Friday, February 11, 2011

Hepatitis C New Drugs In The News Feb 11

Included in this blog entry; From Jan 2011 News "Testing all-oral regimens with and without ribavirin in treatment-naive patients." (see below)

HCV Advocates Pipeline Updated (Feb 10)
HCV Drug Pipeline

.,INX-08189 (“INX-189”)

Inhibitex Receives Fast Track Designation for INX-189 for the Treatment of Chronic Hepatitis C Infections

,Released: 02/11/11 07:00 AM EST
Inhibitex, Inc. (Nasdaq: INHX) today reported that the U.S. Food and Drug Administration (“FDA”) has designated the investigation of INX-08189 (“INX-189”), a potent guanosine nucleotide polymerase inhibitor for the treatment of chronic hepatitis C viral infection, as a Fast Track development program. Under the FDA Modernization Act of 1997, Fast Track programs are designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life threatening conditions and that demonstrate the potential to address unmet medical needs. The characteristics of INX-189 that contributed to it being granted Fast Track status include a high genetic barrier to resistance, its pan-genotypic activity, and once-daily oral dosing.

02/11/11 Inhibitex Receives Fast Track Designation for INX-189 for the Treatment of Chronic Hepatitis C Infections
02/09/11 Inhibitex to Present at the Leerink Swann Hot Topics in Therapeutics Roundtable Conference
01/09/11 Inhibitex Reports Positive Interim Safety and Antiviral Data from Ongoing Phase 1b Study of HCV Nucleotide Inhibitor INX-189

Idenix Updates

Idenix Pharmaceuticals, Inc. at Leerink Swann & Company Hot Topics in Therapeutics: Roundtable Conference (Live) 02/16/11 at 2:20 p.m. ET

Idenix Pharmaceuticals Provides Updates on Three Clinical Development Programs
* The FDA removes the full clinical hold on IDX184, and places it on partial clinical hold; Idenix anticipates initiating a Phase IIb study in the second half of 2011* The company discontinues clinical development of IDX320* The FDA places GSK2248761 ('761, formerly IDX899) on clinical hold

CAMBRIDGE, Mass., Feb. 9, 2011 /PRNewswire via COMTEX/ --
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 updates to three clinical development programs.

IDX184, a liver-targeted HCV nucleotide prodrug
The U.S. Food and Drug Administration (FDA) has verbally informed Idenix that the full clinical hold for IDX184 has been removed. The program has been placed on partial clinical hold, and Idenix anticipates initiating a Phase IIb12-week trial of IDX184 in combination with pegylated interferon and ribavirin in the second half of 2011.

The clinical hold was issued in September 2010 as a result of three cases of elevated liver function tests observed during a drug-drug interaction study of the combination of IDX184 and IDX320, an HCV protease inhibitor, in healthy volunteers. Idenix reviewed available data and conducted additional preclinical studies. With the help of independent experts and an external safety committee, the company concluded that the observed toxicity was likely caused by IDX320. Idenix submitted a response to the clinical hold to the FDA in January 2011.
IDX320, an HCV protease inhibitor

Based on Idenix's conclusion that the observed toxicity in the drug-drug interaction study was likely caused by IDX320, the company has discontinued the development of IDX320. Next generation protease inhibitors that may potentially avoid the observed hepatotoxicity are in preclinical development at Idenix.

GSK2248761 ('761, formerly IDX899), an HIV non-nucleoside reverse transcriptase inhibitor
Idenix was informed by ViiV Healthcare Company (ViiV), an affiliate of GlaxoSmithKline (GSK), that '761, a non-nucleoside reverse transcriptase inhibitor drug candidate for the treatment of HIV/AIDS licensed by Idenix to GSK, was placed on clinical hold by the FDA. ViiV has full responsibility for the development of '761, including any regulatory interactions.
Under the collaboration arrangement between Idenix and GSK, Idenix has received $60.5 million in license fees, equity investment and milestone payments to date and is eligible to receive up to $390.0 million in additional milestone payments as well as double-digit tiered royalties on worldwide product sales.

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 chronic hepatitis C infection. For further information about Idenix, please refer to

Forward-Looking Statements
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," "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 our drug candidates, the likelihood and success of any future clinical trials involving our drug candidates.

