Friday, June 21, 2013

IDX20963 - Idenix sees delay in hep c drug human trials as FDA seeks more data

June 20, 2013
Idenix Pharmaceuticals Announces Update on Development Program for Its Lead HCV Nucleotide Prodrug Candidate, IDX20963

CAMBRIDGE, Mass., June 20, 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 the Company has received verbal communication from the U.S. Food and Drug Administration (FDA) requesting additional preclinical safety information for IDX20963, Idenix's lead uridine nucleotide prodrug candidate. Initiation of clinical trials for IDX20963 is on hold and the Company must provide a satisfactory response to the FDA before clinical trials can begin in the United States. As a result, the Company anticipates a delay in the initiation of the clinical program for IDX20963 while it responds to the FDA's comments. Idenix recently submitted an Investigational New Drug (IND) application for IDX20963 to the FDA, including preclinical data demonstrating potent, pan-genotypic activity.


Hepatitis C virus (HCV) is a common blood-borne pathogen infecting three to four million people worldwide annually. The World Health Organization (WHO) estimates that more than 170 million people worldwide are chronically infected with HCV, representing a nearly 5-fold greater prevalence than human immunodeficiency virus.


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 HCV infection. For further information about Idenix, please refer to


This press release contains "forward-looking statements" for purposes of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995, including but not limited to the statements regarding the Company's future business and financial performance. For this purpose, any statements contained herein that are not statements of historical fact may be deemed forward-looking statements. Without limiting the foregoing, the words "expect," "plans," "anticipates," "intends," "will," and similar expressions are also intended to identify forward-looking statements, as are expressed or implied statements with respect to the Company's potential pipeline candidates, including any expressed or implied statements regarding the efficacy and safety of IDX20963 and the likelihood of any future clinical trials involving IDX20963. Actual results may differ materially from those indicated by such forward-looking statements as a result of risks and uncertainties, including but not limited to the following: there can be no guarantees that the Company will advance IDX20963 or other clinical product candidate to the clinic, to the regulatory process or to commercialization; management's expectations could be affected by unexpected regulatory actions or delays; uncertainties relating to, or unsuccessful results of, clinical trials, including additional data relating to future clinical trials evaluating its product candidates; the Company's ability to obtain additional funding required to conduct its research, development and commercialization activities; changes in the Company's business plan or objectives; competition in general; and the Company's ability to obtain, maintain and enforce patent and other intellectual property protection for its product candidates and its discoveries. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. These and other risks which may impact management's expectations are described in greater detail under the heading "Risk Factors" in the Company's quarterly report on Form 10-Q for the quarter ended March 31, 2013 as filed with the Securities and Exchange Commission (SEC) and in any subsequent periodic or current report that the Company files with the SEC.

All forward-looking statements reflect the Company's estimates only as of the date of this release (unless another date is indicated) and should not be relied upon as reflecting the Company's views, expectations or beliefs at any date subsequent to the date of this release. While Idenix may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, even if the Company's estimates change.
CONTACT: Idenix Pharmaceuticals

Thursday Jun 20, 2013 | Reuters -

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

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 30 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.

Hepatitis C is an disease that affects the liver and if left untreated can lead to cirrhosis, cancer or need for a transplant.

In early February, the company stopped the development of two other hepatitis C drugs, IDX184 and IDX19368, after the FDA continued with a clinical hold, initiated following the death of a patient in a mid-stage trial conducted by Bristol-Myers Squibb Co using a similar compound.

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.

Idenix shares were down at $3.61 in after-market trading. They closed at $5.13 on the Nasdaq on Thursday.

(Reporting by Pallavi Ail in Bangalore; Editing by Sriraj Kalluvila)

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This article was distributed through the NewsCred Smartwire. Original article © Reuters 2013 

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