City of Winter Haven v. Cleveland Indians Baseball Company Limited Partnership

Filing 470

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Case 6:06-md-01769-ACC-DAB Document 417-7 Filed 08/30/2007 Page 1 of 5 DOXS_OCR.TXT ___________________ ***** Image # 1 File: 3C722FCA.tif ***** ___________________ SEROQUEL Effective and Well-Tolerated CONTACTS: James G. Minnick Steve Lampert AstraZeneca AstraZeneca 302/886-5135 302/886-7862 j im. mi nn i ck@astrazeneca. com steve.lampert@astrazeneca. com Clinical Studies, Suggest ttasat" SEROQUEL,ffective and WellTolerated in Long-Term Treatment of Patients With Schizophrenia SAN JUAN, Puerto Rico- Dec. xx, 2000-Results of three studies presented today at a major US psychiatric conference suggest that SEROQUEL® (quetiapine fumarate) Tablets continue to be safe, effective and well-tolerated in the long-term treatment for both positive and negative symptoms of schizophrenia in adults. l 2,3 e _ rar «~ t it@ -curcti~: %_ _-rr a3 it -tl: -, afar; a3:c." of ifacC, of `~I?RS3 ~_~, :?Z_ e ..E":?011 ~fE e i;hrco si.1:l`Ee'. ' -------------------------------------------------POSITIVE AND NEGATIVE SYMPTOMS OF SCHIZOPHRENIA Major signs of schizophrenia include positive symptoms such as delusions, delirium, and hallucinations, and negative symptoms such as apathy, depression, and social withdrawal. While older antipsychotics have frequently been used to relieve the positive symptoms of psychosis, the newer class of atypical antipsyhotics including SEROQUEL, have been shown to be effective while controlling both the negative and positive symptoms.4 "Approximately one in every 100 people develops schizophrenia. This psychiatric disorder occurs worldwide despite a person's gender, culture, race and religion," said Jonathan Hellewell, (TITLE), Department of Psychiatry, Trafford General Hospital, Manchester, United Kingdom and lead author of one of the studies. "Typically, schizophrenia is a lifelong illness with symptoms that change in severity over time. It is therefore critical to maintain treatment for a long period of time." - more Deleted: Show ------- -----------------------Deleted: May Be ------------------------------------------------------------------ ---- ----- ----1 Deleted: Deleted: ¶ ---- - --AZ/SER 4865045 ___________________ ***** Image # 2 File: 3C722FCB.tif ***** ___________________ SEROQUEL Effective and Well-Tolerated DATA SUGGEST SEROQUEL IS WELL-TOLERATED The first of these studies suggest that SEROQUEL® (quetiapine fumarate) Tablets continue to be well-tolerated for patients after 12 months of treatment.' The open-label extension (OLE) evaluation assessed the long-term safety of SEROQUEL for patients treated for periods up to Page 1 Case 6:06-md-01769-ACC-DAB Document 417-7 Filed 08/30/2007 Page 2 of 5 DOXS_OCR.TXT three years.' A total of,-1`;' patients with a mean age of 39 years who were diagnosed with schizophrenia or schizoaffective disorder were included in the assessment. (Since he tide :>f t l:is pi'eSS 3'els,,3~E ]7:~3f' i[5 t7ra';4t 3 ;a, r33"t]:h? 33 E~7 3 ~E t3 ti}';1Ct )C',':l}'~ 3_ii t~3s; t'eaiY(3s,YIE of Sc,]"LE7el'I')}:'Crrl 3. ilfv \^I. 1~TPe:'ti5% Yhr ".pi3J Plb Patients' exposure to SEROQUEL lasted an average of 47.2 weeks (ranging from 0 to 246 ttrdv 411mc( l that ti] ( )Q J 11'1'>s, 1a1SLdlk) 11CCv Sd1ely C01lcLl1J, an( 101 Lin the,,e 011;ul %Cd in t}lt tilc ~ i1, nl voe u nut q, :_a, t h ille, trst_+7f _l tr~3}: c3p13)I ------ ------- ---------STUDY SUGGESTS THAT SEROQUEL IS APPROPRIATE FIRST-CHOICE TREATMENT OPTION o d tin-oast°ate thr ma-intazHcd of c;ay and S 3fetc o p e iz.hitia d:3ri no 1irt~ is r rt tts, 3a rtzati oC s:,hit+~111-:rert .