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HCV Drugs, by Alan Franciscus

Hepatitis C Blog Posted on July 1, 2014 by HCV AdvocateDecember 1, 2015

 
  —Alan Franciscus, Editor-in-Chief

In this month’s column I will discuss many news
stories related to HCV drugs in development, including a study from
Japan on Gilead’s combination of sofosbuvir/ledipasvir to treat HCV
genotype 1, and, also from Japan, BMS’s combination of daclatasvir plus
asunaprevir to treat HCV genotype 1b. There is more information from
AbbVie: The 3-D combination to treat HCV genotype 1, the FDA priority
review and AbbVie’s collaboration with OraSure Technologies.  Also in
the news was Merck’s acquisition of Idenix and Achillion’s resurrection
of one of their HCV drugs that was on clinical hold and on another
Achillion drug that is about to begin a proof of concept study.   
Hepatitis C is a disease with a largely
unmet need for drugs to treat it.  But in Japan this need is even more
pressing since the HCV epidemic began earlier there and, as a result,
the impact of hepatitis C on the health system is much worse in Japan
than in the United States and Europe.  The newer interferon and
ribavirin-free therapies can slow the expected severe health-care crisis
and prevent deaths related to hepatitis C in Japan.   The results from
two studies on interferon and ribavirin-free treatments conducted in
Japan were recently released: Gilead’s ledipasvir plus sofosbuvir and
BMS’s daclatasvir plus asunaprevir. 
Gilead
Ledipasvir/Sofosbuvir:
Gilead reported on a Phase 3 study using a
once-a-day fixed-dose combination of ledipasvir (NS5A inhibitor – 90 mg)
plus sofosbuvir (polymerase inhibitor – 400 mg) with and without
ribavirin.  The treatment period was 12 weeks for all groups treated. 
All of the patients in the study were genotype 1; 166 treatment- naïve;
175 treatment-experienced; 76 had compensated cirrhosis.  The cure
rates (SVR12) are listed below.
The most common side effects in
the non-ribavirin containing arms were nasopharyngitis (inflammation
of the nasal passages), headache and malaise.  In the groups that
received ribavirin the additional side effects included anemia,
pruritus (itching) and rash.
HCV Medications
Cure Rates
Treatment Naïve
LDV/SOF
100% (83 of 83 pts)
Treatment Naïve
LDV/SOF/RBV
96% (80 of 83 pts)
Treatment Experienced
LDV/SOF
100% (88 of 88 pts)
Treatment Experienced
LDV/SOF/RBV
100% (87 of 87 pts)
ledipasvir (LDV); sofosbuvir (SOF); ribavirin (RBV)
Comments:  The
results with and without ribavirin are excellent.  Gilead indicated in
their press release that they plan to submit a New Drug Application to
the Japanese Pharmaceutical and Medical Devices Agency (PMDA) by the
end of 2014.
BMS
Daclatasvir/Asunaprevir:
Bristol-Myers Squibb (BMS) has multiple HCV drug
regimes in clinical development for the treatment of HCV.  This article
will discuss the data from a recent article published in Hepatology
on a Phase 3 trial for the treatment of HCV genotype 1b with the
combination of daclatasvir (NS5A inhibitor – 60 mg dosed once-a-day)
plus asunaprevir (HCV protease inhibitor – dosed twice a day).  A
journal article provides the best type of information since it is
peer-reviewed and, in this case, has been published in a prestigious
medical journal.
BMS has submitted the Phase 3
data to the Food and Drug Administration (FDA) for approval.  The
treatment period was 24 weeks. 
There were two groups in the study:
Group 1: 135
patients who were either interferon-ineligible or intolerant: 100
medically ineligible for interferon, and 35 intolerant to interferon.
The median age was 64 yo, male (28%), IL28B cc genotype (70%),
cirrhosis (8%), interferon intolerant (26%).
Group 2:  87
patients who were non-responders: 48 null responders, 36 partial
responders, and 3 who were previously treated but their treatment
status was undetermined. The median age was 60 yo, male (45%), IL28B cc
genotype (18%), cirrhosis (13%), prior null response (55%).
The sustained virological response rates (SVR 24) or cure rates were 80.5% to 87.4% (see table).
Comments:  The
results are encouraging and relatively high for people with HCV
genotype 1b, a patient population that is typically difficult to
treat.  It is important to know that this is a relatively small
population of patients so once this combination is approved and given
to a larger population of people we will get a better picture of the
effectiveness and safety of the combination of these two medications.
Group 1
Interferon-Ineligible
/ Intolerant
(Daclatasvir / Asunaprevir)
Group 2
Non-responders
(Daclatasvir / Asunaprevir)
Cure Rates
87.4%
(118 of 135 patients)
80.5%
(70 of 87)
patients

