1996 BUDGET PLAN 552590K 21? PP00006 OxYContinm. II. A. The classic model.utilized in treatment of cancer pain is the World Health Organization (NJ-1.0..) Three Step' Analgesic Ladder. The recommendations of the W.H.O. are: Step 1: Use NSAIDs to treat mild pain, aspirin. Step 2: Use' Weak opiOids to treat moderate pain, codeine, orycodone and hydrocodone combinations. Step 3: Use strong opioids to treat severe pain, morphine. Opioid choices in treating moderate to moderately severe pain in Step 2 have been limited by oxycodone, 'hydrocodone, and codeine combination products. Their short?acting duration of action. provides peaks and valleys in pain control. The combination of the opioid .Ci with APAP or ASA limits the maximum dosage because of potential liver toxicity. The APAP or .ASA .component also has the potential to mask a fever in the cancer patient. All these problems associated with the choice of opioid analgesics in Step 2 present an opportunity for the introduction. of a single-entity, long-acting oxycodone product. The introduction of longaacting morphine and the transdermal fentanyl patch provides the physician with two long-acting' ;products to meet the needs of moderately severe to Severe pain in Step 3. Morphine/Fentanyl, available in) treat Step possess 'disadvantages, ?such as the patient stigmas that surround morphine; and the M.D., R.N., pharmacist reluctance to use. Fixed Combination Opioids Fixed combination opioids (oxycodone, hydrocodone, and codeine combined with APAP or ASA) have been the drugs of choice for treating moderate to moderately severe cancer pain (W.H.O. Step 2). Because they contain APAP or ASA, these products. are limited by a recommended dosing ceiling, as the. non-opioid can cause renal or hepatic toxicities. Sales ?for 'generic combination opioids are expected to continue growing, while the -branded products will be flat. 'Combination opioids are .- considered primary competition for OxyContin. MS CONTIN has become the gold standard for treating moderately severe to severe cancer pain (W. H. 0. Step 3) Although faced with stiff competition from Duragesic? and Oramorph MS CONTIN sales grew by 26.5% in 1994. 'It is expected that health care professionals will continue to support the use_of MS CONTIN for severe pain.in 1996. I?n Because a bioequivalent- AB-rated generic controlled- release morphine sulfate is expected to be available sometime during the latter part of 1996 or early 1997, one of the primary objectives is to switch patients who i would have been started on MS CONTIN to OxyCOntin, as quickly-as possible. It is _expected Ithat Duragesic will continue heavy promotion in the cancer market for moderate to severe pain. The patch is mainly used for moderately severe to severe pain, but Janssen has been targeting the moderate to moderately severe market for the past two years. Their progress has been slow but Steady in obtaining patients. coming straight off of fixed combination Opioids. Janssen will continue to target-primary care physicians (namely' internists) as ?well as ioncologists. In] 1995, PPCBOLI other primary care specialistsr Because OxyContin? will be targeted for' patients who would have been started cx1 fixed combination opioids, from 'which Duragesic draws approximately 25% sales.r it is expected that Janssen will try to counter the OxyContin position by_stressing fewer side effects, and easier titration; As a result, that proper titration and treatment of side effects are stressed in the promotion of OxyContin. Radian" It is expected that will receire FDA approval to market Kadian (morphine sulfate extended release capsules) during mid- to late-1996.-It is anticipated that Kadian will receive a q24h dosing indication, but no less than a quh approval, Although not bioequivalent to MS CONTIN, it is expected that of lits it will be critical Kadian will be positioned as a "better alternative." In Australia the product was launched by Glaxo. whose promotional focus overseas has centered Iaround the inference that flatter plasma concentrations equate to better efficacy than MS CONTIN. It is unlikely that Kadian will be primary competition for Ox?Contin since the use of morphine for moderately to 'moderately'.severe _pain has not_ been an -accepted practice among? health care professionals. Kadian will replace MS CONTIN and reduce the available prescriptions for ?switching from MS CONTIN. to OxyContin. It is anticipated,.however, that Kadian will position itself as the logical next step as patients no longer- tolerate? or receive adequate analgesia -from OxyContin. Just as with Duragesic, it will be critical that proper titration and treatment of side effects are stressed when selling _OxyCOn?tin, thereby reducing the number of patient failures. 