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The Drug Development Pipeline, 2001

Development Terminated

GW420867X/HBY1293 GlaxoSmithKline JAIDS 2000; also summer IAS meeting
ALX40-4C Allelix Pharmaceuticals Formulation difficulties, lack of efficacy
AMD3100 AnorMed Inc. Cardiac arrhythmias at high doses, lack of efficacy at low
PD-178390 Parke-Davis Casualty of Pfizer merger
CI-1012 Parke-Davis Casualty of Pfizer merger
PNU-142721 Pharmacia & Upjohn Casualty of P&U’s decision to leave HIV field
NSC 651016 Pharmacia & Upjohn Casualty of P&U’s decision to leave HIV field
UC781 Biosyn Inc. Being developed as topical microbicide
zintevir/AR-177 Antigenics (formerly Aronex) Terminated subsequent to takeover and poor results

Clinical Hold

emtricitabine/FTC/Coviracil Triangle/Abbott Submission of NDA to be “significantly delayed
(-)dOTC/BCH-10618/SPD754 Shire Pharmaceuticals PLC Deaths in monkeys
capravirine/S-1153/AG-1549 Agouron (Pfizer) Vasculitis in dogs may mean curtains for capravirine
mozenavir/DMP-450 DuPont (now BMS) Electro-cardiographic abnormalities in animals

Glacial Development

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

Late Pipeline

tenofovir/Viread Gilead FDA hearing set for October 3; Expanded Access info
emivirine/MKC-442/Coactinon Triangle/Abbott Triangle hopes to file NDA by year end; ICAAC

Middle Pipeline

atazanavir/BMS-232632 Bristol-Myers Squibb Moving slowly but deliberately through phase II
tipranavir Boehringer-Ingelheim “Trinity of major obstacles,” paper at summer IAS
VX-175/GW433908 Vertex/GlaxoSmithKline Amprenavir prodrug, PK dose-ranging at 8th CROI
SCH-C Schering/Praecis Recently released from clinical hold, but future dim; IAS paper
PRO 542 Progenics Pharmaceuticals Phase II; being studied in combination with T-20
DPC-083 DuPont (now BMS) Eyed to hit market in 2003; paper at 7th CROI

Deep Pipeline

DADP/amdoxovir Triangle Pharmaceuticals Phase I/II dose ranging study presented at 8th CROI
TMC-120, 125 Tibotec/Virco “Resistant repellent”; Russian-Polish study at 8th CROI
TMC-126 Tibotec/Virco Paper at 8th CROI
DPC-961, DPC-963 DuPont (now BMS) Atazanavir may take priority over these
Calanolide-A SarawakMed Paper on this at 7th CROI
GPG-NH2 Tripep AB/Karolinska Institute Early activity in humans not too impressive
SCH-D Schering/Praecis Follow-up compound to SCH-C
UK-427,857 Pfizer Said to be moving into Phase I “soon”
DPC-681, DPC-684 DuPont (now BMS) Phase I studies on-going; paper at 8th CROI
AMD-3465, 8445, 8664 AnorMed AMD8664 is orally available analogue of AMD3100
TAK-779 Takeda Pharmaceuticals Being studied in combination with T-20
HE2000 Hollis-Eden Pharmaceuticals Phase I/II enrolling in U.S.; info from company; other
PRO 140 Progenics Pharmaceuticals Moving into Phase I/II; press release
PRO 367 Progenics Pharmaceuticals Phase I recently completed
TNX-355/Hu5A8 Tanox Biosystems, Inc. Phase I clinical study began 8/1/01
PEHRG214 Virionyx Phase I at Boston Deaconess Hospital, 3/01
HIV NCp7 Achillion Pharmaceuticals Pre-clinical; also in Phase I for HBV; see CRADA announcement
SPD-756 Shire Pharmaceuticals PLC Formerly BCH-13520; company press release
Fd4C/ACH-126,443 Achillion Pharmaceuticals L. Dunkle on this, but will it go the way of other “F” drugs?
5-helix Howard Hughes Medical Inst. Science 2001, 291:884-888
ADA (azidocarbonamide) Hubriphar Phase I/II: AIDS 2001, 15:33-45
S1360 Shionogi Pharmaceuticals Phase I/II PK currently enrolling Cornell, Columbia, UAB
TAK-449 Takeda Pharmaceuticals Company officials refused request for information
T-649 Trimeris/Roche Similar to T-1249; paper at 7/01 IAS meeting

Missing in Action

L-756,423/MK-944A Merck Reportedly moving into Phase II/III; paper at 7th CROI
AG-1776/JE-2147 Agouron (Pfizer) All appearances suggest this drug is history
L-708,906, L-731,988 Merck Hazuda, D.J., et al., Science 287 (Jan. 28):646 (also, Science News)
Didox, Trimodox Molecules for Health Ribonucleotide reductase inhibitors — circa 1995
AOP-RANTES Gryphon Sciences Animal (mouse) data only, J Virol 5/99; paper at summer IAS
FP-21399 Lexigen Pharmaceuticals Bruce Dezube again: J Infect Dis 2000 182:607-10
PRO2000 Genetics (formerly Procept) Being tested as topical microbicide at Fenway Center
HGTV43 Enzo Biochem, Inc. Paper at summer IAS meeting
SJ-3366 Samjin Pharmaceuticals Ltd. Paper at 14th Intl. Conf. on Antiviral Research, 4/01


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