The most common side effects were nasal congestion, elevated liver enzymes, headache, diarrhea and fever.
AbbVie
In June AbbVie announced that their New Drug
Application (NDA) had been accepted by the Food and Drug Administration
(FDA) and that it had been granted priority review.  In addition, it
was noted earlier that AbbVie submitted marketing authorization
applications (MAAs) for regulatory approval in the European Union and
that these applications and priority review had been accepted.  AbbVie
is seeking marketing approval for their 3D combination of HCV
medications to treat HCV genotype 1 patients. 
In a related story, OraSure
Technologies announced that it had reached an agreement with AbbVie on a
co-promotion agreement for an OraQuick HCV Rapid Antibody test.  The
agreement will provide OraSure  $75 million in payments for the
exclusive use of its HCV tests through December 31, 2019.  This means
that AbbVie will be sponsoring mass testing to identify the other 50%
to 75% of people with hepatitis C who don’t know they are infected.  It
is definitely going to be a very interesting coming decade. 
Merck/Idenix
Acquisitions seem to be a permanent part of the HCV
treatment landscape.  In June, Merck announced that they had offered
3.85 billion dollars in a bid to acquire Idenix Pharmaceuticals Inc. 
The offer goes to Idenix stockholders, but I can’t imagine that any
sane stockholder would turn this down!  In the news, however, there
have been stories about the bid being undervalued and overvalued.  Who
knows! 
Idenix has three HCV inhibitors
in Phase 1 and Phase 2 clinical development—IDX21437 and IDX21459
(polymerase inhibitors) and samatasvir (NS5A inhibitor).  Merck has its
own MK-5172 plus MK-8742 with and without ribavirin in Phase 3 clinical
development.  If and when these drugs come to market it will be
interesting to see how they are priced since the acquisition price tag
is a bit hefty for the Idenix pipeline.
Achillion

In June, Achillion announced that the FDA removed a
clinical hold on their HCV protease inhibitor—sovaprevir—at doses of
200 mg once daily and that they have completed Phase 2 clinical trials
of this drug.  Additionally, Achillion announced that they have begun a
proof of concept study in people with HCV genotype 1 on a new drug
candidate—ACH-3422—an HCV polymerase inhibitor.

Source: HCV Advocate Newsletter – July 2014 

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Tagged ACH-3422, achillion, daclatasvir + asunaprevir, Idenix, Orasure, sofosbuvir + ledipasvir, sovaprevir

Merck to Acquire Idenix

Hepatitis C Blog Posted on June 9, 2014 by HCV AdvocateDecember 1, 2015
Acquisition Expands Portfolio of Promising Investigational Therapies for Hepatitis C
Monday, June 9, 2014 7:30 am EDT

WHITEHOUSE STATION, N.J. & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, and
Idenix Pharmaceuticals, Inc. (NASDAQ: IDIX), today announced that the
companies have entered into a definitive agreement under which Merck
will acquire Idenix for $24.50 per share in cash. The transaction, which
values the purchase of Idenix at approximately $3.85 billion, has been
approved by the boards of directors of both companies.

“Idenix has established a promising portfolio of hepatitis C candidates
based on its expertise in nucleoside/nucleotide chemistry and prodrug
technologies,” said Dr. Roger Perlmutter, president, Merck Research
Laboratories. “Idenix’s investigational hepatitis C candidates
complement our promising therapies in development and will help advance
our work to develop a highly effective, once-daily, all oral,
ribavirin-free, pan-genotypic regimen that has a duration of treatment
as short as possible for millions of patients in need around the world.”

Idenix is a biopharmaceutical company engaged in the discovery and
development of medicines for the treatment of human viral diseases,
whose primary focus is on the development of next-generation oral
antiviral therapeutics to treat hepatitis C virus (HCV) infection. The
company currently has three HCV drug candidates in clinical development:
two nucleotide prodrugs (IDX21437 and IDX21459) and a NS5A inhibitor
(samatasvir). These novel candidates are being evaluated for their
potential inclusion in the development of all oral, pan-genotypic
fixed-dose combination regimens.

