text: 1anitOO ~tatfS ~£natc t(.'JMtJln EI£ 0'" nN-"'Nct W1J.iWNGTOr...,. DC 20!l.ll).ot.:tOO August 12, 2009 Via Electronic Transmission The Honorable Herb Kohl Chairman United States Senate Special Committee on Aging Washington, DC 20510 Dear Chairman Kohl: The United States Senate Committee on Finance (Finance) has jurisdiction over the Medicare and Medicaid programs and, accordingly, a responsibility to the more than 100 million Americans who receive coverage under these programs. As Chairman and Ranking Member of the Finance Committee we have a duty to protect the health ofa11 Americans and safeguard taxpayer dollars authorized and appropriated by Congress for health programs. On August 5, 2009, you sent us a letter requesting documents related to continuing medical education (CME) and other issues regarding the relationship between industry and academia. We are attaching several documents to this letter that are responsive to this request with the understanding that these documents are now public. Thank you for your attention to this matter and dedication to transparency. If you have any questions, please do not hesitate to contact Christopher Law with Senator Baucus or Paul Thacker with Senator Grassley at (202) 224-4515. Sincerely, Max Baucus Chairman Charles E. Grassley Ranking Member Lexapro Documents CME Payments Payments to Professional Societies Payments for Studies Payments to Physicians Lexapro FY04 Marketing Plan Confidential FCA0017642 ACe FOREST LABORATORIES. INC. . . pro escitalopram oxalate FISCAL YEAR 2004 MARKETING PLAN PRESENTED BY: John Amexes Liat Ashkenazi Steve Closter Nefertiti Greene Laura Lavell John MacPhee Nikhil Nayak Frank Preziosi Renata R.eis Dawn Walters Matt Warburton Kelvin Wong Claire Zinnes Developed April 1. 2003 Confidential FCA0017643 EXECUTIVE SUMMARY Fisc:al Y cor 2004 (FY04) .till matks the launch phsse fOJ: LexapIO"', escita1op= oxalale. This document outlines Forest Laboratories, Inc.'s aw:keting plan for the continued launch ofLexapro in the U.S. market. TIns plan covetS all aspeClS of the launch period including a markel analysis, objec1ives. SWOT analysis, critical issues, a detai1ed description of FY04 strategies and tactics, including the launch oE the generalized anxiety disorder (GAD) indication in Q4 FY04. LEXAPRO nEVELOPMENT On August 12, 2002 LexapIO received approval from the FDA fOr the treatment of major depressive disoIdel. After stoclcing the tIlde and training the sales represenlatives. sales foree promotion of Ltxapro commenced on September 5, 2002. As of .April 1, 2003, Lexapw hss 10.4% of the new prescription market .hare and 7.7% of the total prescription nfarkel share. This market share demonstrates the initial succas of Lexapro's launch. Lexapro is ~t1y tracking as the sixth besl launch in phsrmtctutical history w;th a high likelihood of surpassing Viagra" (sildena61 CItrate)' and Clarine," (deslotllldine)2. which began dechning after initial spikes in the firsl 4 months of launch. Although Le""l'w hss encountered initial success, the aggressive launch phose oontinues as curren' and upcoming SRI competiro'" are increasing their efforts. Further motivation for the competitive response can be gleaned from the fact that Lexaprots gains in new prescription market share have come ae the expense of all competitors, nOt just Celexa. As of April I, 2003, 50% of Lesapro's growth hss come from Cel... and 50% from the other competitors. primarily the PaxiJ'" (paroxetine hydrochloride) franclus.. Since the launch of Lexapro, every SSRI hss lost market share and the growth for Effexor" XR (venlafuine hydrochloride)' hss slowed down. However, ainee January of 2003, the competito'" are beginning 10 rebound as EfEeso, XR has slowly continued its growth, Zoloft" (scrtraline hydrochloride)' has steadied its declines and even the fluosetine franchise has stabilized. Furtheenore, another Eli UJly oompound, CymbaltaN (duJoxetine hydrochloride)', an SNRI used in the treltmenl of MOD with a potential focus On pain and other somatic symptoms is due to launch in FY04. For all of these reasons, in FY04, Lesapro will need 10 increase its competitive efforts in order to combat the competitive responses and new competitor entries. I Viqra if; • regWcred ttademuk of Pfizer Inc. S hxi' it a n:gUttrcd tnlderruk nf GIu,oSmn:lll<lu1e' 10 tole. fI ua registered :.:radt;MUlio ,.,' :~fiut: JIIC • CyrrbailtJ, IS. uademl.l:k o{Eli .tslly l~d Colftpan~. ;XECUTIVE SUMMARY Confidential , ,~f.\. . COMMUNICATION OBJECTIVES • Communicate the positioning ~f Lextpro scross oll promotional venues: "Lenpro, the effective first-line SSRI for all sdult depressed patients, single isomer of Celexa, is wbich offers superior efficaey and tolerability over all SRI•.• an. • Incorporate the seven key .elling poinlS in every progrsm PIlOMOTIONAL OIlJECTIVES • • • Achieve first place in detail dollar share of voice in the SRI market Maintain SRI category leacler!hip in number of ioumslad inserts Maintain SRI category leadership in total number of medical edueanon events (Including CME sympocia, speaker Pr0pm8, tekconferenc.., and peer scIling program.) • Generate significant Leupro specific news coverage to both consumers professionals BDd hea1tbcare • Have Lexapro included in olldepression/anxiety related round up article./storie. that diacuu treatment MANAGED CARE OB}ECTIVES • • Gain =tricted formulary acCess for Lexapro Improve the formulary position ofLexapro in the SSRI class by: 1) Continue to establish, (avoftble tiered competitors c~pay pOSition for Lex.pro versus 2) Pre launch GAD data initiativ.. to improve formulary statu. 3) Improve existing Lenpro (onnuiat)' statui to mote favorable position 4) Non formulary to formulary S) 3'" to 2"" tier 6) 2"" tier to 1 of 2 prefersed • Exceed individual MeO m:u:ket shue and net .ales goals as defined in account manager business plans thro\JSh enhanced, ta.tg<:ted pull-through effons. T.uget pull-through efforu and resources 1) 60% for top tier accounts Sl Ot • bclow national market share 2) 40% to ~e·.polential and reinforce positive relationships in high performing top tier MeOs EXECUTIVE SUMMARY Confidential FCA0017651 • • Incr.... Lexapro promotioml noise level through improv.d communication to exa:ma1 cu.tomers regarding the valu. of Leupro in lIWlIgod care E.llblish ba••Iin. managed cue training for field force beginning with Pha.e I training. 1) Develop ongoing coaching tools for District Manager'. to implement on a oontinou. basis with 6eId teptclentatives • lntegnt. communication between Managed Heolthcar. Opentions, LexaptO Brand Team, and Field Sal.. Fore. CRITICAL ISSUES SHARE OF VOICE LIlADERSlnF Th. antideptes.ant market is the most h..viIy detailed category in the pharmaeeutical industry. It i. ther.fore imperative that LeuptO maintain SOV leader.hip in FY04 by: • Continue to competitively a.1I: Lev.rage sttOng comparativ. and clinical data ineluding hcadto-head venlafaxine and sertt1lin. data m MOD and h..d-to-head paroxetin. data in GAD. Maintain/inc"'ase field IUppott: Continue leader.hip in inac2•• samples • Lwich & Learns and d.ttiling. and • Inctease Med Ed efforto: Mote sponsOtships of CME, ineteosed level of .pcaket ptogtUl1S. mointain level of tcleconfctenccs and peet .elling Expanlion condngencieo: Prepare for intem>l chsruption. in the field due to the ptOmotion of other products and potentiallaunch.s • "Our PERFORM" IN AlL ~ SEGMENTS In order to achiev. market dominance, Lexapro C2n/lot lag in any market LcxaptO will out p.rform in the following market .egmen..: • • Dilorder (anxiety): Maximiz. pre-launch and launch efforts in GAD .egmen... In F'i04, Provider (poycb): Accelerate psychiatry penettlluon and make LexaptO the .tandard of care. Be proactive with selectivity message to addtcS. competitors head on Padent Segment (age): GenCllte more geriatrIC and pedistric data and pur.ue indication... necessary 3" Party Aceea.: Secure ace... (formularies and VA.) and pull thteugh (LTC) • • EXECUTIVE SUMMARY Confidential FCA0017652 INNOCULATION In an effort to be prepared for the ""Pected and unOl<pOcted .ttacks &om competitors and competitive entry, it i. nece..ary to predict and provide respon.es for .uch .itu.tions. A number of issues effecting Lexspro h.ve been identified They are: • SSRI. venus non-Ieleclive MUptake Inhlblton (SNRlI, others) There h.. been a trend in the SRI category of promoting reuptoke inhibition at more than one receptor site IS a benefit to patients in terms of efficacy. Products.uch as Maar XR .nd duloxetine have reuptake inhibition at multiple .ites (5AT and NE). Even SSRI. such as Zoloft and Paxil have promoted their more modest effects It the Popomine and NE receptor sites re.pectively. The promotional m....ge &om these liIldillgs ha. focused on enhanced effiacy venus products th.t have their primary effects mediated by reuptake blockade It only the .erotonin receptor site. Since Lexlpro is the most .e1ective SSRI, it could be the subject of criticism relating to this issue. • Pending Launch of Cymbalta Lilly i. poi.ed to I.ooch Cymbalta (duloxenne Ha) an SNRI that will be po.itioned ... dual .ction agent frem its .wang do.e and .. the "new .tandsrd of depres.ion thcrspy." Lilly is puamg focus on the .omstie symptoms of psln in their depression trials and m.y pursue this Indiation in the future. Currendy, Lilly h.s .ome manuf.eturing issues .t its Indianapolis plsnt th.t h.. delayed the launch. HO"'CYer, when .pproved, Cymbal,. could be • m.jor threst .. Lilly h.. tremendous resource potential. • Generic Paroxetine G1sxoSltlIthKline is currendy In Iitigstion with Apotex reguding the p.tent of Paxil and the .v&ilability of. generic paroxetine. There is a streng likelihood thot this will not occur until late 2004 or 2005; however, Lexapro must be prepared especially in m&naged care ar.na. with the intrcducaon of. second generic to the d .... • European Newa Although a completely different reptary environment e&.ists in Europe, news .nd events there m.y have an .dve..e affect on the U.S. market. Lsbeling langusgc and potential non-approvsJ in certain counttie. may have II negative effect on Lexapm in the U.S. market. SUMMARY/CONCLUSION The FY04 l&cticaJ plsn contsin. msny field and non-field b.. ed progrsms to continue the successful launch of Lexapro. AU tactics are designed to mcr.... promotional shue of voice and help Lexapro outperform In all market segments of indications (snxicty), providers (psychiatrists), third-pUty p.yen (msnaged care) and age group. (pediatric and geriatric development progruns). The 1sunch of the GAD indication will also ..,ill Lcxapro achieve multet dominance 11\ yesrs to come. With more data and indiation. on the _y, Lexapro promotion will Mmsln sll:ong throughout the immedi&te future. . EXECUTIVE SUMMARY Confidential FCA0017653 Madeet Sale." A. TOTAL SALES Zoloft dominated the SRI market in teans of dol1at sales in 2002, while Prouc sales were more than cut in half. Paxll salcs were above $2 billion, with Celen and Effexor close behind at $1.587 billion and 11.524 billion respectively. Being a late entrant into the market in 2002, Lex.pro's sales were just shy of $1 million. While the overall lIl2%ket remained constant. all of the SRI., with the exception of Prozae. Effexor. Remeroll, Luvox. Fluvoxatinc, and Serzone cmibited double-digit sales growth in 2002. Table 3.0: SRI Dollar Sales Product SRI Market Zoloft Paxil PaxilCR CeJexa EfJexorXR F1uoxetine Prozac RemelOD SenoDe PaxilCR Effexor RemeroD Soltab prozac Weeklv Sarafem LexanlO FIuvoxaJD.ine Luvox 2001 Total Salest lbillions\ 2002 Total Salest lbiWous\ Change (%) Share (%) 110.695 $2.271 $2.154 $0 $1.156 $1.106 $0.631 $2.074 $0.399 $0.385 -0$0.137 $0.045 11Q.690 $2.545 $2.341 $0.205 $1.587 $1.524 $0.749 50.428 $0.388 $0.272 $0.205 $0.135 $0.127 $0.105 50.103 50.099 $0.062 $0.022 ,.