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Content:
Pharmaprojects provides up-to-date intelligence on new
pharmaceutical products under development, from early
pharmacological studies to launch.
PHAR includes over (9,500) investigational drugs believed to be in
active development by over 1,150 pharmaceutical companies worldwide.
It also includes licensing offers relating to over 1,200 products.
Approximately (30,000) discontinued drugs are documented in PHDI,
and PHLP contains about (2,700) launched products (figures correct
as at March 2009).
PHAR includes product information from the publication
'Pharmaprojects'. It covers pharmaceutical products, including
biotechnological products, new formulations and combinations under
development anywhere in the world. Each record in the file is a
report on a single product, providing: its generic name, trade names
and research codes; chemical name and CAS registry number; the
originating company and licensees; detailed information on its stage
of development in 40 countries; and standardized therapeutic
activity descriptors and pharmacological classification codes. Many
records also include an image of the chemical structure.
The text is updated with each stage of the product's development,
initially detailing pharmacological studies, then clinical studies,
progressing through registration and, finally marketing. Each
product entry contains a number of selected literature references,
where appropriate.
Use PHAR to answer questions like:
- what anti-inflammatory compounds are currently being developed by
GlaxoSmithKline ?
- which compounds are in Phase III clinical trials in Japan?
- have any antibiotics been made available for Licensing?
- has Sanofi-Aventis licensed any products to Pfizer?
Pharmaprojects now includes chemical structure images for many
product profiles.
Sources:
PHAR uses literature references to compounds as a starting point for
direct enquiries to the drugs' developers, eliciting stage of
development information which is not available elsewhere.
The database was first launched by PJB Publications (now Informa) in
1980. 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. Also, if no development is reported on a
drug for 12 months, Pharmaprojects contacts the company concerned.
In most cases the company does not respond and the status is changed
to 'No Development Reported'; this change is reflected in the
following week's update to DataStar and the document is moved from
PHAR to PHDI. In some cases, editorial discretion is employed so
that the 12 month time-frame can be extended. This would happen in
the case of late stage compounds where clinical trials take longer
to conduct.
Conference proceedings, annual reports, brokers' reports and other
less widely available literature sources are also used.
Pharmaprojects staff attend major conferences and meetings to report
the most up-to-date information. Offers of licensing or
joint-development agreements are obtained direct from originating
companies. Every week some 50-100 new compounds are added to the
PHAR database and major changes are made to around 100 existing
product entries. Minor changes are made to all entries on a
continuing basis. The file is completely reloaded annually.
Products whose development has been discontinued, those for which
there is no evidence for continuing development and those which have
been launched in all major markets for which they are in development
are removed from the file every week and placed in the PHDI
(Discontinued Products) and PHLP (Launched Products) databases,
respectively, leaving only those which satisfy the criterion of
being in active development.
AN - Accession number & update
020171 MINOR ACTIVE 20081013.
TI - Title
cetuximab.
SO - Source
Pharmaprojects, Informa UK Ltd.
SY - Synonyms
Generic name: cetuximab.
Synonym: anti-EGFR MAbs, ImClone; C225; Erbitux; IMC-C225;
Mab C225.
CI - Chemical information
New chemical entity: No.
CC - Therapeutic classes
Monoclonal-antibody-chimaeric (T3A4); Anticancer-
immunological (K3).
IN - Indications
Cancer-colorectal (Launched); Cancer-head-and-neck
(Launched); Cancer-pancreatic (Phase III Clinical Trial);
Cancer-lung-non-small-cell (Phase III Clinical Trial);
Cancer-breast (Phase II Clinical Trial); Cancer-prostate
(Phase II Clinical Trial); Cancer-ovarian (Phase II Clinical
Trial); Cancer-cervical (Phase II Clinical Trial); Cancer-
endometrial (Phase II Clinical Trial); Cancer-oesophageal
(Phase II Clinical Trial); Cancer-brain (Preclinical);
Cancer-bladder (Preclinical); Cancer-gastrointestinal-general
(Preclinical).
