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Coming, Going and Gone:

The Drug Development Pipeline, 2001

tagline September 2001

Development Terminated

GW420867X/HBY1293GlaxoSmithKlineJAIDS 2000; also summer IAS meeting
ALX40-4CAllelix PharmaceuticalsFormulation difficulties, lack of efficacy
AMD3100AnorMed Inc.Cardiac arrhythmias at high doses, lack of efficacy at low
PD-178390Parke-DavisCasualty of Pfizer merger
CI-1012Parke-DavisCasualty of Pfizer merger
PNU-142721Pharmacia & UpjohnCasualty of P&U's decision to leave HIV field
NSC 651016Pharmacia & UpjohnCasualty of P&U's decision to leave HIV field
UC781Biosyn Inc.Being developed as topical microbicide
zintevir/AR-177Antigenics (formerly Aronex)Terminated subsequent to takeover and poor results

Clinical Hold

emtricitabine/FTC/CoviracilTriangle/AbbottSubmission of NDA to be "significantly delayed"
(-)dOTC/BCH-10618/SPD754Shire Pharmaceuticals PLCDeaths in monkeys
capravirine/S-1153/AG-1549Agouron (Pfizer)Vasculitis in dogs may mean curtains for capravirine
mozenavir/DMP-450DuPont (now BMS)Electro-cardiographic abnormalities in animals

Glacial Development

Pentafuside/T-20Trimeris/RochePhase III; awaiting construction of peptide plant
T-1249Trimeris/RochePhase I; longer half-life may allow QD dosing

Late Pipeline

tenofovir/VireadGileadFDA hearing set for October 3; Expanded Access info
emivirine/MKC-442/CoactinonTriangle/AbbottTriangle hopes to file NDA by year end; ICAAC

Middle Pipeline

atazanavir/BMS-232632Bristol-Myers SquibbMoving slowly but deliberately through phase II
tipranavirBoehringer-Ingelheim"Trinity of major obstacles," paper at summer IAS
VX-175/GW433908Vertex/GlaxoSmithKlineAmprenavir prodrug, PK dose-ranging at 8th CROI
SCH-CSchering/PraecisRecently released from clinical hold, but future dim; IAS paper
PRO 542Progenics PharmaceuticalsPhase II; being studied in combination with T-20
DPC-083DuPont (now BMS)Eyed to hit market in 2003; paper at 7th CROI

Deep Pipeline

DADP/amdoxovirTriangle PharmaceuticalsPhase I/II dose ranging study presented at 8th CROI
TMC-120, 125Tibotec/Virco"Resistant repellent"; Russian-Polish study at 8th CROI
TMC-126Tibotec/VircoPaper at 8th CROI
DPC-961, DPC-963DuPont (now BMS)Atazanavir may take priority over these
Calanolide-ASarawakMedPaper on this at 7th CROI
GPG-NH2Tripep AB/Karolinska InstituteEarly activity in humans not too impressive
SCH-DSchering/PraecisFollow-up compound to SCH-C
UK-427,857PfizerSaid to be moving into Phase I "soon"
DPC-681, DPC-684DuPont (now BMS)Phase I studies on-going; paper at 8th CROI
AMD-3465, 8445, 8664AnorMedAMD8664 is orally available analogue of AMD3100
TAK-779Takeda PharmaceuticalsBeing studied in combination with T-20
HE2000Hollis-Eden PharmaceuticalsPhase I/II enrolling in U.S.; info from company; other
PRO 140Progenics PharmaceuticalsMoving into Phase I/II; press release
PRO 367Progenics PharmaceuticalsPhase I recently completed
TNX-355/Hu5A8Tanox Biosystems, Inc.Phase I clinical study began 8/1/01
PEHRG214VirionyxPhase I at Boston Deaconess Hospital, 3/01
HIV NCp7Achillion PharmaceuticalsPre-clinical; also in Phase I for HBV; see CRADA announcement
SPD-756Shire Pharmaceuticals PLCFormerly BCH-13520; company press release
Fd4C/ACH-126,443Achillion PharmaceuticalsL. Dunkle on this, but will it go the way of other "F" drugs?
5-helixHoward Hughes Medical Inst.Science 2001, 291:884-888
ADA (azidocarbonamide)HubripharPhase I/II: AIDS 2001, 15:33-45
S1360Shionogi PharmaceuticalsPhase I/II PK currently enrolling Cornell, Columbia, UAB
TAK-449Takeda PharmaceuticalsCompany officials refused request for information
T-649Trimeris/RocheSimilar to T-1249; paper at 7/01 IAS meeting

Missing in Action

L-756,423/MK-944AMerckReportedly moving into Phase II/III; paper at 7th CROI
AG-1776/JE-2147Agouron (Pfizer)All appearances suggest this drug is history
L-708,906, L-731,988MerckHazuda, D.J., et al., Science 287 (Jan. 28):646 (also, Science News)
Didox, TrimodoxMolecules for HealthRibonucleotide reductase inhibitors -- circa 1995
AOP-RANTESGryphon SciencesAnimal (mouse) data only, J Virol 5/99; paper at summer IAS
FP-21399Lexigen PharmaceuticalsBruce Dezube again: J Infect Dis 2000 182:607-10
PRO2000Genetics (formerly Procept)Being tested as topical microbicide at Fenway Center
HGTV43Enzo Biochem, Inc.Paper at summer IAS meeting
SJ-3366Samjin Pharmaceuticals Ltd.Paper at 14th Intl. Conf. on Antiviral Research, 4/01