2-27 Roxane is expected to continue promotion of Oramorph SR positioning it as a cost effective alternative to MS CONTIN. They will spend a large portion of their marketing and sales. promotion convincing formulary decision makers for hospitals, hospices, and state formulary committees that Oramorph SR is a less i expensive, but just as effective replacement for MS It is expected that they will continue to spend a. significant amount of promotional money for journal advertising and direct mail. As with Kadian, this product reduces the prescriptions available for switches to OxyCont' 1n. Generic Morphine Sulfate Controlled?Release It is possible that a generic morphine sulfate controlled-release product that is bioequivalent to MS CONTIN will be FDA approved in the latter part Tof 1996. This product is not considered primary PP 00014 competition for OxyContin. as it will compete mainly with MS CONTIN. However, since it will has twice-a- day, long-acting opioid, if'2H: is priced considerably lower than OxyContin, it will'likely be_poSitioned as a- cost-effective alternative to OxyContin. As with Kadian, this product reduces the prescriptions available for switches to OxyContin. - ?During 1994, sales of _injectables have I stopped declining and actually showed some increases. This is likely due to the_FDA problems that Duragesic faced as patients who could not swallow were placed on PCA Pump regimens in place of Duragesic. PCA Pumps _are not considered primary Hor- secondary competition for OxyContin since a large majority of these patients can no longer swallow. l-I' I .After FDA.approval is received, the OxyContin exhibit structure will feature graphic panels of the OxyContin core creative concept; NEW depicting a.m. and p.m. dosing" represented by two dosing cups. Various promotional activities will be conducted an the booth to draw attendees into Ra discussionl 'with our representatives about OxyContin. The Iproposed convention schedule is listed at the end of the promotional plan. Clinical Support/Dates Study:- - Dosing Guidelines Test (Label Validation Study) Date of Completion: Third Quarter, 1996 Date of Marketing Usage: Fourth Quarter, 1996 To demonstrate how* to obtain effective pain control by following the OxyContin package insert directions. Marketing Usage: Study: Opioid Naive and Fixed Combination . (PRN) Patients (OC94-0506) Date of CompletiOn: First Quarter, 1997 PP 00016 . 9" amps-t,? - Date of Marketing Usage: Marketing Usage: Study: 'Date of Completion: Date of Marketing Usage: Marketing Usage: Study: Date of Completion: Date of Marketing Usage: Marketing Usage: Study: Date of Completion: Second Quarter, 1997 To demonstrate that OxyContin can be EH1 effective analgesiC' in opioid naive patients or in patients currently taking fixed combination Opioids. OxyContin vs. Percocet? in Ostheorarthritis Patients (OC95-0103) Fourth Quarter, 1996 First Quarter, 1997 head?to-head comparative study to measure the -safety, efficacy, and quality of life of OxyContin vs. Percocet in' osteorarthritis patients. OxyContin vs. Placebo -in Patients with? Low Back Pain Second Quarter, 1997 Third Quarter, 1997 Designed to demonstrate that OxyContin is effective and safe for patients with low back pain compared to placebo. OxyContin vs. Percocet Outcomes in Patients with Low Back Pain-(OC95-0201) Third Quarter, 1997 Date of Marketing Usage: Marketing Usage: Study: Date of Completion: Date of Marketing Usage: Marketing Usage: Study: Date of Completion: Date of Marketing Usage: Marketing Usage: Study: Date of Completion: Date of Marketing Usage: i I Fourth Quarter, 1997 To. demonstrate that 'OxyContin provides a .better quality of 'life than Percocet for patients with low back pain. OxyContin vs. Percocet in Cancer Pain (OC95-0304) Fourth Quarter, 1997 First Quarter, 1998 To prove that OxyContin is as. safe and effective as Percocet in cancer - patients but provides a ibetter? quality of life because of its q12h adminstration. OxyContin vs. Placebo Outcomes in Osteoarthritis Patients (OC95-0202) Second Quarter, 1997 Third Quarter, 1997 Designed to demonstrate that- OxyContin is safe and effective in Patients with osteoarthritis and can provide outcomes benefits. Opioid Stigma Survey First Quarter, 1997 Second Quarter, 1997 PP 00018 10. Marketing Usage: Study: Date of Completion: Date of Marketing Usage: Marketing Usage: Study: Date of Completion: Date of Marketing USage: Marketing Usage: To Show .the differences in stigma among various -opioids when treating patients in pain. The intent is to prove that oxycodone is a more well accepted opioid than morphine. OxyContin vs. DUragesic Random Site (OC95-0804) Second Quarter, 1998 Third Quarter, 1998 An Open label random site study designed to measure quality of life'of OxyContin vs. Duragesic. OxyContin vs. Duragesic Double Blind First Quarter, 1998 Second Quarter, 1998 A double blind study designed to compare OxyContin_ and Duragesic with regards to .efficacy safety and 'other outcomes to be determined. PRODUCT STRATEGY fies during the first - To generate escriptions in year by capturing? 