ME - Mechanism of action
Enzyme-Transferase-ErbBiochemical-1-inhibitor (E-TR-KI-TYE1-AN).
RO - Route of administration
Parenteral-intravenous (P-IV).
OS - Origin of substance
Biological-protein-antibody (BI-P-A).
PK - Pharmacokinetic info
Model: Human
Dose: 400 mg/m2 2 hr infusion
Parameter: t1/2
Value (Range): 97 hr.
Model: Human
Dose: 400 mg/m2 2 hr infusion
Parameter: Cmax
Value (Range): 92.32 microg/ml.
Model: Mouse
Dose: 0.04-1.0 mg ip
Parameter: Cmax
Value (Range): 16.5 - 407.6 mg/ml.
Model: Mouse
Dose: 0.04-1.0 mg ip
Parameter: AUC
Value (Range): 0.53 - 19.21 mghr/ml.
Model: Mouse
Dose: 0.4-1.0 mg iv
Parameter: Vd
Value (Range): 0.06 - 0.07 l/kg.
TG - Target data
1956: epidermal growth factor receptor (erythroblastic
leukaemia viral (v-erb-b) oncogene homologue, avian).
Synonym: EGFR; ERBB1; erbB-1; epidermal growth factor
receptor kinase; HER1; v-erb-b oncogene homologue; cell
growth-inhibiting protein 40.
<http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=gene&cmd
=Retrieve&dopt=Graphics&list_uids=1956>.
Target family group:
Enzyme > EC number > 2.7.10.1;
Receptor > Cytokine receptor;
Enzyme > Kinase.
CO - Company name
Originator:
ImClone-Systems (USA) Launched.
Licensee:
Merck-KGaA (Germany) Launched;
Bristol-Myers-Squibb (USA) Launched.
PA - Patent information
Patent publication number: Priority date:
US 5770195 US 19880112.
PH - Drug development phases
Region: Phase: Licensing
availability:
World Launched;
Argentina Launched 2004 Not Available;
Australia Launched Not Available;
Austria Launched 2004 Not Available;
Belgium Launched Not Available;
Brazil Not Available;
Canada Registered Unknown;
Chile Launched 2004 Not Available;
China Launched 2006 Not Available;
Colombia Not Available;
Denmark Registered Not Available;
Finland Launched 2004 Not Available;
France Launched 2004 Not Available;
Germany Launched 2004 Not Available;
Greece Registered Not Available;
Hong Kong Launched 2005 Not Available;
India Launched 2006 Not Available;
Ireland Launched 2004 Not Available;
Israel Launched Not Available;
Italy Launched Not Available;
Japan Pre-registration Not Available;
Luxembourg Launched Not Available;
Malaysia Launched 2005 Not Available;
Mexico Launched 2004 Not Available;
Netherlands Registered Not Available;
New Zealand Phase III Clinical Trial Not Available;
Norway Launched 2004 Not Available;
Peru Not Available;
Philippines Launched 2005 Not Available;
Portugal Registered Not Available;
Russian Federation Not Available;
South Africa Phase III Clinical Trial Not Available;
South Korea Launched 2006 Not Available;
Spain Launched 2005 Not Available;
Sweden Launched 2004 Not Available;
Switzerland Launched 2003 Not Available;
Thailand Not Available;
Turkey Not Available;
UK Launched 2004 Not Available;
USA Launched 2004 Unknown;
Venezuela Not Available.
HP - Highest phase
Launched.
HI - Development history
20061001 (estimated): Additional Launches: China.
20060822 (actual): Additional Launches: India.
20060430 (actual): Additional Launches: S Korea.
20060217 (actual): Additional Registrations: China, India and
Taiwan.
20051115 (actual): Additional Launches: Malaysia.
20051004 (actual): Additional Launches: The Philippines.
