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AZSEE10769859

Last Update: 18/12/2000 Version: 1

'SeroctueF Strateav Summai


Compound Description REDACTED debilitating side effects of EPS, extreme weight gain and increased prolactin are also
important to the psychiatrist and patient - and are a major cause of non-com pi sa nee and
'Seroquel' - an oral atypical antipsychotic (dibenzothiatepine derivative) indicated
hence relapse. Seroquel is the only first line antipsychotic which is weight neutral in the
for schizophrenia with a superior tolerabiiity profile and at least as effective as the
major competition. Situation Analysis: long-term and has an EPS and prolactin profile which does not exceed placebo. This is
the major differentiator for Seroque! - 'Improvement without impairment 1 : the only first line
Unmet Me dical Needs:
antipsychotic which offers efficacy without associated EPS, weight and prolactin-related
Approximately 1%of the global population suffers from schizophrenia and 1.5%
side effects EVEN at the highest dose. This translates into unsurpassed clinical
from Bipolar Disorder. Older typical antipsychotics are not we!! tolerated
effectiveness. This profile is highly suited to Bipolar patients.
resulting in a low rate of compliance. The medical need for an effective, well
tolerated antipsychotic was high. W h i l s t t h e atypical antipsychotics achieve
this to a greater or lesser extent, the typicals are still the most widely prescribed
hotics globally :
Key Success 'RequiredActions • RfSK/ Responsible
Factor-1---•,.-•-• - :'. --Urgency-
1 Maintain Increased $ and CNS M/H SET
competitive SoV experienced manpower, MCP
both globally and tJSCs GPT
2 Delivery of Publication/communication UH GPT
compelling data of data to support stronger
into marketplace efficacy message and t o
differentiate on superior
tolerability via:
Data mining, clinical trials,
comparative data, !STs
3 Broaden Seroque! Utilise whole selling team. UH MC
use on and off label Educational programmes t o
share off label data.
4 Maintain Successfully deliver LCM WH GPT
competitive label programme:
Granules 2002
Sustained Release 2003
Bipolar Disorder 2003/4
Remove eye monitoring from
US label.
Defend against potential
FDA label threats: QTc,
diabetes
Superior tolerability t o typicals and first line atypicais 5 Communicate Communicate clear dosing UH GPT
efficacy at the right guidelines and da!a. MC
Weight neutral, placebo-level EPS and prolactin levels, and no clinically significant
dose Promote starter pack.
QT prolongation
SR formulation

LCM claims Timing


PRODUCT STRATEGY - Grower Megabranri
Effective in the treatment of acute mania as monotherapy / adjunct to 2002 Brand Strategy -Win Competitors Customers
mood stabiliser. (Likelihood of achieving claim: High)
AZ aims to optimise Seroquels market penetration, in order to maintain a position of at
Does not induce depressive symptoms in patients with manic 2004 least third (in value terms) in the antipsychotic class The objective for Seroquel is to grow
episodes. (Likelihood of achievinq claim: Hiqh) sales faster than the market and maintain its lead over the expected new market entries.
Significant anxiolytic/calming effect. (Likelihood of achieving claim: 2004 This will be achieved in an increasingly intense competitive environment as Pfizer
High) (ziprasidone) and BMS (aripiprazole). amongst others, enter the marketplace. The long
Efficacy in controlling manic episode demonstrated within 4 days 2004 term aspirationa! target for Seroquel is to overtake the safes of risperidone. The
((Likelihood of achievinq claim: Medium) incidence (per year) of schizophrenia is low, s o a switch strategy is key to achieving this
Placebo-level EPS, prolactin, weight in patients with acute mania. 2004 target.
(Likelihood of achievinq claim: High)
Therapeutic dose achieved at day one with the SR formulation. 2003 Strategic objective Implementation Responsible
(Likelihood of achieving claim: High) Launch (0-2 years) W i n competitors customers i.e MC
Once daily dosing suitable for all patient groups. {Likelihood of 2003 switches from;
achievinq claim: Hiqh) "Penetrate the rapidly • typicals (first fine switch)
Superior risk:benefit profile compared with olanzapine, (Liketihood of 2003 growing atypical market" » atypicais
achieving claim: Medium) Establish Seroquel as atypical
Granules will offer better compliance and more flexible dosing 2002 of choice in the first episode
(25mg, SOrnq, 100m$ t 150rrtg) than ripseridone liquid Differentia) Analysis schizophrenia patients - this
The perceived efficacy of an antipsychotic is the most important attribute to has
psychiatrists when treating patients, In schizophrenia efficacy is viewed in a halo effect as these patients
terms of a spectrum of domains; positive, negative and affective symptoms, are particularly sensitive to EPS
cognition and hostility. Unlike the typical antipsychotics Seroquel is highly and weight gain.
effective in treating all these domains The main atypical competition, Secure launch take off above
ripseridone and olanzapine, have a similar efficacy profile to Seroquel. The ripseridone.

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EXHIBIT NO.
*• >-* Confidential
AZSER 10769859
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