GEN Exclusives

More »

GEN News Highlights

More »
Nov 23, 2010

Idenix Achieves $20M Milestone in HIV Deal with ViiV Healthcare

  • Idenix Pharmaceuticals will receive $20 million from ViiV Healthcare for the achievement of a clinical milestone relating to GSK2248761 (known as '761). ViiV is testing the compound in a Phase IIb trial as a treatment of HIV/AIDS.

    In February 2009, GlaxoSmithKline (GSK) paid Idenix $34 million for a worldwide license to '761, a non-nucleoside reverse transcriptase inhibitor (NNRTI) for HIV/AIDS. In November 2009, GSK and Pfizer created ViiV Healthcare, an independent company focused solely on research, development, and commercialization of HIV medicines.

    Idenix says that it has received approximately $60 million in total collaboration-related payments. The firm could earn another $390 million in milestone fees as well as double-digit tiered royalties on worldwide product sales.

    ViiV was seeded with 10 approved products from GSK and Pfizer and has five developmental candidates. 1349572 and S/GSK 1265744 are integrase inhibitors in Phase III, UK-453061 is an NNRTI in Phase IIb, and PF-232798 is a CCR5 antagonist in Phase II.

    S/GSK 1265744, a once-daily, unboosted treatment, is being developed in partnership with Shionogi. In October the companies reported the start of a Phase III program that includes two studies (SPRING-2 and SAILING) evaluating the drug in treatment-naïve patients and treatment-experienced but integrase-naïve patients.

    Idenix is now focused on drug development for hepatitis. On September 3, the FDA placed a clinical hold on the firm’s two lead candidates, IDX184 and IDX320. The decision was made after Idenix notified the FDA that three healthy volunteers in a drug-drug interaction study of IDX184 in combination with IDX320 showed elevated liver function. During follow-up, the liver function tests had reportedly returned to nearly normal levels in all three subjects.

    IDX184 is a nucleotide inhibitor, and IDX320 is a protease inhibitor. Idenix expects to submit full data to the FDA from recently completed preclinical and clinical studies including three-month chronic toxicology studies of IDX184, a 14-day study of IDX184 in combination with pegylated interferon/ribavirin, a three-day proof-of-concept study of IDX320 in HCV, and the IDX184 and IDX320 drug-drug interaction study in healthy volunteers to assess next steps in the development of both compounds.

    The company has a non-nucleoside inhibitor IDX375 in Phase I development and a discovery-stage program to find an NS5A inhibitor. It has one product on the market: Tyzeka/Sebivo for hepatitis B was co-developed with Novartis, which has worldwide, exclusive commercialization rights.


Add a comment

  • You must be signed in to perform this action.
    Click here to Login or Register for free.
    You will be taken back to your selected item after Login/Registration.

Related content

Jobs

GEN Jobs powered by HireLifeScience.com connects you directly to employers in pharma, biotech, and the life sciences. View 40 to 50 fresh job postings daily or search for employment opportunities including those in R&D, clinical research, QA/QC, biomanufacturing, and regulatory affairs.
 Searching...
More »

GEN Poll

More » Poll Results »

Stopping Research Fraud

What is the best approach to curbing scientific misconduct and outright fraud?