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Pharmaprojects provides up-to-date intelligence on new
pharmaceutical products under development, from early
pharmacological studies to launch.
PHAR includes over 8,400 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 28,000 discontinued drugs are documented in PHDI, and
PHLP contains about 2,500 launched products.
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 Aventis licensed any products to Pharmacia?
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 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 14-18 months,
Informa 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 14-18 month time
point 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 25-40 new compounds are added to the PHAR
database and major changes are made to around 250 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. All companies with products appearing
in PHAR are contacted at least annually and are offered the
opportunity to comment on the completeness and accuracy of their
products' entries.
AN - Accession number & update
005358 20070118.
SO - Source
Pharmaprojects, Informa UK Ltd.
TI - Title
aldesleukin.
SY - Synonyms
Generic name: aldesleukin;
Synonyms: IL-2, Novartis-3; interleukin, Novartis-3; Leuferon 2;
Macrolin IL- 2; Proleukin; Ro-23-6019;
Chemical name: 2-133-Interleukin 2 (human reduced), 125-L-serine-
(CAS).
RN - CAS Registry number
110942-02-4.
OR - Originator
Originator:
Novartis (Switzerland) Launched.
LC - Licensee
Licensee(s):
Orion Pharma (Finland) Launched
Hoffmann-La Roche (Switzerland) Launched
Genesis Pharma (Greece) Launched
Ajinomoto (Japan) Phase III Clinical Trial.
PA - Patent information
Patent publication number: Priority date:
US 4752585 US 19851217.
PH - Drug development phases
World Launched;
Argentina Licensing Availability Unknown;
Australia Launched 2000
Licensing Availability Unknown;
Austria Launched
Licensing Availability Unknown;
Belgium Launched
Licensing Availability Unknown;
Brazil Licensing Availability Unknown;
Canada Launched 1995
Licensing Availability Unknown;
Chile Licensing Availability Unknown;
China Licensing Availability Unknown;
Colombia Licensing Availability Unknown;
Denmark Launched 1989
Licensing Availability Unknown;
Finland Pre-registration
Licensing Availability Unknown;
France Launched 1990
Licensing Availability Unknown;
Germany Launched 1990
Licensing Availability Unknown;
Greece Launched
Licensing Availability Unknown;
Hong Kong Launched
Licensing Availability Unknown;
India Licensing Availability Unknown;
Ireland Launched 1989
Licensing Availability Unknown;
Israel Launched
Licensing Availability Unknown;
Italy Launched 1990
Licensing Availability Unknown;
Japan Phase III Clinical Trial
Licensing Availability Unknown;
Luxembourg Launched
Licensing Availability Unknown;
Malaysia Licensing Availability Unknown;
Mexico Launched
Licensing Availability Unknown;
Netherlands Launched 1989
Licensing Availability Unknown;
New Zealand Licensing Availability Unknown;
Norway Licensing Availability Unknown;
Peru Licensing Availability Unknown;
Philippines Licensing Availability Unknown;
Portugal Registered
Licensing Availability Unknown;
Russian Federation Launched 1992
Licensing Availability Unknown;
South Africa Licensing Availability Unknown;
South Korea Launched
Licensing Availability Unknown;
Spain Launched 1990
Licensing Availability Unknown;
Sweden Pre-registration
Licensing Availability Unknown;
Switzerland Launched
Licensing Availability Unknown;
Thailand Licensing Availability Unknown;
Turkey Licensing Availability Unknown;
UK Launched 1992
Licensing Availability Unknown;
USA Launched 1992
Licensing Availability Unknown;
Venezuela Licensing Availability Unknown.
HP - Highest phase
Launched.
TX - Text
Aldesleukin is a stable human interleukin-2 (IL-2) mutein,
developed by EuroCetus (Chiron) (now Novartis). A liquid
formulation of aldesleukin (aldesleukin, Chiron-2; qv) is also in
development (Company Web Page, Chiron, 18 Aug 2003; Press
release, Chiron, 23 Jul 2003).