“Merck has established a strong legacy of leadership and innovation in
treating hepatitis C,” said Ron Renaud, Idenix’s President and Chief
Executive Officer. “This agreement creates shareholder value by
positioning Idenix’s strong portfolio of candidates for future success
with a leading healthcare company with the experience and commitment to
develop fixed-dosed combinations with the potential to impact the global
burden of hepatitis C.”

Merck’s research and development portfolio includes several HCV
medicines in development, the leading of which is a combination of
MK-5172, an investigational HCV NS3/4A protease inhibitor and MK-8742,
an investigational HCV NS5A replication complex inhibitor. The
combination of these two investigational candidates has received
Breakthrough Therapy designation from the U.S. Food and Drug
Administration for the treatment of HCV. In April 2014, Merck announced
initiation of Phase 3 clinical trials for MK-5172/MK-8742 to evaluate
the combination with and without ribavirin in various genotypes and
across a broad range of patient populations with chronic HCV. Study
information can be found at www.clinicaltrials.gov.

Under the terms of the agreement, Merck, through a subsidiary, will
initiate a tender offer to acquire all outstanding shares of Idenix
Pharmaceuticals, Inc. The closing of the tender offer will be subject to
certain conditions, including the tender of shares representing at least
a majority of the total number of Idenix’s outstanding shares (assuming
the exercise of all options), the expiration of the waiting period under
the Hart-Scott-Rodino Antitrust Improvements Act and other customary
conditions. Upon the completion of the tender offer, Merck will acquire
all remaining shares through a second-step merger. The companies expect
the transaction to close in the third quarter of 2014.

Credit Suisse acted as financial advisor to Merck in this transaction
and Hughes Hubbard & Reed LLP as its legal advisor. Centerview Partners
acted as financial advisor to Idenix and Sullivan & Cromwell as its
legal advisor.

– See more at: http://www.mercknewsroom.com/news-release/corporate-news/merck-acquire-idenix#sthash.x5fX0Ulh.dpuf

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Tagged Idenix, IDX21437, IDX21459, Merck

Merck & Co. to Buy Hepatitis-Drug Maker Idenix

Hepatitis C Blog Posted on June 9, 2014 by HCV AdvocateDecember 1, 2015

Merck & Co. (MRK), the second-biggest U.S.
drugmaker, agreed to buy Idenix Pharmaceuticals Inc. (IDIX) for about
$3.85 billion to expand its experimental pipeline for hepatitis
C treatments. 

Idenix’s lead drug, IDX21437, works similarly to Gilead
Science Inc. (GILD)’s Sovaldi, which won U.S. regulatory in December
and costs $84,000 for a 12-week course of treatment. Prior to
the development of Sovaldi, hepatitis C treatment entailed a
regimen of two or more antiviral drugs with many side effects.

Merck is racing Gilead, Johnson & Johnson (JNJ) and Abbvie Inc. (ABBV)
to establish a strong presence against a disease that affects an
estimated 170 million people worldwide and carries a potential
market of $20 billion a year.

“What we would like to do, insofar as it is possible, is
cure them all,” Merck’s Perlmutter said in commenting on the
number of people who carry the disease. To do that, Merck will
need a three-drug combination pill that has few side effects and
can be taken for a shorter period of time.

Read more….

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Idenix Announces Promising Clinical Data and Continued Progress in Nucleotide Prodrug Development Programs for the Treatment of Hepatitis C

Hepatitis C Blog Posted on April 7, 2014 by HCV AdvocateApril 7, 2014
  • Idenix Reports Positive Proof-of-Concept Data for Lead Nucleotide Prodrug, IDX21437

  • Idenix on Track to Initiate All-Oral Pan-Genotypic Phase II Combination Clinical Study of IDX21437 and Samatasvir in mid-2014

  • Idenix Initiates Phase I Clinical Trial of Follow-on Nucleotide Prodrug, IDX21459

  • Idenix to Host Conference Call / Webcast at 8:00 a.m. ET today

CAMBRIDGE, Mass., April 7, 2014 (GLOBE NEWSWIRE) — Idenix Pharmaceuticals, Inc.
(Nasdaq:IDIX), a biopharmaceutical company engaged in the discovery and
development of drugs for the treatment of human viral diseases, today
announced continued progress of the Company’s program to develop
nucleotide prodrug inhibitors for the treatment of hepatitis C virus
(HCV) infection. Idenix is reporting potent antiviral activity of mean
maximum 4.2-4.3 log10 IU/mL reductions for patients infected
with HCV genotype 1, 2 or 3 receiving 300 mg once daily of IDX21437 in
the seven-day proof-of-concept portion of a phase I/II clinical trial.
Based on this progress, the Company’s goal is to initiate a combination
clinical trial of IDX21437 and samatasvir, a
pan-genotypic NS5A inhibitor, in mid-2014. In addition, Idenix has
selected a follow-on uridine-based nucleotide prodrug, IDX21459, from
its ongoing nucleotide discovery program and initiated enrollment for
the healthy volunteer portion of a phase I clinical trial.

