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Content:
R&D Focus provides the complete picture on scientific and
Commercial developments in international pharmaceutical R&D.
IPUR allows you to monitor stages of development of drugs
Including biotechnological products, combinations and new
formulations. All aspects of drug development from earliest
laboratory or patent report to international market launches are
presented. IPUR provides easy access to latest intelligence on
drug development worldwide.
Each document includes full product synonyms, licensing status,
patent development history, pharmacological mode of action,
phase changes, commercial potential and estimated launch dates
by country.
Use IPUR to:
- monitor changes in phase of analgesic drugs in development
- identify licensing opportunities worldwide
- continually track competitor drugs in development
- find all antibiotics approaching worldwide launch
Sources:
IPUR is compiled from information provided directly from companies
involved in R&D, interviews with key executives, official press
releases and meetings.
The database was first launched by IMS in 1991. Any drugs under
investigation at that time will continue to appear in the database.
Even if research is discontinued, or a drug has been successfully
launched, the record relating to the drug remains in the database.
Additional sources include:
medical and clinical symposia, research conferences and meetings,
scientific journals, trade journals and patents.
AN - Accession number & update
2000273 MAJOR ACTIVE 20061002.
TI - Title
quetiapine.
SO - Source
IMS R&D Focus Drug Updates, IMS Health.
SY - Synonyms
Generic name: quetiapine (pINN); quetiapine fumarate.
Laboratory code: ZD 5077; Zeneca 204636; ICI 204636; FK 949.
Trade name: SEROQUEL.
Chemical name: 2-(2-(4-dibenzo(b, f)(1,4)thiazepin-11-yl-1-
piperazinyl)ethoxy)ethanol.
RN - CAS Registry number
111974-69-7 (quetiapine); 111974-72-2 (fumarate (2:1), Zeneca
204636); 111974-71-1 (maleate (1:1)); 111997-26-3
(dihydrochloride).
IM - Image
[Contains a drug structure when viewed on DataStar Web!
CC - Therapeutic classes
Antipsychotics (N5A); Psycholeptics-Anxiolytics (N5C);
Psychoanaleptics-Antidepressants (N6A).
IN - Indications
schizophrenia; bipolar-disease; psychosis; anxiety;
depression.
ME - Mechanism of action
dopamine-antagonist; dopamine-D2-antagonist; 5HT-antagonist;
5HT2-antagonist.
RO - Route of administration
oral.
OS - Origin of substance
chemical-synthesis.
CO - Company name
AstraZeneca (UK);
Parent: AstraZeneca (UK);
Role: licensor.
Astellas (Japan);
Parent: Astellas (Japan);
Role: licensee;
Region: Japan.
PA - Patent information
Primary patentee: ICI.
Summary: Product: EP 240228 B 1990, priority GB 7684 1986,
designating 13 states. Equivalents identified in 24
countries.
PH - Drug development phases
Phase Region Indication
----- ------ ----------
Marketed Worldwide schizophrenia
Phase III Worldwide depression
Phase III Worldwide anxiety
Marketed UK bipolar disease
Marketed Japan bipolar disease
Phase II Japan psychosis
Registered Mexico bipolar disease
Registered USA bipolar disease
Registered New Zealand bipolar disease
Registered EU bipolar disease.
HP - Highest phase
Marketed.
HI - Development history
DEC 2005: Pre-registration, USA (depressive episodes
associated with bipolar disease).
APR 2005: Fujisawa merges with Yamanouchi to form Astellas.
JUN 2004: Marketed, Japan (bipolar disease).
FEB 2004: Registered, Japan (bipolar disease).
JAN 2004: Marketed, UK (bipolar disease). Registered, USA
(bipolar disease).
Q4 2003: Registered, New Zealand, Italy, UK (bipolar
disease).
OCT 2003: Registered, EU (bipolar disease). Approvable
letter, USA (bipolar disease).
SEP 1987: Phase I, USA.
AUG 1986: Preclinical, USA.
MAR 1986: Priority product patent application filed in the
UK, by ICI.
TX - Text
13 February 2006: AstraZeneca reported on 2 February 2006
that it is conducting phase III trials of its sustained
release formulation of the D2/5HT2 antagonist quetiapine
(SEROQUEL) in the treatment of generalized anxiety disorder
(GAD) and in major depressive disorder. An estimated MAA
filing for each indication is 2008, with an NDA for sustained
release quetiapine for GAD predicted for second half 2007 and
for major depressive disorder in 2008. Phase III trials of
this formulation are also being conducted in the treatment of
schizophrenia, and MAA and NDA filings are predicted for
third quarter 2006. Quetiapine is also being evaluated in
phase III trials for bipolar maintenance, with MAA and NDA
filings in this indication expected second half 2007 and
first half 2007, respectively. An NDA for quetiapine in
bipolar depression has been filed in the USA, and an MAA in
this indication is predicted for first half 2007. 20 February
2006: Analyst prediction.