15% of MS CONTIN written for cancer pain.; 0 10% of oxycodone combination written for_ cancer pain. 0 10% of hydromorphone 'Rxs written for cancer pain. 0 2.5% of Duragesic combination written for 'cancer pain. 0 'To Convince health care professionals to replace 15% of MS. CONTIN prescriptions (year i) with OxyContin as their drug of choice for cancer pain. 0 To establish OxyContin as the opioid of choice in Step 2 of the W.H.O. analgesic stepladder. an" 1?ou To displace MS and Duragesic in Step 3 cf the W.H.O. analgesic stepladder, by positioning OxyContin as the opioid to start with and stay with, thereby expanding_ the usage of Step 2. Hence, Stepa 3 products, MS CONTIN, Dura?gesic, will become drugs of last resort, as OxyContin is used throughout the clinical progression of the cancer pain. To increase the number of prescriptions_for strong opioids All the analgesic efficacy of immediate-release oxycodone. The importance of the familiarity' of physicians with oxycodone cannot be overstated. This familiarity is a principal factor that should lead to acceptance of OxyContin. All the ease of inh dosing. All of our market research indicates that the most important featUre of Oxycontin beyond oxycodone is the quh dosing schedule. In? all seven. market research. projects conducted among 626 health care professionals, this. was the most compelling reason to prescribe OxyContin. When a opioid naive _patient needs an opioid analgesic, physicians are reluctant to -begin therapy with MS CONTIN. Therefore, OxyCo-ntin is the opioid to start with (for patients who would otherwise be started on Percocet, Lortab, Vicodin or Tylenol Step 2) and the opioid to. stay with as the disease progresses (when patients may otherwise be switched to MS CONTIN or Duragesic; W.H.0. Step 3). At the time of launch, OxyContin will be marketed 'for cancer pain. The. primary Strategy in the cancer pain market will be to establish OxyContin qua: for a broader range of use than is available to MS CONTIN. - As soon as enough appropriate clinical studies are available for' promotional claims. OxyContin. will The most common diagnoses for non- malignant pain are Imusculoskeletal pain, injury and trauma pain. The major competitors for these diagnoses will be oxycodone and. Ihydrocodone combination products. oxycodone combinations, with the benefit of a quh dosing schedule. 3.. Primary Competition Long-acting opioids (MS CONTIN, Duragesic and Kadian) used for moderately severe to severe cancer pain (Step 3 of the W.H.O. analgesic ladder). Long?acting' opioids ?used. for' moderately 'severe to severe cancer pain (Step 3 of the W.H.O. analgesic ladder). Secondary Competition Combination opiOids (oxycodone, hydrocodone and codeine with APAP or ASA) used for moderate to moderately severe cancer pain (Step 2 of the .W.H.O. ladder). Communications Objective To convince MDs to prescribe and RNs to recommend new OxyConthi for opioid naive or opioid exposed patients with moderate to severe cancer .pain instead of combination opioids, and thereby eliminate or delay the need for other long-acting opioids. Selling Points The One to Start with Then logical. "next step" for' patients no longer tolerating or responding to nonopioids - conforms to the three-step W.H.0. analgesic ladder 4' 9m 1'ij The analgesic efficacy of immediate-release oxycodone - the ease of q12h dosing All! the analgesic effibacy of immediate~release oxycodone - all the convenience of quh dosing Pain relief begins within one hour Rapid onset of action Rapidly effective - upon initiation, most patients can expect relief within one hour Pain control lasts 12 hours;..two to three times longer than each 'dose of short?acting productS' lsuch as Percocet?, Percodan?, Tylox?, Vicodin?, Lortab?, Lorcet?, and Tylenol? with Codeine. Convenient inh schedule won't interfere with patients'. daytime activities or nighttime rest, and encourages compliance Patients 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 Three dosage bioequivalent and dose- proportional, are appropriate for a broad range of pain Small color-coded tablets are easy to identify and swallow an important benefit for patients and those on multiple medications In studies of patients with nonimalignant Rapid reduction in' pain intensity over the .first 24 hours By day three, patients had achieved 94% .of their total pain reduction Patients reported improved ability to sleep, walk, perform normal work, get along with other people, enjoy life The One to Stav With dosing provides. smooth and sustained blood levels - fewer peaks and valleys than with immediate-release oxycodone elderly I . Smooth and reliable pain control - less frequent dosing than with Percocet?, Vicodin?, or Tylenol? with Codeine- No _"ceiling" to analgesic efficacy may .be titrated upward as necessary With full agonists, such as oxycodone, "effectiveness with increasing doses is not limited by a ?ceiling'." Higher doses deliver greater pain control; nearly 30%i of cancer' patients 'maintained. on 160 mg' or more per daym ?Patients avoid the added risk of gastric/hepatic/renal toxicity that can occur with products containing aspirin or acetaminophen Excellent compliance,? high degree of patient acceptability during clinical trials A single-entity oral agent, contains no APAP or ASA - allows independent coadministration and dosage adjustments with nonopioid of choice Convenient q12h schedule Won't .interfere with patients' daytime activities or .nighttime rest, and encourages compliance Common opioid side effects may be anticipated and effectively managed or prevented A significant decrease in the percent of patients reporting adverse events (56.5% vs._ 25.9%, was. seen betveen "the first and last weeks of a cancer study - even as daily doses increased The 12?Hour 'Deliverv System Allows Both Rapid and Prolonged Absorption Over a'12?Hour Period Rapid absorption pain relief begins within one hour Prolonged absorption - pain control continues as tablet matrix slowly releases oxyco?done granules at a constant rate over a 12?hour period Special acrylic coating renders oxycodone granule "pH independent," allowing uniform release within an acid environment (the stomach) or an alkaline environment (the intestines). "pH, independence" assuresi..Minimal effect of stomach contents <31 absorption - _bioavailability unaffected. by food or ingestion of other medications Steady-state achieved in 24 ?