\.;~.': 0.0 12.1 8.7 N/A 37.2 37.7 18.7 -(79.4) (2.9 (29.4) N/A (1.6) 182.8 72.3 10.3 100 23.8 21.9 1.9 14.8 14.3 7.0 4.0 3.6 2.5 1.9 1.3 1.2 1.0 1.0 0.9 0.6 0.2 .. We1lbutrin+SR . ' .. ::. , ., . $0.061 $0,093 -050.080 $0.103 N/A 1'22.3) (78.4) ' '. . 51.201 ... ' ,", .', ... .. ;'~i::.:"': . : ...~:..'t: . , .. $1.541 28.4 +llCDeDC T Iodudes chain .tore phumaaes. uxiependent phannaae:s. food stores. LTC fadliacs. mlil otdu house" fedeta1 fadll.... llOft-federai hospitals, clinics. "'d cliuet purch.sing .taff HMO., home heolth ..... misc. chaDneI. ... "ReWland Provider Peraptetiva C2002 IMS Heallh COMPETITIVE ENVIR.ONMENT. Confidential FCA00176B1 B. TOTAL PRESCRIPTIONS Although the ovenll trends are the same Paxil and Zoloft continue to fare better when it cOmes to total prescriptions as a result of continuing re6lls. For the year 2002, Zoloft was the !nUket leader (22.3%), followed by Paxil (20.06%). Celexa demonsti:ated the second to largest growth amongst aU SRIs (33.29%) and secured 15.81% ohotal prescriptions. While Effexor XR continues to grow, it increased growth at a slower rate of 31% [fable 3.2). Leupro's total share of prescriptions for 2002 was .9% and growing. Table 3.2: SRI Total Prescriptions Product Market Zoloft Paxil Ce1exa F1uoxerlne EffexorXR Remeron Sen:one Prozac Paxil CR Remeron Soltab Effexor Prozac Wccldv Lexapro Sarafcm F1uvoxamiDc Luvox z00lTRx (lbo""mda) z002TRx (.houunda) Change ("10)- Share (%) 121,910 27,974 26,058 16612 7,287 11,321 5,330 4,671 16,875 -0634 1,836 705 -01,135 916 556 140,072 31,229 28,103 22 142 21.227 14885 4,877 3,065 2,908 2,386 2,298 1,778 1,312 1,256 1,232 1,212 162 14.90 11.64 7.85 33.29 +++ 31.48 (850) (34.401 (82.771 N/A ......+ (3.171 86.07 N/A 8.53 32.35 00;901 100 22.30 20.06 15.81 15.15 10.63 3.48 2.19 2.08 1.70 1.64 1.27 .094 0.90 0.88 0.87 0.12 1. REFIlLRi\TES Increases in the nwnber of new prescriptions, average prescription sizes, and refill rates have fueled growth of the SRI prescription mukc:L Each product in the !nUket posted eq.w or higher refill rates and prescription sizes in 2002 than 2001 (Figure 3.7). The average ratio of TRx to NRx was 2.26. . COMPETITIVE ENVlkONMENT • Confidential FCA0017686 E. USES BY AGE Depression is an iIltIess that tffeers all ages and SRIs are used for patients nnging from the very young to the very old. Eight percent of total SRI usage is for patients under the age of 20 (this age group represents 29% of the U.S. population.) SRI usage is most prevalent in the adult population. Patients between the ages of 20-39 and 40-59 represent the majority of the market at 30% and 41% of usage, respeetively. Usage of SRIs in older patients (over 60 years of age) mirrors the general population at 16% [Figllre 3.1 OJ. Figure 3.10: CY 2002 Usage by Age: SRIs va. Lexapro SRI Matlc<' 6%4% 80/. LexaptO 3'10 4'10 90/0 ,m~ 41% C<ZO DI5O~14 30% 36% tJ .20-39 .>75 39% .20-39 • >7S C_ 0<20 C4lI-59 Eln/• a,,,,? ma/_ Produet market shares vary by age group, mth Lexapro under perfonning in the under 20 age segment (9%). This is expected since it is a relatively new product mth which physicians are not as comfortable mth the SSRIs in treating children. Despite their product profile, which makes them an ideal product for the elderly, Celexa and Lexapro do not significantly over perform in this segment. Zoloft and Paxil/CR both have a higher percentage of reported uses in the elderly population, both in patients 60-74 and >75.[I'able 3.5]. COMPETITIVE ENVIRONMENT. Confidential FCA0017692 Table 3.5 CY 2002 SRI Usage by Age (Colunms Total to 100%) Product Market LexaDIO ADAp W,) 100.0 3.1 17.4 13.8 1.2 21.0 B.8 4.5 0.8 2.4 20.0 <20 ("I,) Ce1elca Effexor+XR Luvox PaxII+CR ~~(Io""'+ Rell1eron Une Sararem Serzone Zoloft 8.5 3.4 16.0 11.3 2.7 22.3 14.3 3.0 0.3 1.0 25.6 20-39 1"10) 30.1 4.0 17.9 13.8 1.1 22.1 15.8 2.9 1.4 1.8 19.1 40-59 ("10) 40.2 2.8 16.4 16.2 1.2 18.8 17.7 4.8 0.6 3.4 18.0 60-74 (%) 11.2 2.5 17.7 9.4 1.2 22.7 15.0 6.2 0.1 2.4 22.9 >75 1"/,) 6.4 1.6 21.5 9.2 .07 24.4 7.2 10.5 0.0 0.8 24.1 Uaapec:lfied i%) 3.6 3.2 18.0 13.8 0.4 20.9 16.5 3.1 1.5 2.9 19.7 Paxil maintained the positions it achieved in 2001 showing movement only in the 20-39 age group (+3%) and the 40-59 (-2%) age groups. Zoloft showed significant movement only in the 40-59 group (+1%) and maintained (moving only ± 1%) in the other age groups. Lexapro's data cannot be complIed to 2001, but it MS the majority of ia patient population rooted in the 20-39 and 40-59 age group, while Celexa's swe remained constant across all age groups (± 2%). Effexor XR was relatively constant in all age groups showing significant movement in the 60-74 age group (.3%). F. PRESCRIPTIONS BY SPECIALTY Ptinlary care physician. (pCP.) write 30.3% of all SRI NRx and psychiatrists account for another 31.1%. Together, these two specialties prescribe almost eight out of ten SRI NRx with PCPs steadily becoming a large portion. OBGs (3.6%) and neurologists (1.5%) fall well behind in terms of prescribing potential. Celexa till has goodpenettation with the specialist although the gap is nattowing and although Lcxapro's numbers were not huge fox the end of 2002 they are steadily growing [Table 3.6]. Paxil/CR, Zoloft, and Effexox/XR also all ovex perfOlms with psychiatristshaving. greater shOIe than Celexa and Lexapro - and slighdy under petfonns with PCPs and OBGs. Prozac and generic tluoxetine both Mve a higher than average shuc in the OBG office especially since the launch of Sarafem and its PMDD indication. . It should be noted that NRx mOIket shOIe for Celexa (Table 3.6a) indicates that Celexa has an even distribution among all specialties and hovers lIound 14% in all categories. COMPETITIVE ENVlaONMENT • .. Confidential . FCA0017693 ,) Lexap,.. Oral S.INIi.n Lexapro on! liquid wu launched in late 2002. The Lexspro on! liquid is peppeanilltflavored and is concentrated as a 5 mg/5mL solution. It is currendy packaged in 240 mL (8 oz) bottles which deliver approximately twenty-four lOmg doses per bottle. Lexapro oral liquid has not been aggressively promoted to physicians and has never been sampled. Table 3.17: SSW Oral Liquid New Prescriptions Product Market Fluoxetine Paxil Celexa Zoloft Prozsc: 2001NRx ltbousanda\ 166 16 53 19 12 66 2002NRx l!housanda) 172 56 46 31 20 19 Change 1%\- Share (O/,,\ 3.6 +++ 113.2\ 63.2 66.7 (71.2) 100.0 32.6 26.7 18.0 11.6 11.0 VI. SRI MARKET PROMOTION A. DETAILING "."..' The SRI market is a highly competitive one, with 4.5 million physician contacts recorded in calendar year 2002. 'Ibis was achieved through several of the largest sales folCcs in the pharmaceutical industry [Figure 3.18). Both Paxil and Prozac Weekly increased their sales falCes, 18% and 15%, respectively. Romeron d,......."dtheir sales force by 53%. • Integrated Promotional Services Audit C2002 JMS Hca1ch. " National joumll1 Audit C2(lQ2 IMS Health. :It Promotional Mtetitlg and Event Audit C2002 Scott~Levin NPA PI.. C2002 IMS Health, A~. ~ u SptulJ 2002 LTC Promotional Audit C2OO2 Stott-l..tw't As,OCUlC$. COMPETITIVE ENVIRONMENT. FCAD017700 Figure 3.18: SRI Sales Force Size • 2000 t i 1000 o IMS audits reported r.exapro to have 374,000 detailing COQuets in 2002 while Celexa had 611,000. Zoloft was the market leader in this categoty with a little over 1 million detailing conuets. Paxi1/CR and Effexor Xl\. aad were s«ond and thitd behind Zoloft with 983,000 and 653,000 detailing COQUets, respectively. Figure 3.19: CY 2002 SRI Detailing Dollars 10.)5'1. .t.ex.pro DCeIex• • J!lI'exor+XR .PaxiI+CR D Prozae+Weekly .1lem...". Line E1Sanfem WO'I, .Sc:aOllC E1Zoloft Detailing expenditures have increased steadily and signifieandy for Paxil. Celexa and Effexor Xl\. while Serzone, Sarafern, Prozae and Prozae Weekly, and Zoloft have all reduced their spending during 2002. [Figure 3.20]. COMPETITIVE ENVIRONMENT. Confidential FCA0017701 Figute 3.20: SRI DetailiJlg DolWs Over Time i '10 .j;!::~~~~~:r:P.;'" .!!$8~!,:;a.;~~~~~~ l! $14 '12~ '~ff~~i~~~ - Dexor Line -PulI+CR -ProzaC+WeeIdy .5 $6 $4 $2 ......... Une $0 ~~:=.;..::~~~~~ -Saralcm J I 1J ! J ! 1 I I -Sctzooe Zolofi 1. DETAll.ING BY SPECIALTY All of the SRIs spend more dw.iling tiroe ovenllin PCP offices, given the large size of this audience. The bulk of SRI detailing time is spent on PCPS (50.9%) and PSYCHs (34.1%), with OBGs (6.9%) and Neurologists (1.8%) faDing far behind in detailing emphasis [fable 3.8]. This distribution of promotional effort is proportional to the contribution each specialty makes to toeal SRI volume. Table 3.8: CY 2002 SRI Detailing Dollars by Specialty (Columns Toral to 100%) Product Lexaftro Celcxa Effexor+XR Paxil+CR All Specialtiel .(%, PCP PSY 1%' 10.6 17.0 15.5 22.0 6.6 9.8 0.1 3.8 14.3 OBG (%) N (%) AII0the.. ("I.) (%' 10.5 16.9 16.4 22.3 10.1 3.7 1.1 0.4 18.6 PlOzac+WeddV RemelOnUne Sarafem Serzone Zoloft 10.4 16.6 15.5 21.5 8.5 5.4 1.8 1.6 18.9 8.3 12.6 11.1 9.9 152 10.2 15.7 9.4 25.3 5.1 1.2 0.0 1.9 32.0 13.9 22.1 8.6 2.7 0.8 0.3 25.6 11.5 6.8 0.1 16.5 0.0 33.2 COMPHTfTJVE ENVIRONMENT. Confidential FCA0017702 Table 3.8 <a>: CY 2002 SRI Detailing Dollars by Specialty (Rows total 100%> Product SRIMarla:t LexalHO eetexa PCP ("I.) PSY (%) OBG (%) N ('!o) All Othen (%) Efl'exot+Xll Paxll+CR Prozac+Weeldy Il<:meron UDe Sarafem SetzODe Zoloft 50.9 51.5 52.0 54.0 52.8 60.3 34.5 31.5 13.0 SO.3 34.1 35.0 35.1 34.2 35.0 26.7 61.8 1.9 83.6 25.9 6.9 5.6 5.3 5.0 3.7 5.6 0.1 63.7 0.0 12.2 1.8 1.7 1.6 1.1 2.1 1.1 0.4 0.0 2.1 3.0 6.4 6.2 6.0 5.7 6.5 6.5 3.1 2.9 1.3 8.6 In many ways, SRI pe:formaoce with each specialty mirrors the promotional effort devoted to that segment. In the OBG offices, Zoloft aod Prozzc have a grezte: shue of voice and a con:espondingly highe: market shue. Effexor XR appears to have broadened its promotion to hit PCPs more. Its shue of voice with PCPs is now significaotly higher thzo its share of voice with psychiatrists. Lexapro aod CcIexa detailing by specialty is relatively similar with slightly higher shue of voice with psychiatrists aod PCPs and slightly lowe: with OBGs. Meaowbile Pa.xil has its highest share of voice with neurologists and it's lowest with OBGs. Figure 3.21: SRI Detailing Dollats by Speclalty (Psych) -Lex.pro --Celexa --Eft"exor+XR Poxil+CR Prozac+Wcckly -Zoloft COMPETITIVE ENV] RONMENT • Confidential FCA0017703 B. SAMPLING Total extended unit samples were 408.1 million as of MAT August, 2002 which is down 1.9% from 2001. [Table 3.9]. The sampling trend is a bit different than it was in 2001 when the majority of pnxlucts inc:ressed their sampling. In fact, In 2002, PaxiJ and PaxiJ CR, Prozae and Prozae Weekly, CeJexa, the ReII1eron line, Serzone and Luvox all deaeased their sampling efforts. The share of CeJexa samples in 2002 was 12.7%, up only slightly from 2001, and Lexapm was at 7.9% at the end of 2002. A total of 51.7 miI1ion CeJexa tsblcts were distributed in 2002 eornpared to 58.9 million in 2001 (down 12%) and a total of 34 million Lexapm tsblets were distributed in 2002. Ce1exa and Lexapto's sampling efforts were suxpassed by Paxil/CR (88.1 million tablets) and Zoloft (118.5 million tablets) wich showed the mOst growth in 2002 (up 190/0). Celexa and Lexapo were also suxpassed by Effexor/XR (72.8 miI1ion tablets) which was up 10% from 2001.