“As more all-oral regimens become available to treat hepatitis C, an
increased number of patients will be diagnosed and treated. It will be
important to have simple, short duration options for our patients. These
early data for IDX21437 support its potential to be part of future
treatment combinations.” said Professor Edward Gane, MD, Deputy Director and Hepatologist, New Zealand Liver Transplant Unit, Auckland City Hospital in New Zealand,
and a clinical investigator in the IDX21437 proof-of-concept study.
“Nucleotide-based treatment combinations are favored because of safety,
efficacy, high barrier to resistance and low drug-drug interaction
potential and we look forward to seeing further results from studies
with IDX21437.”

“We are very pleased with these positive data for IDX21437 and we are
excited to have two nucleotide prodrug candidates in the clinic,” said Ron Renaud,
Idenix’s President and Chief Executive Officer.  “With the initiation
of the phase II study of IDX21437 and samatasvir later this year, we
will be one of a few companies with an all-oral, pan-genotypic,
nucleotide-based combination approach in the clinic. We believe this
regimen has the potential to play a significant role in advancing HCV
care for the benefit of patients, physicians and payers.”

 
IDX21437: Topline 7-Day Phase I/II Clinical Results

In January 2014, Idenix initiated the seven-day
proof-of-concept portion of a phase I/II clinical trial for IDX21437.
The trial completed enrollment of 44 treatment-naïve, genotype (GT) 1, 2
or 3 HCV-infected patients. Patients were randomized to receive
once-daily doses of placebo, 50 mg, 150 mg, or 300 mg of IDX21437 for
seven days. The topline clinical results include:

  • IDX21437 was well-tolerated with no observed pattern of adverse events or laboratory abnormalities.

  • Treatment with IDX21437 exhibited potent pan-genotypic activity in a dose-dependent manner:

  • In GT 1 HCV-infected patients (n=8), the mean maximal viral load reduction was 4.2 log10 IU/mL in the 300 mg arm.

  • The mean maximal viral load reduction of 4.3 log10 IU/mL was achieved in GT 2 and 3 HCV-infected patients in the 300 mg arm (n=10).

  • More detailed findings are expected to be presented at a future scientific meeting.

  • Based on these findings, the 300 mg dose of IDX21437 has been chosen
    for the anticipated phase II combination study with samatasvir.

IDX21459: Phase I Clinical Program

In April 2014, Idenix initiated enrollment for the healthy volunteer portion of a phase I clinical trial of IDX21459 in Europe.
This portion of the study is expected to enroll approximately 50
healthy volunteers and will evaluate once-daily doses of IDX21459
ranging from 10 mg – 300 mg. The proof-of-concept portion of the study
is expected to enroll a total of 40 treatment-naïve, genotype 1
HCV-infected patients who will receive once-daily doses of placebo, 50 –
300 mg of IDX21459 for seven days. IDX21459 has shown a favorable
preclinical profile including potent, pan-genotypic activity and
favorable safety with respect to cardiac, mitochondrial and genotoxicity
assessments.

 
Additional Nucleotide Candidates

Idenix’s primary efforts in nucleotide development will continue to
focus on its lead candidate, IDX21437, and follow-on prodrug candidate,
IDX21459, as well as earlier-stage nucleotide prodrugs. An important
objective for the discovery program is to identify nucleotides offering
distinct resistance profiles that can be combined with one of the
Company’s current nucleotide clinical candidates to treat HCV. Idenix
also announced today that the Company has elected not to continue its
clinical development program for HCV nucleotide prodrug, IDX20963,
previously placed on clinical hold by the U.S. Food and Drug Administration (FDA).

 
CONFERENCE CALL AND WEBCAST INFORMATION

Idenix management will host a conference call at 8:00 a.m. ET today. To access the call, please dial (877) 640-9809 (U.S./Canada)
or (914) 495-8528 (International) and enter passcode 26004979. A live
webcast will be available through the Investor section of the Idenix
website at www.idenix.com
under “Events & Presentations”. The archived webcast will be
available for two weeks following the call on the Idenix website.

