Showing posts with label IDX20963/FDA Request More Data. Show all posts
Showing posts with label IDX20963/FDA Request More Data. Show all posts

Thursday, June 27, 2013

Updates: Idenix FDA's No New 'Nuc' Attitude and Interferon Free Drugs Near Approval


Website Updates:

In The News June 27

Investment Commentary
Idenix Maintains HCV Hopes Despite FDA's No New 'Nuc' Attitude
On June 20, the company announced that the FDA asked for additional preclinical safety  information on IDX20963. Initiating clinical trials for this one will need to  wait until the FDA is finished playing the wait-respond-wait game.

Idenix's recently shelved IDX20963 is a uridine nucleotide prodrug. Although Idenix insists that it is significantly different than BMS-094, I don't think the FDA is about to allow any "nucs" to enter clinical trials without excessive preclinical safety data. Luckily, Idenix is still in the HCV race with its NS5A  inhibitor samatasvir.

Fruit Company recalls pomegranate kernels in 12 states due to Hepatitis A risk
In a press release this morning, The FDA announced the voluntary recall of Woodstock Frozen Organic Pomegranate Kernels, produced by the Scenic Fruit Company of Gresham, Oregon

All-oral HCV therapies near approval
Source: Nature Reviews Drug Discovery
Published online May 31 2013

Delivering a cure for hepatitis C infection
MedNous  June 2013
Business strategy
This article was prepared by the editors on the basis of a literature review and interviews and email correspondence with Medivir AB; Janssen Research & Development LLC; Gilead Sciences Inc; AbbVie Inc; Inovio Pharmaceuticals Inc; and the European Medicines Agency

Interferon Free Therapies In Development To Treat Hepatitis C

In Case You Missed It - Review Article: Hepatitis C Virus Infection: Looking for Interferon Free Regimens
Recent developments of new drugs' combinations are changing the treatment paradigm in hepatitis C virus infection. Due to the side effect profile of pegylated interferons, interferon-sparing regimens have become the main target in chronic hepatitis C treatment research.

FDA takes action to protect consumers from dangerous medicines sold by illegal online pharmacies
The U.S. Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, took action this week against more than 9,600 websites that illegally sell potentially dangerous, unapproved prescription medicines to consumers. These actions include the issuance of regulatory warnings, and seizure of offending websites and $41,104,386 worth of illegal medicines worldwide.

FDA shuts down 1,677 online pharmacies
The FDA said it has shut down 1,677 sites for selling counterfeit or substandard medication, or for selling drugs without appropriate safeguards. Other sites received regulatory warnings. Officials said they also arrested 58 people and seized more than $41 million worth of illegal medicines.

Many experts agree the problem is daunting. The National Association of Boards of Pharmacy recently performed an analysis of more than 10,000 websites, and found that 97% did not fully comply with state and federal regulations. It said 88% did not require a valid prescription, and almost half sold medicines lacking FDA approval

HCV triple therapy post-liver transplant yields moderate response, significant adverse events

Presentation, Outcomes, and Response to Therapy Among Patients with Acute Exacerbation of Chronic Hepatitis C - spikes in ALTs in chronic infection

HHS releases new Public Health Service guideline to reduce disease transmission through organ transplantation

Hepatitis C Treatment – A Five Part Series: Part One – The Evolution of Hepatitis C Treatment 
Lucinda K. Porter, RN, author of Free from Hepatitis C and the upcoming Hepatitis C Treatment One Step at a Time (Sept release by Demos Health) blogs at

The debate is over – hepatitis C is curable. When I was infected in 1988, this virus didn’t even have a name, let alone a treatment for it. Not only is there treatment for hepatitis C, there is more than one, and many more in development.

Read article here...

In part 2, I will discuss the most common side effects of current hepatitis C treatment. In part 3 I will suggest tips to manage common side effects, and in part 4 I will give some specific, tried and true suggestions for managing the most common side effects that occur during triple therapy.  Part 5 is devoted to what is ahead for hepatitis C treatment. 
The era of DAA therapy in the treatment of hepatitis C is evolving rapidly. The leap forward from the initial proof of concept that HCV infection can be cured without IFN to showing that cure can be attained in an extraordinarily high proportion of patients has occurred more quickly than most observers had anticipated

NICE issues guideline on the diagnosis and management of chronic hepatitis B
NICE has published its clinical guideline on the diagnosis and management of chronic hepatitis B. It aims to ensure the growing number of people with this potentially life-threatening disease are referred to a specialist and receive the right treatments.

Book raises alarms about alternative medicine - USA Today
The 12-year-old girl arrived at the hospital wracked with abdominal pain.
Doctors diagnosed her with acute pancreatitis, in which pancreatic enzymes begin digesting not just food, but the pancreas itself.
The most likely cause of the girl's condition: toxic side effects from more than 80 dietary supplements, which the girl's mother carried in a shopping bag, says Sarah Erush, clinical pharmacy manager at Children's Hospital of Philadelphia, where the girl was treated last summer

Of Interest
How do you sleep?
Modern sleep patterns cause ill health, so it is time to work out how much rest we really need.

Additional updates on the website:

2013 - HCV Triple-therapy Side Effects
HCV triple therapy post-liver transplant yields moderate response, significant adverse events
Webcast - Managing Rashes Associated with Anti-HCV Triple Therapy
Hep C Treatment: Ten Factors Make a Difference with Side Effects
Video- Hepatologist Urges caution among clinicians in the administration of telaprevir
HCV treatment improves survival among anemic patients

Stem Cells
A Science First: Japanese researchers grow human liver using stem cells
Death of 3 politicians following stem cell treatment probed
New Liver Cell for Cellular Therapy to Aid in Liver Regeneration

2013/HCV Multimedia Videos Podcasts
Contemporary Clinical Medicine: Great Teachers: Hepatitis C: From Hippocrates to Cure

Liver Health
Nature - Gut microbes spur liver cancer in obese mice
Intestinal bacteria of obese mice brew up carcinogens to trigger liver cancer.

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)

Copyright (2013) Thomson Reuters. Click for restrictions

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

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