(Note that the tablet/capsule figures are audited and therefore may be understated by as much as 50%. However, audits are useful in determining relative levels of sampling.) Table3.9: CY 2002 SRI Sampling Product SRI Market Zoloft Paxil+CR Etmoor+XR Celcxa Lexa1>lO Prozac+Weekk> Remcron Line Tabs/Cap. Sampled 2001 (millions) 416.2 95.9 94.S 65.S 58.9 .().. Saraiem Serzon. Luvox 422 15.5 14.0 27.6 22 Tab./Caps Sampled 2002 (million.) 408.1 118.5 88.1 72.8 51.7 32.4 14.1 13.3 9.0 8.1 0.1 Change ('!o) (2.0) 23.5 (6.8) 11.1 Share ('!o) 100.0 29.0 21.6 17.8 12.7 7.9 3.5 3.3 2.2 2.0 0.0 (122) NC 66.5 14.1 35. r70.8 ~5.4 COMPETITIVE ENVIRONMENT. Confidential FCA0017705 Table 3.10: CY 2002 SRI Joumal Spend Product SRIMuket Ce1eu 1.elwlro 2OO1]oumaJ Speud (milllott.) $28.59 $14.92 $00$4.84 $2.01 $2.59 S2.046 $1.75 $0.02 Bfl"exor+XR PcciJ+CR Zoloft RemcronUne PlOzac+Weeldv Saral"em 2002 ]oumaJ Spend CmiIIiono)$3925 $11.87 $10.45 $10.25 $2.63 $2.39 $t.61 $0.05 $0.00 Chaar (%f Sbare t'%) 100.00 30.2 26.6 26.1 6.7 6.1 4.1 0.1 0.0 37.3 (20.51 NIl.. llU 31.3 n. (34.5 m.l (100.0) Through the twelve months ending December 2002, Celexa was the SRI market leader in joumal advertising spend, with a total of $15.237 million [T.ble 3.10]. This placed CeJexa third in the entire plw:ma<:eutic:al market in tenns of jouma! advettising. In the SRI Market, Lexapro was second in joumal advettising with $10.45 million [Table 3.10]. Figure 3.29: SRI Journal S~rui 15 § E .5 • c: S4 S3 -_n Paxil+CJt. -PMuc+Wcekly Remeroa LiDe -Zoloft -~ -Cd_ S2 $1 SO 'I ~<f> 'I ~<fo / "! ;-" "!.I' "!.I' The dollars spent by Celexa remained relatively constant for most of 2002. with a dip in the latter portion of the year [Figure 3.29], and as well, the number of inserts decreased (11 %) [Table 3.11]. Lexapro was third amongst SRIs in jouma! ad inserts with 303 for 2002 [Table 3.11] and their dollars spent was the bighest at year end 2002 [Figure 3.29]. COMPETITIVE ENVIRONMENT. Confidential FCA0017708 Table 3.11: SRI Jouma! Inserts Product 2001]ouma' Imerca 1,539 310 676 .(). 2002]oumal Cbange ShIUe ("It) SRI Market Etrtxot+XR Celexa Lexal>ro Paxil+CR Zoloft Remaon Line Prozac+Weeldy 133 175 135 108 IJllerca 1930 602 599 303 160 157 106 3 ("!of 25.4 94.2 (11.4) NA 20.3 10.3'1 '21.5 97.2 100.0 21.2 31.0 15.7 8.3 8.1 5.5 0.2 Figure 3.30: SRI Journal Inserts 8OT':'lC'7.l~=':'I""I::;;;;r.,===:::r:-:l 70 ,,*,~::i';il:i 60 SO '1"7'l::<:;;ll! 40 30 2ll 10 o ~"""~~'T""~~;;;;:"::::':':';'+'-"" \ ' .... ¥ !f' !f' '!fI '" sf' dO .,'" .~... ~... (}- "" ..f \¥ <of \~ .., \# \ ' <of ..f D. PHYSICIAN MEETINGS AND EVENTS Physician meetings ""'d events ue a auci2l element of the muketing mix for any SRI. During 2002, Cdexa dominated the uw:ket with 9,069 even" that reached approximately 60,000 physician•. Lexapro was a clo.e .econd with 7,700 events in 2002 reaching approximately 47,000 physicians[fable 3.12] [Figure 3,31]. The audited cost for these events was $39.5 rni1Iion for CelOl<a which was a 9% decrease from 2001 whereas Lexapro spent $31.4 rni1Iion and was third in the category [fable 3.13], While Effexor increased their spend significandy in this tategory (32%), making them second amongst SRIs. While Pmzac and Prozac Weekly significandy reduced their spend (49%), the number of events diminished at almost the same rate (-35%). In terms of physician meetings and events in 2002, Celexa was the leader followed by Lexapro, EffOl<or /XR and ZoIoft. COMPETITIVE ENVIRONMENT. Confidential FCA0017709 Table 3.12: SRI .Physician MeetiPgs and Events Product SRIMarl<ct Ce1cxa LexaDro Efrexor+XR 2001 Ewn18 2002 Ewn18 Cb{'-;r 24.2 13.4 +++ Shale ('Yo) Zoloft PaxiI+CR Prozac+Weekly RanelOn+Soltab Serzone Saralem DulolCetiDe Cymbalta Luvox 26.695 7996 113 4484 2,699 4;1.37 3602 1366 837 1,349 12 .0-0- 33164 9069 7.700 6,391 3,411 2,895 2,321 618 270 224 136 124 S 42.5 26.4 131.1 (35.6 54.8 6P 83.4 +++ 100.00 27.3 23.2 19.3 10.3 8.7 7.0 1.9 0.8 0.7 0.4 0.4 NC NC 0.0 COMPBTITIVE ENVIRONMENT. Confidential FCA0017710 CRITICAL ISSUES I. SHARE OF VOICE LEADERSHIP Th. aotid.p".ssaot muk.t is the most heavily d.taiIed cat.go;y in the phannac.utical industty. It is ther.fore imperative that Lexapro maintain SOV lead.rship in FYO. by: • Continue to compctidvely sell: Leverage suong comparative and sU'itch clinical data including venlafaain. and s.rtralin. (comparativ. data) and fluoxctlnc (switch data) Maintain/increa•• field .upport: Continu. I.adcrship in Lunch & Learns and detailing, and lOcr.... sampl•• Increas. Med Ed eft'llrts: MIl« spllnsorships of CME, incr.as.d level of speak.r programs, maintain level of tc1econfcrcnc;es and peer selling Expansilln contingencies: Prepare for internal dlsrupullns in the field due to the promotion of oth.r products and potcuuallaunches • • • II. "OUT PERFROM" IN ALL MARKET SEGMENTS In order to achieve market dominanc., L.xapro cannot lag 10 any mark.t segm.nts. In FY04, Lexapro will out perfonn ind.x in the following mark.t s.gm.nts: • • Disllrd.r (anxiety): M~. pre-launch and launch .fforts in GAD Ptovider (psych): Accelerat. psychiatty pen.tanon and make r..e.upro the standard of car.. proacov. withselcctivity message to address compctitors head on B. • Pane,nt Segment (age): Generate more geriatric and ptdlawc data and pursue mdicatlons as necessary • 3"' Party Ace.... Secur. access (formnlari.s and VAs) and pull through (LTC) III. INNOCULATION In an effort to be prepared for the e):pected and unexpected Ittacks from competitors and compcullve entry, it is necessary [0 predict and provide responses for such siNaa.ons. A number of 18$UeS effecting Lexapro have b.en ld.nn!ied. They are: CRITICAL ISSUES Confidential FCA0017722 3) signJficandy improves deptelsion for many patients beginning at week 1 or 2 (effect may take 4 to 6weela) 4) effectively treats anxiety symptoms associared with depression 5) at 10 mg, ovcral1 incidence of side effects and drop out ntes due to AEs no <liff=rthan placebo 6) favorable drug interaction profile 7) sunple 10 mg sruting dose for aU patients IV. PROMOTIONAL OBJECTIVES • Achieve first or second place in detail dollar share of voice in the SRI market • • Mointsin SRI catcgozy leadership in number of journal ad inserts Maintain SRI categOry leadership in total number of mc<li<:al educanon events (inclu<ling CME symposia, speaker prognms, teleconference., and peer selling programs) Generate significant Ltnpro specific news coverage professionals to • both consumers and healthcuc • Have Lexapro included in aU depression/lnxiety related round up articles/stories that discuss treatment V. MANAGED CARE OBJECTIVES 1) Gain unrestricted formulary acce.. for Lexapro 2) Improve the formulary position of Lexapro in the SSRI cia.. br. • Continue to establish favorable tiered co-pay position for Lex.pro versus competitors • • • • • Pre launch GAD data initiative. to improve formulary Status Improve existing Lexapro formulary status to more favonble position Non formulary to formulary 3'" to 2"" tier 2"" tier to 1 of 2 preferred OBJECTIVES Confidential FCA0017726 MARKETING TACTICS I. FIELD SAMPLES Samples will be packaged in two forms: field samples and patient starter kits. A total of 300 MM 10 mg sample table.. will be produced in FY04. Representatives will not receive samples of the Lexapro 20 mg tablet. A. FIELD SAMPLES Lexapro field samples will be provided in individual boxes holding one bhster cord of seven 10 mg tablets (1x7) tn a gnvity-feed dispenser holding eight of the 1 x 7 boxes. 60% of aUsamplos or 180 MM tablets produced will be distributed as field s2mples tn FY04. Ti",i1lg: Qua.Il!y: Ql-Q4 180 MM tablets, 25.7 MM .U<ters (lx7 boxes) B. PATIENT STARTER KITS Patient Statter Kits (PSKs) which contaln two weeks of Lexapro samples along with an educational branded Lexapro brochure will be sampled to phy>icians during FY04. The CllIonale for providing PSKs is twofold. Fun, many phy>iaans and Managed Care Organizations (MeOs) have been asking for patient educal1on. which is incorporated tn a sample. In fac~ many physicians have .tated that they prescribe Paxl1, Zoloft, or Effexor XR because of the PSKs available for those brands. Because phy>icians sre requesting PSKs, their availability will help represenutives gam selling time and incre2se rapport with key physicia.ns. Second, providing patient education to patients could meruse the hkelihood that a patient will £ill a prescription for Lexapro and become It loyal user. A patient who understands what to expect from Lexapro treatment will be more likely to stay on LeXSPfO over the long [ean, brochure in the PSK will be updated to reflect GAD information when appropri2te The educational N01E: Esch PSK will conuin fourteen 10 mg ..blets of LeX2pro along with an educational brochure, Each PSK 15 in a tri·fold design with six PSKs comprising a sample unit. 40'10 of samples will be 10 the form of PSKs equaling over 120 MM ..blets or 1.4 MM sample unlts. QI-Q4 120 MM tablets, 8,6 MM ltarters (14 tablets) Total EJlunottJ Corl; $15,741,464 Confidential FCA0017738 Bylined Article. Bylined articles will allow u. to fold Lexapzo messages into article. ()11 depze..ion, anxiety and comorbidity developed by (or gh""twri'ten for) thought leaders. We will idenl1fy a Lexapro thoughtleader to place 2-3 bylined article. In trade journals, con.umer publication. and on the Inteme,. Estimated costs include article developmen~ revision. and hononria for the authors. Examples of topic. include co-morbidlty of depression and anxiety and selectivity. Timing: Eshm.ud Coil: Ql-Q4 $100,000 PllidMedia Outreach In addition to the ttadltional edi'orial media outreach, there are also opportumUe. III which we can inaea.e control over the final product by paying for the placement. These opportunities, which will supplement our core activities, may include Lexapro messtge placement in radio program' (e.g., American Health Radlo) or other "advertorial" venue•. Expen.e. may include spokesperson honoraria, production costs, logistics and senpt writing. Timing: EtIim.I'" Coil: Ql-Q4 $200,000 VII. ADVERTISING AGENCY FEES The advetl1.ing agency of record will work on a variety of projects supporting Lexapro during FY04. Most of the proJects captured in this tactical plan .are hsted below. Advetl1'mg agency account time is captured in Gencral and Administtative (G&A) fees. All aeative and Out of Pockets (OOP.) ..e captured in indiVIdual project.. The list of projects the agency will work on Illclude (mpre projects rna)' be uUnated once identified and finalized): Annotated Package In.ert Annotated Reprints Patient Education Brochures Annotated Mastet Visual Aid Clinical Serie. and Letterhead SWier Dosing Card Rep Triggered Mail GAD announcement Mailer Kit Brochure Mazke' Research 8 Page Ad Hospi'a1 Panels Convention Panels 4 PsgeAd Sales Resource Binder/POA Guide 2 Page Ad File C..d Master Visual Aid File Card TACTIC.U PLAN Confidential FCA0017746 B. VA/DOD SPONSORSHIP FUNDS Fund. have been allocated to the Govemment Sales Group to increase VA/DoD formu1ary penetration, enhance formular:y position by moving to preferred .tatus, and facilitate pull-through a, all VA/DoD hospitals through individualized programJ including, but not hmited <0: • • • Loal Speci2J Events Local Educational Progn.ms Pull-Through Progn.ms designed to drive Lexapro NIU and enhance compliance/length oftherspy Funding allocations will be dependent