20050915 (actual): Additional Launches.
20050915 (actual): Additional Registrations: Canada.
20050915 (actual): Additional Registrations: Ecuador, Malaysia
and the Philippines.
20050909 (estimated): New Indication: Cancers: ovarian, cervical,
endometrial and oesophageal.
20050715 (actual): Additional Registrations: Bulgaria, Guatemala
and Panama.
20050217 (estimated): Additional Launches: Spain.
20040630 (actual): Additional Registrations: The EU, Iceland and
Norway.
20040630 (estimated): Additional Launches: EU countries.
20040605 (estimated): Additional Registrations: Argentina and
Mexico.
20040229 (estimated): Additional Launches: Argentina, Chile and
Mexico.
20040229 (estimated): Additional Launches: The US.
20040212 (actual): Additional Registrations: The US.
20031201 (actual): First Launches: NAS, Switzerland,
20031201 (actual): First Registrations: Switzerland,
20030814 (actual): Change in Licensee Status: Bristol-Myers
Squibb, Pre-registration.
20030627 (actual): Registration Submissions: Switzerland.
20011228 (actual): Status Reversion: Phase III Clinical Trial.
20010919 (actual): New Licensees: Bristol-Myers Squibb.
20010628 (actual): Registration Submissions: The US.
20000703 (actual): Orphan Drug Status Granted: The US, Cancer,
head and neck.
20000531 (estimated): Names Granted: C225.
19981215 (estimated): New Licensees: Merck KGaA.
19980915 (estimated): Licensing Opportunities: Worldwide.
19980515 (estimated): Change in Status: Phase III Clinical Trial.
19951015 (estimated): Change in Status: Phase II Clinical Trial.
19950415 (estimated): Change in Status: Phase I Clinical Trial.
19930715 (estimated): New Product in Pharmaprojects.
ST - Status
Therapy: Monoclonal antibody, chimaeric (T3A4)
Mechanism of action: (KI-TYE1-AN)
Status: Launched (L).
Therapy: Anticancer, immunological (K3)
Mechanism of action: (KI-TYE1-AN)
Status: Launched (L).
RA - Rating
Novelty rating: Leading Compound (6).
Market size: US$ 2001-5000 million (3).
Development speed: Average (3).
Total rating: 12.
TX - Text
Cetuximab (C225) is a chimaeric MAb specific for epidermal Growth
factor receptor (EGFR), developed by ImClone Systems for cancers
overexpressing EGFR. Cetuximab inhibits the receptor-associated
tyrosine kinase, thus blocking the intracellular signalling
pathway that results in cell proliferation (Direct communication,
ImClone, 22 Mar 2001). ImClone is also developing a
non-chimaeric version of cetuximab (IMC-11F8; qv).
Marketing
It is launched in Switzerland (2003), Argentina, Austria, Chile,
Finland, France, Germany, Iceland, Ireland, Mexico, Norway,
Sweden, the UK, the US (2004), Hong Kong, Malaysia, Spain (2005),
China (2006), Australia, Belgium, the Czech Republic, Israel,
Italy, Luxembourg, Poland and Slovakia, in combination with
irinotecan (qv) or as a single agent, for metastatic colorectal
cancer (MCC) patients who no longer respond to irinotecan (Press
releases, Merck KGaA, 1 Dec 2003 & 17 Feb 2005; Direct
communication, Merck KGaA, 9 Nov 2005). It is launched as
Erbitux in S Korea (2006) for colorectal and head and neck
cancers (HNC) (Pharma Koreana, Jun 2006). It is launched as
Erbitux in India (2006) for colorectal cancer and HNC (Scrip
Daily Online, 22 Aug 2006, S00931184 & 10 Oct 2006, S00936398).
It is approved as Erbitux in Canada for MCC (Press release, BMS &
ImClone, 15 Sep 2005). It is launched in the Philippines (2005)
and approved in Bulgaria, Ecuador, Guatemala, Panama and Taiwan
(3rd Qtr Res, Merck KGaA, 2004 & 4th Qtr Res, Merck KGaA, 2005).