Marketing
It is launched in Denmark (by Orion Pharma, which also has
marketing rights for other Nordic countries), Ireland, the
Netherlands (1989), France, Germany, Italy, Spain (1990), the UK,
the US, the former USSR (1992) for renal cell carcinoma (RCC)
(orphan drug status), Canada (1995) (Ligand had exclusive 5yr
distribution rights), Australia (2000) for metastatic RCC,
Belgium and Luxembourg for advanced/metastatic RCC and melanoma,
S Korea and Switzerland. It is launched as Proleukin in Austria,
Greece, Hong Kong and Israel. It is registered in Portugal
(Scrip, 1992, 1713, 22; 1762, 25 & 1997, 2225, 22; Direct
communications, Orion Pharma, Mar 1994 & Ligand, 20 Mar 1999;
Press releases, Chiron, Sep 1994 & Aug 1998). It is launched in
the US (1998) and Canada for the treatment of metastatic melanoma
(orphan drug status) (Press release, Chiron, Jan 1999). EuroCetus
filed for approval in the rest of the EU (approval recommended)
(Scrip, 1992, 1717, 25). The US FDA granted aldesleukin orphan
Drug status for the treatment of non-Hodgkin's lymphoma (NHL) and
acute myelogenous leukaemia (AML) (Scrip, 1999, 2401, 20). It has
EU orphan drug status for the treatment of RCC (Scrip Daily
Online, 6 Aug 2003, S00811584). Roche has a non-exclusive cross-
licence from EuroCetus for aldesleukin and will co-market
aldesleukin in the EU and Switzerland, except Denmark and Greece.
Roche and Chiron are parties to certain aldesleukin licence and
marketing agreements with Amgen (previously Immunex) (which holds
US patents for aldesleukin production and an anti-IL-2 MAb)
pursuant to which Amgen is to receive royalties on US and
European sales. Roche's agreement for aldesleukin therapeutic and
diagnostic products extends for 15yr. Amgen has a further
agreement with Ajinomoto for the development of aldesleukin in
Japan (Phase III for RCC and melanoma), S Korea and Taiwan
(Company communication, Immunex, Feb 1996). Aldesleukin is
also launched by Tecnofarma in Latin America, including Mexico
(sublicensed to Laboratorios Raffo for Argentina) (Scrip, 1993,
1830, 12 & 1835, 12; Direct communication, Tecnofarma, 15 Jun
2004). It is distributed and marketed by Genesis Pharma in Cyprus
and Greece (Company Web Page, Genesis, 16 Dec 2005). It was
licensed in France for use in people with advanced HIV infection
(CD4 counts <200cells/mm3) (Press release, Chiron, 9 Sep 1999).
The responsibility for the SILCAAT trial was transferred from
Chiron to the Scientific Committee for SILCAAT investigators
(Press release, Chiron, 14 Jan 2003).
Clinical
Phase III
Aldesleukin sc is in a randomized Phase III trial (SILCAAT) in
1400 HIV-infected people with CD4+ counts of 50-300 cells/ml and
viral loads >10000 copies/ml under active antiretroviral therapy
(ART) (Press release, Chiron, 19 Aug 1999; 13th Int AIDS Conf
(Durban), 2000, Abs WePeA4083; Company Web Page, Chiron, 20 Feb
2001). A Phase III trial (003) in low grade NHL is complete (JP
Morgan 23rd Ann Healthcare Conf (San Francisco), 2005). A trial
in paediatric patients with AML has been conducted (Scrip Daily
Online, 7 Jan 1999).
Phase II
It is in a randomized, multinational Phase II trial (PEaRL) in
300 rituximab-naive low-grade NHL patients in combination with
Rituximab (qv) (2nd Qtr Rep, Chiron, 2004). Patients will receive
rituximab alone 375mg/m2 iv 1x/wk x4wk or in combination with
aldesleukin 14MIU sc 3x/wk in wk2-5 or 10MIU sc 3x/wk in wk 6-9.
The primary endpoint is overall response rate and the secondary
enpoint is time to progression within 2yr (Company brochure,
Chiron, Aug 2004). It is in a Phase II trial in combination with
rituximab in patients with low-grade NHL who have failed previous
rituximab monotherapy (enrollment ongoing; 29 patients evaluated
as of Jan 2004). Preliminary data indicated efficacy in patients
refractory or unresponsive to rituximab (2nd Qtr Rep, Chiron,
2004; Press release, Chiron, 8 Jan 2004). A 2nd Phase II trial in
combination with rituximab + chemotherapy for high-grade NHL has
been discontinued as a result of limited efficacy (Company Web
Page, Chiron, 18 Aug 2003; Press releases, Chiron, 29 Oct 2003 &
8 Jan 2004).
(...)
CC - Therapeutic classes
Recombinant-interleukin (T2A2); Cytokine (I2); Anticancer-
immunological (K3); Immunostimulant-anti-AIDS (I1A);
Immunomodulator-anti-infective (J7B).
ED - Entry date
20061215.
CI - Chemical information
Origin of material: BI-P-R; Biological, protein, recombinant;
New chemical entity: No.