upon submission/approval of wdI-deveioped business rationale. A committee composed of members of the LexaptO Brand Tcam, and Managed Health Cue Operations will review all requests. Timiif,f EtJimlJl,d C.tt QI-Q4 $250,000 Spon.orship Funds XI. CONTINUING MEDICAL EDUCATION The genctal goal and pwpose of the CME program i. to: Sponsor the development of conrlnUlIlg medical educanon acuVlties that will educarc physicians and other hca1tbcare providers and assist thertl in acquiring the most Current knowledge 'n the chagnosis and treatment of depresSJon and other tc1sted disorders. A. ENDURING CME In order to amortiu: the content from Fores[ sponsored symposia at academic conventions and regional programJ, Forest willaponsor the development of several enduring CME picees. Forest will sponsor "special repom" and "brief commutuca,ors" in publications like CNS Nnvt, P!Jfh Times, and the J.Nnt.1 of CIi.ir.1 PJYrhiatry, as well as university-affiliated newsletters such a, Duke University. Four of these 6-8 page CME accrechtcd reports will summarize symposia at ADM, APA, MFP, and MGP. Others will be created to educate physicians on the latest information available on anadepressant treatment Timiol' QlUlolity: Corl Per Uoil: Erturr.lld Cort Q1-Q4 6 $100,000 $600,000 A reporter from publications like CNS Newt, P!Jfh Tim", and the J.Nnt.1 of eli.,ral Pry<m.try will be aent to covet key Lexapro data presented at important medical mceongs. Da.. from ADM, APA, ACNP, and WCP will be reported 111 theloumalas a CME supplement. Timi°l: QI-Q4 Confidential FCA0017756 Qlianli!J: CUI p" Viii" 4 Esli/llalltl Cut: $75,000 5300,000 A videotaped sate1lite program will be spoDsored to extend the teach of our medial education activities into the larger psychiatric community. The content will consist of a videotaped sate1lite CME brasdeut of thought leaders discussing new treaancnts for deprcasion. anxiety and related disorders. TiJltin/,: 12JN1nlity: CMI P"Vnil: EstimaluJ CMt: Q3 12,000 $8.30 $100,000 Ta141 Ettima1<l/ Cut: $1,000,000 B. INTERNET/ELECTRONIC CME OnhneCME Many physicians now use the Intemet as a way to gain CME credits. Sponsoring onIine enduring CME programs is an effective way of amortizing the high cost of • live program and extending the reach of the program. Symposia sponsored at APA, ADM. MFP and AAGP will be placed on the InttInet in FY04. A"enue-E/lnutMed will eteate an online wcbeast that will reach the audience from the two lsrgest internet sit.., E-medicine and MedScape. These CME wcbeasts will be available within 4-6 weeks of the live program. Some physicians prefer the interactive format of CD ROMs as their vehicle to gain CME credits. In FY04, Forest will sponsor a CME CD ROM for this audience. Tim;n/,: QIt""lity: CMt PIr Vnit: Estimated Cose QI-Q4 5 $120,000. - Online CME, $200,000... - CD ROM $800,000 C. NATIONAL CME SYMPOSIA Sponsoring symposia at major meetings will allow thought leaders to present new data as it becomes avaibble as well as address questions from theirpe... and attending media. Symposia will be sponsored to address key topics of interest for the medical field. The audience at the majority of the meetings will be psychiatrists and PCPs; however, there will also be meetings with OB/GYNs, managed care and others. The del2lled Lexspro symposia plan is provided as part of the Professional Meeting and Symposia appendix to this marketingplsn (seo,Apptntlix IV'). Tinti'Vi !2Ii'lntity: Cost p" Unil: Est;"llti eMI: QI-Q4 18 -$167,000 each $3,000,000 TACTICAL PUN Confidential FCA0017757 D. REGIONAL CME SYMPOSIA Forest W1l1 continue to sponsor me ccntrtl development and regtonal implementation of a smes of educational programs to serve multiple medu:al subspeciailles, indudmg pnmary care and psychiatry. In conjuncuon Wlth medical education agencies, academic health centers, medical IlSsociations and professional :societies, Forat will address educational needs chat arc relevant, problem-based and timely. Approximately lOO-ZOO ph1"idans will be in attendance at each CME regional program. A series of 80 regional progrsms will be run bj' CME Inc. CME Inc. asked Forest for an unresmcted educational grant to sponsor a series regarding anxiety. Dr. Munay Stein, Dr Mark Pollack and othe.. will serve .. the Chainnen for this series. There are also potenl1ll Opportunilles with Duke University and Stephen Stahl to conduct reglonal series on se1ecllvity and prechnica1 Items for psychiatrists, Timi"!.: Quonti!)': CDl1 Per Uni/: EsllmO/ld COSh' QI-Q4 145 progrsms. 110 Psych, 35 PCP -542.000 each 56,000,000 E. SPONSORSHIP OF SCIENTIFIC SESSIONS Some of me smaller, more prestigious meetings do not accept Industry-suppoucd symposia. In such cases, sponsorship of a study group or plenary session is recommended. Marketing will. work with the professional relations group regarding potential opportunines. SOB?, NCDEU, ACN? and ..\.AFP are the four meetings that will be targeted In FY04. Timinj: Qliontl!J: Cosio' QI-Q4 4 events 5200,000 XII. A. ADVISOR RELATIONS ADVISOR COMMUNIQUES Forest will communicate regularly W1th thought leaders, adviSo", and LC3\apro invesogitors throughout FY04 to keep them abre.. t of all pertinent information Wlth r.exapro. Monthly mailings will be d(\'eloped to transmit inform.non that will include topics like the approVll! of Lexapro for GAO, the fwng of PanIC DISOrder, posters presented at important medical meetings like AD.-\A, APA, .and ACNP, and recently pub~shed data IS The detailed Advisor Communiques plan ApptndIx XI). provided as an append!.. to t1Us matketing plan (see TIming. CDlt: QI -Q4 $30,000 T.\CTlCAL PL.\N Confidential FCA0017758 B. CONSULTANTS During FY04, Forest will employ the consultant services of .everal thought leaders as advisors to Lexapro in order to obtain critical feedback and recommendations on educational and promotional stntegies and taetics. Advi.on will be selected based upon their .pecific area of experti.e and the marketing and/or medical need(.) at the time. Timing: Cul/H.ur: EJtima/.d C.IL· Ql-Q4 5250 5180,000 C. CONSULTANTS MIlETING .A twO·day meeting for key escitalopram con.u1tants and thought leaders will be held one year after launch. The purpose of this meeting will be to provide an update to our consultan" on the progress of Lenpro and .eek advice on the upcoming GAD launch. Half was paid in FYOJ for .pace re.ervation, recli1iunen~ etc. The remainder will be paid in FY04. Timing. CIJII: Q2 $200,000 D. EXECUTIVE ADVISORY BOARDS The primary purpose of the Lenpro Executive Advisory Board is to gain the coun.el of the key opinion lea!!en from around the country. Ancillary to gaining advIce and guidance, the executive advisory board keep. our advisors appri.ed of the commercial d""elQpment and potential benefits of cscitalopnm. Market issues and their potential Jrnpact on" escitalopram, emetging chnical and preclinical Lexapro data are also discussed. Two oncpday meetings in San Franasco & New York are proposed for FY04. Timing: Quanll!y: Co.r/ per _ling: CmL' Ql.Q4 2 5]05,000 5210,000 E. PRIMARY CARE ADVISORY BOARDS liS ~ll The objective of the primary care e..~ecutive advisory board meetlngs is to obtain critical feedback and recommendations on educational and promotiona.1.trateg1es and tactics, as cultivate. build. and maintain professional alliances with key inremi." and primary care thought-leaders. The primSC)' care advisory board will conSl.t of nationally rccogniud internist. and PCP•. The agenda of these meetings will cover an updare on the .laCU. of Lexapro clinical trials and clinical develc:>pmcnt plan, and a discussion of marketlOg strategic. to primSC)' care phySIcians based on the ou[comes to date. Timing: Quanli!}: CUI perm..lil/ll COSI: Q2-Q3 1 SI00.000 $100,000 T.\CTICU PLAN discu.sion on marketing reloted topics they deem importsnt to their mukets. A total of 200 local advisory boards will be conducted in FY04. Appro>:imately 40 speakers partiepate as moderators/presenters for the Lenpro local advisory boord program. Th..e speaker. will be brought together for a traUling and feedback .ession on the program. This would allow u. to min them on the most current data, mcluding GAD, and address any Issue. WIth the program. T,miw/,: Qlllmli!y: eMt P". UWlt: Es4mat,d ClJlt: Ql-Q4 200 528,000 55,600,000 B. REP PROMOTIONAL PROGRAMS Through the approximately 2,000 pS;'c1uatrists and PCP. that have been tecruited and mined to serve as facult), for the Lc.upro Speakers' Bureau Program, rep. will organl2e .peaker .,'ents. These meeongs may be large-scale dinner programs with a shde presencatlon. small roundtable d1Scussions Or one on one ad"ocatc lunches. The tramed ps)"chlatrtsts and PCPs include national and local thought leaders. These meeongs are necessary to maintain the strong presence and share of VOlet of Lexapro. In addition, dinner programs provide an opportunity for the rep to interact and build relaaon.hip. with a number of ph)~icisns in thetr temtory, Timi11J: QllawJl!J.·: CDlt Per Uw;t: ErIIl1lal,d CDI/; Ql-Q4 15,000 (1,942 reps, avg. 7.7 per rep) 52,300 534,700,000 C. SPEAKERS' BUREAU ADMIN FEE The ageng' will provide alIlogJ.cical .upport for the Lexapro Speakers' Bureau. Aca,iti.. covered may include processing of speaker honorarium, travel and expenses, RSVP management, im·ltalJOns/posters, and semng up a venue for the program. The agency's fee 15 based on the level of thelI involvement 10 the planning of the prognm. The different level. are .ummarlzed below: Allocteon 1 ~ Agency lnvoh'ement ll1dudes securing a speaker and processmg honorarium!expenses for the speaker ~nd proyiding invitations and posters CO the rep for distribution. Allocation 2 ..""-genC)t involvement includes secunng a speaker, and processing honorarium! expenses for the speaker and coordinating all travel arrangements. Agency will also provlde inVltations and posters to the rep for distribution. AUoeation 3 - Agency in\·o(vement includes full event planning - securing a speaker, dC'V'tlopmg invitations and pouers, managing RSVPs, aU logistical arrangements (venue Ind menu selection, AV need.) and processing honorarium/"<pense•. TACTICAL PL.\!': Confidential FCA0017762 Tim·1i Ql-Q4 15,000 $300, 650 or 1,500 $4,2S0,000 D. SPEAKERS' BUREAU SLIDE KIT Qt""IJ!J: C/)// Ptr U ntL' Esti~IlI'" C/)/I: A .peaker's slide ku containing a comprehensive review of Lexapro data has been developed. The slide kit will be updated IS new data, includins GAD when approved, becomes ovUable. Speakers at promoaonal events ,uch as dinner program', roundtables, grand rounds and other events will u'e the ,lide kit TimltJ: Ql-Q4 2000 Qua'lilY Est,mat'" C/)/I: S4OO,OOO E. SPEAKER TRAINING Three speaker traJning meetings will take place during October - December 2003. The meetings will be located in New York, Aorida and Los Angeles. 1,000 existing speakers from the apeaker's bureau will be recruited and troined on new Le.~apro data including GAD. The lr21ned psyehiotrisrs inetude national and local thought I""ders. Webcast/CD based speaket trllining will be roDed out In FY04 as weD. Dh'isional Managers will have the opportunity to trllin adc!ltional Lexapro speaker', TIllS prognm or one similar may be used to update existing speakers who cannot attend a bye speaker ttaining meeting on new data. Timi,S' Quanti!)