It is approved in Switzerland and the US (orphan drug) for
previously- untreated advanced squamous cell carcinoma of the
head and neck (SCCHN) and SCCHN where platinum-based therapy has
failed, respectively (Press releases, ImClone, 22 Dec 2005 & 1
Mar 2006). It is approved in the EU, Iceland and Norway in
combination with radiotherapy for locally-advanced SCCHN (Press
release, Merck KGa A, 3 Apr 2006). It is approved in Chile,
Israel and Mexico for HNC (3rd Qtr Res, Merch KGaA, 2006). A US
sBLA to include overall survival in the label for use in 3rd-line
MCC has been made and granted priority review (Press release,
BMS, 11 Jun 2007). US filings for 2nd- and 1st-line nsclc and
1st-line pancreatic cancer are planned (Scrip Daily Online, 22
Nov 2004, S00864506). It is licensed to Bristol-Myers Squibb
(BMS) for development and co- promotion in Canada and the US
(Direct communication, BMS, 19 Sep 2001). BMS and ImClone have
expanded their agreement in order to conduct further clinical
trials in tumour types such as brain, breast, bladder, gastric,
lung, pancreas and prostate cancers (Press release, BMS, 27 Jul
2007). It is licensed exclusively to Merck KGaA for development
and marketing outside Canada and the US (Press release, Merck
KGaA, Dec 1998). Merck KGaA has co-exclusive rights in Japan
where it has been filed for MCC (Press releases, Merck KGaA, 7
Jul 2003 & ImClone, 5 Feb 2007). ImClone has agreements with
Genentech and Centocor (Johnson & Johnson) for the rights to
patents covering aspects of the antibody technology and use of
EGFR antibodies (Press release, ImClone, 26 Jan 2005).
Clinical
Phase III
It is in Phase III trials in 1st-line colorectal cancer, 1st-
line head and neck cancer, and 1st-line nsclc, with Phase III
trials in 2nd-line colorectal cancer planned (Company Fact Sheet,
Merck Serono, May 2007). In a pivotal Phase III trial in 329 MCC
patients, cetuximab + irinotecan response was greater and longer
in irinotecan-refractory patients, cf cetuximab alone (22.9 cf
10.8% and 5.7 cf 4.2mth, respectively) (Scrip Daily Online, 22
Jul 2004, S00851966). In the EPIC study in 1301 patients
examining best supportive care with or without cetuximab in
patients refractory to oxaliplatin (qv) + irinotecan + 5-FU, it
failed to meet the primary endpoint of overall survival. It
strongly favoured the secondary endpoints of PFS and response
rate (42nd ASCO (Atlanta), 2006, Abs 3556; Press release, Merck
KGaA, 6 Nov 2006), with patients on irinotecan + cetuximab, there
was a 54% improvement in survival without disease progression cf
irinotecan alone, and 31% reduction in the risk of disease
progression (Press release, ImClone & BMS, 16 Apr 2007). In the
CRYSTAL Study in 1212 patients with MCC, cetuximab + FOLFIRI
(5-FU + folinic acid + leucovirin) met the primary endpoint of
increasing duration of PFS (Press release, BMS, 10 Jan 2007). In
an open-label, randomized Phase III trial (SWOG-0205) in Canada
and the US, in >700 patients with locally-advanced unresectable
or metastatic pancreatic cancer, 1st-line cetuximab and/or
gemcitabine hydrochloride (qv) failed to meet the primary
endpoint of improving overall survival. However, a pilot study is
planned to study cetuximab + bevacizumab (qv) with or without
gemcitabine hydrochloride in pancreatic cancer (Press release,
ImClone, 10 Apr 2007). A randomized Phase III trial (IMCL-0452)
in 800 2nd-line nsclc patients to compare docetaxel or pemetrexed
