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File Description [top]

Pharmaprojects reports on the progress of new pharmaceutical products, both new chemical entities and biotechnological entities, at all stages of development from early pharmacological studies either to final launch in all major markets or to discontinuation for scientific or commercial reasons.

File 128 is the public file; File 928 is the subscriber file, available to those who subscribe to the print Pharmaprojects.

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Subject Coverage [top]

Pharmaprojects primarily addresses the information needs of the pharmaceutical industry and closely related fields, but is also of interest to those involved in the evaluation of pharmaceutical company performance. Each entry contains the product name, synonyms, originating company and development status, licensees and development status, stage of development in up to 40 countries, rigorously classified therapeutic activity, drug protein target, chemical name (conforming to CAS index name format where possible), CAS^® Registry Number, Lipinski "Rule of 5" data, molecular formula, pharmacology and patent/priority data, and descriptive text with key literature references.

Sources [top]

Pharmaprojects is compiled from both published and unpublished sources. A considerable amount of information is obtained directly from the companies involved in product development. In addition, Pharmaprojects staff attend international meetings to obtain information directly from research scientists. They also scan conference proceedings and the scientific and medical literature to track new products. Pharmaprojects also has a rigorous programme of contacting the companies in the publication and regularly scanning their websites to ensure that Pharmaprojects is a completely up-to-date source of international pharmaceutical product development information.

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SAMPLE RECORD [top]