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 any clinical product candidate or other component of its potential pipeline 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 the ongoing clinical trials evaluating its product candidates; the company's ability to obtain additional funding required to conduct its research, development and commercialization activities; the company's dependence on its collaborations with Novartis Pharma AG and GlaxoSmithKline; changes in the company's business plan or objectives; the ability of the company to attract and retain qualified personnel; 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 each of the company's annual report on Form 10-K for the year ended December 31, 2009 and quarterly report on form 10-Q for the quarter ended September 30, 2010, 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.

Idenix Pharmaceuticals Contacts:
Kelly Barry (617) 995-9033 (media)
Eric Hoffman (617) 224-4485 (investors)
SOURCE Idenix Pharmaceuticals, Inc.

Investment News;

The Silver Lining to Idenix's Bad News
By Brett Chase Feb 11, 2011 7:45 am

Idenix (IDIX) lost a quarter of its market value after the company said the government halted human studies of its AIDS drug, a move that threatens hundreds of millions of dollars in potential revenue.

So why are some analysts recommending buying the stock ?

The Food and Drug Administration is lifting a hold on testing Idenix's hepatitis C drug in the middle-stage of human studies. The FDA halted a trial in September because of concerns about the drug’s potential risk for liver damage. Idenix was testing two hepatitis C drugs and determined that one was probably the cause of concern. That drug is being scrapped while Idenix plans to resume testing the other later this year. With $37 million in cash, Idenix needs to find a partner to help develop the hepatitis drug, IDX184.

But that was expected and analysts say that the FDA’s action will draw potential partners who want a piece of the hepatitis C market. “Lifting the full clinical hold on IDX184 in a relatively short period of time allows the most important asset of Idenix to move forward and Idenix to return to partnership discussions at a pivotal time for the (hepatitis C) field,” Leerink Swann analyst Howard Liang says. He rates the stock a buy with a price target of $5.The company’s cash is enough to fund its operations for the next year, William Blair analyst John Sonnier estimates. Citing the interest in hepatitis C treatments, he rates the stock a buy.Hepatitis C is a liver-eroding virus that infected an estimated 3 to 4 million people in the US over the past 35 years. Worldwide, that figure is about 170 million.Idenix, Merck (MRK), Vertex (VRTX), Abbott Laboratories (ABT), Bristol-Myers (BMY) and other companies are testing treatments because health officials expect to see more cases of the virus. The effects of hepatitis C don’t usually show up until the liver is badly deteriorated and that can take years. Some people carried the virus around over the past three decades after being infected by dirty needles or blood transfusions.

TMC649128, a nucleoside NS5B polymerase inhibitor
Medivir initiates Hepatitis C polymerase inhibitor Phase 1a trial
Medivir, an emerging Swedish research-based specialty pharmaceutical company focused on infectious diseases, has started the double-blind, randomized, placebo-controlled, single-ascending dose phase 1a clinical trial with TMC649128 in Belgium.
The trial aims to assess the safety, tolerability and pharmacokinetics in healthy volunteers.
TMC649128, a nucleoside NS5B polymerase inhibitor with an exciting pre-clinical profile, is indicated for the treatment of chronic hepatitis C virus infection (HCV).
TMC649128 is being developed in collaboration with Ortho Biotech Products, an affiliate of Tibotec Pharmaceuticals, for which a milestone payment of EUR7m has been paid to Medivir.
Medivir chief scientific officer Bertil Samuelsson said the start of the phase 1a trial underlines the company's commitment to the development of novel and innovative hepatitis C treatments, and a TMC649128 component could be a unique departure from other HCV drug classes.
The Press Release; Hepatitis C ; TMC649128 Start of Phase 1a Trial

From Jan 2011 News;Testing all-oral regimens with and without ribavirin in treatment-naive patients..

The Partnership

Bristol-Myers Squibb and Pharmasset Enter into a Clinical Collaboration Agreement for Proof of Concept Combination Study in Patients Chronically Infected with Hepatitis C

The Bad Economy and the Pharmaceutical Companies

If you follow the pharmaceutical news (one great site is Pharmalot), you may have discovered the economic downturn these companies are experiencing. One big player Merck has implemented cost cutting strategies in the past by cutting 17,500 jobs following the merger with Schering-Plough. In todays UK article from entitled "Drugs: Supply running low"by Andrew Jack, the author writes; "Industry estimates of the average cost of bringing a drug to market have jumped in the past two decades from $150m to $2bn". The article covers budget cuts in the pharmaceutial industry touching on America and the global crisis with reference to US pharmaceutical cutting research budgets and moving into non-prescription medicines such as multivitamins. Quoted from the article "A global crisis in productivity, which threatens to leave expensive research laboratories worldwide – like America’s industrial-age “Rust Belt” factories before them – at the mercy of the wrecking ball." Check out the article here.