(both qv) alone, and cetuximab + docetaxel or pemetrexed, on
tumour response rate (primary endpoint), PFS and overall survival
(secondary endpoints) is planned. It is in a randomized Phase III
trial (EMR-046; FLEX) in 1124 nsclc patients in Asia, Europe and
Latin America, comparing a platinum-based therapy + vinorelbine
(qv) alone or in combination with cetuximab (Press releases,
ImClone & BMS, 7 Oct 2004 & ImClone, 16 Feb 2006). In a Phase III
trial in 1st-line treatment of >600 nsclc patients (BMS
CA225-009), it failed to meet the primary endpoint of PFS,
although secondary endpoints including response rates were met
(Press release, BMS, 12 Jun 2007). In a pivotal Phase III trial
(EMR-62202-006/IMCL CP02 9815) in Europe, Israel, New Zealand and
S Africa in 424 patients with locally-advanced SCCHN, cetuximab
400mg/m2 iv 1wk prior to radiation and 250mg/m2 1x/wk x7wk during
radiation, resulted in locoregional control in 69 and 56% at 1
and 2yr, respectively, cf 59 and 48% for radiation alone. Overall
survival was 62, 57 and 56% at 1, 2 and 3yr, respectively, cf 55,
44 and 45% for radiation alone. The median overall survival was
54 cf 28mth for radiation alone. Patients on cetuximab had more
fever, nausea and vomiting cf radiation alone. Fatigue and
stomatitis were not increased with cetuximab. 3% of cetuximab
patients experienced grade 3/4 allergic reactions (Press
releases, ImClone & Merck KGaA & BMS, 5 Jun 2004 & 16 Nov 2005;
40th ASCO (New Orleans), 2004, Abs 5507). In a randomized
European Phase III trial (EXTREME) in 442 patients with recurrent
and/or metastatic HNC to compare cisplatin/ carboplatin (both qv)
+ 5-FU with or without cetuximab, it met its primary endpoint of
increasing overall survival (Press release, BMS, 4 Apr 2007).
Phase II
Phase II monotherapy trials (MC-0144/EMR-62202-027) in 346
patients with refractory MCC in Belgium and the US were conducted
(3rd Qtr Res, Merck KGaA, 2003). In a Phase II trial in
pancreatic carcinoma, cetuximab + gemcitabine hydrochloride
produced an overall survival rate of 32.5% at 1yr (Press release,
ImClone, 14 Aug 2001). In a Phase II European study (LUCAS) in
combination with cisplatin + vinorelbine in 61 chemotherapy-naïve
nsclc patients, cetuximab increased tumour response rates from
32.2 to 53.3% (Scrip Daily Online, 26 Jun 2003, S00806386). In a
Phase II trial (CALGB-80203) in 238 patients with untreated MCC,
receiving FOLFIRI or FOLFOX, cetuximab gave a response rate
(secondary endpoint) of 52 cf 38% on chemotherapy alone (Press
release, ImClone, 5 Jun 2006). In a Phase I/II trial of cetuximab
+ cisplatin in lung cancer, preliminary results in 5 patients
showed 2 minor responses (34th ASCO (Los Angeles), 1998, Abs
1514). In 30 nsclc patients with advanced progressive disease
receiving cetuximab + docetaxel, there were 8PRs and 8SDs (Press
release, BMS, 19 May 2002). In a Phase Ib/IIa trial of 22
patients with nsclc and HNC, cetuximab 5-400mg/m2 was well
tolerated. In the 9 patients who received doses of 100, 200 and
400mg/m2, there were 2PRs, 6SDs and 1PD (Scrip, 1997, 2239, 23).
In a Phase Ib/IIa trial in 15 patients with locally advanced
SCCHN, cetuximab + radiation gave 13CRs and 2PRs. At 2.5yr, 60%
remained progression-free, with 4 patients experiencing 27mth
response (Press release, ImClone, 23 May 2000). It is in Phase II
trials for ovarian, cervical, endometrial and oesophageal cancers
(12th Ann NewsMakers Biotech Ind (New York), 2005).
