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SCHEDULE 14A INFORMATION
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ICN PHARMACEUTICALS, INC.
(Name of Registrant as Specified in its Charter)
ICN PHARMACEUTICALS, INC.
(Name of Person(s) Filing Proxy Statement)
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Antiviral Agent
Bulletin
Antiviral Drug and Vaccine Development Information
Ribavirin Hepatitis C Trial Early Results
Preliminary results from a Phase III clinical trial with oral
ribavirin from ICN Pharmaceuticals (Costa Mesa, CA) indicates
that the drug may have efficacy for treatment of chronic
hepatitis C virus (HCV) infection. Early results from a
double-blind placebo-controlled, 12-month trial being con-
ducted at NIH using orally administered ribavirin in 58
chronic hepatitis C infection patients were published in
Hepatology, Oct, 1993, vol. 18, issue 4, pt.2,abstract #146.
Dr. J.H. Hoofnagle, National Inst. of Diabetes, Digestive
and Kidney Disorders (NIDDK NIH), and co-workers re-
ported results from two groups of well-matched patients (16
patients each, 32 patients total) having completed the full-
year course of treatment.
These clinicians report that "During therapy with ribavirin.
ALT values became and remained normal in 4 patients (25%
responders). ALTs fell by more than 50% in 7 patients
(44%,partial responders); overall mean values decreased by
47% (p<.01) by the end of therapy. No patient lost serum
HCV RNA and mean levels of HCV RNA did not change.
After stopping therapy, ALT values rose in most patients,
including 2 of 4 responders. The histologic activity index
(HAI) decreased with ribavirin, hepatic lobular necrosis
improving most. Only 1 placebo-treated patient had a par-
tial response, none lost HCV RNA and liver histology ap-
peared to worsen." They conclude, "Thus, prolonged
ribavirin therapy was associated with significant improve-
ment in serum ALT levels (despite unchanged HCV RNA
levels) and in hepatic lobular activity." Dosage reductions
form the oral 66 mg twice daily dosage were required in
several patients but all remained on the drug for a full year.
Volume 6 * No. 10 * October 1993
Oral ribavirin appeared to have some efficacy, relatively on
the order of that provided by the only approved treatment (in
the U.S.) for chronic hepatitis C infection, alpha-interferon.
Ribavirin caused distinct decreases in levels of serum ala-
nine aminotransferase (ALT: a liver enzyme surrogate marker
for liver damage), improvements in liver biopsy results, and
patients worsened when removed from treatment. Note, this
is only the first report from one of three ongoing Phase III
trials. Another 58-patient trial with 6-months treatment and
6-months follow-up is ongoing at five centers and a 110-
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patient trial is ongoing in Europe. If comparable or better
results are observed from these trials, ribavirin could be-
come or compete with alpha-interferon for first-line treat-
ment of chronic hepatitis C infection.
Results similar to those from the NTH trial have been re-
ported anecdotally and from other smaller trials, including a
report in the August issue of Hepatology, p.258-63. Re-
searchers form Nagoya University School of Medicine ad-
ministered combinations of ribavirin and beta-interferon in
28 chronic hepatitis C patients for 12 weeks and concluded
that, "ribavirin suppresses hepatitis B virus replication,al-
though its effect is less than that of interferon, and that it
may be useful as adjunctive therapy for chronic hepatitis."
Ribavirin is being tested for treatment of HIV-infection in
combination with other agents, including a NIAID-spon-
sored Phase I trial which is starting up to test combinations
of low-dose ribavirin and standard-dose DDI (Videx from
Bristol-Myers Squibb Co.).
Ribavirin is a relatively simple and cheap drug, compared to
recombinant alpha-interferons, can be taken orally rather
than injected, and appears to have caused fewer and less
severe side-effects. Ribavirin is already approved for vari-
ous antiviral indications in most major markets worldwide
and there should be no scale-up or availability problems as
may occur with recombinant biologies (patients desiring treat-
ment with Betaseron (beta-interferon) from Chiron Corp.
recently approved for treatment of multiple sclerosis must
enter a lottery for eligibility). Eventually, ribavirin may be
used in combination with alpha-interferon or other thera-
peutics. These preliminary results and the availability of
ribavirin worldwide suggest that individual clinicians and
patients may experiment with ribavirin combination and
monotherapy treatments.
Consent of publication has not been received from Antiviral Agent
Bulletin as of the date of this filing.
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INSTITUTIONAL SHAREHOLDER SERVICES, INC.sm
Proxy Contest Analysis
ICN Pharmaceuticals, Inc.
________________________________
ICN Plaza
3300 Hyland Ave.
Costa Mesa, CA 92626
(714) 545-0100
ICN (NYSE)
Annual Meeting
Feb 1, 1994
Record Date
Nov. 2, 1993
CUSIP 449290105
Insert A
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<S> <C> <C>
Mgt. Iss
Proposal of ICN Pharmaceuticals Rec. Rec.
_______________________________ ____ ____
(Blue Card)
(1) Elect Directors For For
Proposals of Rafi Khan (Green Card)
___________________________________
(1) Amend Bylaws Against Against
(2) Elect Directors Withhold Withhold
</TABLE>
Consent of publication has not been received from Institutional Shareholder
Services, Inc. as of the date of this filing.