Enter the collaborative effort of two drug companies;
Recently two pharmaceutical companies Bristol-Myers Squibb and Pharmasset have joined in an collaborative effort on clinical testing for the hepatitis C treatment regimen consisting of BMS-790052 and PSI-7977. The companies will be testing all-oral regimens with and without ribavirin in treatment-naive patients. With this collaboration the drug companies will cut costs and possibly speed up the drug development process . We should benefit with potentially better drugs to treat HCV.

The Deal

Jess Merrill

Bristol-Myers/Pharmasset: Bristol-Myers Squibb Co. and Pharmasset Inc have teamed up in a clinical partnership that marks the first cross-company collaboration to study two investigational oral drugs for the treatment of hepatitis C. The firms announced plans to study Bristol's NS5A replication complex inhibitor BMS-790052 and Pharmasset's nucleotide polymerase inhibitor on Jan. 10.

Drug makers do not generally collaborate on clinical trials for investigative drugs for competitive reasons and tend instead to study combinations within their own pipelines or with at least one already marketed drug. Regulatory uncertainties and, perhaps, just as important, cultural resistance, also present hurdles. But novel-novel combinations increasingly are viewed as the best way to treat certain serious diseases, like cancer and hepatitis C, and have become more common.

In hepatitis C specifically, the primary drug development focus is on combinations that could replace or reduce the use of the current standard of care, ribavirin and pegylated interferon (Roche's Pegasys or Merck's Pegintron), a regimen with a hasty side effect profile and limited efficacy. Bristol's decision to sign a clinical trial collaboration rather than in-licensing a polymerase inhibitor is intersting since the company recently acquired its hepatitsi C partner ZymoGenetics to gain more control over the program. -- Read More...............

From Pharmasset;

Planned Studies

PSI-7977 and BMS-790052 (NS5a) combination study – anticipated initiation first half calendar 2011 (conducted by Bristol-Myers Squibb)
24-week Phase 2b study of PSI-7977 in combination with Peg-IFN/RBV - second calendar quarter of 2011
PSI-938 and PSI-7977 Phase 2 combination study – anticipated initiation mid year calendar 2011

INFORM-SVR – RG7128 and ritonavir boosted RG7227 (protease inhibitor) anticipated initiation first half calendar 2011 (conducted by Roche)

Pharmasset Interferon-Free Combination Trials

PSI-7977 and PSI-938 combination (Phase 1, Part 2)

In December 2010, Pharmasset initiated Part 2 of a Phase 1 study that includes the first combinations of a purine (PSI-938) and a pyrimidine (PSI-7977) nucleotide analog for the treatment of HCV. The cohorts within Part 2 are expected to evaluate PSI-938 QD as monotherapy and in combination with PSI-7977 QD. The primary objective of Part 2 of this study is to assess the safety, tolerability and pharmacokinetics of PSI-938 alone and in combination with PSI-7977 in individuals with HCV GT1 for 14 days. The secondary objective of Part 2 of this study is to evaluate the short-term change in HCV RNA. Forty patients with HCV genotype 1 are expected to be randomized into one of four cohorts (10 patients per cohort, n = 8 and placebo = 2).

We expect to report preliminary results from Part 2 of this Phase 1 study during the first quarter of calendar year 2011. We also expect to initiate a Phase 2b study of PSI-938 in combination with PSI-7977 during mid (calendar year) 2011. This Phase 2b study will explore dosing durations of PSI-938 and PSI-7977, with and without ribavirin, and with an SVR endpoint.

