purdue?s leadership in pain management. As a whole, the CAHO initiative has provided the ?eld force with many door-opening opportunities to conduct. in-service presentatibns and to position OxyContin appr0priately for pain. Expected Entries MthiDexm Algos Pharmaceuticals expected to launch MorphiDex in August of 1999. The FDA issued a nonapproval letter August 2, 1999. This product was 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 is expected that Algos will discuss the research supporting NMDA inhibitor 3 impact on the development of tolerance to analgesia and allow the health care practitioner to make the transition to MorphiDex. It IS likely that MorphiDex will be promoted for malignant and nonmalignant pain Algos merged with Endo Pharmaceuticals. Pending new clinical data in support of MorphiDex, it.is anticipated that Algo-s/Endo will re?le the NDA for Morphid-ex in 2001. 44?" claim of less opioid 51de' ects' due to lower morphme m1ll1gram quantities, may be expected. Physicians reported 1n 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 q3h. This is not a sustained release product, but rather the expansion of duration of effect of the immediate release morphine by the dextrontethorphan. It is likely that Algos/Endo will also promote MorphiDex for nonmalignant pain. Roxicodone SRnil The launch of Roxicodone SR by Roxane Labs has been delayed due to successful litigation based on patent in?ingement of OxyContin Tablets. Dilaudid SR Knoll Pharmaceuticals received an approvable letter for controlled-release hydromorphone in early 2000. It is anticipated that this Oros? formulation of a once daily hydromorphone will be launched in the ?rst or second quarter of 2001 Dilaudid SR poses the biggest threat to OxyContin to date. In 2001 the following challenges are anticipated: - It is anticipated that Dilaudid SR will be available once-daily tablet - The-promotion of a 5:1 morphine to hydromorphone conversion will match I each of the OxyContin dosage including the 160 mg tablet. - It is likely that initial promotions will target cancer pain due to lower market . . entry barriers and acceptability of hydromorphonc in the treatment of cancer pain. - -. --.. - -- - Knoll may employ the use of a co-promotion sales force which has a presence in both oncology and primary care. - Subsequent promotion will target high prescribers of hydromorphone and OxyContin in the treatment of non-cancer pain. - The q24h dosing of a single entity hydromorphone ?-om the Palladone research indicates that Dilaudid SR will have great-market acceptance if it delivers the q24h pain control. The promotional objective for OxyContin Tablets will be to minimize the market penetration of Dialudid SR in both cancer and non-cancer pain, protect OxyContin Tablets ?om potential market erosion, and enable continued growth of O'xyContin Tablets in both the cancer and noncancer pain markets. The delay in availability of Palladone' XL may allow Knoll to obtain a ?rst mover advantage, undermining our own expectations in this category. - 0 Ziconitide An NDA on a fast track status for Ziconitide (SNX-I 1 1) was submitted, and approval of this entity was received in July 2000. Ziconitide is marketed by Elan. Initially, this product will only be available for epidural use. It is expected that Ziconitide will be indicated for intractable neumpathic pain. Ziconitide will present a challenge to OxyContin by competing for neuropathic pain patients, - who are currently on high doses of opioid to treat their pain. Ziconitide will be prescribed by anesthesiologists who are aggressive pain treaters employing the use of the implantable pump. Managed Care have adopted three-tiered formularies to encourage the use of generics and less expensive, preferred brands. As drug costs continue to rise, MCOs are ?nding ways to share costs. Three-tiered cepayments require consumers to pay out of - pocket for a drug of choice. In a typical formulary structure generic drugs are in the lowest tier, formulary brands are in the middle tier, and nonfonnulary brand products are in the highest tier. Drugs in tier 1 cost the consumer an average of $5 to $10; drugs in tier 2 cost $15-$20, and drugs in tier 3 cost $35-$40. OXyContin must maintain its brand name formulary status to eliminate the'threat of a $35-$40 per- prescription cost to the consumer, who in turn may request a generic alternative. Three-tiered ?nancial incentives encourage physicians to write less eXpensive products, even when a more expensive product is clinically superior. Clinical presentations must be supported with an economic message such as .3, reducing long-term costs. - 4?46 - G. -Abu-se/Diversion - . In 2000 OxyContin Tablets experienced signi?cant challenges regarding its abuse- and diversion in the states of Maine, Ohio, Virginia, Louisiana, and Florida. These challenges will continue to be a threat to the continued success of OxyContin Tablets. Educational and public relations efforts will continue in 2001 with a focus on provider education to recognize patients in need of substance abuse counseling and on actions they can take to prevent abuse and diversion. qua PRODUCT INITIATIVES A. Objectives To achieve $1.4 billion in factory sales. To protect our market share from new competitors. To continue to expand OxyCont' Tablets pain market by positioning it as the opioid .. .. i To establish OxyContin Tablets as the 0p101d of choice in. Step 2 of the WHO analgesic ladder by positioning it as the opioid to ?Start With? for cancer and non-cancer pain management. Continue to establish and as the ideal medications for ..- . breakthrough and/or incidental pain for patients on OxyContin Tablets. Effectively position OxyContin Tablets 160 mg for high dose cancer and non- cancer pain patients. I Enhance the acceptance of opioids for non-cancer pain through educational efforts. Continue to educate physicians on actions they can take to limit abuse and diversiOn. I Increase the use of OxyContin Tablets in the mature patient, with new clinical data on osteoarthritis. Increase the use of OxyContin Tablets in acute and sub-acute conditions post-op pain, trauma, and ?'actures) where pain lasts more than a few days. Product Attributes/Core Messages The analgesic ef?cacy of immediate?release oxvcodone. 