SAN DIEGO, June 4 /PRNewswire-FirstCall/ -- Anadys Pharmaceuticals, Inc. (Nasdaq: ANDS) today announced a strategic restructuring to focus its operations on the development of ANA598, in particular a proposed Phase II study in hepatitis C patients of ANA598 in combination with pegylated interferon-alpha and ribavirin.
As part of this restructuring, the Company intends to suspend further development of ANA773 and is reducing its workforce by approximately 40%. Pending the outcome and analysis of data from current cohorts in ongoing studies in hepatitis C and oncology, Anadys intends to manage the ANA773 programs as potential out-licensing opportunities.
'We have now completed three Phase I studies of ANA598 and we have seen potent antiviral activity, as well as good tolerability,' said Steve Worland, Ph.D., President and CEO of Anadys. 'As we complete preparations for the first Phase II study of ANA598 in combination with interferon and ribavirin, we have decided to focus our future investments on this important asset and to take these cost-sparing measures which we expect to ensure our ability to complete the Phase II study with our expected cash resources. The proposed Phase II study is expected to provide important data at the end of this year and in the first two quarters of 2010.'
The Company anticipates the reduction in force to generate annual cash expense savings of between approximately $4.0 million and $5.0 million. The Company estimates that it will incur one-time cash charges of approximately $1.1 million in severance costs and $0.2 million in continuation of benefits and outplacement services. The Company will retain the clinical development infrastructure required to conduct the Phase II study of ANA598, key capabilities directed toward pharmaceutical development and next-generation non-nucleosides, and a streamlined administrative staff.
Dr. Worland added, 'I want to acknowledge the tremendous effort and commitment of all our Anadys colleagues, especially those whose positions have been impacted by this restructuring. The current status of ANA598, which now demands our focused investment, has been achieved as a result of each of their contributions.'
Proposed ANA598 Phase II Trial Design
Anadys is preparing for the first Phase II trial in hepatitis C patients of ANA598 in combination with interferon-alpha and ribavirin (current standard of care, or SOC) and intends to submit a protocol to the U.S. Federal Drug Administration (FDA) containing the proposed trial design in July 2009.