Pharmasset Calendar Year 2011 Anticipated Milestones:

-- Pharmasset expects to report SVR12 data from its ongoing phase 2b trial with PSI-7977 in HCV genotype 2/3 patients in the second quarter of 2011

-- Pharmasset expects to report the 12 week interim analysis from its PSI-7977 Phase 2b genotype 1 arms in the second quarter of 2011

-- Pharmasset expects to initiate a 24 week Phase 2b trial with PSI-7977 in the second quarter of 2011

-- Pharmasset expects to initiate a Phase 2 study with PSI-7977 and PSI-938 in mid-2011

-- Pharmasset plans to file an IND for PSI-661 in the first quarter of 2011 and to initiate a phase 1 trial in the second quarter of 2011

-- Roche expects to initiate INFORM-SVR with RG7128 and RG7227 in the first quarter of 2011
-- Roche expects to initiate a phase 2 study with RG7128 in HCV genotype 2/3 patients in the first half of 2011
-- Roche expects to initiate a phase 3 program with RG7128 in 2011

About PSI-7977PSI-7977 is a uracil nucleotide analog inhibitor of the NS5B polymerase being developed for the treatment of chronic HCV infection. Nucleotide analog polymerase inhibitors work by acting as alternative substrates that block the synthesis of HCV RNA, which is essential for the virus to replicate. PSI-7977 has been studied in combination with peginterferon and ribavirin for up to 12 weeks in genotype 1, 2 or 3 patients and is currently in two Phase 2b studies, one of which is investigating an interferon sparing regimen in genotype 2 or 3 patients. PSI-7977 is also being investigated in a 14-day combination study with PSI-938, a guanine nucleotide analog.

About BMS-790052BMS-790052 is an investigational oral hepatitis C NS5A replication complex inhibitor. NS5A is one of the essential components for HCV replication. BMS-790052 is one of several molecules Bristol-Myers Squibb is studying for the potential treatment of chronic hepatitis C. The portfolio of investigational compounds, which also includes a novel pegylated interferon lambda, fits into the company's overall R&D focus on diseases where there is major unmet medical need.

Symposium on Hepatitis C virus management held at Nust
Our correspondent Friday, February 11, 2011 Islamabad

Due to unprecedented increase in pollution, industrial mobilisation at fast pace and other related reasons; the developing countries like Pakistan have become susceptible to health hazards, said Comstech Adviser Science Dr. Anwar Nasim. Addressing the 1st Annual Hepatitis C Virus Management Symposium held here on Thursday, he said the swift rise in cases of Hepatitis C Virus has already rung the alarm bells. It is therefore imperative that well thought-out efforts, both at individual and institutional levels, be made to eradicate this growing nuisance from the country.

The two-day event has been organised by the NUST Centre of Virology and Immunology (NCVI) in collaboration with Higher Education Commission (HEC). The target audience of the symposium are scientists, clinical pathologists, students and selected members of the community. The theme of the seminar is to share knowledge, new research areas, unexplored territories and experiences regarding Hepatitis C virus and associated diseases. Dr. Anwar Nasim asserted one of the most serious contemporary challenges that the human society faced was to effectively cope with the life threatening diseases, saying that human health is the most precious asset for any nation without which it becomes too weak to confront the emerging challenges.

Hepatitis C is an infectious disease of the liver that in majority of cases acts as a silent killer and is rising alarmingly throughout the world including Pakistan, he added. He was all praise for NUST to have established Centre of Virology and Immunology with state-of-the-art laboratories and staff comprising distinguished and experienced scientists. Eulogising the endeavours the university had taken towards the promotion of science and technology, he stressed the need for dissemination of scientific information that could help confront challenges of diversified nature.Dr. Ishtiaq Qadri, NCVI Principal, in his inaugural address welcomed the chief guest and other participants of the symposium.

He also pointed out that epidemics of HCV had plagued the entire developing world including Pakistan, saying HCV associated diseases impose heavy burdens on national economies and individual families due to costs arising from acute and chronic morbidity and mortality. The aim of the symposium is to address Hepatitis C spread in Pakistan, which is the major cause of liver diseases like liver steatosis, liver cirrhosis and hepatocellular carcinoma, he maintained.He said that they had tried to provide a forum whereby the investigators from across the country could introduce new work for peer review and discussion focusing on HCV management. Dr. Muhammad Idrees from CEMB gave his presentation on the changing epidemiology pattern and frequency distribution of HCV in Pakistan.

FDA Updates: Boceprevir and Telaprevir
.Boceprevir Receives FDA Priority Review and EMA Accelerated Assessment
Telaprevir "Gets FDA Priority Review" In U.S. and Canada/Jan 20

No comments:

Post a Comment