	DIALOG(R)File 128: PHARMAPROJECTS
	(c) 2007 INFORMA UK LTD. All rights reserved.
	0028927        ** Image available **
/DN,DN=,/NA,NA=	Drug Name:     lestaurtinib
/ST,ST=	World Status:  Phase III Clinical Trial
	Pharma Status: Active
/SY,SY=	Synonyms:      A-154475.0
	CEP-701
	KT-5555
	SP-924
	SPM-924
/CO,CO=/LO,LO=	Originator:   Cephalon (USA) [Phase III Clinical Trial]
/CO,CO=,/LI,LI=	Licensee:      Abbott  (USA) [Phase II Clinical Trial]
	Takeda  (Japan) [Phase II Clinical Trial]
	Kyowa Hakko  (Japan) [Preclinical]
	UCB  (Belgium) [Suspended]
LU=	Latest Upd:    Updated On  By  Latest Change
	20070320    SR  Preclinical data in myeloproliferative
	disorders reported
	ACTIVITY DATA
/TC,TC=	Therapy:       Code     Description
	K6Z      Anticancer, other
	D5A      Antipsoriasis
/RO,RO=	Rte of Admin:  Code     Description
	A-PO     Alimentary, po
/PH,PH=	Pharmacology:  Code -- Description
	KI-FLT3-AN -- Flt-3 kinase inhibitor
/LG	Therapy  Pharmacology                  Developement
	Linking:       Code     Code1       Code2   Code3     Status
	K6Z      KI-FLT3-AN                    Phase III Clinical Trial
	D5A      KI-FLT3-AN                    Phase II Clinical Trial
/IN	Indication:    Description -- Status
	Cancer, leukaemia, acute myelogenous -- Phase III Clinical
	Trial
	Cancer, prostate -- Phase II Clinical Trial
	Cancer, pancreatic -- Phase II Clinical Trial
	Cancer, CNS -- Phase II Clinical Trial
	Cancer, myeloma -- Phase II Clinical Trial
	Psoriasis -- Phase II Clinical Trial
/TG,TG=	TARGET DATA
	Target Name [LocusLink/Entrez Gene ID]
	2322: fms-related tyrosine kinase 3
	http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=gene&cmd=Retrieve&dopt=Gra
	phics&list_uids=2322
	4914: neurotrophic tyrosine kinase, receptor, type 1
	http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=gene&cmd=Retrieve&dopt=Gra
	phics&list_uids=4914
	Target Data Codes:
	2322: FLT3; 2322: FLK2; 2322: STK1; 2322: CD135; 2322: stem
	cell tyrosine kinase 1; 2322: CD135 antigen; 2322: FL
	cytokine receptor; 2322: foetal liver kinase 2; 2322:
	tyrosine-protein kinase receptor FLT3; 4914: NTRK1; 4914:
	MTC; 4914: TRK; 4914: TRKA; 4914: tyrosine kinase receptor A;
	4914: DKFZp781I14186
/TF	Target Families:
	2322: Enzyme > EC number > 2.7.10.1;
	2322: Enzyme > Kinase;
	2322: Receptor;
	4914: Enzyme > EC number > 2.7.10.1;
	4914: Enzyme > Kinase;
	4914: Receptor.
/PK	PHARMACOKINETICS
	Model (Dose)--Parameter--Values--Unit
	Human (40mg po bid)--Tmax--3 - 1--hr
	CHEMICAL DATA
/OM,OM=	Origin:   Code      Description
	CH-SY   Chemical, synthetic
NC=	New Entity:    Yes
RN=	CAS Reg. No:   111358-88-4
RB=	Rot. Bonds:    3
MF=	Mol. Formula:  C26H21N3O4
HD=,HA=	Hydrogen Bond Donors: 3     Hydrogen Bond Acceptors: 4
MW=,AL=	Mol. Weight:   439.47       AlogP: 3.07
/CN,CN=	Chemical Name:
	9,12-Epoxy-1H-diindolo(1,2,3-fg:3',2',1'-kl)pyrrolo(3,4-
	i)(1,6)benzodiazocin-1-one,
	2,3,9,10,11,12-hexahydro-10-hydroxy-10-
	(hydroxymethyl)-9-methyl-, (9S,10S,12R)- (CAS)
	STRUCTURE
	COUNTRY DATA
/ST,ST=	Status:     (Active)
	Japan              Preclinical/Licensing Availability Unknown
	USA                Phase III Clinical Trial/Licensing Availability Unknown
	World              Phase III Clinical Trial
	MAJOR EVENTS
/UP,UP=	Event Date  A/E    Event—Details
	20061023    Est    Change in Status--Phase III Clinical Trial
	20061023    Est    New Indication—Psoriasis
	20061023    Est    New Therapeutic Activity--Antipsoriasis D5A
	20060404    Act    Orphan Drug Status Granted--The US, Cancer,
	leukaemia, acute myelogenous
	20060110    Est    New Indication--Cancer, myeloma
	20041101    Est    Names Granted--CEP-701
	20040413    Est    New Indication--Cancer, CNS
	20030611    Est    Pharmacology Identified--Flt-3 antagonist KI-FLT3-
	20020419    Est    New Indication--Cancer, leukaemia, acute myelogenous
	20010220    Est    Suspended Products--Phase II Clinical Trial
	20000608    Est    New Licensees--Kyowa Hakko
	20000308    Est    New Chemical Structure—New
	20000120    Est    Change in Licensee Status--TAP Abbott/Takeda,
	Phase II Clinical Trial
	20000111    Est    New Licensees--Schwarz Pharma
	19991013    Est    Licensing Opportunities—Europe
	19990317    Est    New Product in Pharmaprojects
NR=,SR=,MR=,TR=	RATING:   Novelty: 6  (Leading Compound)
	Development Speed: 2  (Slower than Average)
	Market Size: 3  (US$ 2001-5000 million)
	Total Rating: 11  (Total Rating)
/TX	TEXT:
	Lestaurtinib (CEP-701) is an oral indolocarbazole inhibitor of
	several tyrosine kinases, including Flt-3 and TrkA, under
	development by Cephalon for the treatment of acute myelogenous
	leukaemia (AML), pancreatic cancer and multiple myeloma (MM)
	(Direct communication, Cephalon, 9 Mar 1999; Ann Rep, 2001,
	Cephalon; Press release, Cephalon, 4 Apr 2006).
	Marketing
	A filing for AML is expected in the 4th qtr of 2007 (Company
	presentation, Cephalon, 27 Nov 2006). It is licensed to Kyowa Hakko
	for Japan (as KT-5555) (Scrip Daily Online, 5 Jun 2000, S00667230).
	It is licensed to Schwarz Pharma (UCB) for development and
	marketing (as SPM-924) in Europe and certain other territories
	outside Japan and the US (Scrip Daily Online, 30 Dec 1999; Direct
	communication, Schwarz Pharma, 9 Sep 2000; Company Web Page,
	Schwarz Pharma, 6 Feb 2001). It has US orphan drug status for the
	treatment of AML (Press release, Cephalon, 4 Apr 2006). It was
	previously put on hold by Schwarz Pharma, as a Phase II study was
	halted due to side-effects and drop-outs (Direct communication,
	Schwarz Pharma, 27 Feb 2001).
	Clinical
	Phase III
	It is in Phase III trials for AML (Company Web Page, Cephalon, 23
	Oct 2006).
	Phase II
	It is in Phase II trials for prostate cancer, paediatric
	neuroblastoma and AML in early-stage patients, and in combination
	with other therapies (Analyst Day, Cephalon, 13 Apr 2004; Company
	Web Page, Cephalon, 7 Jun 2005). It is in Phase IIa trials in MM
	(JP Morgan 24th Ann Healthcare Conf (San Francisco), 2006).
	(. . .)
	Preclinical
	In vitro, lestaurtinib inhibited wild-type JAK2. In human HEL92.1.7
	V617F mutated cells, HEL92.1.7 wild-type cells and HEL92.1.7
	xenografts in nude mice, lestaurtinib was inhibitory. In CD34+
	peripheral blood cells from myeloproliferative disorder patients,
	lestaurtinib >100nM inhibited growth by >50% in 2/4 polycythaemia
	cell lines, 10/11 essential thrombocytopenia cell lines, 2/2
	agnogenic myeloid metaplasia cell lines and 1 AML cell line. In
	CD34+ cell cultures from normal bone marrow, lestaurtinib did not
	inhibit growth. Lestaurtinib 30-100nM strongly inhibited JAK2/STAT5
	and AKT signalling, and suppressed expression of BclxL and cyclin
	D1/D1 (48th Meet Am Soc Hematol (Orlando), 2006, Abs 3594).
	Lestaurtinib was in preclinical trials in Japan (as KT-5555) for
	prostate cancer (Ann Rep, Kyowa, 2001; Scrip Daily Online, 5 Jun
	2000, S00667230). Updated by SR on 20/3/2007.
PD=	Published:    20070406
RD=	Revised:      20070321