·: C/)// PtrMItIJ'ng: Ertimd'" Corl: Ql-Q4 3 $800,000 53,300,000 F. SPEAKERS BUREAU ON.LINE COMPONENT Communication and trllining of thought leaders and speakers can be optimized by offenng them an online resource to. alleviate the burden of: • Disseminating new data • • Training Provide current rnaterWs A small secure site will be built for these physicians. Potential site features will include: • • • Promotional guidelines Slide decl's and slide deck updates Relevant literature and literature updates • • • Press releases Travel expenses Contact list for Forest TimiJt,g: Esli1llall' CM: Ql-Q4 $300,000 Confidential FCA0017763 XV. LUNCH AND LEARNS Providing lunch for a physician creares an extended am01Jl\r of selling time for representatives. It also gives them the opportunity to utilize other 'elling tool' like the lunch and learn video, teleconferences, etc. TimlnJ: QuanllIY: CDlt P,r RIp: EsI;",.kJ CDlt: QI-Q4 1,942 sale, reps SIS,SOO/rep/ year S36,ooo,OOO XVI. FIELD AIDS FIeld aids provide support to the field force [0 help drive Lexapro prescriptions. In FY04, the ,ales force will be armed with strong clinical and promotional support for Lenpro. The.e marerials Wtll pro.'lde vehides fot rep utilization that will generate interest and holp the rep engage the phySICIan U1 a consultanve cllscusSJon. The Lexapro marketing team will provide new selling matenals each POA to prevent rep fAtigue. In addition, product and category updates will be delivered for rep' to keep phYSIcian calls relevant and engag>ng. A. CLINICAL REPRINTS/POSTERS The follo...ing reprints will be made available in FY04: I. Gorman J. et aI. Efficac)" compan'on of escltalopnm and citalopnm in the treaanent of Major Depre'''''e Disorder. Pooled AnalySIS of Placebo-ContrOlled Tnals. CNS Spttt",,,,t. 2002; PU1/JOt,: To compare rhe effiaC)' of e'citalopram 10-20 mg vs citalopnm 20-40 mg. 2. Burke, W. et aI. Fi.~ed dose trial of the single isomet SSRI escitalopram in depressed outpatients. journal ~rClinll.'1f1 P!><bi4lry. 2002;. PllfpDl': Compare the efficacy and tolerability of escitalopam and citalopnm in the tteatment of MaJor Depresst\°e Disorder. 3. Wade, A. et al. E'citalopnm 10 mg/day is effective and well tolented in the treatment of depression in pcimary care. lnlmtalio/ffll Clini",1 Pry,bophtJ""afOlogy. 2002 P"f/JOtr. Demonstrate the efficacy and loleability of escitalopram at a dose of 10 mg/day. .-\ddiuonaJ reprints will be made available during FY04. The following posters will be made avwable during FY04: Confidential FCAO017764 designed to include dinici2n. th.t m.y not be .b1e to attend. dinnet meeting due to scheduling conRicts or geographic challenge•. Ten physicians from around the United State. are convened by teleconfe=ee to di.cu•• their experience with Lexapro and to hear specific clinical m ge. about Le:<apro pre.cribing. Lexapro Peer Group moderators ho.t each 90-minute TeleMAP sion. Both MAP••nd TeleMAP. l!'ve Forest • way CO reach healthcue prof...ional. with .trong, consistent product mes.age. and to provide peet-co-peer dialogue. The Peer Group will di.logue with product management to facilitate ongoing training and provide new dati to the moderators in order to create .ynergistic ptopm. that leverage sale. effons as well. The particip.nts of e.ch program will recewe a pre-meeong and po.t-meeting ourvey along with relevant literature provided by Lex.pro Product Management .t each event Each participant will al.o recen'e an AMA apptoved honorarium valued at $100 for his or her puticipaoon. Ti",illJ: Qwnli!}: C." PIr Unil: Etlintaud CD/I: Q1-Q4 MAPS-480 TeleMAPS - 720 MAPS - $4,800 TeteMaps - $3,300 S4,800,OOO XXI. A. SPONSORSHIPS ASSOCIATION SPONSORSHIPS Funds have been alloC2ted to aJd the ProfesSlonal Relations Group in their mission of cstablidung mutually benefiCIal long.tean relationships with appropriate professionals and Issoci2QOns. These relationships will further b..t medical practice. and poliCies in the treatment of depre.sion and will optimize connmerdal opportunioe. for Lexapro. Th..e relationship' will al.o proVlde the basis for ampocacy development and issues management, and will est2blish an appropriate environment for commercial and pohcy actiVJbes. Additional infonnation on assocu.tionso£ poority is provided as an (.ee App,.,ux T/11). Timi'i: EJlil1lllleJ Cosl: append1~ [0 this marketing plan Q1-Q4 51,900,000 B. EMORY UNIVERSITY UNRESTRICTED EVCATIONAL GRANT The eNS marketing team has committed to Ern0'1' University [0 provide funds [0 the Department ofPsychiatI)· and Behavioral Science. (Department) at Em0'1' for a pUlod of three years; FY04 is the final year. The .nnual grant will cre"e a fund for 'Clencific discovery to support activity and programs rel.ted [0 JUNor faculty advancement. within the Deparonent and recognition of outstanding commitments in the field. Pubhc relations. activities surrounding this imtiative to raise the awarenea' of Fore.t'••upport in the field of p.ychiatry will be explored. Ti",illJ.· Ettintaltd CD/t: Q4 S100,000 TACTICAL PL.~N Confidential FCA0017775 MEDICAL SCIENCE LIAISONS The Medical SCIence Liaison (MSL) gtoup for Forest Labotlltoaes, Inc. 1S dedicated to proViding thought leaders with the most =ent scienufic and clinicsl Informauon. Criticsl areas of con!abution are developing and Identifying strategic opportunities through phase IV research anitiatives, publicaaons, and estabhsbing I close rapport 'With key members. of the medical communny unportant to Fores ts theupeu'tic areas of interest. Comprised of, but nOI limited to, professional industry Mechcal LialSons, PhumDs, and MDs, these positions form th(: outreach network c:manllung from the: Medical Bnd Marketing departments assuring contio.uc:d interaction \\lith local, national. and mtemational opmion and thought leaders within the global medical communi!)', The 19 CNS MSLs are charged with establishing, developing, and malOtaining long term sustainable working partnerships \vith memben or the mc:wcal community whom may have regional, national, and/or intemation.l unp'C! Through these coU.bonuve rel.tionships, 19 MSLs promote 'WBreness of mechc.1 knowledge .nd issues relating to the company's ongoing development efforts, and Illuketed products essential to the organlzauon. This group also ser\·es as a front line, advanced mechcal/technical force to be t2pped lOto by region.l/local opimon le.ders. In adchtion, these inchviduals serve as a medical Information resource to managed care efforts, and facilitate vanous company educanon.1 programs, most notably the speaker's bureau, rell10nal ad,';sory boards, .nd regional sClcncfic programs and symposia. A. MSL INVESTIGATOR GRANTS MSL Investigator Grants cover the cost of Thought Leader lrutiatc:d Phase IV studies "lVith Lexapro. In ea,ch of these cases, the: uwestigator approaches an MSL with his/her concept Ind protocol for the ,study. The detaJled Lexapro Pha.. IV prngram is proy;ded as an .ppendi.x to thIS marketing plan (see App,.,Jix II). Ti11lin&: Qa••Ii!)!: Cott ptr tta4;': EJtim.ltd Om: QI-Q4 45 -$87,400 53,934,000 B. MSL REGIONAL CME SYMPOSIA The MSL. will fund regionally developed Ind O/TI. initiated CME sympoSIa. Symposia will be funded based on the specfic educational needs of the region. The symposia will be conducted in conjunction with academic health centeno mecheal assoaations and professional societies. Approximatelr 10(}.150 physlc12ns. mostlJ' psychiatrists, will be in attendance at each regional CME program. Cost for co· sponsorships is based on2 co-sponsorships of established CME symposia per MSL in _ year at a cast of $20,000 per co-sponsorship for a lotal cost of $40,000 per MSL per year. SUlce we have 19 MSLs, 2 cosponsoISlups/MSL x $20.000/co-spon.ership x 19 MSLs "approximately $750,000. TI11ltng,· Qa••Ii!;: COli ptrgra.t: £Slim.t,d COil: QI-Q4 38 (2 per MSL; 19 MSLs) $20,000 $750,000 T.\CTIC.'L PUN Confidential FCA0017776 C. MSL UNRESTRICTED GRANTS MSL unrestricted grants cover non-symposium educational programs, publicanon grants, lttvel grants to enable 0/11.s to present Le:tapro posters or presentations, support of local chapters of the APA at the request of an 0/11. etc. .Timi11&: QI-Q4 B.4gl1ptr MSL: Ellimat,d Gm: -S4O,ooo (about 52,100 per O/TL) S750,ooO D. REGIONAL GRANTS Can Regional grant funds can be used to support local or regional sympos,.. RD, 520,000 in the form of unrestricted educational grants. provide up ro Trmiwg: Cosl: Etlimat,d Cosl' Ql-Q4 S20,OOO/RD (26) 5520,000 XXII. A. SEMINARS AND TRAINING ANNOTATED MASTER VISUAL AID The annotated sales sid provides helpful hints and Ideas so that representatives can better understand the content of the Master Visual Aid Each bullet point in the MYA is <>plsined and helps to provide a consistent message to the field force. The annotated sales aid will be updated once for each POA. This piece is for ttaming purposes only and will not be used in promotion. Timi.,,: QI-Q4 11,000 (1,942 reps, 5/rep) $8.75 590,000 B. ANNOTATED PACKAGE INSERT Q...nfi!J': CDII Per UOlI: E.rfimautl Cosl: The annotated plc:b~insert allows representatives the opportunity to review me key points of the package insert and the selling message' that the poinl$ reference. The annotated package inserts will be used train representatives on the revised package insert which will include GAD information when appropriare. This piece i, for training purposes only and will not be used In promonon. Tii1Ji"l: QI-Q4 2,000 $9.00 $15,000 C. ANNOTATED REPRINTS Q...nh!J: Cosf Per Unil: Erhmal,ti CDII: As nev.' reprints arc selected for promotional USC" the representatives need to be trained on them.. The annotated reprints allow representatives the opportunity to review the key points of the chnial 'tudy and the 'elling messages that the points reference. The,e pieces Ilre for tI:uning purposes onl)" Ind will nor be u'sed in promotion. Confidential FCA0017777 Ti1lfing: QNantity: Uti PIT Unil: EJli1lfaild COil: QI-Q4 40,000 i3.15 $120,000 D. MEETING WORKSHOPS POA workshops will include PI and MVA reviews, clinical reprint and ob)ecuen hand!lng workshops, and role-plays. A vendor will be responsible for desigrnng the workshops and will create aU neees'at)' leader', and participant" guide,. Thrce POA meetings are scheduled for FY04. Ti1lfiltJ: Blltmat,d COlt: QI-Q4 il,300,OOO E. LEARNING SYSTEM. DEPRESSION The r..e."'apro Deprcs,ion Leurung Sys-tcm has been developed 1n FYO.3and each conttJ.ns sL", written modules, five audiotapes. two videou.pes, and a complete glossary. In FY04, we expect to reproduce approximately 1000 due to expansion and other traming needs. The contents of each module are: Modul< 1: Module 2: Module 3: Module 4: Module 5: Module 6: Tl1Iflng: FUlltiamutl411 DjNtJm1f1"atomy a"d l\TellnJl1tJnJ111;m(lfl BRJIC1 '!f Drpmsion and OlhIT Duordm n"'SpUlllr Optianlfor tiN Trral1lf..t of Drprrlflan Th, Campetitarl and 1M Mark,rpla" UntkrJlantisltJ Uxapro C,lexa O",TllitW QI-Q3 1,000 $100 S100,000 F. LEARNING SYSTEM· ANXIETY QNanli!J: Utt PIT Unit: Eil11Jlate.d COlI: The Laapro An:cict)' Lcarrnng Systcm will contam 4 modules with audiotapes/vIdeotapes. The: GAD lnining will mOSt likely begin in September 2003 and the Parnc DIsorder training in January 2004. The suggested contents of each module are: Module 1: Module 2: Module 3: Module 4: A.",.!