Phase I
In a Phase I dose-escalation study in recurrent SCCHN, cetuximab
100-500mg/m2 + cisplatin 100mg/m2 q 3wk produced 1 mixed
response, 3PRs and 1CR, with fully resolvable AEs, including
fever, allergic reactions and skin toxicities (35th ASCO
(Atlanta), 1999, Abs 1502).
Preclinical
In mice implanted with human breast cancer cells, an EGFR Ab
enhanced the antiproliferative effect of doxorubicin (Scrip,
1993, 1861, 27). It is covered by US5770195 (Press release,
ImClone, 26 Jan 2005). Updated by IL on 30/7/2007.
Major change date
20061001: Additional Launches: China.
Entry date
20070730.
Latest Change: 20070730: Expansion of BMS and ImClone
agreement reported (IL).
Label/Description Example
AN Accession number 1_: 020171.AN.
- new records in the database 2_: NEW=YES
- major change to a record 3_: MAJOR=YES
- minor change to a record 4_: MINOR=YES
& update - see Limit options -
TI Generic name 5_: CETUXIMAB.TI.
SO Source - Pharamprojects (same for
all documents) -
SY Synonyms 6_: ANTI ADJ EGFR ADJ
MABS.SY.
RN CAS registry numbers 7_: 110942-02-4.RN.
MF Moleular formula 8_: C34H63N9O8S.MF.
IM Image(s) - displays only when
accessed via Web-based
platforms -
- documents with drug structure
images 9_: IMAGE=YES
CI Chemical information
- molecular weight 10_: MOLECULAR ADJ WEIGHT
WITH '337.42'.CI.
- hydrogen bond acceptors 11_: ACCEPTORS WITH
'4'.CI.
- hydrogen bond donors 12_: DONORS WITH '1'.CI.
- AlogP 13_: ALOGP WITH '3.20'.CI.
- rotatable bonds 14_: ROTATABLE WITH
'6'.CI.
- new chemical entities 15_: NEW-ENTITY=YES
CC Therapeutic classes 16_: ALIMENTARY ADJ
METABOLIC.CC.
- display a list of terms with a
common stem 17_: ..ROOT METABOL.CC.
17_: A16.CC.
- add # for broader retrieval 18_: T3#
IN Indications 19_: CANCER ADJ
ENDOMETRIAL.IN.
- display a list of terms with a
common stem 20_: ..ROOT CANCER.IN.
- display a full list of
Indications 21_: ..ROOT IN=
ME Mecahnism of action 22_: ERBBIOCHEMICAL ADJ
'1' ADJ INHIBITOR.ME.
or 23_: E-TR-KI-TYE1-AN.ME.
- display a list of terms with a
common stem 24_: ..ROOT CYCLASE.ME.
- display a full list of
mechanisms of action 25_: ..ROOT ME=
- see also Notes, below -
RO Route of administration 26_: PARENTERAL ADJ
INTRAVENOUS.RO.
or 27: P-IV.RO.
- display a list of terms with a
common stem 28_: ..ROOT TOPICAL.ME.
- display a full list of
routes of administration 29_: ..ROOT RO=
OS Origin of substance 30_: BIOLOGICAL ADJ
ANTIBODY.OS.
or 31_: BI-P-A.OS.
- display a list of terms with a
common stem 32_: ..ROOT SYNTHETIC.OS.
- display a full list of
origins of substance 33_: ..ROOT OS=
PK Pharmacokinetic info 34_: MOUSE WITH CMAX.PK.
TG Target data 35_: EPIDERMAL WITH
RECEPTOR.TG.
or 36_: TG=1956
CO Company name (includes OR and LC) 37_: IMCLONE ADJ
SYSTEMS.CO.
or 38_: JOHNSON-AND-
JOHNSON.CO.
or 39_: ..ROOT BRISTOL.CO.