BASIC INDEX [top]

¹ Searchable in the Basic Index and in the Additional Indexes.

² Includes Originator and Licensee.

³ Use the (S) operator to link with Status.

⁴ Includes Chemical Name, Laboratory Code, Brand Name, and Generic Name.

⁵ Includes Laboratory Code, Brand Name, and Generic Name.

⁶ Present for about 40% of records. Includes Target Data Codes, Terms, and Families. Records that do not have Target Data display: "99999999: Unspecified..."

ADDITIONAL INDEXES [top]

⁷ Most of these codes are searchable only as PH= but not as /PH.

⁸ For records starting 2001.

LIMIT [top]

SORT [top]

RANK [top]

MAP [top]

USER-DEFINED FORMAT OPTIONS [top]

PREDEFINED FORMAT OPTIONS [top]

DIRECT RECORD ACCESS [top]

Rates [top]

Rates For File: Pharmaprojects[128]
Cost per DialUnit:                $43.67
Cost per minute:                   $9.12
Rank Elements                      $0.00
ALERT (default)                   $22.00
ALERT (Monthly)                   $33.45
ALERT (Biweekly/twice a month) *  $26.30
ALERT (Weekly)                    $22.00
ALERT (Daily)                  *  $22.00
ALERT (Calendar weekly)        *  $22.00
ALERT (Intraday)               *  $22.00
* = custom scheduled Alerts only
ALERT Number of included prints        0

Format    Types   Prints
     1    $0.00    $0.00
     2   $23.15   $23.15
     3   $23.15   $23.15
     4   $23.15   $23.15
     5   $23.15   $23.15
     6    $0.00    $0.00
     7   $23.15   $23.15
     8    $0.00    $0.00
     9   $23.15   $23.15
    14   $26.30   $26.30
    19   $26.30   $26.30
KWIC95   $23.15       NA
KWIC96   $23.15       NA

REDIST/COPY Multiplier Table:

      Range      Multiplier
        1-2       1.00
       3-25       1.50
     26-100       3.00
    101-200       4.00
    201-500       6.00
   501-1000       8.00
 1001 or more    10.00

ARCHIVE Multiplier Table:

      Range      Multiplier
       1-25       1.50
     26-200       3.00
    201-500       6.00
   501-1000       8.00
 1001 or more    10.00
---------------------------------

A charge of $20.00 applies to each CSS (Chemical Structure Search)
whether searching in one database or across multiple databases.  The
standard output charges for each database apply to any documents
retrieved.

Rates For File: Pharmaprojects - subscribers[928]
Cost per DialUnit:                $43.67
Cost per minute:                   $9.12
ALERT (default)                   $22.00
ALERT (Monthly)                   $33.45
ALERT (Biweekly/twice a month) *  $26.30
ALERT (Weekly)                    $22.00
ALERT (Daily)                  *  $22.00
ALERT (Calendar weekly)        *  $22.00
ALERT (Intraday)               *  $22.00
* = custom scheduled Alerts only
ALERT Number of included prints        0

Format    Types   Prints
     1    $0.00    $0.00
     2   $12.00   $12.00
     3   $12.00   $12.00
     4   $12.00   $12.00
     5   $12.00   $12.00
     6    $0.00    $0.00
     7   $12.00   $12.00
     8    $0.00    $0.00
     9   $12.00   $12.00
    14   $15.20   $15.20
    19   $15.20   $15.20
KWIC95   $12.00       NA
KWIC96   $12.00       NA

REDIST/COPY Multiplier Table:

      Range      Multiplier
        1-2       1.00
       3-25       1.50
     26-100       3.00
    101-200       4.00
    201-500       6.00
   501-1000       8.00
 1001 or more    10.00

ARCHIVE Multiplier Table:

      Range      Multiplier
       1-25       1.50
     26-200       3.00
    201-500       6.00
   501-1000       8.00
 1001 or more    10.00
---------------------------------

A charge of $20.00 applies to each CSS (Chemical Structure Search)
whether searching in one database or across multiple databases.  The
standard output charges for each database apply to any documents
retrieved.