Tuesday, October 8, 2013

Hepatitis C Interferon-free Combo - J&J Acquires Rights to NS5A inhibitor from GlaxoSmithKline

J&J buys GSK Hep C compound, BI completes trial enrollment
Deborah Weinstein
October 08, 2013

GlaxoSmithKline sold its investigational hepatitis C NS5a replication complex inhibitor to Johnson & Johnson subsidiary Janssen. The J&J unit said in a statement it plans to use Phase II GSK2336805 in interferon-free combinations with its in-house drug simeprevir and its non-nucleoside polymerase inhibitor known as TMC647055. Simeprevir is expected to go before an FDA advisory panel later this month.

This mix-and-match drug approach is common to the space, and competitor Gilead's investigational nucleotide hep. C virus polymerase inhibitor is set to go before an FDA committee one day after J&J's contender gets a thumbs-up or down.

As Boehringer Ingelheim noted in a statement Tuesday, an interferon-free hep. C treatment is an innovation of need, because around 50% of patients cannot take the infusion drugs. This is in addition to patients who are turned off by side effects and the amount of time it takes to complete a course of interferon therapy.

Boehringer's patient-perception walk-through was part of a larger HCV announcement, which was that it had completed enrollment for its all-oral Phase IIa treatment that combines BI's protease inhibitor faldaprevir, its non-nucleoside NS5B polymerase inhibitor deleobuvir, and Presidio Pharmaceutical's pan-genotypic NS5A inhibitor, PPI-668 with and without ribavirin. BI and Presidio's collaboration dates to March, with each company holding on to the rights of their respective compounds. A Phase IIIb faldaprevir-deleobuvir study showed strong efficacy among hepatitis C genotype 1 patients without interferon. Genotype-1 is the most difficult hep. c variation to treat.
Press Release: 
Janssen Acquires Investigational NS5A Inhibitor for the Treatment of Hepatitis C from GlaxoSmithKline
TITUSVILLE, N.J., Oct. 8, 2013 /PRNewswire/ -- Janssen Pharmaceuticals, Inc. (Janssen) announced today the acquisition of the investigational compound GSK2336805, an NS5a replication complex inhibitor in Phase 2 development for the treatment of chronic hepatitis C, from an affiliate of GlaxoSmithKline plc. Janssen has acquired all rights to develop and commercialize GSK2336805, including in combination with other drugs. Financial details of the agreement have not been disclosed.
Janssen plans to initiate Phase 2 studies to evaluate the use of GSK2336805 in interferon-free combinations with the investigational protease inhibitor simeprevir (TMC435) and TMC647055, Janssen's non-nucleoside polymerase inhibitor, for the treatment of chronic hepatitis C in adult patients with compensated liver disease.
"We're excited to add GSK2336805 to our existing portfolio of direct-acting antivirals (DAAs). This addition will broaden our clinical development program as we continue to look for new investigational interferon-free treatment combinations to combat the hepatitis C virus," said Gaston Picchio, Hepatitis Disease Area Leader, Janssen. "Janssen is dedicated to working with the hepatitis C community to investigate our portfolio of DAAs in a number of different treatment combinations and hepatitis C patient populations."  
About GSK2336805
GSK2336805 is an investigational once-daily NS5a replication complex inhibitor in Phase 2 development for the treatment of chronic hepatitis C in adult patients with compensated liver disease, including all stages of liver fibrosis.
About Simeprevir
Simeprevir is an investigational NS3/4A protease inhibitor jointly developed by Janssen R&D Ireland and Medivir AB for the treatment of genotype 1 and genotype 4 chronic hepatitis C in adult patients with compensated liver disease, including all stages of liver fibrosis. Simeprevir works by blocking the protease enzyme that enables the hepatitis C virus to replicate in host cells.
Janssen is responsible for the global clinical development of simeprevir and has acquired exclusive, worldwide marketing rights, except in the Nordic countries. Medivir will retain marketing rights for simeprevir in these countries. Simeprevir has been submitted for regulatory approval in the United States, Canada and Europe, and was approved in September 2013 in Japan. To date, more than 3,700 patients have been treated with simeprevir in clinical trials.
Additionally, simeprevir is being studied in combination with several DAAs with different mechanisms of action, with and without ribavirin, as part of interferon-free regimens. These include:
  • The Phase 2 COSMOS study of simeprevir and Gilead's nucleotide inhibitor sofosbuvir (GS-7977) in treatment-naive and previous null-responder genotype 1 hepatitis C patients, including patients with cirrhosis; 
  • A Phase 2 study of simeprevir and Bristol-Myers Squibb's NS5A replication complex inhibitor daclatasvir in treatment-naive and previous null-responder genotype 1 hepatitis C patients;  and
  • The Phase 2 HELIX-1 study of simeprevir and Idenix's once-daily pan-genotypic NS5A inhibitor samatasvir (IDX719) in treatment-naive genotype 1b and genotype 4 hepatitis C patients.
For additional information about simeprevir, please visit www.clinicaltrials.gov.
About Hepatitis C
Hepatitis C, a blood-borne infectious disease of the liver and a leading cause of chronic liver disease, is the focus of a rapidly evolving treatment landscape. Approximately 150 million people are infected with hepatitis C worldwide – including approximately 3.2 million people in the United States – and 350,000 people per year die from the disease globally. When left untreated, hepatitis C can cause significant damage to the liver including cirrhosis. Additionally, hepatitis C may increase the risk of developing complications from cirrhosis, which may include liver failure.
About Janssen
At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in infectious diseases and vaccines, oncology, immunology, neuroscience, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we develop innovative products, services and healthcare solutions to help people throughout the world. Janssen Pharmaceuticals, Inc. and Janssen R&D Ireland are part of the Janssen Pharmaceutical Companies of Johnson & Johnson. Please visit http://www.janssenrnd.com for more information.
(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995.  The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events.  If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Pharmaceuticals, Inc., any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson.  Risks and uncertainties include, but are not limited to, general industry conditions and competition; economic factors, such as interest rate and currency exchange rate fluctuations; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; challenges to patents; impact of business combinations; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; changes to governmental laws and regulations and domestic and foreign health care reforms; trends toward health care cost containment; and increased scrutiny of the health care industry by government agencies.  A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 30, 2012.  Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson.  None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertake to update any forward-looking statements as a result of new information or future events or developments.)
Media Contact: Daniel De Schryver 
Mobile: +49 173 76 89 149
Media Contact: Craig Stoltz  
Mobile: +1 (215) 325-3612
Investor Contact: Stan Panasewicz 
Office: +1 (732) 524-2524
Investor Contact: Louise Mehrotra 
Office: +1 (732) 524-6491

SOURCE Janssen Pharmaceuticals, Inc.


No comments:

Post a Comment