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. I Onset within one hour, comparable to inaniediate-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. The 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?, Vicod?in?, Tylenol? #3 or Darvocet?, WHO Step 2), and the opioid to stay with through proper titration as the disease progresses. W. In 2000 OxyContin Tablets has been marketed for moderate to 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 than is available to combination opioids- OxyC?ontin Tablets will be positioned as mph?id PP 002.64. C. physicians can initiate and patients can stay with through the entire course of therapy. I Effective in non-malignant pain states. In 2001 OxyContin Tablets will continue to be 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. OxyContin Tablets will be positioned as providing the equivalent ef?cacy 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, neuIOpathic type pains, etc. A single agent with no acetaminophen aspirin or ibuprofen- OxyContin Tablets is a single entity opioid agent without the dosing limitations present in products that are fixed combinations of an opioid and a second. agent such as acetaminOphen, asPirin, ibuprofen, or dextromethorphan There 15 added dosing ?exibility with a 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 OxyContin Tablets as high as is clinically necessary. There 13 also a decreased risk of side effects, or organ toxicity, compared to products containing acetaminophen, aspirin, or ibuprofen. Competition Combination opioids, (oxycodone, hydrocodone, codeine, and propoxephine with APAP, ibuprofen, or ASA): moderate-to?moderately severe pain (Step 2 of the WHO ladder), including the Percocet 2mg. Ultram. SR: non-cancer pain. Duragesic: cancer and non-cancer pain. Duragesic 12.5 meg. patch in non.- cancer pain. Actiq: Fentanyl oralette. used for breakthrough cancer pain Mzethadone Market research, as well as reports from the sales force, indicate that methadone use is. increasing in both the management of cancer pain and n0n~malignant pain due to its low cost. Clinical studies have also been published over the last year regarding the e?'ectiye use of methadone for cancer pain management. While not yet a serious competitor, this trend needs to be monitored. MorphiDex: As noted earlier, this product may become a competitor in the ?mrre, although its future is quite uncertain at this time. Generic morphine sulfate extended release PP 00265 . El 1 1" Kin-?if Communication Obiectives 0 Recently completed clinical trials in osteoarthritis have produced significant data for OxyContin Tablets. Future promotional objectives will be to communicate this data to health care professionals. - Convince MDs to prescribe, (as well as RNs and appropriate pharmacists to recommend), OxyContin Tablets, instead of combination opioids for Opioid? na'ive or op-ioid-exposedpatients with moderate?to-severe pain lasting more than a few days. Through preper dosing and titration, eliminate or delay the need for other long?acting opioids. 9 Broader OxyContin Tablets usage among various pain back pain, osteoarthritis, neuropathic pain, post-operative pain, etc.) will be stressed. 0 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 will be stressed, with particular emphasis on OxyContin Tablets. 0 Convince patients and their families to actively pursue effective pain relief. The importance of patients assessing their own pain and communicating the status to the health care giver will be stressed. .0 Educate physicians regarding abuse and diversion issues. Evolution of Ox'vContin Tablets OxyContin Tablets is expected to achieve $942 million in factory sales in 2000. Given the new millennium and the signi?cant achievement of the OxyContin Tablets brand, it is important to examine the history of OxyCon?tin Tablets in order to understand the ?Jture of. the brand. Campaig Evolution -- The initial launch of OxyContin Tablets in 1996 was success?il with a promotional campaign focusing on ?The Old Way, the New Way? along with a core message. of ?The Opioid to Start With and Stay With.? In 1997 the OxyContin Tablets promotional campaign focused on ?The Hard Way, The Easy Way.? Both of these promotional campaigns targeted the ?Start With? message, which was vital to the success of OxyContin Tablets. In 1998 OxyContin Tablets continued a rapid growth phase and market expansion with the ?Patient Profiles? campaign, which utilized patient types ?'om the clinical study data in a pro?le format to support the expanded utility of OxyContin Tablets. This campaign focused mainly on non?cancer pain. In 1999, facing the eminent launch of MorphiDex, the OxyContin Tablets promotion campaign shifted to ?Keep It Simple.? The message of the Keep It Simple campaign was to speci?cally address the issue of the irrational combination of a ?xed amount of morphine and dextromethorphan in MorphiDex. This targeted ?Keep It Simple? message was directed to anesthesiology and oncology in an effort to block acceptance of MorphiDex in these Specialties. The ?Keep It Simple? OxyContin Tablets promotional campaign continued in 2000 and capitalized 0n the growing acceptance of aggressive pain treatment and wideSpread acceptance of the bene?ts of OxyContin Tablets over ?xed combination analgesics. In light of future competition, 2001 will prove to be a challenging year. There is a growing need to keep the promotional campaign. focused by building on the proven effectiveness of the ability of OxyContin Tablets to ?meet the challenge? of moderate to severe pain patients. Promotional Initiative Evolution O'xyContin Tablets began a market penetration campaign in cancer pain. This was imperative based on acceptability of oxycodone in cancer pain. In addition, this initiative was imperative to penetrate the barriers by managed care organizations. After the initial penetration phase and Widespread formulary acceptance of OxyContin Tablets by Managed Care, the promotional initiative focused on market expansion in noncancer pain through aggesSive promotion and education on preper pain