~ . ,eta frolxt 4 :>~~er-las,l ?xter_i,i:>:+ (t <[ ,` :~ta.:~ e.. Lti ~,w (1 .:E1 c]"7!1 patielts t+~'.i.6 pert F rt r+ 3: c it}t a : Eler:ti .l ;e c i'',6 ear.: reees ce;I ;~; .; d ),_+}T , fc u, lo ",r) c,ee k > },P}?S ~'(_i. t3 i S \] J` v e;? t+~,e~:i t,) In ~+s:~ra t (:>:+. terna _fjlic. c:v of S! :[ t )<)i l[ _[, (]I TSFI R ' 1-)AT A FIE}d ; "We were pleased to see that SEROQUEL continues to maintain its effectiveness for treatment of both the positive and negative symptoms of schizophrenia for patients who require long-term treatment," said Siefgried Kasper, M.D., (TITLE), Department of General Psychiatry, University of Vienna and lead author of the study. "With medications such as SEROQUEL, patients suffering from schizophrenia may now continue taking an effective medication that has been shown to improve their quality of life for an extended period of time." - more Deleted: 455 -------------------------------------------------------------Deleted: The second study found that SEROQUEL therapy offers a maintained response for both positive and negative symptoms of schizophrenia over the longterm, while being well-tolerated. 2 The results further suggest SEROQUEL is an appropriate first choice atypical antipsychotic in the long-term treatment of schizophrenia. 2 I --------------------------- ----------------------------------------DeletedThe results were gathered from data collected from four open label extension (OLE) studies in which 674 patients (65.6 percent male), with a mean age of 36.4 years received SEROQUEL for up to 130 weeks z Various assessment scales for mental illness were used to measure the long-term efficacy of SEROQUEL. Each measurement tool revealed significant (p<0.001 for each) improvements from the baseline, being reported at 13, 26, 52, 78, 104, and 130 weeks? Page 2 Case 6:06-md-01769-ACC-DAB Document 417-7 Filed 08/30/2007 Page 3 of 5 DOXS_OCR.TXT Formatted: Bullets and Numbering -----------------------------AZ/SER 4865046 ___________________ ***** Image # 3 File: 3C722FCC.tif ***** ___________________ SEROQUEL Effective and Well-Tolerated SEROQUEL OFFERS MAINTAINED LONG-TERM RESPONSE Results from a third study suggests that, among adult and elderly patients who showed an initial response to SEROQUEL ®(quetiapine fumarate) treatment, the medication offers maintained response for both positive and negative symptoms of schizophrenia over the long-term at rates similar to those for other atypical antipsychotics. 3 Results were gleaned from data collected from 52-week, open label extension (OLE) trials of three studies in adults (n=267), and one study of elderly patients (n=184).3 Patients who had a meaningful clinical response to SEROQUEL in the acute phase were eligible for the OLE phase.3 Response was defined as 40 percent reduction in Brief Psychiatric Rating Scale (BPRS) total score from baseline or a BPRS total score of 18 points at week six. 3 The mean scores at the start of the OLE after one year of treatment showed that the beneficial effects of SEROQUEL® (quetiapine fumarate) Tablets were maintained; these effects were again measured by various measurement tools. s At the end of the 52-week interval, the mean scores were lower for each test, suggesting that SEROQUEL continued to help control both positive and negative symptoms of schizophrenia.' (BPRS 14.0 vs. 12.7; CGI Severity of Illness 3.0 vs. 2.8; BPRS Positive Symptom Cluster score 1.3 vs. 1.0; and Scale for Assessment of Negative Symptoms 9.5 vs. 8.2). In the study of the elderly patients, statistically significant differences were observed in changes from the baseline to week 52 on all rating scale scores.' SEROQUEL® (guetiapine fumarate) TABLETS AND ASTRAZENECA SEROQUEL is indicated for the management of the manifestations of psychotic disorders. In studies supporting the approval of SEROQUEL, there were no differences from placebo across the clinical dose range in the incidence of EPS, including rigidity and difficulty starting and stopping movement, or in elevation of plasma prolactin levels. In addition, studies have shown that SEROQUEL exhibits a low incidence of hormonal, reproductive system (sexual dysfunction), and