-48 hours and remains constant thereafter - if needed, pain assessment ?and titration are possible on a daily basis In cancer studies..; 0 Titration enhanced efficacy of therapy only 3.5% of cancer patients discontinued (due_to inadequate pain control) when. allowed to titrate and use rescue medication 0 Patients were titrated as quickly and easily - with OxyContin as with immediate-release oxycodone PP 00029 gal 92% of patients were titrated to stable pain control with OxyContin, compared with 79% for oxycodone - Average time to stable pain control was 1 6 day'si - The goal of titration - to effeCtively control pain with two or fewer rescue doses per day - ESmall, 'color-coded. tablets are easy" to identify and swallow - an important benefit for patients on multiple medications 0 Variety of permit precise titration to an effective dose. Breakthrough or incident pain _can be managed with - avoids polypharmacy 4r" Run-n" 1. Primary Audiences Site 0 Staff Models Primary Audiences Targets Comments Physicians 0 Office and 13,000 _Iarget List 1A 'HoSpital Decile 8, 9, or 10 for 0 ONCs "Strong" opioids who Hem/Oncs are also Decile 8, 9, Rad/Ones or 10 for "Combo" 0 IMs opioids Fp/Gps 7,600 _IarGet LiSt lB . 0 DOS Decile 9 and 10 for . Other "Strong" opioids only I B. ONC RNs 0 Hospice 27,000 Oncology Nurses - 0 Home Care 0 Office 0 Hospital C. Wholesalers 15 0 National Accounts responsibility- 200 0 Ethical Sales Force responsibility_ D. Pharmacies 0 Hospital 6,000 . Retail. 23,000 . Stock MS CONTIN 35,000 0 Stock combos/not MSC E. Managed Care TED PBMs Organizations IPAs 2. Secondary Audiences Secondary ., Audiences Site Targets Comments A. Consultant Long-term 25,000 Influence-decision?makers Pharmacists Care at LTC facilities Facilities B. Patients and 6 - 7 0 1.2 million new cancer Caregivers million casEs annually patients . 0 30?40% experience pain(early/intermediate) 0 65?90% experience pain (intermediate/late) C. Physicians 1 0 Office 33,000 Target List #2 0 Hospital Decile 10 for combo onlf but not in Target List Inf non-malignant market Dr Teaching Residents/Fellows Hospitals . .950 IV. TACTICS A. The deployment of our most valuable resource, the sales force, will be critical to the success of OxyContin. subject to change as the ?launch -into chronic non- malignant pain becomes more eminent. 4 Sales force allocation should be implemented as follows: OF PRIMARY SALES YEAR CALLS 1 70%- 78,424 2 60% 67.221 3 50% 56,017 4 40% 44,814 5 40% 44,814 Quarter will be.lower as physician selling will not begin until March. 21300033 . . 4w? Representative Delivered Promotional Materials~' Distribution slam to Trade Pharmacists are generally reluctant to stock Class II opioid analgesics. This reluctance is based on the fears that drug abusers will try to obtain these drugs for other ,than. medicinal purposes. The concerns for stocking Class II Iopioids are also related. to the voluminous paperwork required for receiving, distributing, and returning' these Iproducts. In nine states, triplicate ;prescription laws monitor the distribution of Class II opioids to patients. As a result, stocking this product into _the retail distribution channels may be somewhat problematic. Obviously, adequate distribution His one of the noSt essential factors to the_ successful launch of any product. Therefore, it will be critical for the Sales Department to coordinate efforts between the National Account Managers and the ethical field force. Qua (kl?Hm All promotional efforts for the retail distribution of OxyContin will _focus on the incredible success that Purdue Frederick has achieved and sustained with. the MS product line. Wholesale pharmaceutical buyers and retail pharmacists should be reminded of how MS CONTIN created. such allarge market for the use of sustained release opioids for the treatment of pain. on 'the market potential for OxyContin and patient populations to be targeted, including the number of preScriptions written for Class .II and Class opioids every year. The Executive Director of National Accounts should work with drug wholesalers in developing programs to utilize the wholesalers' sales representatives to ensure adequate distribution. Consideration should also be given to advertisements in drug wholesaler ad books or computer programs. A cooperative direct mail/advertising sales sheet Ioffering a rebate on the initial order of OxyContin to retail pharmacists will be mailed every month during the first three months of launch. This promotion will increase awareness and supplement field force efforts in gaining adequate distribution. Hthesalera In an effort to ensure fast and adequate distribution of OxyContin, National Account. Managers will begin making pro-launch sales calls during October, 1995.