Commercial overview
AstraZeneca has developed quetiapine (SEROQUEL), an atypical
antipsychotic agent, which is a dopamine D2 antagonist and
5HT2 antagonist. Quetiapine was first launched in the UK in
September 1997 for the treatment of schizophrenia, and has
subsequently been launched in the USA, Canada, New Zealand,
Latin America and most of Europe and Japan for this
indication. In January 2004, quetiapine was marketed in the
UK for the treatment of bipolar disorder, and has been
launched in Japan for the same indication. The agent has been
granted marketing approval in the EU, Mexico and New Zealand
for the treatment of manic episodes associated with bipolar
disorder. In addition, in January 2004, quetiapine was
approved in the USA as a monotherapy and adjunct therapy with
lithium or divalproex for the short-term treatment of acute
manic episodes associated with bipolar disorder, and is
pending approval for the treatment of depressive episodes
associated with bipolar disorder, following an sNDA filing in
the USA in December 2005. AstraZeneca is conducting phase III
trials of a sustained release formulation in schizophrenia,
generalized anxiety disorder and major depressive disorder.
In March 1986, ICI (now known as AstraZeneca) filed a
priority product patent application in the UK. In December
1998, Zeneca (now known as AstraZeneca) granted Fujisawa (now
known as Astellas) rights to market quetiapine in Japan.
Launches
AstraZeneca has launched quetiapine in the UK for the
treatment of schizophrenia (Zeneca, SEP 1997). Further
launches have taken place in the USA (IMS, OCT 1997), Canada
(IMS, MAR 1998), New Zealand, Latin America and most of
Europe for this indication. Quetiapine has been launched in
Japan by licensee Fujisawa (now known as Astellas) as a
treatment for schizophrenia (Fujisawa, FEB 2001). Quetiapine
has also been marketed in the UK for the treatment of manic
episodes associated with bipolar disorder (AstraZeneca, JAN
2004). Fujisawa (now known as Astellas) has launched
quetiapine in Japan for the treatment of biopolar disease
(Fujisawa, JUN 2004).
Clinical data
Schizophrenia
In phase II trials, quetiapine had a clozapine-like profile.
It had a high affinity for 5HT2 receptors and a lower
affinity for dopamine-D2 and dopamine-D1 receptors. In a
pilot multicenter trial of 105
patients receiving quetiapine at 75-750 mg/day for 28 days, a
significant change was seen in Brief Psychiatric Rating Scale
score. Clinical response was seen in 36% of patients. No
granulocytosis was reported. Results from three phase II
trials showed no significant difference between quetiapine
and placebo in terms of elevated plasma prolactin levels
after up to six weeks of treatment, and in the degree of
decline of prolactin levels. Prolactin levels in quetiapine-
treated subjects fell to a greater degree than in
chlorpromazine-treated subjects, and in all three trials
quetiapine did not cause a sustained elevation of prolactin
(Hammer, M.B., EMBASE: 96176663).
Results from placebo-controlled studies, one open-label study
and one study in which quetiapine was compared with
chlorpromazine, showed quetiapine to be an effective
treatment of both the positive and negative symptoms of
schizophrenia, with significantly superior efficacy to
placebo and comparable to chlorpromazine. Quetiapine also
caused fewer side effects or acute dystonic reactions (rates
similar to placebo) across the dose range, with no sustained
elevations in serum prolactin (Casey, D.E., EMBASE:
96242530).
In phase III trials comparing quetiapine with haloperidol,
quetiapine decreased symptoms as assessed by BPRS, the
Clinical Global Impression (CGI) of Illness and the Scale for
the Assessment of Negative Symptoms (SANS) to the same extent
as haloperidol. Extrapyramidal symptoms (EPS) induced by
quetiapine were similar to placebo, whereas haloperidol
increased EPS. Common side effects of quetiapine were
agitation, headache, dizziness and postural hypertension. No
sustained elevation of prolactin levels, or tendency
to cause cardiac arrhythmias were observed.
ED - Entry date
20060213.
Label/description Example
AN Accession number 1_: 20000273.AN.
& update - see Limit options
- see also Notes below -
TI Generic name 2_: QUETIAPINE.TI.
- see also Notes below -
SO Source - same for all documents -
SY Synonyms 3_: ZD ADJ 5077.SY.
4_: SEROQUEL.SY.
5_: THIAZEPIN WITH
ETHANOL.SY.
RN CAS Registry number 6_: 111974-72-2.RN.
7_: FUMARATE.RN.
IM Drug structure image(s) 8_: IMAGE=YES
- see also Notes below -
CC Therapeutic class 9_: PSYCHOLEPTICS-
ANXIOLYTICS.CC.
10_: N5C.CC.
11_: N5#
IN Indications 12_: BIPOLAR-DISEASE.IN.
ME Mechanism of action 13_: DOPAMINE-ANTAGONIST.ME.
..ROOT ME= for a list
RO Route of administration 14_: ORAL.RO.
..ROOT RO= for a list
OS origin of substance 15_: CHEMICAL-SYNTHESIS.OS.
..ROOT OS= for a list
CO Company names 16_: ASTELLAS.CO.
(CO includes OR and LC)
OR Originator 17_: ASTRAZENECA.OR.
LC Licensee 18_: BRISTOL-MYERS$.LC.