 
ABOUT IDX21437

IDX21437, Idenix’s lead uridine-based nucleotide prodrug inhibitor, has
completed the single-dose and seven-day proof-of-concept portions of a
phase I/II clinical trial. Extensive preclinical testing for IDX21437
has demonstrated favorable antiviral activity across genotypes 1-6 and a
safety profile which supported advancement into clinical trials. Based
on this progress, the Company’s goal is to initiate an Idenix-sponsored
combination clinical trial of IDX21437 and samatasvir in mid-2014.

 
ABOUT SAMATASVIR

Samatasvir is an NS5A inhibitor with low picomolar, pan-genotypic antiviral activity in vitro.
To date, samatasvir has been safe and well-tolerated after single and
multiple doses of up to 150 mg in healthy volunteers up to 14 days
duration, and in HCV-infected patients up to 12 weeks duration.
Samatasvir has demonstrated potent pan-genotypic antiviral activity in
HCV-infected patients with mean maximal viral load reductions up to
approximately 4.0 log10 IU/mL across HCV genotypes 1-4 in a proof-of-concept, three-day monotherapy study.

Under a non-exclusive collaboration with Janssen Pharmaceuticals, Inc.,
Idenix is evaluating all-oral, direct-acting antiviral HCV combination
regimens including samatasvir, simeprevir (TMC435), a once-daily
protease inhibitor jointly developed by Janssen R&D Ireland
and Medivir AB, and TMC647055/r, a once-daily non-nucleoside polymerase
inhibitor boosted with low-dose ritonavir being developed by Janssen.
In this program, Idenix is conducting two ongoing phase II 12-week
clinical trials, HELIX-1 and HELIX-2.

Read complete press release here

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Idenix files lawsuits in Europe, charging Gilead infringed on its patent by marketing hep C drug

Hepatitis C Blog Posted on March 14, 2014 by HCV AdvocateMarch 14, 2014

Cambridge drug developer Idenix Pharmaceuticals Inc. has filed
lawsuits in Europe charging that biotechnology giant Gilead Sciences
Inc. infringed on an Idenix patent when it marketed a popular new
hepatitis C treatment in England, France and Germany.

The suits escalate a three-month-old legal battle between Gilead
and Idenix over the drug, called Sovaldi. Idenix — in which a Boston
hedge fund has taken a growing position — claims it has exclusive
rights to the intellectual property for sofosbuvir, the compound on
which Sovaldi is based. The company lodged similar complaint against
Gilead in a California court in December.

“These are the first offensive moves Idenix has taken in this
landscape of litigation against Gilead,” said Teri Dahlman, an Idenix
spokeswoman. “We feel strongly about our intellectual property and we’re
defending it.”

Read more…

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Tagged Gilead, Idenix, patent infringement, Sovaldi

Idenix Pharmaceuticals Files Patent Infringement and Interference Lawsuits Against Gilead Sciences

Hepatitis C Blog Posted on December 2, 2013 by HCV AdvocateDecember 2, 2013

CAMBRIDGE, Mass., Dec. 2, 2013 (GLOBE NEWSWIRE) — Idenix Pharmaceuticals, Inc.
(Nasdaq:IDIX), a biopharmaceutical company engaged in the discovery and
development of drugs for the treatment of human viral diseases, today
announced that it has filed two lawsuits against Gilead Sciences, Inc. (Nasdaq:GILD): a patent infringement lawsuit in the United States District Court in Boston, Massachusetts and a separate patent infringement and interference lawsuit in the United States District Court in Wilmington, Delaware.

The Massachusetts
infringement lawsuit alleges that Gilead infringes two U.S. patents
co-owned by Idenix (6,914,054 and 7,608,597) that cover methods of
treating the hepatitis C virus using 2′-methyl nucleosides. In this
lawsuit, Idenix is seeking a declaration that Gilead’s imminent
distribution, importation, use, sale or offer to sell drugs containing
sofosbuvir, a 2′-methyl nucleoside compound, infringes Idenix’s patents.

The Delaware
infringement and interference lawsuit alleges that Gilead infringes a
separate U.S. patent co-owned by Idenix (7,608,600) that covers methods
of treating the hepatitis C virus using 2′-methyl-2′-fluoro nucleosides.
Idenix is seeking a declaration that Gilead’s imminent distribution,
importation, use, sale or offer to sell drugs containing sofosbuvir
infringes the Idenix ‘600 patent. Additionally, the Delaware
lawsuit asserts a claim for interfering patents between the Idenix ‘600
patent and a U.S. patent (8,415,322) owned by a Gilead subsidiary, Gilead Pharmasset LLC. Idenix is seeking to have the Gilead ‘322 patent declared invalid.