management. In. addition, the American Pain Society and AAPM introduced a positiOn paper on the aggressive and appropriate treatment of nonmalignant pain, employing the use of opioids. Purdue continued the growth of OxyContin Tablets by educating physicians on the bene?ts of Oxycontin Tablets in non-cancer pain through patient pro?les and case studies. Patients who had suffered for long periods. of time were soon tellingtheir physicians that OxyContin Tab-lets ?gave me my life back.? . In 1998 and 1999 thMOmotional initiatives for OxyContin Tablets continued. Facing a po from MorphiDex and Roxicodone SR, the promotional efforts also employed an initiative to create market entry barriers to these new competitors. ?Near the end of 1999 and through the year 2.000, additional corporate initiatives and partnering- e??orts were very successful with the Veterans Administration, American Pain Society, and JCAHO in an effort to make Pain: The 5th Vital Sign. This ?call to action? was an important promotional initiative for Purdue. In addition to building sales for OxyContin Tablets, it also positioned Purdue as the leader in pain management education. Comgtitive Evolution The competitive marketplace continues to evolve for OxyContin Tablets. Initial competitive threats to OxyCon?dn Tablets include MS Contin Tablets, Oramorph SR, Kadian, and Duragesic in the cancer market. As OxyContin Tablets continued to grow in non-cancer pain, competitive threats includedshort?acting combination hydrocodone and oxycodone preparations". New combination and single entity products (MorphiDex and Roxicodone SR) continue to threaten OxyContin Tablets. PP 00267 Going forward in 2001. and 2002 many new competitors will enter the OxyContin Tablets market. The most serious competitive threats to date for OxyCont-in Tablets will be Di'laudid SR. The single entity 24-hour dosing of in Dilaudid SR may have some advantages over OxyContin'Tablets. The market research data from Palladone shows a high level of market acceptability of this potential new competitor. In addition, new long-acting single entity opioids and other nonopioid entities, such as Ziconitide, will be a future threat to OxyContin Tablets. Future Evolution of OxvContin Tablets Brand In Spite of impending competitive threats, the future for OxyContin Tablets is very bright. Future growth of OxyContin Tablets will be achieved through targeted efforts to penetrate: . Rheumatology Dentistry - - Physician Assistants and Nurse Practitioners Surgical .Oncology Dentistry . -3 Sports/Physical Medicine/Rehabilitation The promotional campaign utilized to achieve ?rrther market penetration in the above?mentioned categories will be a pronouncement of the widespread success of the OxyContin Tablets brand to treat various pain states. A focus on the wide clinical use and acceptance (documented by NDTI) will be the bridge used to raise awareness and interest in OxyContin Tablets. In addition, a focus, on intermittent. versus persistent. pain will be a key positioning tactic used to gain physician starts with OxyContin Tablets. A continued focus on the bene?ts of around-the-clock pain control with the ?exibility of q12h dosing will be critical to differentiate OxyContin Tablets from current and future competitors. The ?exibility of q12h in terms of patient titration along with the analgesic onset and quality of life claims will be expanded and reinforced. Market research data (NDC Health Information Services data) indicates that among OxyContin Tablet patient Opioid naive when initiated therapy on OxyContin Tablets. In 23de OxyConu'n Tablet ?patients were on a prior opioid or opioid?like analgesic when initiated therapy with Oxy?Contin Tablets. Among those OxyContin Tablet patients who were on a prior therapy, 72% of patients were on combination opioids containing hydrocodone or Oxycodone. It will be imperative for the promotional focus of OxyContin Tablets to emphasize the ?Start With?- message. Marekt Ewart1-wa- 4?34 initiated on opioids to control their pain. This is further evidence of the importance of the OxyContin Tablets ?Start With and Stay With? promotional theme. The ?Start With? message in non-cancer pain will focus on patients whose pain is currently not controlled on medications or combination opioids taken on a p.r.n. basis. OxyContin Tablets provides the logical next step in these patients based on their persistent or around-the-clock pain. The ?Start With? mess-age in cancer pain will focus on patients who are uncontrolled on p.r.n. combination opioids or maximum doses 'of Ultrarn SR. The ?Stay With? message in non-cancer pain will f0cus on the value of OxyContin . ?Tablets in improving quality of life, mood, and sleep. In addition, the clinical data with OxyContin Tablets supports our claims of no signi?cant tolerance development- Tolerance is a great barrier for most physicians who have concerns relative to the use of opioids in chronic non-cancer pain. The ?Stay With? message in cancer pain will be focused on the availability of the 80 and 160 mg dosage The ?exibility and convenience of these dosage allows OxyContin Tablets to be titrated to ?meet the challenge in cancer pain.? F. . Target Audiences- 1. Primary Audiences Audiences Site Targets Frequency Comments Total Calls Required A. PhySicians (Primary) Of?ce 80,000 10 Target List 800K IMS and Contains 100% of Hospital decile 10 and 50% of a DOS decile 9 combo and ANS single entity unique 0 Oncologists 77,358 6 prescribe-rs Surgeons . . 0 Physical Medicine Target List 464K Neurologists Contains 50% of docile . Rheumatologists 9, and 100% of decile 3 .. combo and single entity 0 Other unique pres-cribers. B. Nurses - - 27,000 (Secondary) . orne . ONC RNS . Care a 11:21:38 Practitioners Office . ysiclan 't'al Assistants 05131 C. Managed Care IManaged TBD PBMS Organizations Care IPAs - Directors of 13361111135 . Staff Models - Pharmacy 0 IHN - Clinical Pharmacists - Case Managers 0 Quality Assurance Managers 0 Other D. Long-Term Care Long- 6,000 In?uential decision- . Consultant Term 10,000 makers at faclilities Pharmacists Care. . and corporate if? . Nursing Home ac111t1es nursmg home ains MDs and RNs 2. Secondary Audiences Secondary Audiences Slte Targets Comments A. Patients and Caregivers B. Residents/Fellows Teaching TBD Provides the ability to in?uence HOSpitals physicians still in training. Chief residents can be eSpecially in?uential in teaching facilities. C. Wholesalers 1 50 . D. Pharmacies Hospital 6,000 To assure appropriate stocking of the ?ve . Retail 60,000 dosage pp 00271 TACTICS Sales Force Allocation - - -- - - tial promot1onal resource the .