OR Originator - as per CO -
LC Licensee - as per CO -
- documents with licensee data 40_: LC=AVAILABLE
PA Patent information 41_: US ADJ 5770195.PA.
- see also Limit options -
PH Drug development phases 42_: ITALY WITH
LAUNCHED.PH.
- launched in Ireland in 2004 43_: IRELAND WITH LAUNCHED
ADJ 2004.PH.
- availabile for licensing in
South Africa 44_: LICENSING=AVAILABLE
WITH SOUTH ADJ
AFRICA.PH.
- see also Notes -
HP Highest phase 45_: LAUNCHED.HP.
- display a list of all phases 46_: ..ROOT HP=
HI Development history 47_: 2003$4 WITH FIRST ADJ
LAUNCHES.HI.
- see also Notes, below -
ST Status 48_: T3A4.ST.
or 49_: CHIMAERIC WITH
LAUNCHED.ST.
RA Ratings
NR= Novelty rating 50_: NR=6
MS= Market size 51_: MS=2
DS= Development speed 52_: DS=4
TR= Total rating 53_: TR=12
- see also Notes, below -
TX Text 54_: MICE WITH BREAST ADJ
CANCER.TX.
MJ Major change date - see Limit options -
- see also Notes, below -
ED Entry date - see Limit options -
- see also Notes, below -
1_: TRANPLANT ADJ
REJECTION.IN.
MJ Major change date 2_: ..L 1 MJ GT 20070726
LA Latest change date (in ED) 3_: ..L 1 LA>20071231
ED Entry date 4_: ..L 1 ED GT 20080401
PR Priority date (in PA) 5_: ..L 1 PR<19841203
UDATE Update date 6_: ..L 1 UPDATE=20081012
UMONTH Update month 7_: ..L 1 UMONTH WL
04,
200810
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 - Generic name, Source _: ..P TI, SO 1-5
SHORT AN TI SO SY CC IN CO (OR LC) HP ED
MEDIUM AN TI SO SY CC IN ME RO OS PK CO (OR LC) PH HP RA TX MJ ED
LONG AN TI SO SY RN MF CI CC IN ME RO OS PK TG CO (OR LC) PA PH
HP HI ST RA TX MJ ED
ALL AN TI SO SY RN MF IM CI CC IN ME RO OS PK TG CO (OR LC) PA
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KWIC Context of search terms from TX paragraph
FREE AN TI SO ED
_: ..P SHORT 1-10.
CHANGES IMPLEMENTED WITH THE NOVEMBER 2008 RELOAD
There are significant changes to the layout of documents - in terms
of paragraph names and labels, and the sequence in which they are
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paragraphs - e.g. data in ST (Status) is no longer presented in
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Search functionality has been improved - all searches which work in
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Changes being implemented:
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TI - Title
SO - Source
SY - Synonyms
RN - CAS Registry number
MF - Molecular formula
IM - Image(s)
CI - Chemical information
CC - Therapeutic classes
IN - Indications
ME - Mechanism of action
RO - Route of administration
OS - Origin of substance
PK - Pharmacokinetic info
TG - Target data
CO - Company name
OR - Originator
LC - Licensee
PA - Patent information
PH - Drug development phases
HP - Highest phase
HI - Development history
ST - Status
RA - Rating
TX - Text
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ED - Entry date
- Paragraph changes - new:
MF - Molecular formula (previously in CI - Chemical information)
ME - Mechanism of action (previously in PC - Pharmacological
codes)
OS - Origin of substance (previously in CI)
HI - Development history (previously in DT - Date of update)
MJ - Major change date (previously in DT)
- Paragraph changes - deleted:
CN - Country and product status (unnecessary synonym for PH -
Phase of development)
DE - Descriptors (unnecessary synonym for CC - Therapeutic
classes)
PC - Pharmacological codes (to new paragraph ME - see above)
DT - Date of update (to new paragraphs HI and MJ - see above)
LA - Latest change (to ED - Entry date)
OC - Occurrences (obsolete)
- Quick-code changes - new:
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MF= - Molecular formula (MF)
IN= - Indications (IN)
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RO= - Route of administration (RO)
OS= - Origin of substance (OS)
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- Lipinski data (Molecular weight, Hydrogen bond acceptors and
donors, and AlogP)
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The data in the CI paragraph is all prefixed with the appropriate
label (e.g. Molecular weight, Rotatable bonds etc) so that it is
easily identified. All of these prefixes are searchable.
