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J&J, BMS join forces in race to develop interferon-free hep C combos
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"a market some analysts have said could be worth $20 billion by 2020" [maybe 50 billion]
foxbusiness.com December 2, 2011
As interest in interferon-free hepatitis C combos reaches a fever pitch, a unit of Johnson & Johnson and Bristol-Myers Squibb revealed plans to combine oral drugs and test them in patients with the liver-damaging illness. The news follows Gilead Sciences' recent move to buy clinical-stage developer Pharmasset for $11 billion to gain control of its interferon-free treatment for hep C.
With analysts projecting the interferon-free combos to become the next frontier of treatment, BMS and Tibotec Pharmaceuticals will put their respective compounds, daclatasvir and TMC435, to the test in a Phase II study in patients with genotype 1 hepatitis C. The study, slated to begin in early 2012, will test the pair of experimental drugs alone, in combination with the antiviral drug ribavirin and with interferon. It will enable the companies to compare the sustained viral response of the three regimens at 12 weeks and 24 weeks, according to the companies' release.
Tibotec's TMC435, which it's developing with Swedish biotech Medivir, is already in late-stage development, but in combination with interferon, an injected drug notorious for side effects that often make patients with hepatitis C feel sicker than their disease does. Today, even the latest approved treatment regimens, including Vertex's hot new hep C drug Incivek and Merck's Victrelis, require interferon injections. Doctors are expected to embrace the interferon-free options if they get approved. Pharmasset's lead in developing such an option with its experimental PSI-7977 drew Gilead to the developer for the blockbuster buyout.
Medivir said in July that it planned to begin a midstage trial to test an interferon-free combo of Pharmasset's PSI-7977 and its TMC435. Bristol-Myers Squibb is also testing its experimental antiviral daclatasvir in combination with PSI-7977. Clearly, competitors in this field see a big opportunity to cooperate and combine their assets to grab a piece of the multibillion-dollar market anticipated for interferon-free cocktails to combat the disease.
"Bristol-Myers Squibb is dedicated to developing innovative treatment options for patients with serious diseases like HCV," stated Brian Daniels, the company's senior vice president of development. "We are pleased to work with Tibotec to advance the scientific understanding for the potential for an all-oral regimen of direct acting antivirals, which would be an important advancement for patients with HCV. This is a continuation of our leadership in forging partnerships to advance combination antiviral therapy."
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Global HCV - (12/01/11)
OraSure Technologies Receives CLIA Waiver for OraQuick(R) HCV Rapid Test - (11/30/11)
AASLD: Single-Dose Pharmacokinetics of Daclatasvir (DCV; BMS-790052) in Subjects With Hepatic Impairment Compared With Healthy Subjects - (11/16/11)
AASLD: Daclatasvir (DCV; BMS-790052) Has No Clinically Significant Effect on the Pharmacokinetics of a Combined Oral Contraceptive Containing Ethinyl Estradiol and Norgestimate in Healthy Female Subjects - (11/16/11)
AASLD: Daclatasvir (DCV; BMS-790052), an NS5A Replication Complex Inhibitor, in Combination With Peginterferon Alfa-2b and Ribavirin in Japanese Treatment-Naïve and Nonresponder Patients With Chronic HCV Genotype 1 Infection - (11/10/11)
AASLD: TMC-435 New PI Effective, Safe in HCV Trial - (11/16/11)
AASLD: Combination Therapy of Treatment-Naïve and Nonresponder Patients With HCV Genotype 1 Infection With Daclatasvir (DCV; BMS-790052), an NS5A Replication Complex Inhibitor, in Combination With Peginterferon Alfa-2a and Ribavirin - (11/10/11)
- High Rates of SVR24 for BMS-790052, an NS5A Replication Complex Inhibitor, in Combination With PegIFN-alfa-2a and Ribavirin: Phase 2a Trial in Treatment-- Naive HCV Genotype 1 Subjects - (09/19/11)
- BMS-790052 Plus Peginterferon Alfa and Ribavirin Demonstrated up to 83% - Sustained Virologic Response 24 Weeks Post-Treatment (SVR24) in Phase II Study of Genotype 1 Hepatitis C Patients - (09/19/11)
Bristol-Myers Squibb Enters Clinical Collaboration Agreement with Tibotec Pharmaceuticals for Phase II Combination Study in Patients Chronically Infected with Hepatitis C
NEW YORK- Bristol Myers-Squibb (NYSE:BMY) announced today that it has entered into a clinical collaboration agreement with Tibotec Pharmaceuticals, one of the Janssen Pharmaceutical Companies, to evaluate the utility of daclatasvir (BMS-790052), Bristol-Myers Squibb's investigational NS5A replication complex inhibitor, in combination with Tibotec Pharmaceuticals' investigational NS3 protease inhibitor, TMC435, for the treatment of chronic hepatitis C virus (HCV).
Under the agreement the companies will evaluate the potential to achieve sustained viral response 12 and 24 weeks post treatment in patients with HCV genotype 1 in a study with three treatment regimens: an oral, once-daily treatment regimen of daclatasvir and TMC435 with pegylated-interferon alpha plus ribavirin; an oral, once-daily treatment regimen of daclatasvir and TMC435 with ribavirin and an oral, once-daily treatment regimen of daclatasvir and TMC435 alone. The study is planned to start in the first half of 2012.
"Bristol-Myers Squibb is dedicated to developing innovative treatment options for patients with serious diseases like HCV," said Brian Daniels, senior vice president, Development. "We are pleased to work with Tibotec to advance the scientific understanding for the potential for an all-oral regimen of direct acting antivirals, which would be an important advancement for patients with HCV. This is a continuation of our leadership in forging partnerships to advance combination antiviral therapy."
About daclatasvir (BMS-790052)
Discovered by Bristol-Myers Squibb through a genomics approach, daclatasvir is the first NS5A replication complex inhibitor to be investigated in clinical trials and is currently in Phase III development. Daclatasvir is part of a portfolio of investigational compounds that the company is developing for the treatment of hepatitis C.
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