- .. . to the contmued success "of OxyContin Tablets. Heavy 3'3 tonal support- will continue in order to ensure appropriate awareness of - OxyContin Tablets 1n the Opioid market Due to the launch of Ultrarri SR, 50% of the calls to oncologists and surgeons will be allocated to OxyContin Tablets. OxyContin Tablets will remain the primary product accounting for 100% of calls on all other specialties, with the exception of anesthesiology, where OxyContin Tablets will account for 70% of primary calls. The share of voice for OxyContin Tablets among anesthesiology will be critical to the continued success. The physicians 1n this important specialty are the innovators and early adopters of new products and technology. An effort to remain the dominant voice with anesthesiologists will prevent "market penetration by future competition. Representative Delivered Promotional Materials Wholesalers/Chain Headquarters (National Account Managers) Contacts will be made with wholesalers to ensure that there are appr0priate inventory levels for the 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 strength Representatives will also continue to increase the distribution of 0):le and at the retail level. - Hogitals . In. an effort to continue gaining hospital formulary acceptance of OxyContin Tablets, representatives will work with their Abbott counterparts to make calls on all Pharmacy and Therapeutic committees. The hospital forrnulary kit and product data brochure will be. utilized by the sales force to provide the appropriate clinical data necessary to continue to add OxyContin Tablets to hospital formularies. In addition, representatives will continue to use the OxyContin Tablets tabletop hospital diSplay panels. Speaker-5? 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 armamentarlum. JCAHO (Joint Commission Agency that accredits hospitals) will continue to be a major initiative focusing on pain assessment and treatment. Purdue has taken a major leadership role 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 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. 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/E-DetailinE I Mailings A number of mailings are planned to support OxyContin Tablets in 2001. Mailings will be done to support key OxyContin Tablets messages following the launch of Dilaudid SR as well as to support the use of OxyContin Tablets in treating non?cancer pain, with a focus on quality of life. In. addition, Internet detailing initiatives will be directed to targeted physicians to support representatives? efforts. Representative Follow-Q 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 focus on ?meeting the challenge? 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 cancer and non-cancer pain. pp: i i . mun?refr- 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 -5pec:i?c pain states from our Patients? Pro?les campaigns will be utilized at appr0priate conventions. For example, a panel highlighting the use of OxyContin Tablets for osteoarthritiswill 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. 2001 Consumer Initiative) The 2001 consumer non-branded initiative program is designed to increase the number of chronic pain patients who speak with their physician about their pain and Seek effective treatment. This will be accomplished through tactics that raise the level of discussion between health care professionals and consumers about the right to adequate pain relief and the availability of effective pain relief options. The program will continue to build and strengthen ongoing relationships with I consumer and medical trade and third-party af?liates in 2001. The primary focus, however, is consumer-based for the following reasons: . - Consumers want information that empowers them to make informed choices about the issues affecting their lives. They want to feel informed and in control when reviewing alternatives. They want to understand what their health care options are and participate in the decision making process. By edUcatin consumers about their right to adequate pain. Int-Ina: . - .. . management therapies . I and the types of questions I 'ey So be asking their physician, the program provides them with the information they need to have voice in their treatment options. - I More than half of chronic pain patients currently initiate dialogue with" their . physician about their pain management. However, there is still a large percentage that relies on their health care professional to begin the conversation. If the health care professional is uncomfortable discussing pain management or doesn?t recognize its value, the patient will remain under-treated.- This reinforces the need for the consumer initiatives. program to provide patients with the information they need to feel comfortable when talking with their health care professional. - JCAHO has issued new evidence-based pain management standards to ensure that health care providers respond appropriately to patients? pain, an initiative that educates a segment of the physician population currently prescribing Purdue Pharma product. These standards require that every patient has the right to'seek and receive appropriate pain assessment and management- Adherence to the PP 00274 . i Joint Commission (J CAHQ) standards will provide a framework for patients to receive appropriate pain management. Effective pain management is expected as part of the optimal achievable care represented by JCAHO accreditation. Health care professionals working at a CAHO accredited facility must adhere to guidelines for effective pain. management. 