AV Availability 19_: AVAILABLE WITH
WORLDWIDE.AV.
- drugs available
for licensing 20_: LICENSING=AVAILABLE
PA Patent information 21_: ICI.PA
PH Drug development phases 22_: PHASE ADJ II WITH JAPAN
WITH PSYCHOSIS.PH.
HP Highest phase 23_: MARKETED.HP.
..ROOT HP= for a list
- see also Limit options -
HI Development history 24_: REGISTERED.HI.
EL Estimated launch dates 25_: PRECLINICAL WITH USA.EL.
TX Text 26_: MARKET$3 WITH
(TX includes LI, CS and SS) APPROVAL.SU.
LI Latest information 27_: PHASE ADJ III.LI.
CS Commercial summary 28_: LAUNCHED WITH JAPAN.CS.
SS Scientific summary 29_: MULTICENTER ADJ
STUDY.SS.
ED Entry date - see Limit options -
1_: ANTIBIOTICS
HP Highest phase 2_: ..L 1 HP>20
- to retrieve drugs reaching AT LEAST phase I
clinical trials
- see Notes below for a list of phases and their
corresponding stage numbers
EL Estimated launch date 3_: ..L 1 EL>20051231
- only available for a minority of documents
ED Entry date 4_: ..L 1 ED=20060726
UDATE Update date 5_: ..L 1 UDATE>20061004
UMONTH Update month 6_: ..L 1 UMONTH GT 200610
Images (IM) will display ONLY in the ALL/FULL format, and only
When searching via DataStar Web or DataStar Classic on the Web.
By paragraph _: ..P SY, CO 1-10
SHORT AN TI SO SY CC IN CO (OR LC) HP ED
MEDIUM AN TI SO SY CC IN ME RO OS CO (OR LC) PH HP
TX (LI CS SS) ED
LONG AN TI SO SY RN CC IN ME RO OS CO (OR LC) AV
PA PH HP HI EL TX (LI CS SS) ED
ALL AN TI SO SY RN IM CC IN ME RO OS CO (OR LC)
AV PA PH HP HI EL TX (LI CS SS) ED
KWIC Context of search terms from TX paragraph.
FREE AN TI SO ED
_: ..P MEDIUM 1-5,19-20
AN - Accession number & update - useful flags for Alerts:
The AN paragraph contains 'flags' providing useful information
particularly for Alerts customers:
- NEW - include NEW=YES in your Alert strategy to retrieve
only those drug profiles which are completely new to
the database with the latest update.
- MAJOR - include MAJOR=YES in your Alert strategy to retrieve
only those drug profiles that have undergone a major
revision since the latest update
- ACTIVE - include ACTIVE=YES in your Alert strategy to retrieve
only those profiles where the drug is known to be
under active development.
These flags can be mixed and matched as appropriate, e.g.:
1_: (NEW=YES OR MAJOR=YES) AND ACTIVE=YES
TI/SY - Title/Synonyms:
The generic name (where available) appears in both the TI and SY
paragraphs. If a generic name is not available one of the other
alternative names from SY (laboratory code, trade name, chemical
name) will be repeated in TI.
Remember to use TI to check you have the correct documents
without incurring display charges i.e. ..P TI 1-10.
IM - Drug structure image(s):
From May 2002, documents in IPUR may contain drug-structure
images.
These images are only viewable via Web-based interfaces:
DataStar Web or DataStar Classic on the Web.
Additionally, note that the IM paragraph is included in the ALL p
print format only.
For very large structures, it may not be possible to display the
full image. In these cases the structure is shown as a group of
letters. Each letter group represents an amino-acid.
HI - Highest phase range searching (stage number):
In addition to being able to retrieve only those profiles where
a drug has reached a specific phase of development, it is also
possible to restrict retrieval to all drugs which have reached
that phase or beyond. Equally, you can retrieve only those
drugs which have NOT reached a certain phase of development.
For example to retrieve all records relating to antineoplastics
that have reached at least phase I clinical trials or beyond,
search as:
1_: L1#
2_: ..LIMIT 1 HP GT 20
Equally, to retrieve only those neoplastics in phase I, II or
III clinical trials, search as:
3_: ..LIMIT 1 HP WL 30,50
The following is the list of stage numbers that correspond to
phases of development:
- Withdrawn 1
- Discontinued 2
- Suspended 3
- Technology 5 (new, May 2004)
- Discovery 10 (new, May 2004)
- Pre-clinical 20
- Phase I clinical trial 30
- Phase II clinical trial 40
- Phase III clinical trial 50
- Pre-registration 60
- Registered 70
- Marketed 80
EL - Estimated launch date:
LIMIT operates on the earliest date only when more than one date
is present.
To find all drugs launched since a particular date, search as
e.g.:
1_: L1#
2_: ..LIMIT 1 GT 20051231
Note that estimated launch dates are only available for a small
umber of drug profiles.
Search Options:
..SET PLURALS ON and ..SET MEDWORD ON can be selected in IPUR.
Guides:
The database guide to IMS R&D Focus Drug Updates can be found in
the BASE database - search as BASE-IPUR.
.
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