-The objective of these sales calls His to obtain EPIC numbers for OxyContin and have the product down?loaded into computer systems so when FDA approval is granted there is no delay in shipping product to wholesalers. A pre-launch wholesaler. sell sheet will be_ developed, supplying all appropriate information NDC numbers, package sizes,_pricing, etc,). Since FDA does not allow promotion of a brand's effectiveness, safety, or lindications during the pre?launch. phase, no PP 00036 information 'other than product specifications NDC numbers, dimensions, pricing, be included in the pre?launch sell sheet. A launch sell sheet will be developed for OxyContin. It will carry promotional messages about OxyContin ?and will explain the level of marketing and sales support that the brand will receive. A.separate sell sheet will be developed for These ?materials will be provided. to National Account Managers and the ethical field force as soon as possible after FDA approval is received to ensure adequate and fast distribution. _Representative promotion .to retail pharmacies will begin once adequate Iwholesaler distribution His attained. Representatives will be provided with a launch sell sheet for both OkyContin and Initial_ targets will be all 25,000 Stores who stock MS CONTIN. Representatives will be provided with lists showing all stores purchasing MS CONTIN within the last 6 to gum .1 a Fl! 12 months. Stocking will then be expanded to the additional 35,000 stores remaining in the market; In an effort to create demand at the pharmacy level, a K?mailing will be ?sent to physicians announcing the introduction of OxyContin. A business reply card will be included, which they will return to Purdue Frederick if they are interested in having their local pharmacy stocked with OxyContin. These business reply cards will be distributed to- the appropriate sales representative and used when stocking local retail pharmacies to create a pull-through demand program. Hospitals In an effort to gain formulary acceptance of OxyContin, representatives will make calls on all committees to_gain hospital formulary acceptance'during the first three _months. of .launch. This will entail contacting directors of pharmacies and committee members in all hospitals of 100 beds Or more. .0. A hospital formulary kit and product data brochure will i be utilized by the sales force to provide the I appropriate clinical data necessary to add OxyContin to hospital formularies. In addition, representatives will be 'given tabletop? hospital display' panels. Speakers? i -Bureau lectures will be conducted during grand rounds, tumor bOards, etc. The focus of these presentations will be the addition of a new opioid;(0xyContin) to the analgesic treatment armamentarium. . Managed Care AccOunt Executives will target all major PBMs and IPA plans in an effort to add. OxyContin- to their 'formularies. committee members will be uprovided with a formulary kit that has_been customized for their managed care organization, personalized with their? name on the cover. In addition, they" will be provided with product data brochures. The Partners .Against Pain" Program ?will be expanded I significantly" for the managed care market, providing customized materials to meet their needs. Items such as a caSe manager education 'video, titration' guideline cards. .and conversion calculators will be offered to. managed care. organizations mith their? plan's .indicia printed on, them: In addition, -various educational programs such as regional physician and nurse educators, consultations -with pain management specialists, etc. are being explored as possible value- added' services Hoffered through the Partners Against Pain Program. Predlaunch mailings will be. sent to wholesalers announcing that OxYContin is coming soon from Purdue. The objective of these mailings is to ensure that EPIC numbers are assigned to OxyContin by each wholesaler. This will speed up the distribution process, since it takes-approximately 60 days to complete this task. FPOOQK) Elinor- AW As soon as adequate retail distribution announcements ?will be sent to? MDs, RNs, RPHs, MCOs, hoSpitals and hospices. The objective of these mailings is to build awareness of the OxyContin name. The focus of mailings at and after launch will be on OLD versus NEW of oxycodone pain control{ The graphic of two cups representing a.m. and p.m. dosing will be the main message that is conveyed. These launCh mailings will have the objective of' creating brand awareness of OxyContin and also campaign awareness that_ carries the most important benefit OxyContin has to?offer} q12h dosing..' Representative Follow-up Mailings Representatives will be given the ability to send follow-up mailings to MDs and RNs after making a call. .This will be aocomplished through the Precise System. E. .1 E: The launch ad f0r OxyContin will contain the core creative concept of 24 hr. Oxycodone the (6 dosing cups) vs. the (2 dosing cups). This ad will be a 4?page insert .placed in journals from February 1996 through July 1996. Starting in August, 1996, a three page run-of?book post launch ad will be utilized to reduce advertising space costs and to remind the physician of the main message 'of OxyContin, a;m. and p;m. dosing. It will carry the I same graphic as the launch ad. Constantine A new exhibit structure has been constructed specifically for the OxyContin launch. 