33 5 L: . . ured both in terms of salesand image or professional standing Within the industry and High visibility consumer initiatives that focus a positive Spotlight on the company will enhance its image and reputation, as well as build its sales. Porter Novelli -- a; - 0f the TOP 10 Pharmaceutical . believes that the consumer-directed tactics recommended in. this plan vvill. help Purdue Pharma recognize its goal. The sales force is an excellent vehicle for one-on?one communication and combined with Purdue?s attendance at medical meetings, will reinforce messages communicated in medical journals. PP 00275 a? - OXYCONTIN Tablets Promotional Plan First Quarter Second Quarter Third Quarter Fourth Quarter Total Cost Program . 2001 . Jan Feb Mar Apr May Jun July Aug Sept Oct Nov Dec Promotional Materials! $5,000,000 X- We. 'Pain Education NewRep?nts_ meow x. x'x ?CompleteP'ain $80,000 Management' Selling . -. . Brochure ?Complete Pain .fjsizoo?oo Management' Self? . - Assessment Quiz Pads .- New Market Opportunities I Surgical Surgical Setting Flashcard Quick Reference Dosing Card carom OBIGYN Case Study Flashcard Consensus Pane; 1- Symposium on Pain PNNP AANP Leadership Summit $200000 . on Pain Management - . . Hospital CME Program $250,000 upon Tablets Promotional Plan First Quarter Second Quarter Third Quarter Fourth Quarter Total Cost Program 2001 . Jan Feb . Mar Apr May Jun Juty Aug Sept Oct Nov Dec Core Market Oncology xs-?ioopaoix x'x_ .x Challenge' Wsuat Aid it - Cancer ControtJoumal 530,000 . i? Supptement esthesiaiPain 3"7115'55511 .Z Management. . i . i American Academy of Pain Medicine Symposium - - . Highlights CME 'Cn?tical Pathways in Pain Management' CD ROM Oncology and Pain Management Nurses 'Hosptce Care in the Long- Term Care Fadlity' Video Primary Care Primary Care Visual Aid CME ?Communicating with your Patients About Pain' Arnerican Pain Society (APS) Arthritis Treatment Guidelines PP 00277 Tablets Promotional Plan First Quarter Second Quarter Third Quarter Fourth. Quarter - Total Cost Program - 2001-. Jan Feb Mar Apr May Jun July Aug Sept Oct Nov Dec Pharmaclelinica'i Pharmacy Community Pharmacy $53300 X. Residency Program in Pain j. Management - School of Pharmacy Curricular Review The Pharmacists Role in Pain Management Compendium Competition National Experts on Pain CD ROM 3 . f- JCAHO Regional Program Sponsorshipll-iighiights Partners Against Pain Clipboards Special Populations Video Abbott/Northwestern CD ROM lnternet Resource Guide Internet Branding E-Detailing OXYCONTIN Tablets Promotional Plan First Quarter Second Quarter Third Quarter Fourth Quarter Total Cost Program '2001-: Jan Feb Mar Apr May Jun July Aug Sept Oct Nov Dec Special Programs Strategic Alliance Building I $500,000 Patient Starter Program Veterans Administration Pain Team Grant- W?Partiers Against Pain Programs Direct Mail 'Case Study Direct Man . PNNP Mailer Cards OBIGYN Mailer 'Meet the Challenge? Mailers Journal Ad Production Osteo Post-op OBIGYN - Cancer Journal Advertising Managed Care CME Programs Cancer Pain CME Patient Pro?le Series CME Qua Tablets Promotional Plan First Quarter Second Quarter Third Quarter Fourth Quarter Program Total Cost Feb Mar Apr May Jun July Aug Sept Oct Nov Dec Case Managers Cancer Program ln-Service Managing Pain in Managed Care ln-Service Program of Ame?m (CMSA) Grant Case Manager Premium Item Publication Plan obeys-lie Study Data 0096-1003 Osteoarthritis Study Data Survey and Algorithm . ReprintfReferenoes Fund Reorder-s BusinessPlan Template/Toolbox Formkitcom NCOAJHEDIS Report Strategic Alliances Corporate Branding . American Hospital Association Grant i t. . Patient Pro?le ill-Service 1 Case Management Society i . a . Protocare Sciences Patient - v-u?uww?ur?u' 2001- Jan $5.000 $190.00? $00,000 4-64 oxvconrm Tablets Promotional Plan First Quarter Second Quart?r? Third Quarter Fourth Quarter Total Cost Program . 2001. Jan Feb Mar Apr May Jun July Aug Sept Oct Nov Dec My; Nursing Programs Relaunch oiSeminars in Pain Management Educational Program New Nurse Packet Pain Map Assessment Tool Consultant Pharmacist AGS Quick Reference Guide; Pain in the Elderly LTC Resident CMEICE The Consultant Pharmacist '2 Review Article Medical Directors Managing Pain in the PPS Environment Series - A . collaboration with American Medial Directors Association (AMDA) Third Party Reference Compendium Philadelphia College of Pharmacy LTC Treatment Guidelines Publication Painin the Elderly VisualAid second PP 00231 OXYCONTIN Tablets Promotional Plan Second Quarter Third Quarter Fourth Quarter PP 00282 First Quarter Program Jan Feb Mar Apr May Jun July Aug Sept Oct Nov Dec Managed Care JournalAdvertising ?AgengFee x'xix xx OXYCONTIN Tablets Promotional Plan Program Usage New or Repeat Qtr. No. Pieces 3rd Qtr. 4th Qtr. an'Cttr. No. No. No. Pieces Pieces Pieces 1st Qtr. Cost 20d Qtr. 3rd Qtr. 4th Qtr. Total Cost 2001 Promotional Materials! Reorders Pain Education at" New Reprints 'Complete Pain Management' Selling Brochure ?Complete Pain Management? Seli- Assessment Quiz Pads To provide reprints of successful promotional materials based on 2000 utilization and field force expansion. includes outsert purchases used for promotional items. includes giveaways such as penslpadsletc. Purchase of new reprints [or OxyConlln. A brochure which features the eight slide kit series on pain management for promotion by representatives. A self-assessment tool designed to qutz'heallhcare professionals on the content of the 'Complete Pain Management? Series Repeat New New New - NIA 125.000 100.000 400.000 1 25,000- NIA - no} 125.000 PP 00283 125.000 $200,000 1 $125,000 $00,000 Cost Cost . Cost 1,250,000 . 