“Idenix has invested significant resources in nucleoside drug discovery
and in building an intellectual property portfolio that aids in the
discovery and development of drugs for the treatment of the hepatitis C
virus and other viral diseases,” said Maria Stahl,
senior vice president and general counsel at Idenix. “While we have
attempted to resolve this matter with Gilead without resorting to
infringement litigation, we intend to diligently and vigorously protect
our patent rights for the benefit of our company and our shareholders
and prevent infringing use by others. Idenix remains confident in its
patent portfolio and has several patent families that provide the
Company coverage for 2′-methyl nucleoside compounds and 2′- methyl, 2′-
fluoro nucleoside compounds specifically.”

Other Ongoing Patent Disputes 
Idenix and Gilead are currently involved in a separate patent
interference before the United States Patent and Trademark Office
involving a pending Idenix patent application (Application 12/131,868)
covering certain 2′- methyl, 2′- fluoro nucleoside compounds and another
granted Gilead patent (7,429,572) also related to certain 2′- methyl,
2′- fluoro nucleoside compounds.

Gilead Sciences has also filed suit against Idenix in various jurisdictions outside the United States
to invalidate granted Idenix patents covering certain
2′-methyl-2′-fluoro nucleoside compounds and their use in treating HCV
or other Flaviviridae viruses.

The patents asserted by Idenix in its Massachusetts
infringement lawsuit are not the same patents at issue in the ongoing
U.S. patent interference or the ongoing foreign litigations. The patent
asserted by Idenix in its Delaware lawsuit is not the same patent application at issue in the ongoing U.S. patent interference, but is in the same patent family.

ABOUT IDENIX
Idenix Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts,
is a biopharmaceutical Company engaged in the discovery and development
of drugs for the treatment of human viral diseases.

Idenix’s current
focus is on the treatment of patients with hepatitis C infection. For
further information about Idenix, please refer to www.idenix.com.

CONTACT: Idenix Pharmaceuticals Contact:
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Tagged '600 patent, 2'-methyl nucleosides, Gilead, Idenix, lawsuit, Sofosbuvir

Idenix Pharmaceuticals Announces Nucleotide Prodrug Program Poster Presentation at the American Association for the Study of Liver Diseases (AASLD) Annual Meeting

Hepatitis C Blog Posted on October 1, 2013 by HCV AdvocateOctober 1, 2013

Idenix Pharmaceuticals Announces Nucleotide Prodrug Program

CAMBRIDGE, Mass., Oct. 1, 2013 (GLOBE NEWSWIRE) — Idenix Pharmaceuticals, Inc.
(Nasdaq:IDIX), a biopharmaceutical company engaged in the discovery and
development of drugs for the treatment of human viral diseases, today
announced a poster presentation featuring preclinical data for its
uridine nucleotide prodrug candidate for the treatment of hepatitis C
virus (HCV) infection at the 64th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), which will take place in Washington, DC, November 1-5, 2013. Full abstracts can now be viewed at the AASLD website at www.aasld.org.

The following abstract will be presented in a poster session during the AASLD Annual Meeting in the Poster Hall on Saturday, November 2, 2013, 2:00pm — 7:30pm Eastern Time:

  • Abstract No. 485: “A Novel Uridine Nucleotide Prodrug, IDX20963, and
    Its Potential for Use in a Low-Dose Direct-Acting Antiviral Regimen for
    HCV.”

Source:

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Idenix sees delay in human trials for hep C drug as FDA seeks more data

Hepatitis C Blog Posted on June 21, 2013 by HCV AdvocateJune 21, 2013

(Reuters)
– Idenix Pharmaceuticals Inc said it expects a delay in human trials of
one of its experimental hepatitis C drugs after the U.S. Food and Drug
Administration asked for additional safety data, sending its shares down
21 percent after the bell.

Clinical trials of the drug,
codenamed IDX20963, has been put on hold until it provides a
satisfactory response to the FDA, Idenix said in a statement.

Idenix’s
hepatitis C drugs have been developed using a technology called
polymerase inhibitors, or nucs. Nucs prevent the virus from multiplying
and represent a new class of drugs for the disease.

IDX20963
belongs to a sub-class of nucs called uridine nucleotide, and the
company has said previously that it is distinct from the two drugs whose
development was stopped.

Read more…

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Tagged Drugs in Development, FDA, Idenix

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