1 998 BUDGET PLAN OxyContin?Tablets Pages 4-25 through 4-34 redacted PP 00125 II. 35313212119118 A. The market for OxyContin Tablets consists of patients with. both. cancer" pain. and :non?cancer' pain. The non- cancer pain narket'is much larger. Approximately two- thirds of OxyContin. Tablet prescriptions are ?written for non-cancer pain. The classic model utilized in treatment of cancer pain is the World Health Organization (W. H. 0.) Three Step Analgesic Ladder. This same ladder is often. used..by physicians as a guide for treating non- cancer pain. The recommendations of the W. H. O. are: Step 1: Use NSAIDs to treat mild pain, aspirin,? acetaminophen, and NSAIDs. Step 2e Use weak ?opioids to treat moderate pain, codeine, oxycodone, and hydrocodone combinations. Step 3: Use. strong Opioids to treat severe pain, morphine, hydromorphone, fentanyl, etci Opioid choices in treating moderate? to- -moderately seve.re pain in Step have previously been limited to combination products containing oxycodone, hydrocodone,' codeine and APAP. The short duration of action of these products causes peaks and valleys in blood levels which can contribute to increased side. effects and poor, inconsistent, pain control. The Combination of an opioid with APAP or ASA limits the number of tablets that can be prescribed because of potential liver toxicity. The APAP or ASA component also has the potential to, mask fever in Cancer and other patients with infections. All these factors; associated with the choice of- opioid analgesics in Step 2, provide an opportunity for a single-entity, long-actimg oxycodone product, OxyContin Tablets. Long?acting morphine and the transdermal fentanyl patch provide physicians with two long-acting 'products .to PP ?BW'-b'eu meet the needs of patients with moderately severe?to- severe pain as described in Step 3. Morphine and fentanyl, available to treat Step 3 pain, possess disadvantages such as the stigmas that surround morphine, and the M.D., R.N., pharmacist reluctance to use them. They? are also considered ?potent" Opioids .which- physicians may not want to prescribe until the pain is severe. I: 1 I 3 Fixed combination opioids (oxycodone, hydrocodone, and codeine combined with APAP or ASA) have been the drugs of choice for treating moderate-to-moderately severe cancer pain Step 2). 'These products which contain- APAP or ASA are limited by a ?dosing ceiling caused by the nonsopioid, which. can cause renal or hepatic toxicities. Sales for generic combination opioids are expected to continue to grow, while sales of the branded combination products will continue to decline. Combination opioids are considered primary competition for OxyContin Tablets in its position as the opioid to ?start with? for treating pain. CONTIN Tablets- has become the gold standard for? treating moderately severe-to-severe cancer pain (W.H.O. Step 3). In fact, some. physicians, particularly oncologists, will switch patients with more severe pain from OxyContin Tablets to MS comm Tablets. MS comm Tablets is perceived as being stronger than OxyContin Tablets. Although faced with stiff competition from Duragesic? and Oramorph sales of MS CONTIN TabletS' are expected to be similar in 1997 as 1996, with dollar sales decreasing by 0.38% from the 1996 total of $129,357,000. It is expected that health care' professionals will continue to support the use? of MS CONTIN Tablets-for_severe pain in 1998 for patients who need morphine, . Because a bioequivalent rated generic controlled- release morphine sulfate is expected to be available sometime in the near future, one of the primary objectives of the OxyContin Tablets marketing plan is to start patients on OxyContin Tablets who would otherwise have been 'started on MS CONTIN Table-ts. If the patient's- medication is titrated appropriately, he/she may never require another Opioid such as MS Tablets.- mzagesic Janssen has been targeting the moderate- to? ?moderately severe pain market for the past two to three years. Their progress has been slow but steady in obtaining patients coming directly off fixed combination opioids. A major thrust for Duragesic, accounting for about 30% of its prescriptions, has been in the long- term care market? (nursing home and hospice) We assume that Janssen will continue to target primary care physicians (namely internists) 'as well as oncologists. In 1997, Janssen spent a reduced amount of money advertising Duragesic in journals. Total estimated journal. spend for Duragesic in 1997 is- $654,000 versus $2,285,000 in 1996, down 71.49. Because OxyContin Tablets is .being' positioned for patients who would have been started .on fixed combination opioids,? it is expected Janssen will try to counter the OxyContin Tablets position by stressing fewer side effects constipation) and simplicity of use of a three-day patch delivery system. A recent market research survey conducted with. oncologists at the 1996 ASCO'mee-ting revealed that lack of efficacy, breakthrough pain and side effects are the most common reasons why patients are switched' from OxyContin Tablets to another opioid. As a result, when selling against Duragesic, it will be critical that proper titration and treatment of side effects are stressed in the promotion of OxyContin Tablets. Proper dosing and Ititration with OxyContin Tablets will prevent the problems which cause physicians to switch patients to MS CONTIN Tablets or Duragesic. Another tactic to use when selling against Duragesic is; to stress the early use- of OxyContin Tablets to help prevent comparisons to other strong opioids such as Duragesic and MS CONTIN Tablets. At recent (1997) focus group sessions, a product attribute analysis was conducted. It showed that Duragesic is perceived by physicians to have ?a 'slow onset of action, lacks the ability to be titrated quick.ly, and is not considered cost effective. We will attempt to take advantage of these Duragesic weaknesses in our OxyContin Tablets promotion. K: anus Faulding_received FDA approval to_market Kadian on July 3, 1996. Zeneca Pharmaceuticals, the company which has marketing rights to Kadian in the USA, began promotion during September 1996. Kadian can be dosed either q2-4h or qlzh. Although not bioequivalent to MS CONTIN. Tablets, Radian is being positioned as a "better alternative." In Australia, the product was launched by_ Glaxo whose promotional focus has centered around the inference that flatter plasma'concentrations equate to better efficacy than MS CONTIN Tablets. Kadian has achieved a market share of only 0. 4% of the strong opioid market after 12 months of sales. When physicians choose to use morphine, they continue to use MS CONTIN Tablets in most instances. Kadian will continue to slowly replace a small portion of prescriptions of MS CONTIN Tablets and may reduce the available prescriptions for new patient starts on OxyContin Tablets instead of MS CONTIN Tablets. As patients no longer tolerate or receive adequate analgesia from OxyContin Tablets, Kadian will attempt to be used as the logical next step. As with Duragesic, it will be critical that proper titration and treatment of side effects are stressed when selling . 22 00129 4-0- "as" OxyContin Tablets, thereby reducing the number of patient failures requiring switches to other opioids. At this time, the principal concerns we face from Radian-are that Zeneca may attempt deep price cuts or other market destabilizing tactics. Qzameznhj? Roxane is expected to continue promotion of Oramorph SR by positioning it as a cost effective alternative to MS CONTIN Tablets. It is expected ?that Roxane will continue to spend a significant amount of promotional money? for' journal advertising' and