1,250,000 $125,000 $125,000 1,250,000 3125.000g $5,000,000 $500,000 $00,000 $200,000 4-66 OXYCONTIN Tablets Promotional Plan Program Usage New or Repeat No. 1st Qtr. Places 2nd Qtr. No. Place: 3rd Qtr. 4th Qtr. No. No. Places Places Qtr. Cost 2nd Qtr. Cost 3rd Qtr. Cost 4th Qtr. Cost Total Cost 2001 NJW Market Opportunities Surgical Quick Reference Dosing Card OBIGYN Case Study Flashcard Surgical Setting Flashcard A ?ashcard which graphically depicts the operating room with the message ?control the pain. control the racovery.? This. will be targeted to multiple types of surgeon subspeclaltles. A smelt pocket-sized quick reference dosing card for OxyContln. Targeted to all surgical subspecialtles. A case study series which focuses on the most prevalent pain conditions In gynecology. New New New PP 00284 80,000 80,000 80,000 $120,000 $60,000 $160,000 . .. mun-n. $60,000 $130,000 4-67 OXYCONTIN Tablets Promotional Plan Program 3rd Qtr. No. Pieces 4th Qtr. lilo. Pieces New or Repeat 1st Qtr. No. Pieces 2nd Qtr. No. Pieces 1st Qtr. Cost 2nd Qtr. Cost 3rd Qtr. Cost 4th Qtr. Cost Total Cost OBIGYN Consensus Panel Symposium on Pain PNNP AANP Leadership Summit on Pain Management Hospital CME Program Usage A roundtable consensus panel of thought leaders on the topic of pain in the female patient. includes production for enduring educational materials. New 60.000 - A cancerlnoncancer pain management summit with nurse practitioners designed to develop a position paper by the AANP on the treatments of pain, including new Information addressing abuse and diversion. New 50,000 An educational grant to Cogent Healthcare for the development of a CME program speci?cally for the practicing h05pltailsts on New 5,000 $250,000 pain management. 00235 $250,000 $200,000 2.001 escapee $250.00!) 4-68 YCONTIN Tablets Promotional Plan 3rd Qtr. 4th Qtr. New or 20d Qtr. No. . No. 2nd Qtr. 3rd Qtr. 4th Qtr. Total Cost Program Usage Repeat No.Pleces No. Pieces Pieces Pieces Cost Cost Cost Cost 2001 Core Market - Oncology "OxyContin Meets the A visual aid designed to New 40.000 Challenge? Visual Aid relaunch OxyContin In cancer pain with targeted? promotion to oncologists. $100,000 1 . $100,000 Cancer Control Journal A Journal supplement for New 80.000 Supplement by representatives which focuses on cancer pain management and favorably represents Oxy-Contin. $80,000 $80,000 AnesthesiaiPaln Management American Academy of Pain An educational program New . 50.000 Medicine Symposium developed out of the Highlights symposium at AAPM entitled . 'Bene?ls of Drug Screening? - - . at the 2001 AAPM annual 3; . meeting. $100,000 $100,000 . PP 00235 4?69 OXYCONTIN Tablets Promotional Plan . I 3rd Qtr. 4th on. New or 1st Qir. 2nd Qtr. No. No. 1st Qtr. 2nd Qtr. 3rd Qtr. 4th Qtr. Total-Cost Program Usage Repeat No. Pieces No. Places Places Places Cost Cost - "Cost Cost .2001' .- CME ?Critical Pathways A case study format New 20,000 - I in Pain Management'. designed to challenge the CD ROM pain treating physician. $200,000 $200,000 Oncology and Pain Management Nurses ?Hospice Care in the Long- A video designed to help New 20.000 Term Care acillty' Video hospice nurses educate the LPN in the tong-term care -.. facilities regarding cancer - pain management. $200,000 "$200,000 Prlmary Care Primary Care Visual Aid A visual aid which New 40.000 addresses the Issues faced by primary care physicians in the treatment of pain, Including new Information addressing abuse and .. . .. diversion. $00,000 $00,000 i; - - PP 00237 4?70 OXYCONTIN Tablets Promotional Plan 3rd Qtr. 4th Qtr. I New or 1st Qtr. 2nd Qtr. No. No. 2nd Qtr. 3rd Qtr. 4th Qtr. Total Cost Program Usage Repeat No. Pieces No. Pieces Pieces Pieces PiecesT1-200?l Cost Cost Cost Cost 2001 3 CME "Communicating with An educational program New 100.000 your Patients About Pain?I designed to educate PCP on the value of using pain as a diagnostic tool. This will be developed In conjunction with APS. Includes recognition of the addict, pseudoaddictl etc. i $250,000 American Pain Society To purchase and distribute New" 200,000 (APS) Arthritis Treatment the APS treatment Guidelines guidelines for arthritis. 3400.000 $400,000 m. an" ulwuw'uu. we at an .m PharmacyIClinical Pharmacy 3 i i i i i Community Pharmacy Purdue will support. through New NIA Residency Program in Pain a residency program 1 . 5. 1 I Management in the community setting - designed to locus on pain -.- i management and palliative I .l care. see-.000 . 596.000: . . . PP 00233 . 4-71 nrrum OXYCONTIN Tablets Promotional Plan Program Usage New or Repeat 1st Qtr. - No. Plecee? 2nd Qtr. No, Pieces 3rd Qtr. No. Pieces 4th Qtr. No. Pieces Total 1st Qtr. Cost Cost 2nd Qtr. 3rd Qtr. Cost 4th Q'tr. Cost Total Cost 2001 School. of Pharmacy Curricular Review The Pharmacists Role in - Pain Management Compendium This program will commission the AphA to do a review of pharmacy school curricula to determine how pain management and- palliative? care are integrated into Doctor of Pharmacy programs through the nation. In addition. it will uncover the resources which would be most helpful to support their teaching efforts In pain management. A compendium of six articles focusing on the role of the pharmacist in the treatment of patients In pain; Including new Information addressing abuse and diversion00289 Pieces 2001? $90,000 $100,000 $90,000 $100,000 in 4?72 as" XYCONTIN Tablets Promotional Plan Program Usage New or Repeat 1st Qtr?. No. Pieces 2nd Qtr. No. Pieces 3rd Qtr. No. Pieces 4th Qtr. No. Pieces TmaliE . Qtr. Cost 2nd Qtr. Cost 3rd Qtr. Cost 4th Qtr. Cost Total Cost 2001 Competition National Experts on Pain CD ROM - JCAHO Regional Program SponsorshipIHighlights Partners Against Pain 211900.200 A branded promOtionai CD ROM which features national experts on pain. Experts on the topic of neuropathy. sickle cell. post- operative patn, cancer pain. and arthritis pain give their opinions of the effectiveness of OxyContin Tablets in these paln states. A Series of regional educational programs will be conducted focusing on pain standards implementation. Purdue will underwrite the costs as well as publish the results to attendees. A pain assessment educational resource provided as a service of Purdue and Partners Against Pain. New New Repeat 3,000 NIA 75,000 NA ?5.000 NIA 75.000 NIA PP 00290 75,000 90003100} $155,000 $125,000 $187,500 $125,000 $187,500 $125,000 . $187,500 I $125,000 i 2 .. 5107.500; i i $155300 n--u\p $500,000$750,000i i i i i 1 1 4?73 OXYCONTIN Tablets Promotional Plan Program 4th Qtr. No. Pieces 3rd Qtr. No. Places 1st Qtr. 2nd Qtr. No. Pieces No. Places New or Repeat ist Qtr. Cost 2nd Qtr. Cost 3rd Qtr. Cost 4th Qtr; U?ge Cost Total Cost 2001 Special Populations Video AbboitiNorihwestern . CDROM tnternet WebiMD Resource Guide Internet Branding i- New A video developed by the Joint Commission to educate providers on pain management In special populations. 