'This exhibit will be used during the pre-launch phase and in the first year? after launch, ?just to .promote Oxycontin_ After the first year, consideration will be" given to converting the structure ?Iinto the Purdue pain management. eXhibit, where all Purdue ?analgesics could be displayed. 2mm Prior to FDA approval, in an effort to create broad awareness of- the upcoming launch of OxyContin with large target aUdiences -(primary .care MDs), the OxyContin convention exhibit was displayed at and ADA conventions. Since FDA guidelines do not allow promotion of .effectiveness, safety, or- indications, prior to approval, the emphasis at the pre-launch booth focused on "coming soon. from Purdue Pharma OxyContin (oxycodone hydrochloride controlled release) Tablets. Attendees visiting this booth during the pre? launch-phase will be entered into a database which will be used to send mailings when FDA approval is received. math After_FDA approval is received, the OxyContin exhibit structure will feature graphic panels of the OxyContin core creative concept; NEW depicting a.m. and dosing represented. by two dosing cups.- Various promotional activities will be conducted at the booth to -draw attendees into a discussion 'with our representatives about OxyContin. IThe proposed_ convention schedule is listed at the end of the promotional plan;- PP 00?44 . qua Launch Visual Aid File Card Pharmacy Stocking List OxyContin Prescription- Pad Portfolio Cost Comparisoh Card Titration Guideline Card Sonversion Calculator Phone Message Pads OxyContin In+Service Slide Module File Card OxyContin Wholesaler/Chain .Sell Sheet Wholesaler/Chain Sell Sheet Pull Through Demand Program OxyContin Retail Pharmacy Sell Sheet Retail Pharmacy Sell Sheet 59 PROMOTIONAL MATERIALS cont: 4 Hospital Formulary Kit I Make?A4Wish Phones Pabletop Displays Product Data Brochure_ Formulary Kit (customized) Formedics Patient Chart Forms Physician Reminders Oxycontin/OxyIR Flash Card Office Premiums Reprint Fund Reprint Binder 'Eile Card (reorder remove the word new) Slim Jim Side Effect Management Slim Jim PAP Assessment Scale PAP Assessment Record Form Case Studies Brochure aw PPOGM6 PROMOTIONAL MATERIALS Cont: ?Start with Stay With" Premium Case Manager Video Life Style Detailer PAP Professional Newsletter Wu: PDR Addendum MD Approval Announcement RN Approval Announcement Consultant RPH Approval Announcement Managed Care Approval .Announcement Hospital Approval Announcement Hospice Approval Announcement Wholesaler/Chain Launch Announcement Pharmacy Power Pack Mailing Managed Care Launch Mailer anal PPOGMW DIRECT MAIL cont:- Rep Follow-Up Mailings Physician Direct Mail Services: Features and Benefits (3 waves) RN Direct Mail Series: . Features Benefits (3 waves) JOURNAL ADVERTISING: Journal Advertising SPECIAL PROMOTIONS: Push Monies for Drug . Wholesaler Incentives Rebates on Initial Retail Drugstore Orders Drug Wholesaler I Advertising Programs CQHEEHIIQMS: American College of . Osteopathic Family Physicians Oncology Nursing Society American Society of Clinical Oncology American Academy of Physicians Assistants W: American Academy of Hospice Physicians International Association Study of Pain American Academy of Family Physicians American Osteopathic 3Association American College of Rheumatology National Hospice Organization Oncology Nursing Society Fall Teaching Institute American Society of"- Consultant-Pharmacists American Pain Society American Society Health System ITEM FIRST QUARTER Bromotional Materials: Launch Visual Aid File Card Pharmacy Stocking List OxyContin Prescription Pad Portfolio- l996 PROMOTIONAL PLAN BY QUARTER NEW OR NO. New' 5,000' _$45,000 New 150,000 $55,000 New 25,000 $5,000 New 12,000 $100,000 A 20?page retained visual that will be the cornerstone sales aid for the representatives. A mini visual/file card to be used as a leave?behind, includes package insert. Leave?behinds to let health care professionals know which pharmacies stock OxyContin. A portfolio bearing the ?Partners Against Pain" and OxyContin logos, designed_to hold the physician?s prescription pad. These will be given to the physician with a OxyContin file card, conversion calculator, titration guidelines card, and conversion pen in them. IIEM FIRST QUARTER cont. Promotional Materials cont: Cost Comparison Card Titration Guideline Card Phone Message Pads PP 00051 -NEW 100,000 300,000 200,000 100,000 $40,000 $80,000 $225,000 $35,000 A flash card used to demonstrate the daily cost of OxyContin versus Duragesic, Percocet, and MS Contin. A two?sided flash card explaining the TIME principles of titration to ensure appropriate titration is? carried out with OxyContin. A slide rule calculator providing appropriate conversions from other opioids to OxyContin. Pads giVen to the receptionist for recording phone messages for physicians. Because it bears.the OxyContin logo, physicians will constantly be reminded of OxyContin every time they get a phone message. IIEM FIRST QUARTER cont. Promotional Materials cont: OxyContin In?Service Slide Module File Card OxyContin Wholesaler/Chain Sell Sheet Wholesaler/Chain? 