>· SIaI'J Ltxapro and GAD Canrp'l1l11rf and 1M GAD M.rk'rpla" Call1J'llilorr and lhe Pan" Dua""r M.rlutpla" Q2-Q4 2,000 $100 $200,000 T,mi".!: QNanlity: Cost P,r Unit: Bllim./ed Coli: Confidential FCA0017778 XXIII. CONTESTS A. CONTESTS The Lexapro 20% market share club will be introduced the field during the June 2003 National Sales Meeting. Each representative will recoil'e an individually chosen high value gift item when they reach 20% new marke' share (or Lexapro. Gif, items are .tiIl under development but will likely be a small selection of rarefully cho.en i,ems rangmg from watches, walle.. to candle stick holders. The ongoing Le."pro fa.. start conte" will also be funded domng FY04. '0 Timi,,&: E;liml1l111 Co;I: Ql.Q4 $350,000 XXIV. CONVENTIONS The presence of a Lexapeo booth display and promotional activities at medical conventions serves to increase awareness DC Lexapro and ilS benefits for the tre2ltment of depression with target audiences. The detailed Lexapro convention schedule is provlded as an appendi.'\ to this markeung plan (scc App<_tIix 1). A. ABSTRACTS-ON.DISK Fore.. will continue sponsor the Abstracts-on-Disk program a' the national meeting of the APA and ACNP. The Abstracts-on·Disk program makes all of the abstracts and new data submissions at the meering available to meeting putic.ipants. '0 Tn.i_g: QNtJ#Ii{y: Erli11lale4 CDII: QI-Q4 2 545,000 B. ADVERTISEMENTS A Lexapro advertisement will be placed in convention meeting booklets which arc handed out to meeting participants. The advertisement is designed '0 be a reminder ad '0 physicians. Timing: E;lim4JIIi CIJJI: QI-Q4 $190,000 C. BOOTH AND PANELS The Le.apro convention booth panels will be updated in FY04 to reflec' new Lexapro data. The purpose o( the panels is attnc' and retain booth traffic wi'h captivating graphics and a powerful product me..a3C. Also included are panels fOt tabletop and in·line display•. '0 Timinl/ E;Iim."tI CDJ/: Q]-Q4 $100,000 T.\CTICAL PLAN Confidential FCA0017779 D. DIlAWS/GIVEAWAYS EvelY professio~1 association meeting has 1ts own chaneter. Appropriate booth a.ctivities for each major meeting will be developed in order to encourage booth traffic Ind complement tbe meeting's overall tone. Forest will take ad,rantage of many meeting sponsored IIdoor drops" by .inserting a L..apro promouonal piece that is meeting-specific (symposia invitations, etc.), booth draw (giveaways, coupons, etc.) or brand message. The Lexapro Interactive Challenge will continue to be offered at \"U"ious mec:cngJ. This activit)· is designed to engage mec:tm.g participants in a fun, lemung activity where they learn about Lexapro's promotional messages. TUfSing: Q""nli!F C.II Fir Unil: Elkmaltd CDII: QI-Q4 26 conventions $30,000 5755,000 E. MEETING RECEPTIONS Opportunities for Forest medical aad markcUtlg staff, as well as MSLs, to interact 'With opInion leaders (in both sman and larger groups) will be scheduled at J. number of major medical mecungs dunng FY04. The purpose of these event, is to develop personal relationships and provide intimate semngs for scientific discussion. Programs may include dessert receptions with association members Jnd other special events. Invitations will be issued VIa the MSLs. Among the meetings targcred U1 FY04 arc the follo'ving: • • * Collcgc of PsychIatric and NeurolOgIcal Pharmacist' (CPNP) - May 2003 American SOClet)" of Hcalth Systcrn Pharmacist. (ASHP) - May 2003 Ncw Clinical Development Evaluation Unit (NCDEU) - May 2003 American College of Neuropsychopharmacology (ACNP) - December 2003 Anxicty DlSordcrs Associaoon of Amcdcs (ADM) - March 2004 • Tz11lin,g; QI-Q4 5 rccepoons @ $24,000 $120,000 Quanll!>' Es"",,#,d CO!I: XXV. PUBLICATIONS Pubhcations will be geared towtrd psychiatrists. PCPs, pharmacists} osteopaths, nurses, managed care organizauons, LTC and others. .-\rucle. will appear in several formats, inclutlmg original reports, review arucles, and journal supplements; It is' the brAnd team's meennan co aggresSively disseminate all new chnlcal data analys.. when available. A. ABSTIlACTS AND POSTERS Emerging preclmical and clinical data, as well as pooled analys.. of Lcxapro data, will be disseminated in pOStet (or QccaSJonally onl/slide) format at all approptiate medical me.ang•. Dunng FY04, approximately 70 abstracts/posters (both original and retread) will be presented It T.\CTICAL PL.\N Confidential FCA0017780 US. meetings with a simi1Ar number of abelncto/pOsters presenced at European meetings. The focus of the presentations in FY04 will be compArative and switch data in both depre..ion and anlaety, clinieal data in depression, GAD, panic disorder, SAD, and safety data. There will also be ample preclinieal data and data from investigator initia'ed studies. See Apptnriix IT for the detailed publication plan Timing: QManli!J'.· CDtt P". Uait: BtIi.,.t,tI Cut: so QI-Q4 56,OOO/poster 5300,000 B. MANUSCRIPTS IlJ, publications As deuiJed in the Forest/LWldbeck Escitalopnrn Poster and Monuscrip. Preparation Plan I.!lpp'nriix will be generated based on preclinical and clinical dalll, as it becomes available. Articles will appear in several fonnats, including original reports, review article., and journal supplements. Approximately 10-12 manuscripts based on onginal dalll (generated by Forest) will be developed and submitted for publication during FY04, supPorting the usefulness of L""apro in the acute and long-term treatment of depression•.and in the treatment of .maety disorders (GAD, panic disorder, and SAD). There will also be publications on the comparative "'aIs with vcnlafaxine, puoxettne, and setttaline, as well 1.$ the switch study with fIuoxcane. Addinonall)'. up to 10-12 review articles will be denloped and submitted for publicanon during FY04. Articles will include te\'iews of Lexapro-specific pharm.cology. efficacy in depression, efficacy in anxiety disorders, and safety induding geriatric and pediatric patients (e.g., targeted to psychiatry, primary cue, psychopharmacology, and pharmacy/fonnulary journals), as weU as articles that include Lexapro data within the context of I broader review (e.g., safety in tbe geri;ltric population, current approaches to treating anxiety disorders, and sdcctivity of lcoon). See Appendix 11 for the deuiJed publication plan Timing: QManti!J: eDtf: Ql-Q4 24 manuscripts 5700,000 C. PUBLICATION PLANNING AND STRATEGIC COUNSEL Publication plannmg include. aU agency time spen' managing the publication grid, reseucbing potential publicatlon topics and attending all publication related accivitiesand meetings. Strategic counsel and input to muketing actIvities .s well u th,e developmenr of stntegic and [attical plans for the FY05 marketing pion. Timing: CIMI: QI-Q4 5350,000 D. ROUNDTABLES Closed roundtables provide opportunities for a small group of experts dlscuss topics especially relevant to the positioning and marketing of Lcxspro. The deliverable from a roundlllble is a journal supplement that is disseminated ro a much luger audience. Cased roundtables can be held in conJunction wnh major medical meetings, or as .tand-alone events~ It 15 recommended that four '0 TACTICAL PLAN Confidential FCA0017781 closed roundtables be held during FY04. Suggested topics include: 1) Panic DISorder; 2) SAD; 3) Geriatnc; 4) Pediatric; and 5) Somatic S}'ttlptomJ assowted WIth depression and anXIety. TimIng: Q2-Q4 4 even,ts $500,000 (Includes event only) E. SUPPLEMENTS Ql«lnllty: Out· As part of a comprehenSIVe publication plan, journal articles and supplements will be developed based on important content of particular Forest-sponsol'cd symposia and roundtables. These published manuscript> will help dISseminate reb..nt Lexapro data and mcssogcs to key target audiences, including psycluattistl, prunary care physicians, managed care organizations. long-term care medical directors, and others. This amount assumes submission and publication of (ow: lupplemcnts, and includes editorial ,support and page charges and docs nor include costs for reprints. Til1lilll: Q~Q"'i!J: Q2-Q4 4 $162,500 5650,000 CUfI Per Unil: EsllTllal,d Cot!: TACTIC.~L PUN Confidential FCA0017782 APPENDIX I CONVENTION SCHEDULE 1-3 3·5 3-5 AAN - American Academy of Neurology Honolulu, HI PRI-MED WEST Long Beech, CA ACP/ASIM • Amencan College 01 PhYSicians American Sociely of Internal Medicine San Diego, CA AMCP - American Managed Care Pharmacy MinneapolIS, MN ACOG - American CoUege of Obstetricians & Gynecologists New Orieans, LA 8,000 7,000 6,000 1OX10 20><30 20.30 9-12 3,000 5.000 30><30 MIK 20><30 28-30 MAY 14 ·16 ASCP • American Society of Consunant Phannacists Midyear Geriatrics '03 - Tampe, FL AGS - American Geriatncs Soclely Baltimore, MO APA· Amencan Psychiatric Association San Francisco, CA 1,500 20.40 15 -16 18 -21 2.500 16,000 20.30 60xBO MIK JUNE 9-10 19-21 19-21 NADONM.TC Cincinnati, OH PRI·MED MIDWEST Rosemont, IL US GERI· US GeriatrICS & Long-Term Care Congrea. San Franclsoo, CA 400 10>20 30.30 30><30 7,000 2,000 Confidential FCA0017822 JULY 10 ·12 AUG ST Nurse Practitioner Symposium Keystone, CO 1,500 10x30 23·27 NACDS • National Assoclalion of Chain Drug Store Pharmacists Philadelphia, PA 2,600 10><30 SEPTEMBER 0 OBER 2-4 2-4 12-15 16-18 19-22 10130-11n AAFp· Am. Acad. of Family Physicians New O~eans, LA APNA • American Psychiatric Nurse Assoc. Uanla,GA OA • American Osteopathic Association 6,500 2,000 3,500 5,000 1,300 2,200 3OXSO MIK '0x20 20><30 20><30 New Orleans, LA PAI·MED MID-ATLANTIC Weahington, DC ANA - American Neurological Association San Francisco, CA APA~ • Am. Psychiatric Assoclallon Inslilute at Psych. Services Boston, MA 10x20 20><30 ?? NAVYACP Location? 200 TableTop NOVEMBER 6-9 US PSYCH" MHC • US Psych" Mental Health Congr.... O~ando.Fl PR~MEDEAST 3,000 3Ox30 7·9 12 -14 7,000 2,000 30x40 30x3O Boslon, MA ASCP Annual - American Society of Consuilanl Pharmeojsts San Antonio. TX ARMYACP localion? BI!R ASHP • Am.~can 60cIety ot H••llh System ?? DEC 200 TableTop 8 -11 18,000 3Ox30 Pharmacists New OrIeans,LA Confidential FCA0017823 ~ANUARY FEBRUARY 13-15 MARCH 1-4 NMHCC - National Managed Health Cara Congress Washington, DC AMDA - American Medical Directors AasoelaUon Phoenix, lIZ. AAGP • American Academy of GeriatriC Paychlatry Atlanta, GA ADM - AnXiety Disorders of Americe Location?? APhA - American Pharmaceutical 3,000 10lC3O PRHolED WEST Long Beach, CA 8,000 30X40 4-8 1,200 20x20 12 - 15 1,250 30lC3O MIK 350 5,000 10x20 20x20 11 28-30 Association SeaUle, WA Confidential FCA0017824 APPENDIX II PUBLICATION PLAN APPENDIX n PUBUCATION PI.>\N Confidential FCA0017B26 ~ a. (I) ~ b' ~ APPENDIX II Publication Plan Forelt/Lundbeck Eacltalopram - .. - . I>ao: .. ~~~~#'.ut;:'.JJ~~.~:~~ Studies Poster and MsnuacrlDt PreDanlllan Plan Key . . . . . . ..... ,,, .~~'" . •.:;.... ~:,.;.-~: ..._ f_;'";:"·•. .- -, • " .- • '?-i;" 11'1_ 201 palhMy -*GIn-.3A4 ....--. "'" ...- "'" II. 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I~ jI I; I~ I I; If I I II ., 1- I Ii Ii iI i~ Ii d I I. d. i!~ !~ II~ I~ I~ Ii HI I lilt ul u I i Ii II d d i J II Ii Ii ~ n II Ii I Ii ... I I I~ i if I HI· i- t·f 1- If n~ If I~I Ut iu' II U U U U ~l U U U ~t i~ 'I UUH II ~ I I j f I ! I ~I x !s I.. i 1II Iff i I I til !II I f ~ If: i II f I. . JIll f II I il h I) I ~ fit hit • JIll I ; Confidential FCA0017B29 i. I Ii J I' ~ II U U U i I r J u II I I c < Confidential FCA0017830 I I Confidential FCA0017831 i. Ii I I Ii t it t It t it t it~ i f 1 i' I I f I, I Ii Ih Ii I j! f I ~ f f! il I! J J J j I I I i i ~ ~ j j I. I I I ..f . !s !jl hi f f f f ~ ~ ~ ~ I J II t! HI I - ~I JH~ ~t ~ ~ II ~ U H U I I f J ~l Un ~ ~ uIfi U U J J J J J .. ~ I • I J I I 8 J ~ If'II I~ I J t I t I . I Ih ;1 Ii I ~. ! It if I I I t J I t ,j i t I i ,i I I I, I I f J I, !, Ji i I I II I, I, i I! II I f ~t ~I f f ,f I • I J • J t I Ii II I it h E ~ J I I J • , ~ ~ ~ Ii I 'II I iI II j i ~ ~ I! ,.II c • I Confidential It 3 lit ,2) ~, 'I III i "' II 'III ':it 1.1. if It II f II • 0 J iii I'· Q Ii 2. h Ii .I, •i i f ~ ~ II Q Q I I i i FCA0017832 g I II II I ;; ~ tt s I~ r I ~ I I~ ~I Il II I-- u I~i I • zl lJ, . j i i ~ I AI ~ x iI I Itt~ 'I' I J "r Iii I It' i~! 