5.000 A multi-hour accredited New 100 educational program promoted by the Medical Liaison group to key targeted institutions in the country. Developed by AbbottiNorthweslern Hospital. 100 100 100 $30,000 $30,000 $30,000 $30,000 Sponsorship of a reference New 100.000 guide to medicai information on the Internet targeted to physician internal users. $200,000 New NIA $125,000 A series of tactical programs $125,000 designed to effectively position OxyConlin on web - browsers. NIA NIA $125,000 $125,000; 3. PP 00291 $100,000} $120,000 $200,000 $500,000 9-74 gnu OXYCONTIN Tablets Promotional Plan rt Program Usage New or Repeat 1st Qtr. No. Pieces 2nd Qtr. No. Pieces 3rd Qtr. No. Pieces 4th Qtr. No. Pieces Qtr. Cost 2nd Qtr. Cost 3rd Qtr. Cost 4th Qtr. Cost Total Cost . E-Deiailing Special Programs Strategic Alliance Building An Internet detailing . New TBD TBD TBD TBD. program targeted to high prescribers of combination opioids with a branded OxyContln message. This program is a follow up to the pilot program which ran in 2000. $375,000 New TBD TBD TBD A series of programs targeted at major institutions. organizations, and thought leaders in pain management including AAPM, APS. American Academy of Pain Management. and Veterans Administration as well as major teaching institutions in the country, including new information addressing TBD $125,000 abuse and diversion. PP 00292 $375,000 $125,000 $375,000 $125,000 $37500 5125,0003 i i i i i i 2001 $1,500,000 5.500.000 4?75 OXYCONTIN Tablets Promotional Plan 3rd Qtr. 401 Qtr. . New or Qtr. 2nd Qtr. No. No. ist Qtr. . 2nd Qtr. 3rd Cttr. 4th Qtr. Total Cost Program Usage Repeat No.Pieces No.Pleces Pieces Pieces Placer-2001 Cost Cost Cost Cost 2-001 49,252,; i $4,000,000: Patient Starter Program A PCS program targeted to Repeat NIA NM NM key ?early adapters)I of new products or technology. This program will be used as part of a preemptive competitive strategy. In addition. it will be .usedto capture the early patient who is a candidate for opioids. $1,000,000 $1,000,000 $1,000,000 $1,000,000 i i . nu?u-u?m H-v-t-r?Ha - a $50,000 $50,000 $50,000 $50,000:i 0200,0003 Veterans Administration A grant program which New TBD TBD TBD TBD Paln Team Grant I focuses on quarterly roundtable meetings among Veterans Administration National Pain team members at the VISN level. .. Partners Against Paln To expand the in?uence of New T80 T80 TBD TBD Programs - Partners Against Pain through public relations and build brand In?uence with consumer initiatives. $500,000 $500,000 $500,000 $500,000 $2,000,000 a. a PP 00293 - . a ?We - - - 4?76 OXYCONTIN Tablets Promotional Plan Program Usage New or Repeat Qtr. Pieces No. 2nd Qtr. No. Places 3rd Qtr. No. Pieces 4th Qtr. No. Places Intel; 1st Qtr. Cost 2nd Qtr. Cost 3rd Qtr. Cost 4th Cir. Total Cost Cost 2001 Direct Mail JCAHO Direct Mail Case Study Direct Mail PNNP Mailer Cards OBIGYN Mailer ?Meet the Challenge? Mailers Targeted lo hospital adminiSiratlon and JCAHO liaisons in the Institutional setting. Designed to build a database of leads for the sales force. Combines existing pro?les with remlnder points to PCPs. Cards with quick remlnders of OxyContln features and bene?ts. A direct mail campaign focusing on quality of pain management after Operative gynecological procedures. A direct mail campaign focusing on ?early adapters? of new technology or medications in light ot future competition.000 ,000 2,000 150,000 200,000 10,000 50,000 2.000 50,000 50,000 PP 00294 2,000 80655929191 $37,500. $72,000 537.500 $450,000 $100,000 $100,000 $72,000 $37,500 $72,000 $37,500 $159,000 _.$459.oqo $100,000 szeeboof $72,000; I. 4-?77 OXYCONTIN Tablets Promotional Plan 3rd Qtr. 4th Qtr. New or Qtr. 20d Qtr. No. No. . 2nd Qtr. '3rd Qtr. 4th Qtr. Total Cost Program Usage - Repeat No. Pieces No. Places Pieces Pieces Cost Cost Cost Cost 2001 . Journal Ad Production Creation of new ads which Near TBD TBD incorporate the message of 'meets the challenge" $50,000 $50,000 - $100,000 - Osteo Post-op - OBIGYN - Cancer Ira-ital- $1,000,000 $1,000,000 $1,000,000 $1,000,000 JournalAdvertising Expanded locus for 2001 to Repeat TBD - TBD TBD TBD $4,000,000; include oncology, primary care, orthopedics, OBIGYN, surgery, anesthesia, rheumatotogy. emergency medicine, and dental. Managed Care CME Programs $150,000 Cancer Pain CME A CME program by Eric - New 100,000 . Chevlen focusing on the ?rt treatment of cancer pain. I This will be targeted to providers through M003. 5150.000.-., Patient Pro?le Series CME A CME program focusing on New 1003.00 1 190,000 ?25.000 - patient pro?les In chronic - pain management. r' is? i PP 00295 4?78 OXYCONTIN Tablets Promotional Plan til Program Usage New or Repeat 1st Qtr. Places No 3rd Qtr. No. Pieces 2nd Qtr. No. Pieces 4th Qtr. - No. Pieces 1st Qtr. Cost 2nd Qtr. Cost Cost 3rd Qtr. 4th Qtr. Cost Total Cost Case Managers Cancer Program ln-Senrice Managing Pain in Managed Care ln-_Service Program Patient Pro?le ln-Service Case Management Society of America (CMSA) Grant Case Manager Premium Item An in-service program built. An in-service program built An inrservice program built series. A grant to produce a supplement to the Purdue sponsored symposia at CMSA in 2001. I premium item to remind the case managerol OxyContin and Partners Against Pain. off the cancer CME targeted to case managers at MCOs. from the Cole CME program. from the Patient Protile CME New New New New New 20. I 000 20 10.000 2'0 $35,000 $5,000 $75,000 $5,000 2091 um$5,000 I . $5.000 33.5909 $75,000i 4~79 - OXYCONTIN Tablets Promotional Plan Program I Usage New or Repeat 1st Qtr. No Pieces 2nd Qtr. 3rd Qtr. No. No. 4th Qtr. Pieces 1st Qtr. Cost -2nd Qtr. 3rd Qtr. Total Cost Cost 4th Qtr. Cost Publication Plan Chevelte Study Data 0096-1003 Osteoarthritis . Study Data Survey and Algorithm Fund Protocare Sciences Patient A strategy to capitalize on the most efiectlve use of the results from the study by Andrea Chevelie, MD in Journal of Bone and Joint Surgery. A strategy to capitalize on the publication of this study data showing improved function In patients with osteoarthritis taking OxyC'ontln. A patient survey with algorithm development designed to help Identify patients in need of pain intervention. Phase it of the program be Implemented during 2001. To allow for the purchase of reprints for account executive distribution. New New New Repeat TBD No. Pieces TBD TBD TBD Pieces TBD TBD . PP 00297 TBD $15,000 Cost $50,000 $50,000 $15,000 2001 $50,000 new I i i. $150,000 $150,000 i i g' i . $15,000 $15,000,- $60,000 .I 4-80 OXYCONTIN Tablets Promotional Plan 3rd Qtr. 4th Qtr. New or 2nd Qtr. No. No. Total-i: 2nd Qtr. 3rd Qtr. 4th Qtr. Total Cost Program Usage Repeat No. Pieces No. Pieces Pieces Places Pieces-2001 Cost Cost Cost Cost 2001 'Reorde'rs Designated'to cover the cost Repeat TBD TBD TBD $67,250 $67,250 $67,250 $67,250 $269 000? of reprinting promo?tlon at materials for use by account execu?ves. i Business Plan . - Repeat .