anticholinergic side effects (dry mouth, constipation). more ___________________ ***** Image # 4 File: 3C722FCD.tif ***** ___________________ SEROQUEL Effective and Well-Tolerated The efficacy and atypical profile of SEROQUEL is supported by several placeboand comparator-controlled Phase II and III clinical trials in patients hospitalized for acute Page 3 Case 6:06-md-01769-ACC-DAB Document 417-7 Filed 08/30/2007 Page 4 of 5 DOXS_OCR.TXT exacerbation of chronic or subchronic schizophrenia. SEROQUEL was well tolerated by more than 4,000 male and female patients 18 years and older in these trials. No blood monitoring is required. In clinical trials, efficacy was demonstrated in a dose range of 150 mg/day to 750 mg/day. An initial target dose range of 300-400 mg can be given in two divided doses daily. The drug is manufactured in the United States by AstraZeneca and is available by prescription in strengths of 25-mg, 100-mg, and 200-mg tablets. Since its approval in September of 1997, there have been more than 2.4 million prescriptions written for SEROQUEL for more than 623,000 patients in the United States.s'6 As with other agents in its class, the labeling for SEROQUEL Tablets includes a warning relative to a rare condition known as tardive dyskinesia (which is often associated with long-term use of antipsychotic agents) and neuroleptic malignant syndrome (NMS symptoms include muscle rigidity, fever, and irregular pulse). Labeling precautions include orthostatic hypotension and the possible risk of cataract development. As with other antipsychotics, therapy with SEROQUEL should be used cautiously in patients with a history of seizures or with conditions that can potentially lower the seizure threshold. The most common adverse events exhibited across placebo-controlled trials included headache (19%), somnolence (18%), and dizziness (10%), and the majority of events were rated mild or moderate. The safety and effectiveness of SEROQUEL® (quetiapine fumarate) in pediatric patients (less than 18 years of age) have not been established. AstraZeneca (NYSE:AZN) is a major international health care business engaged in the research, development, manufacture and marketing of ethical (prescription) pharmaceuticals and the supply of health care services. It is one of the top five pharmaceutical companies in the world with health care sales of $15 billion and leading positions in sales of gastrointestinal, oncology, anesthesia including pain management, cardiovascular, central nervous system (CNS), and respiratory products. In the United States, AstraZeneca is a $7.4 billion health care business with approximately 9,500 employees. 444 ___________________ ***** Image # 5 File: 3C722FCE.tif ***** ___________________ SEROQUEL Effective and Well-Tolerated NOTE: For full prescribing information for SEROQUEL® Tablets, please visit the U. S. SEROQUEL website at or call Jim Minnick at 302/886-5135. 1 Hellewell MB, Westhead E. Safety During Long-term Exposure to Quetiapine. Poster presented at the American College of Nurse Practitioners 2000 Annual Meeting in San Juan, Puerto Rico. Page 4 Case 6:06-md-01769-ACC-DAB Document 417-7 Filed 08/30/2007 Page 5 of 5 DOXS_OCR.TXT 2 Kasper, S. Maintenance of Long-term Efficacy and Safety of Quetiapine in the Treatment of Schizophrenia. Poster presented at the American College of Nurse Practitioners 2000 Annual Meeting in San Juan, Puerto Rico. s Rak IW. Maintenance of Long-Term Efficacy With Quetiapine. Poster presented at the American College of Nurse Practitioners 2000 Annual Meeting in San Juan, Puerto Rico. 4 Juncos J., Kidder SW., Trosch, MD. A Guide to Better Monitoring. 5 Source TM Prescription Audit (SPA) 32-Month Period Ending June 2000, Scott Levin, a division of PMSI Scott-Levin, Inc. 6 NDC Health Information Services, SEROQUEL Patient Tracking Analysis. 31-Month Period Ending June 2000. Page 5

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