1! jl IIi II e: f ~ i t f If! II ·1 t· 1 II t II il iIit iii III II it i I i~ II t! II! Ii h ~l I t i I ti j I I I wi • I- I!fi '. =1 "I ill j! I~ !~ z' ii I I I I i i i i I I I I f t t f I ~ i I ! ! ! ! I e: e: ! i i f ~ Ii ~~ Ii I II~J II , • cc c U .~ j j J lid < II· ~ c H~ J j I c < ·1 il .z ,~ it ,~ • J J c c Jl ~ I J r c l! • ii i • • i i • • ; i ; i Confidential FCA0017833 ; II;dll I r r ir I g 2 r :II ~!! iUl II III II U 31 If -II il "'I It IIIJ 0' II i II Ii u J. i~ !l. ~. l- U r It II ai 'i ~t o~ Ih Ih IiI II H 1i .,:,s " III I ~ 11 I U I I I ], I II o • i i 1 II [1_5 f- ! I u ;fn f II 11 U U u i f n u'h ~ un . " j I I I r ~ ! " I -. I ~ '2{r, 5 r"J ,, rf I if J i Ii .1 It ii It it t I Ii I t J i t I, I , I 'I i I I i J I J I J ' I i il h , • .. I .. II .1 It ~ II I I j i II co I II I Confidential FCA0017B34 I 'i II ~ ~ !l h Ij 1& I I~ I§- II -f i· If if -'" § i ,1& ;~ IG j1l I" lUI U ., II if H I' I I' II I )til I~ , (Ill. II fi If • i I U! II" I~ • 1"1 Ii II, It I,tI f IIi I ~ IIi i I hi d'I h~f Ih U II II U ~ ~jH IIr I II f i Jf ~ If I -11 r Ii II h n H n -" I~ u J i I r ~. ~l II i H n u ~I ~I U ~I , I U U n I I I i 1 , 11 I •• !d I I" I 3 x I : r I " t II lit i II . .. J ! f i i• lit lfz t f Jf I , ILl j " tP "I JI, )1 .1 I I I ~ 0 I " I I I 1"6 Confidential FCA0017835 Iii II _II 1m :1 ~h r I ,il - Jl I !I II i. ~I Ii. rr U U it U Ql U n -:~ if if II I III, u ~s i I i t if jl ) :1 II ·s if II til II ~ ~ -----1 ! >; II UH U ~ J w~ U H U n~~ ~I I I i I -. I ~ ttl f I I} I I ; I J jl f II J !s I Ii I I~ 'i Ii! ! iU j Ii II Ii Iii Idb I Ii· II Uiili I i t ). • i • '1 1If I f f · iii j i IIi II I ) I t I III I r I, I f ~ j I : I J ; f I I ~ ~ • I ¥ i ~ It II a , h 't f if II a ~I ~ Jr i JUI ~I· It c I j I i Confidential FCA0017836 I I II 1 Ii II II t Itt I II II) I1 III II 1 t" I ~! Ii II!: i" 4 i" it ih ~ I J I II 1 I n Ij iii It II it n u i U n JIJ~ ~ ~ I I IJ t t I I ~ I J I II n H U U Uunun JI I II H if • ~ l I i I ~ I J I I I I I I ! is i II 11 I:~ i II 'f i I ~J i ~ !I ! lit i t • I J I I I j i i i ~ t • J ttl ! • w w J II -. I ~ il ~ ~ ~ if I f Ii IIH II ~ ~I i111 '~I I I - Ipl ')' ~ t Ii • 'It i( Jji ~ l 1 h I IIJI iif; i I Confidential FCA0017837 Confidential FCA0017838 I.: I: d t~ I." I~ : J' jf ~ . i: II U !~ ~ 1 " 1 I I I u It f J .. J .... , J I ~ • J I II n Ii U f I. .~ u i J .. J .. f I J I .. . I I I I. i IiI !, i I i iI j! i Ih i! ! Ii ~I ! Ii ~J ! I.I ~I !f Ii ~I ! Ii ~j ! I ~I ! If .. Ii f itlt} Ii t ut i it . 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IUt iI ~IJ i. jlli if II iI !~ ~Ii I ~J H U FCA0017848 Confidential I I I I i J • J J ) I • • G i· Ii iI II I. il HII lin iI Confidential FCA0017849 I I " J I II~ I I I til ', f i lie Iii · t • it !I! !l I In II J hi t III FCA0017B50 Confidential M 1 I I i:i I~ .:i II iii, iii' j~, !~ j~, lli t i lli t ~h ~ :~ ~h !' j~: If Iii ~ :, ~ II j~l -'t I • I i I~l I; w - lSi ~t n II UUI U U Un It u t I i s ~ II I t t, I -i • j ~J ! Ii iii J h I, !I ! !I II in jl I, !II jl III it hIii it dhil 11i·1 .1 i f ~ I I t ~ J ~ II 11 ~I &1 !i , w 1 s l; • , n n i J Ii i I f I : u FCA0017B51 Confidential Confidential FCA0017852 APPENDIX IV PROFESSIONAL MEETING AND SYMPOS~ PLAN A. PSYCHIATRY Sode!)' of Biological fl,YChia'O' (SOBP); • • 5lt5/03· 5/17/03 in San Fnncisco, CA Expected attendance of 600 Amtrican PfYChhltric AuQsiation 1APA); • 5/17/03. 5/22/03 in San Fnncisco. CA • E'"Pected attendance of 18,000 New Clinical Drug-Evaluation Unit Program CNCDmn: • 5/27/03 - 5/30/03 in Boca Raton, FL • Expected attendance of 1,000 Conc;gium Inttmarlwak Ncum.PSJ'CbOJilianpaco\oaicUJD (CINP); • • 10/12/03 -10/15/03 in BeljmB. China Expected attendance of SJOOO World Pl,YChjatric AlSocia!ion/World Coop" orPmhiatQ' (WPA/WCl!) • 9/10/03 - 9/15/03 in Cairo, Egypt American PfYShiatric As80ciation IO,lity" on P'i)"cbi.tric $ettice tAPA.1) • • 10/29/03 -11/02/03 in Boston, MA Expected attendance of 2,000 u,s. Paychiatrie CoOP" • • 11/6/03 -11/9/03 in Orlando, FL Expected attendance of 3,000 APPENDIX IV SYMPOSIA PI.~N Confidential FCA0017857 Amerisag CaUeU gfNcur9pl"S"opb vmllti0 )g1Y (ACNe> • • 12/7/03-12/1I/03inPucrtoRico Expected attendance of 1,300 International C9DC'CII of Geriattic PlYcboneutD»barmacg!Pgy QCGP) • 12/12/03 - 12/14/03 in Puerto Rico Amcrk.n At8oci'rion fpr Gedaqis Piycb"w lMGP) • • 3/12/04 - 3/15/04 in Baltimore, MD Expected attendance of 1,200 Anxien" DisordeR " ..odati9D gfAmeric. (ADM,) • • 3/04 Expected attendance of 650 PriMed Puehjatty Updates • Fall 03 • B. Miami, New York, Chicago, Wuhington, DC, San Francisco, Los Angeles PRI~lo\RY c.~RE American Academy of Family Physician' <MFP> • • 10/1/02-10/5/03 in New Orleans, LA Expected attendance of 20,000 American CPUcge of Obatetrieians and Gynecol9IPsts (ACQG) • • 4/26/03 - 4/30/03 in New Orlesns, LA Expected attendance of 5,000 u.s. Geriatric!- .nd Lone Term care Copm" • • 6/19/03 - 6/21/03 in San Francisco, CA Expected attendance of 2,000 Amerism CoIls;p ofPhnkianl=Asperisap SoclctY Q(Intapa1 MedisiM CACP} • • 4/3/03 - 4/5/03 Expected attendance of 10,000 APPENDIX IV SYMPOSIA PUN Confidential FCA0017858 American GerlaW" SocleI,Y (M§) • • 5/14/03 - 5/14/03 in Washington, DC Expected attendlnce of 2,000 'Pri-Med RqiopaJ Mecrings • Mid-Wesc 6/19/03 -6/21/03 in Chicago,lL • • C Eut.Il/7/03-1l/9/03inBoston,MA Expected attendlnce of 5,000 at both OTHERALUED HE..\LTH PROFESSIONS Academy of Manlpd eire PbarrnKY (AMCP) • • 4/19/04 - ~/12/03 in Minneapolis, MN and 11/10/03 -11/15/03 in Pasadena, CA Expected attendance of 4,000 American Medica! DiJecton ",mianon (MID.\) • • 3/4/04 - 3/7 /04 in Pboenix,AZ Expected attendance of 21000 American SodeN of ConlullaJ!t Pbarmacilq (ASCP) • • 5/14/03 - 5/16/03 in Tampa Florida Ind 11/12/03 -11/14/03 in San Antonio, TX Expected attendance of 4,000 APPENDIX IV SYMPOSIA PLAN Confidential FCA0017859 o o 3. a. eD ~ !!!. c!: APPENDIX V LEXAPRO PHASE IV CLINICAL STUDIES ,• - .u. . .. • , •• •*- , , , , , , -. ..,Q.1 • . "" ".. •• , , .. ••• .... w •• ....... 111 Y , , •_aa., 411l1'U Y , , , , ...... .- " nOfI" - "" '"""" .."., ... .... ,,. • . •• • . $"'.... ., 10I1'WJGlll 34'''_ 111.150. I .. • - - " • .-. """l' JllIll Y , , , , .. ."".. .. ... ... ... ,In; • ... .... .... .... """" """" ... ... IfOUKIlO , HI·U·" ...... Sll,6fJ2S .... , n. ut InJ .. ... I i I i J I. 1 rh ~ h I~ I~ • • • • :. • II I • • • • • i i II ! · . . • • • • • ~ • , • • · • .... ........ 1 • ! • • ! • ; • h ~l iii I!, hI!i IJ 1 • III II .f If ~ Ih [ J IJ It t nit H!.i. Jhhlh linUuUm lIn. ~h ~1t rto~~hUH lUUiU filiI! I: e • ~a • h tlJ!f IIIi L HI • Ii Il I~ • • Ii • Confidential FCA0017862 t It J JJ • I; ~ I. I lH > > > > > > > > > > > > > > > > > • i · • • . ~ S 8 ~ • • a > > .. • ! > > > > i I i : If • • 9 ! • : JI i. 8 • i • I Ii II If hhih JMluHJ hili ~mf ilt ~nh 11.IUIJblil IUn lihliU • • • Confidential FCA0017B63 hi!H IHil !Ih~ liHl'i1H ~Jl HiH'lllh UI lAIr IHh 1. I i i • J .f J.f • It Ie I. I. In 't I~ In III I, '. • I~ • J Ii Ii I I Ii • II Ill: lih • • · . • • • • • · . • • s • ~ • § • ! • • • • • ! • • i • I • I' • • I • • ;. • ~ ~ • • i 8 • f = If Ii ,I j IlllH ;; d,fuU, hlhJ,hllu In;! Hll !Uhh, UhJiUJiUlllJh IHiH ~ ,~hiJ IUn liII iwiJ : ~ • I Ilh ·hll) Uhf IHtl I. ! ! ~. Confidential FCA0017864 • II II I{~ I~ II ~B I i II II! i J d i~~ I .~ i!! I t • t III t r t. If £ J £ 8 I~' I I ,Ii £ II .T ! • i • i Ii • ~ i • j 8 ~ • • ! 8 ~ • 8 • • • • i I Ii i i I i ! m III 1m • • • lh m !n • ;> 8 • i m m iii• • ' ! · · • · · • • • • • 8 8 • • • · · i 8 • • • ~ • • • 8 ~ • il • • i u VI 1 ~ • ! 8 ~ t • ; • • • • ii ! · • • • • • • • ~ · ! • • 5 = I J; • , • • I · ! l f I ! • h ill ~. ~ J H It B.I rl • 1. h It H ~ P • it 'Jm nHi .' II Uhl, HI Until Willi hUH lfinHUffllUi' hli ,hlJ Iflb ~ p. I hdl lh ~ I~ hUu i 1 ! ~ ~ a ~ ! I i ~ ~ • Confidential FCA0017865 1 • ., n J 1 5 H I § i 1 • II I i Ii > > h J Ih » :1 > > i~IHl fth > > n~ > > > > .. I~ ~ U ; ~ • ~ • ~ • • • • • ; > • I , • r Ii • • · • ~ · • ! · J » .' · • • r: ! > • e 1 I > • T. Ii i Ii ! ! H lU, rl t " OJ !111J If In ItfllI InU Ifh mI ~ . ~ II] ,r, u. ': ~ I Hl!flhnJH n]iii IHUi ·11 dllh 'JihltJ ,!rrdlhH Ihill Ii II I;H 1 1 J H! rl i I.~! ! J ilf m • ~ FCA0017866 • I ! ! ~ ~ I ; ! ! ! ~ ! Confidential Confidential FCA0017867 . f fj f- I & f- 1 I ,~ ~ ~ I 8 • • !~ • !; ; 0 8 I! I~ I~ ~ I• I~ 1 8 Ultl In ~U ItH Ilf Ii ! J Hi l.tJU HU JdH 'h Ilh, IH HI In JJ U In "P !I,H 11liu Ilil ItilU Iflji In !ifd fhh iulbhUh hI III I( ~ 1 • • i t. J f iilJJ j uj • ! ! :: ! ! ! - Confidential FCA0017868 h f" I" j~ h I" h fr ~ 1 ~ i i ] ~ • i Ii , , II 1 ., i ~ • ii .j ~ . I ! ] t If • III H ulf Ht IdH III d .' ilru. I{il .. I IiJlin " Uill J~ JJiitlhhillfi'! i< <h InUHhJ Hi IHilh if If1{U f 5 A H I. , HI iU nfl. ,. ! • ! 9 Confidential FCA0017869 IJ ~ ~B Ii Ii If:! h f. i • !il Ii i i I L 1 iii : - I It ;it ,it -! tJ ., 1 IHlul h lUI .i J liJlU JhiJ 'H J i• fIJi' titl Jf -.l,lltiUd !~nJl'1 ltd ,iJjIHiJ lill ') 'I • I ~! IH 1, if iiu I i t ih ! § Confidential FCA0017870 Ii r § i ! i ! I E I • I - i I - 1 I 1 II - i I I ·It Confidential FCA0017871 • J l• I. j ! I J t I ·jJl~iUJ Ii lhnhij ,uu; [nUt] Confidential "Ul IIlllliuhl III II till FCA0017B72 APPENDIX VII ; PROFESSIONAL ASSOCIATIONS OF PRIORI'l;Y j ; I. I AMERICAN PSYCHIATRIC ASSOCIATION The .American Psychiatric Association (APA) is recognized worldwide the prelrller psychiatric society. Ito 44,000 U.s. and inrernational physicians specialize in the eli goosis and treatment of mental and emotional illnesses and substance us< disorders. In FY03 Forest Professional Rciations provided an unrestricted gnnt and technical support to create collabontion between APA, AAFP and ACP to develop "reasonable pnctice" gwdelines for the management of chronic depression in primary cue prtctice. The clinical objective is to ""Prove the pen:ent of patienta who adhere to the full duration of therapy. The first step, u1entifying a Standard ofGue evaluation instrument, was completed in October 2002. In 2003 the Workgroup will determine a Standard of Gue Intervention Strategy and identify the instructional materials needed to unplernent the strategy in office setting. The strategy will be tested in each orgaruzation's Pnctice Research Network to validate its ability to improve adherence and prolong duntion of therapy. The WOtkgroup seeks to publish the results of each step in a peerrmewed Primary CareJoumaJ to begin clisS£mination of the re..onable pnctice guidelines. At the State level, APA Chapters engage in significant lobbying of State Health Dep=enrs to maintain mental health care budgets, including suppott for open Medicaid drug formularies. FOlCSt h.. expanded its involvement with APA in this regard, creating an infoanation coUabontion to aS51st mutual effotts at the State policy level. AMERICAN ASSOCIATION OP GERIATRIC PSYCHIATRY The American Association of Geriatric Psychiatry (hAGP) represents and serves the field of geriatric psychiatry. The mission of hAGP is to enhance the knowledge base and standard of pnctice 10 geriatric psycluatry thtough education and research and to advocate for meeting the mental health needs of older Americana. In 2002/03 AAGP is developing, for the first time, evidence-based Pnctice Guidelines for Late Life Depression. Publication