- MA I NIA um Templaterroolbox $200,000 $200,000 $200,000 $200,000; $800.000i? Formkitcom A reworking of the New 10.000 OxyContin product data in the formulary kit and subsequent availability on formkit.com a targeted Internet site which is password protected and used by key Committee members. 0200.000 - 3 $200 000- .. Report A report publishing the New 50.0.00 importance of pain management program in overall quality improvement. $50,000 $50 00' .. ?An-hm. PP 00298 4?81 OXYCONTIN Tablets Promotional Plan Program Usage New or Repeat Qtr. No. 3rd Qtr. No. Pieces 4th Qtr. No. 2nd Qtr. Pieces Pieces No. Places 1st Qtr. Cost 2nd Qtr. Cost 3rd Qtr. Cost 4th Qtr. Cost Total Cost 2.001 Strategic Alliances Corporate Branding . American Hospital Association Grant A publication which is overview of Purdue .and discuss our initiatives to aid patients in pain. including new Information addressing abuse and diversion. In addition. this would discuss present and future marketing locus by Purdue. Target of publication will be MCO executivasldecision makers. A grant to aid in pain management efforts on behalf of the American Hospital Assoclallon and Purdue. designed to give a corporate New New TBD TBD TBD rso reo' TBD ran erases 20.01 PP 00299 TBD TBD TBD ran TBD TBD TBD TBD $100,000 5100.000 it; OXYCONTIN Tablets Promotional Plan 3rd Qtr. 4th Qtr. . Newer 2nd Qtr. No. No. 20d Qtr. 3rd Qtr. 4th Qtr. Total Cost Program Usage Repeat No.Pieces No.Pleces Pieces Pieces Place82001 CoSt Cost Cost Cost 2001 Long-Term Care - .- Programs Relaunch of Seminars in A relaunch of this valuable New TBD Pain Management programto the Educational Program pharmacy providers at the corporate level. in addition. modules 6-10 will be - developed. Includes major publicity to providers. $500,000 . 5500.000 $75,000 $75,000 New Nurse Packet A kit containing primary New . 10.000 educational tools in pain management for distribution to new nurses in the long- term. care setting. Pain Map Assessment Tool Atool designed from the New 25.000 Weiner, el al edicts in the Journal Pain . $50,000 $50,000 Consultant Pharmacist AGS Quick Reference Guide A quick reference guide New 50.000 adapted from the AGS Guidelines for the treatment of chronic pain. PP 00300 5150.000 $150,000; . L1: -: -: 4*83 i I oxvccunn Tablets Promotional Plan . . 4?8-4 1 3rd Qtr. 4th Qtr. . New or 1st Qtr. 2nd Qtr. No. No. 5:1 1 1st ctr. 20d Qtr. 3rd on. 4th on. Total Cost Program Usage Repeat No.Plecas No. Pieces Pieces Pieces 190000001 Cost - Cost Cost Cost 2001 Pain in the Elderly LTC . A program . New 100,000 . Resident CMEICE discussing the challenges of - pain management In the long-term care setting. $150,000 . $150,000 The Consultant Pharmacist A review article to New 30.000 Review Article accompany the consultant pharmacist Journal on pain management. $120,000 . 5120.000 . Medical Directors Managing Pain in the PPS Modes of quick reference New I 20,000. $50,000 $25,000 $25,000 Environment Series - A cards designed to educate - collaboration with American medical directors at LTC Medical Directors facilities on the value of Association (AMDA) proper pain management In a PPS environment. pp 00301 I XYCONTIN Tablets Promotional Plan 4th Qtr. No. Pieces 3rd Qtr. No. Pieces New or Repeat Qtr. No. Pieces 2nd Clir. Program Usage No. Pieces our er. Cost 2nd Qir. Cost 3rd Qtr. Cost 4th Qtr. Cost Total Cost 2001. Third Party Reference Compendium A compendium of lhird party references which outline the issues of pain management In the long-term care selling. Includes Information from HCFA. JCAHO. AGS. AMDA. and otherjournal articles on pain In the elderly. Also Includes the Philadelphia College Guidelines. New 20000 Philadelphia College of Pharmacy LTC Treatment Guidelines Publication To publish the guidelines developed by the Philadelphia College. New 50.000 Pain in the Elderly Visual Aid An updated visual which incorporates a renewed focus on pain in the elderly. New 30,000 Managed Care Journal Advertising Updated corporate ad and expanded circulation. Repeat TBD TBD TBD LLNS PP 00302 Tao "906652001 . Ufa.? - illicit) $50,000 $90,000 TBD $422,500 $75,000 .n mum.? .m TBD TBD TBD $422,500 $422,500 $422,500 575.000.; .i .. mum ?moguls-10? ?r o- ?v a i 550.000..E $90.000 1 5500.000? 3 $1,090,000 4*85 Sales Marketing Promotion Promotional Materials Direct Mail Journal Advertising Internet Total Direct Advertising Samples Agency Fee Special Promotions Co-op Advertising Conventions Abbott Commission Total Marketing Promotion Total Allocation Other Total IncIUdes MHC and LTC 1999 Actual $621,640 $5,449 $572 $2,279 $0 $2,850 $0 $952 $2,692 $0 $1,096 $40,310 $54,349 $87,290 $141,638 V. Total Overview 3 (0005) 2000 - 2001 of Sales Est. 100% $1,100,000 . of 'Sales 100% Pro]. $1,440,000 $13,710 $1,088 1.0% $8,960 0.1% $1,711 0.2% 0.4% $4,125 0.4% NA $592 0.8% $2.200 0.5% $5,836 0.5% $5.566 00%r $0 0.0% $0 0.2% $1,397 0.1% $1,990 0.4% $9,915 0.9% $6,700 0.0% $0 0.0% $0 0.2% $1,551 0.1% $1,555 9.5% . $71,664 9.5% $99,241 9.7% $99,313 8.9% $129,684 14.0% I . $154,336 14.0% $173,688 22.8% $252,649 23.0% $303,372 PP 00303 $4,500 %30f Sales 100% 1.0% 0.1% . 0.2% 0.4% 0.0% 0.1% 0.5% 0.0% 0.1% 9.9% 9.0% 12.1% 21.1% Change 00/99 77.0% 39.0% 199.1% 81.1% NA 104.8% 0.0% 45.7% 231.2% NA 41.5% 77 - 80.9% 76.8% 79.4% 01l00 30.9% 53.0% . -36.4% 9.1% 271.6% NA 21.8% -24.8% . NA 0.3% 37.1% 31.9% 12.5% 4?86 ., MS Contin? Tablets PP 00305