PC - Pharmacological codes
IL-2-AG: Interleukin 2 agonist
Physiological, Hormonal, Interleukin 2 agonist: Proleukin
agonist: TCGF agonist: IL 2 agonist: T cell growth factor
agonist: P-H-IL-2-AG.
ST - Status
Therapy Pharmacology Status
T2A2 IL-2-AG L
I2 IL-2-AG L
K3 IL-2-AG L
I1A IL-2-AG C3
J7B IL-2-AG C3.
PK - Pharmacokinetic info
Model Parameter Value Unit
(range)
Human (iv) bioavailability 41 %
Human (iv) t1/2alpha 0.22 hr
Human (iv) t1/2beta 1.42 hr.
TG - Target data
3559: interleukin 2 receptor, alpha.
Synonym(s): IL2RA; CD25; IL2R alpha; TCGFR; CD25c; IL2 receptor
alpha; IDDM10.
<http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=gene&cmd=
Retrieve&dopt=Graphics&list_uids=3559>.
Target family group:
Receptor > Cytokine receptor > Class I.
RO - Route of administration
P-SC; Parenteral, subcutaneous P-IV; Parenteral, intravenous.
IN - Indications
Cancer, renal Launched;
Cancer, melanoma Launched;
Infection, HIV/AIDS Phase III Clinical Trial;
Cancer, leukaemia, acute myelogenous Phase III Clinical Trial;
Cancer, lymphoma, non-Hodgkin's Phase III Clinical Trial.
RA - Rating
2; Novelty Rating - Established Strategy
4; Market Rating - US$ 5001-10000 million
0; Speed Rating - Not available
0; Total Rating - Total Rating.
DT - Date of update
20051216 Est New Licensees; Genesis Pharma, Cyprus and Greece;
20040615 Est Additional Launches; Latin America including Mexico;
20030808 Act Orphan Drug Status Granted; The EU, Cancer, renal;
20001130 Est Additional Launches; Australia;
19981015 Est Additional Registrations; S Korea;
19960815 Est New Licensees; Ligand;
19960115 Est Additional Registrations; Switzerland;
19950915 Est Additional Launches; Canada;
19941215 Est Additional Registrations; Canada;
19941215 Est New Licensees; Ligand Pharmaceuticals;
19930815 Est New Licensees; Laboratorios Raffo, Tecnofarma
Internacional;
19921215 Est Additional Registrations; Portugal;
19920915 Est Additional Launches; The US;
19920615 Est Additional Launches; Belgium, Luxembourg and the
former USSR;
19920615 Est Additional Registrations; Austria and the US;
19920615 Est New Licensees; Laevosan;
19920315 Est Additional Launches; The UK;
19920215 Est Additional Registrations; The UK;
19900615 Est Additional Launches; France, Italy and Spain;
19900415 Est Additional Registrations; Italy;
19900215 Est Additional Launches; Ireland and W Germany;
19891215 Est Additional Launches; Denmark;
19891215 Est Additional Registrations; Spain;
19891015 Est Additional Registrations; Ireland;
19890915 Est First Launches; The Netherlands;
19890815 Est First Registrations; Denmark.
LA - Latest change
20060420 (AG) Acquisition of Chiron by Novartis reported.
OC - Occurrences
SY (1).
Label/Description Example
AN Accession number 1_: 005358.AN.
& update - see Limit options -
SO Source - Pharamprojects - the same
for all records
TI Generic name 2_: ALDESLEUKIN.TI.
SY Synonyms 3_: PROLEUKIN.SY.
or 4_: IL WITH CHIRON.SY.
IM Image - display in DSWeb only -
- documents with drug structure
images 5_: IMAGE=YES
RN CAS registry numbers 6_: 110942-02-4.RN.
CO Company name (includes LC and OR) 7_: GADOR WITH TIVA.CO.
OR Originator 8_: CHIRON.OR.
LC Licensee 9_: GADOR WITH TIVA.LC.
PA Patent information 10_: US ADJ 4752585.PA.
PR= Priority date 11_: PR=19851217
PH Drug development phases 12_: ITALY WITH LAUNCHED.PH.
(or use CN synonym)
- Availability for licensing 13_: LICENSING=AVAILABLE WITH
(see also Notes below) JAPAN
HP Highest phase 14_: LAUNCHED.HP.
TX Text 15_: BONE ADJ MARROW.TX.
CC Therapeutic classes 16_: ALIMENTARY ADJ
METABOLIC.CC.
17_: A16.CC.
(or use DE synonym)
DE Descriptors 18_: ALIMENTARY ADJ
METABOLIC.CC.
19_: A16.CC.
(or use CC synonym)
ED Entry date
ED= Entry date 20_: ED=20000407
CI Chemical information 21_: BI-P-R.CI.