ME - Mechanism of action codes:
Mechanism of action (pharmacological) codes are hierarchical, so an
adrenergic alpha agonist has the code ADR-A-1-AG. To retrieve all
adrenergic alpha agonists, search as:
4_: ADR-A$
CO/OR/LC - Company names:
The company name paragraph is subdivided into originator companies
(OR) and licensees (LC). For information relating specifically to
licensees or originators use the appropriate paragraph
qualification, e.g.:
5_: INTERNEURON.LC.
PH - Drug development phases:
New in February 2007 is the addition of mandatory licensing
availability information for all 40 countries covered by
Pharmaprojects.
Four availability statuses are available - which are retrievable
with the following quick-codes:
LICENSING=AVAILABLE (currently available for licensing)
LICENSING=UNAVAILABLE
LICENSING=UNKNOWN
You can, additionally, add the name of one of the countries covered
by Pharmaprojects to find licensing status in that country, e.g.:
6_: LICENSING=AVAILABLE WITH JAPAN
HI/MJ/ED - Significant dates:
Only major changes in the status of a drug's development are
reported in the HI (Development history) paragraph. A full list of
what constitutes a major change appears in the Pharmaprojects
database guide - refer to the section on how to search the HI
paragraph.
The most recent major change in the development status of a drug (as
listed in HI) is also given in the MJ (Major change date) paragraph.
Use the MJ Limit option to restrict retrieval to a previously
completed search to only those documents which have undergone a
major status change within a defined time-frame, e.g.:
7_: CANCER ADJ BILIARY.IN.
8_: ..L 6 MJ GT 20061231
The ED (Entry date) paragraph lists two dates:
- the date of the latest change in the development status of the
drug; this can be either a major or a minor change so may or
may not be the same as the date shown in HI and MJ. The nature
of the change is also described. If you want to retrieve
documents for which ANY change was made within a defined time-
frame, search as e.g.:
9_: ..L 7 LA GT 20061231
- the date on which the document was most recently entered into
the Pharmaprojects database (as opposed to when it was loaded
onto DataStar - which appears in the AN paragaph). Generally
this is the same, or perhaps a few days later than the latest
change date that also appears in the ED paragraph.
Search options:
..SET PLURALS ON and ..SET MEDWORD ON can be selected in PHAR.
.RANK and ..MAP: Are available in RN, CC, IN, ME, RO, OS, OR, LC,
PH AND HP.
..START is available in PHAR, PHLP and PHDI but not PHZZ.
Refer to Pharmaprojects's online guide in BASE for a full
description on searching the database - search as BASE-PHAR.
TERMS AND CONDITIONS
TERMS AND CONDITIONS FOR THE DOWNLOADING AND ELECTRONIC STORAGE
AND/OR DISTRIBUTION OF DATA FROM THE PJB PUBLICATIONS LTD ELECTRONIC
NEWS AND INFORMATION DATABASES AS FOLLOWS BUT NOT LIMITED TO: PHID
PHIC, PHIN, PHCO, PHAR, PHAB, PHAX, PHAZ, PHLP, PHZZ, PHID,
PHAR-THERA, PHAR-COMP AND DIALOG FILES 128, 928, 129, 130 AND 131
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