'Sell Sheet Pull Through Demand Program New New New New New pp(m0$2 _500 100,000 10,000 10,000 $15,000 '$30,000 $25,000 $5,000 A set of 20 slides to be used by representatives for ineserViCes _on OxyContin. A mini visual/file card used as a leave-behind for To be used with wholesalers/ chains to stock OxyContin and offer terms of sale. To be used with wholesalers/ chains to stock and offer terms of sale. program to encourage physicians to return a business reply card requesting that their ?local pharmacy be stocked with OxyContin. Representatives will then nee this card to stock the local pharmacy for the physician. .OxyContin Retail Pharmacy Retail Pharmacy Sell 1996 PROMOTIONAL PLAN BY QUARTER- IIEM FIRST QUARTER cont. Promotional Materials cont: New Sell Sheet (300,000 for Power' Pack Mailing - 50,000 for sales force) - New Sheet (300,000 for Power Pack Mailing 50,000 for sales force) 350,000 '350,000 mileage $50,000 $50,000 To be used when stocking retail pharmacies with OxyContin. It will offer a rebate on the initial order of OxyContin. A mailing of 200,000 of the sell sheets will be made to all retail pharmacies across the country through Pharmacy Power Pack. To be used when stocking retail pharmacies with It will 'offer a rebate on the initial order of A mailing of 200,000 of the sell sheets will be made to all retail pharmacies across the country through Pharmacy Power Pack. IIEM FIRST QUARTER cont. Promotional Materials cont: Hospital Formulary Kit MakemA-Wish Phones Tablet0p Displays Product Data Brochure Formulary Kit (customized) New New 'New New New 100- 1,000 50,000 1,000 $60,000 $15,000 $100,000 San non A binder given to committee members when requesting the addition of OxyContin to a hospital formulary. This binder will contain all relevant clinical data for OxyContin. Video conferencing phones to be ?given to the top 100 cancer centers across the nation as a donation. These phones are used by patients in isolation to speak with loved ones. Display panels used by representatives when exhibiting at hospitals, hospices, etc. A brochure summarizing all and clinical studies. P-?1?m1 ?1 ITEM FIRST QUARTER cont. _Bromotional Material cont: Formedics Patient Chart Forms P?m .1. PDR Addendum NEW OR NO. OF New New New 50,000 $35,000 $55,000 Patient record forms given to physiCians_free of charge; These forms will contain an advertisement for OxyContin. ?Various-giveaways to constantly remind the physician of the .availability of q12h OxyContin. Once adequate retail distribution is attained, a mailing will be sent to physicians announcing the launch of OxyContin, and providing them with a package insert to be inserted into their Physicians' Desk Reference manual. ITEM FIRST QUARTER cont; MD Approval Announcement ?rm RN Approval Announcement Consultant Approval. Announcement NEW OR New New New NO. OF 30,000 25,000 6,000 $41,000 $30,000 $10,000 in. 0 Once adequate retail distribution is attained, a one? page letter will be sent to all high prescribers of opioids announcing the launch of OxyContin. Once adequate retail distribution is attained, a one~ page letter will be sent to all members of-the Oncology Nursing Society announcing the launch of OxyContin. Once adequate retail -distribution is attained, a one~ page letter will be sent to all members of the American Society of Consultant Pharmacists announcing the launch of OxyContin. I.cn_mi a, can,? NEW OR. ITEM FIRST QUARTER cont. .1 Managed Care Approval New _Announcement Hospital Approval . New Announcement Hospice Approval Announcement New 12,000 20,000 2,000 $15,000 $25,000 -$5,000 Once adequate retail distribution is attained, a one~ page letter will be sent to all members of Managed Care Committees announcing the launch of OxyContin. Once wholesaler distribution is attained, a one?page letter will be sent to all members of Hospital P&T_Committees announcing the launch of OxyContin. Once adequate retail distribution is attained, a one? page letter will be sent to all hospice directors announcing the launch of OxyContin; IIEM FIRST QUARTER cont. I. Wholesaler/Chain Launch Announcement Pharmacy Power Pack Mailing (2 waves) (Retail, Hospital, Consultant Pharmacies) Managed Care Launch Mailer Rep Follow?Up Mailings New? New New New NO. OF 300 $4,000 100,000 $20,000 15,000 $30,000 200,000 $150,000 Once FDA approval is attained, a launch announcement will be sent all wholesalers/chain pharmaceutical buyers announcing the availability of OxyContin. A mailing of our sell sheet to .all retail, hOSpital, consultant pharmacies announcing the availability of OxyContin. A mailing sent to managed care administrators explaining the features and benefits of OxyContin. A series of letters that representatives can send to NUS, RNs and as a follow?up to their sales call. This program is administered through the Precise system. .iwm_i M., IIEM FIRST QUARTER cont. Journal Adxextising: Journal Advertising .: Push Monies for Drug Wholesaler Incentives Rebates on Initial Retail Drugstore Orders Drug Wholesaler Advertising Programs NEW OR New New New New. $187,500 $100,000 $70,000 $100,000 Budget used to advertise OxyContin in journals. A budget used to provide wholesalers with an incentive for stocking OxyContin into . i pharmaCies. -A fund uSed to pay rebates to retail pharmacies on their initial order of OxyContin. Budget used to advertise OxyContin in wholesaler advertising booklets and computer programs. 