- New chemical entities 22_: NEW-ENTITY=YES
- see also Notes below -
PC Pharmacological codes 22_: IL-2-AN.PC.
(mechanism of action)
or 23_: TCGF ADJ ANTAGONIST.PC.
ST Status 24_: M2C.ST.
or 25_: D4A WITH IL-2-AN WITH
C.ST.
PK Pharmacokinetic info 26_: HUMAN WITH CMAX.PK.
TG Target data 27_: INTERLEUKIN WITH
RECEPTOR.TG.
RO Route of administration 28_: TOPICAL WITH OINTMENT.RO.
IN Indications 29_: TRANSPLANT ADJ
REJECTION.IN.
RA Ratings
NR=Novelty rating 30_: NR=6
MS=Market size 31_: MS=2
DS=Development speed 32_: DS=4
TR=Total rating 33_: TR=12
DT Information update 34_: NEW ADJ LICENSEE.DT.
or 35_: 20020130.DT.
- see also Limit options -
MAJOR=Major change 36_: MAJOR=YES
MINOR=Minor change 37_: MINOR=YES
NEW=New document 38_: NEW=YES
LA Latest change 39_: 200212$.LA.
OC Occurrences - display only -
1_: TRANPLANT ADJ
REJECTION.IN.
LA Latest change date 2_: ..L 1 LA>20011214
MJ Major change date 3_: ..L 1 MJ GT 19991101
PR Priority date 4_: ..L 1 PR<19841203
ED Entry date 5_: ..L 1 ED GT 20000401
UDATE Update date 6_: ..L 1 UPDATE=20000404
UMONTH Update month 7_: ..L 1 UMONTH WL 200004,
200005
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 SO TI SY OR LC HP CC ED IN
MEDIUM AN SO TI SY OR LC CN HP TX CC ED CI PK RO IN LA
LONG AN SO TI SY RN OR LC PA CN HP TX CC ED CI PC ST PK RO IN LA
ALL AN SO TI SY IM RN CO OR LC HP PA CN PK TG RO IN TX CC CI ED DE
CI PC ST RA LA
KWIC Context of search terms from TX paragraph
FREE AN SO TI ED
_: ..P SHORT 1-10.
PHAR - use PHAR to search for drugs under development
PHLP - use PHLP to search for fully launched products
PHDI - use PHDI to search for discontinued, withdrawn and 'no
development reported' products
PHZZ - use PHZZ for complete coverage, unless you are sure of a
drug's status
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.:
1_: 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=FUTURE (available for licensing in the future)
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.:
2_: LICENSING=AVAILABLE WITH JAPAN
ED - Entry date:
This is added by the database producer and indicates the date on
which new documents were added to the database or when any change at
all is made to the document.
CI - Chemical information:
This paragraph contains information on Origin of material, Lipinski
- Origin of material,
- Indication if substance is a new chemical entity (new Feb 2007)
- Lipinski data (Molecular weight, Hydrogen bond acceptors and
donors and AlogP)
- Rotatable bonds
- Molecular formula.
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.
DT - Information update:
A brief history of the major changes made to the document during the
Pharmaprojects subscription year - see also MJ limit option below.
IM - Image
Images are only viewable via Web-based interfaces: DataStar Web or
DataStar Classic on the Web.
Additionally, note that the IM field is included in the ALL print
format only.
MJ - Major change date:
If a document is new to the database, or has had a major change made
to it (i.e. an entry is added in the DT paragraph) it is possible
for you to retrieve only these documents by using the MJ limit
option. For example, to retrieve all new or 'major revision'
documents on antidepressants added to the database since 30 June
2001, search as:
2_: N10A.CC.
3_: ..L 2 MJ>20010630
When carrying out an Alert in PHAX (which contains the most recent
update data for PHAR, PHLP and PHDI), you can use the MAJOR=YES
quick code to retrieve only 'major revision' documents e.g.:
4_: N10A.CC. AND MAJOR=YES
PC - Pharmacological codes:
Pharmacological codes are hierarchical, so an adrenergic alpha
agonist has the code ADR-A-1-AG. To retrieve all adrenergic alpha
agonists, search as:
5_: ADR-A$
Search options:
..SET PLURALS ON and ..SET MEDWORD ON can be selected in PHAR.
..RANK and ..MAP: Are available in the RN paragraph.
..START is available in PHAR, PHDI and PHLP but not PHZZ.
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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, PHAP, PHZZ, PHID,
PHAR-THERA, PHAR-COMP AND DIALOG FILES 128,928,129,130 AND 131
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