is expected in 4Q03. An instructional "toolkit" to assist guideline implementation and an updated depression slide kit will also be issued. Forest Profeasiona! Relations is the sole support of thes. projects, providing an unrestricted gtant and technical support. APPENDIX VII PROPESSlONAL ASSOOAnONS Confidential FCA0017922 AMERICAN COLLEGE OF' NEUROPSYCHClPHARMACOLOGY The American College of Neuropsychopharmaco1ogy (ACNP) is an elite, research-orien.ed profe.siOlla1 organization with limited membership of 600 natiooally recognized Members are eleered based on their origiml research contribution. to the field of neuropsychophumacology, representing behavioral pharmacology, brain imaging, clinial psycho-pharmacology, epidemiology, genetic., neurology, neurophysiology, psychiatry and psychology. .cion".tI. The principal functions of the College ue re.earch and education in mental health, including substance abuse. ACNP provides investigators the opportUnity for ctOas-di.ciplinuy communication " scienulic meetings, and promotes a multi-discipline approach ro rcseuch in the pharmacology of brain and behavim. Forest is a major contributor to ACNP annual programming, and is a founding 'pon.or of it'. newly created International College of Geriatric P.ychophumacology (lCGp). AMERICAN ACADEMY OF' FAMILY PHYSICIANS The American Academy of Family Physicians (MF?) is one of the1argcst national medial organizations, with more than 93,000 members. The Academy ha. a strong educational and policy platform, representing comprehensive primary care to patients and their &.milles. AAFP has a rich catalog of mark.ting oppornmittes and communication vehicl.s to their members and their pati.nts. Forest has been a Corporate PreSIdent'. Cu:de Sponsor ofMFP since 2001, wluch provides additional mark.ting opportunities. Forest is also a major .ponsor of the Academy's Doctors wit Heart philanthropic program. In conjunerion wid> physician specialty groups (e.l} APA) MFP develops evidence-based practic. guidelin.s, which must be ratified by their Boud of Directors at the Annual Scienulic SesSIon. AAFP is actively puticipating in the Forest-led collaboration with APA to develop reasonable practice guidelines for managing chronic depr.ssion in the Primary Cu. Physician oflic.....tring. Forest is actively puticipating in d>e MFP's Annual Clinical Focus: "Caring for the Aging in America," a year-long comprehensive educational program (October 2003 - 2004). The objective is to inctease the Family Physician's ability to identify and eff.ctively manage hctlh conditions in the elderly. Late Life Depression and Alzheimer's Dementia ue key elements of this comprehensive educational program. APPENDIX vn PROFESSIONAL ASSOClAnONS Confidential FCA0017923 AMERICAN COLLEGE OF PHYSICIANS [PREVIOUS NAME, AMERICAN COLLEGE OP PHYSlCIANS - AMERICAN SOCIETY OP INTERNAL MEDICINEI In 1997 the American College of Physician, (ACP) and the American Society of Internal Medicine (ASIM) merged to fOlln the nation', lugest medical specialty society with over 115.000 membm. Since 1997, they Were known as ACP-ASIM. In May 2004, the College changed its name back to simply ACP. Over 95,000 of ACP members ate general Intemlsts (Internal Medicine). while about 20,000 phys,aans have a sub-specWty. including cardiology, nephrology, Iheumatology, neurology, pulmonology, allergy and inununology, and gastroenterology. Thus, this organization is influential aaoss much of the Porest product portfoho. ACP is headquartered in Philadelphia and I1U1IltainS an educational focus for members. Their Washington, D.C. office represents the strong policy ann of the organization and actively lobbies 00 health care issues. The D.C. office also houses the department responsible for creating office-based program' aimed at impro\'ing the practice of medicine. Forest became a Corporate Sponsor of ACP in FY03, which provides additional marketing opportunities. ACP is actively participating in the Forest-led collaboration with APA to develop reasonable practice guidelines for managing chronic depression in the Primary Care Physician office-settlng. AMERICAN GERIATRIC SOCIETY The American Geriatric Society (AGS) is the premier physician organization dedicated ro improving the health and well being of all older adul... The majority of the 6,000 AGS members are Primary Care Physicians. In the last decade, AGS has become a pivotal force in shaping attitudea, policies and practices regatding health cau for older people. Most AGS members practice Internal Medicine, and may also be members of ACP. AMERICAN MEDICAL DIRECTORS ASSOCIATION Whil. the majority of the American Medical Directot:s Assoaation (AMDA) members are Medieal Directors of Long Tenn Care Padliae. and Nursing Homes, the organization has always served the in.....ts of both medieal directors and attending physician.. AMDA currendyhas over 8,700 members and a databa.e of over 2,000 attending pbyalcians. all of whom are Primary Care Physicians. Fores' has been a Corporate Sponsor ofAMDA for the last few years. In 2002, AMDA ,evised their Dopresaion Guideline. for Residents ofLTC!NH, and expect to publish them by mid-2003. Pores, Professional Relation. is the major 'pon.or of this endelvor, providing financial, technical, and infonnation support. APPENDIX VIl PR.OFESSIONAL ASSOCIATIONS Confidential FCA0017924 Fore.t helped co-'ponsor AMDA's major p<Ojeet in drug safety in LTC/NH. Mubidisciplina.ry Medication Msnagement Tool Ki~ focuoiDg on reducing errors. Selection of drugs with low potential drug interaction. ODd drugs that are well rolerated by an elderly population are the core them... Th..e Kits. which were introcluoed at AMON. Annual Meeting in March 2003. may be purchased for distribution to LTC/NH as a high·value added program. Foreat has committed to provide major sponsoahip of AMOA's Practice Guideline on the Msnagement of Falls in LTC/NH. A body of evidence supports chonging the current Guiddin..: evaluating medication for potential drug interactions. changing drug therapi.. to reduce drug intetactions and side effects. nther than discontinuing anti.depr....nts. Forest hal committed to provide major .ponsonhip of AMDA's Pncllce Guideline on Dementia, which i. scheduled to begin revisions 4~ quaner2003. Publication is estimated u second-half 2004. AMERICAN ACADEMY OF CHILD AND ADOLESCENT PSYCHIATRY , The Amecican Academy of Child and Adolescent P.ychiau), (MCAP) focus is treating children affected by menw, bebavionl or developmental disorders. and improving the qU2lity of life for their famili... The majority of its 6,500 membea are child and adol..cent psychiatrists. who actively research. evaluate, diagno.e, and treat psychiatric disorders. During FY04 For..t Prof..sional Relations will work withAACAP to explore the potential for consensusguidelin.. On treatment of pediatric depression. Results from any MCAP projects will be shared with APA. AAFP and the American Academy of Pediatrics. NATIONAL ALLIANCE FOR THE MENTALLY ILL The National Alliance for the Mentally ill (NAMI) is a nonprofit, gtassroots, self.help. auppon and advocacy organization of consumers, famili... and mends of people with severe mental illnesses, such as achizophrenia, major depression. bipolar disorder, obsessive-compuaive di.order. and anxiety disorders. The ~traditional· focus of NAMI I12s been on mOre severe mental illn.... though they have recently begun involvement with more moderate di.orders that are managed in a nonpsychistric .etting. Founded in 1979. NAMI has more than 210.000 members who seek equitable service. for people with .evere mental illn.s.... which are known to be physical btain disorders. Working on the national, .tate, and local level•• NAMI provid.. eclucanon abou.t severe brain disorders••upports in......ed funding for research.• and advocs... for adequate health insurance, bouaing, rebabilitation. ODd jobs for people with serious psychiatric illn...... NAMI has an active lobby effort, operating primuily at the State level with some lction at the Federal level. InsUtUlce parity and open farmularies are two of their positions. Forest has been a major Corporate Sponsor ofNAMI ainee 2000. •~PPENDIX VII PROFESSIONAL ASSOCIATIONS Confidential FCA0017925 NATIONAL MENTAL HEALTH ASSOCIATION Established in 1909, the National Mental Health Association (NMHA) is the country's oldest and largest nonprofit organinlion addtemng all aspeelll of mental health and mental illness. With more than 340 affilistes nationwide, NMHA wodu to improve the mental health of all AmeaCIDs, especially the S4 million individuals with mental disorders, through advocacy, education, research and service. NMHA's foundation is consumer-oriented education. In recent years, NMHA has become a saong lobby in support of in,unnoe puity and open fottOulsries. Their national/feden.J lobbying effort is IS strong IS their chaplet·based SlIte activity. Forest has been a major C01porate Sponsor of NMHA since 2000, and participates In several of their educational conferenoes. NMHA has a very effective gra..roots organintion, ,.mob d.votes significant effort in lobbying State Health Departments on maintaining mental health care budgets, including supporting an open Medicaid drug fottOula,y. Forest has e"Panded Its involvement with NMHA, creating an information collaboration to a..ist mutual efforts at the State pohey level. DEPRESSION AND BIPOLAR SUPPORT ALLIANCE IPREVIOUS NAME: NATIONAL DEPRESSIVE AND MANIC·DEPRESSIVE ASSOCIATIONI The JnIssion of the Depression and BIPolar Support Allianc. (nBSA) is to educate patients, families, professionals. and the pubhc: concerning the nature of depresSlve and ma~c-depressive illnesses as treatable mediral diseases; to foster self·help for patients and families; to eliminate discrimination and stigma; to improve ae<:ess to care; and [0 advocate fOl reseuch toward the elimination or these illne..es. Th. DBSA is the nation's largest patient.directed, illn.....pecific organization. Of the 3 la.rgest patient advocaey groups, it is the only one that focuses on depression disorders. DBSA bas a nationwide grassroots network of chapters and ,upport groups. It is governed by a IS-member board of directon and guided by a 65-member Sci.ntific Adviaory Board composed of the leading researchers and clinicians in the field of mood disorders. Forest has been a major Corporate Sponsor of DBSA since 2000. ANXIETY DISORDERS ASSOCIATION OF AMERICA The Anxiety Disorders A.sociation of America (ADM) is the only national, non·profit membership organization dedicated to informing the public, healthcare professionals and legislators that anxiety disorders are real, .erious anel treatable. APPENDIX VII PROFESSIONAL ASSOCIATIONS Confidential FCA0017926 Membe.. include clinicians and reoea:cben who treo. and study anxiety dis"'ders, individuals with anxiety disO<der. and their famili.., and other interested individuals. ADM is a relatively ss:nalJ 0"ll"nization, which hopes to expand its influence in the next few yeus. ADM is very open to active eoUab_tion with industty, including puticipation in public relations activities. Foiea. hu been a Co<pora.e Sponsor since 2000. Marketing opportunities with ADM will inereue when Lc:xapro labeling expands .0 include anxiety disorders. At that tim.. Fora. can take advantage of opponunities .0 disseminate imPOrtall. brand infonnation to their mcmben. APPENDIX va PROFESSIONAL ASSOCIATIONS Confidential FCA0017927 t ~ ~ H H Confidential FCA0017928