2-73 aw" IIEM SECOND QUARTER W: OxyContin/OxyIR Flash Card Office Premiums Reprint Fund Reprint Binder NEW OR New: New New New NO. OF EIECES 200,000 TBD 400 USAGE $100,000 $75,000 $25;000 A simple two?sided flash card used to explain the benefits of using OxyContin and together. - Premium_giveaways for the physician's office constantly reminding them to prescribe OxyContin. A fund used to purchase reprints as OxyContin manuscripts are published. A binder used to hold all published abstracts and studies for OxyContin when making _presentations. ITEM SECOND QUARTER cont. El I I Physician Direct Mail Series: Features and Benefits (3 waves) RN Direct.Mail Series: Features Benefits (3 waves) Journal Adyertising: Journal Advertising 1296 PROMOTIONAL PLAN BY QUARTER NEW OR ?New New New' 25,000 $215,000 25,000 $150,000 $187,500 A three?wave, tbree?dimensional mailing to high-prescribing opioid physicians explaining the unique features and benefits of OxyContin. A three-wave mailing to all members of the Oncology Nursing Society explaining the unique features and benefits of OxyContin; Budget used to advertise OxyContin in journals.1 2-75 IIEM THIRD QUARTER . . 1: File Card (reorder remove the word.new) Slim Jim Side Effect Management Slim Jim NEW OR New New New NO. OF 150,000 100,b00 100,000' $55,000 $170,000 $95,000 Reorder of the OxyContin file card removing the word ?new" from the headline and logo per FDA regulations. Reduced version of the OxyContin retained visual in slim jim size for reps to use in a stand-up selling situation and as a leave-behind piece. Handy reference guide for physicians and nurses to use when treating opioid side effects. This piece will emphasize the aggressive and prophylactic treatment of side effects caused by all opioids. ITEM THIRD QUARTER cont. Promotional Materials cont: PAP Assessment Scale PAP Assessment Record Form inf NEW50R New New NO. OF 30,000 30,000 PPOGEB $75,000 $60,000 A pain assessment scale incorporating the faces of pain visual analog and 0-10 scales onto one standardized pieCe. This will be a ?Partners Against Pain" value?added service tool. A form for progress notes in patient charts. This form will help physicians identify and document the reason for giving an opioid to avoid any complications with the DEA for prescribing a Class II narcotic. This will be a value?added service tool through ?Partners Against Pain." IIEM THIRD QUARTER cont. Promotional Materials cont: Case Studies Brochure .?gll ?Start with Stay With? Premium Case Manager Video 1? Journal Advertising 4-!0 NEW OR NO. OF- New_ 50,000 New 36,000 New 10,000 New cos: (ESLL 113m $50,000 $75,000 - $100,000 .An educational videotape A brochure presenting patient case studies in both malignant and non?malignant pain describing the benefits of OxyContin therapy. A premium reminder item to position OxyContin as the opioid to start with and stay with_for the treatment of moderate to severe pain. designed to teach case managers at managed care organizations the most appropriate pain management Budget used to advertiserme~eewmw~ OxyContin in journals. 53a. NEW OR NO. OF . IIEM REREAI BIECES FOURTH QUARTER EerQLanaL Matgrial: Life Style Detailer New TBD $50,000 A sales aid demonstrating the quality of life benefits that OxyContin offers to patients through its q12h dosing schedule. The ?Cups" campaign will be incorporated into this visual aid. 1-0 PAP Professional Newsletter New 40,000/Qtr $180,000 A newsletter for health care professionals updating them on the latest advances in pain. management. This newsletter will be geared as an educational tool to teach them the most apprOpriate ways to manage pain. Journal Advertising - New $187;500 Budget used to advertise OxyContin in journals. PPOGXE .. v. TQTAL 5'0 9 OVERVIEW - (0003) . .t us?com?m0 oxrconwxn? M50 1994 MSC 1995 1996 1996 Combined Actual Sales Hot. Sale: Proj. Sales Proj. Sales 1996 Sale A. Sales $93,725 $110,473 $113,272 $25,963 $139,235 Marketing a Promotion Promotional Materials $1,360 1.5% $1,458 1.3% $1,352 1.2% $2,700 10.4% $4,052 2.9% Journals/Direct.Mailn? 659 0.7% 630 0.6% 356 0.3% Direct Mail -- -- 750 2.9% 750 0.5% Journal Advertising -- -- - 700? 2.7% 700 0.5% JOurnal Production -- -- 50 0.2% 50 0.0% Total Direct Mail/ 659_ 630 . 356 1.500 5.8% 1,856 1.3% ?"Journa1 Advertising Public Relations -- -- -- 0 0.0% - 0 Samples 11 --I -- . -- -- Agency Fee 225 0.2% 50 0.0% -- 600 2.3% 600 0.4% _Specia1;?romotions I 336 0.4% 400 0.4% 270 1.0% 270 0.2% (Devoted to Wholesalers) 'Conventions 168 0.2% 180 0.2% 224 0.2% 395 1.5% 619 0.4% Other Programs - I -- r- -- 0 0.0% 0 Incremental Bonus -- -- -- -- -- 2,400 - 2,400 1.7% (OxyContin) - . . .2- Total Marketing a promotion - $2,746 2.9% $2.716 2.5% $1,932 1.7% $7,665 30.3% $9.797"? 273?"' Total Allocation $10,810 11.5% $20,292- 16.4% $18,922 16.7% 527,490 105.9% $46,412 33.3% Total 3 a 9 $13,558 14.5% $23,010 20.6% $20,654 13.4%. $35,355 136.2% $56,209 40.4%' .. 3-20.. All