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. If the FDA allows this trial to proceed, Anadys intends to initiate the trial during the third quarter of 2009.
The current protocol design calls for 12 weeks of dosing ANA598 in naive genotype 1 patients in combination with SOC, compared to a control arm that will receive a placebo and SOC. After 12 weeks, patients are expected to continue to receive SOC alone. The primary endpoints of the study are designed to be safety, tolerability and the percentage of patients with undetectable virus at four weeks (defined as Rapid Virologic Response, or RVR) and 12 weeks (defined as Early Virologic Response, or EVR). For patients who achieve an RVR and EVR response, the duration of treatment with SOC after week 12 will be at the clinical investigator's discretion. Anadys expects that some patients who achieve RVR would stop receiving all treatment at 24 weeks. All patients who complete 24 or 48 weeks of treatment will be assessed for virus negativity 12 and 24 weeks after treatment is ended.
The proposed dose levels in this study are 200 mg and 400 mg, each dosed twice daily (bid). In order to maximize early viral suppression, each patient receiving ANA598 would receive two 800 mg doses on day one, known as a loading dose. The decision to initiate dosing of patients in the 400 mg dose group will be determined after assessing 28 day data from the 200 mg dose group. Anadys intends to enroll 90 patients in this study, in the proportions of 30 patients receiving ANA598 and 15 receiving placebo at each dose level. The study will be conducted at a number of clinical sites in the United States.
Anadys Pharmaceuticals, Inc. is a biopharmaceutical company dedicated to improving patient care by developing novel medicines for the treatment of hepatitis C. The Company believes hepatitis C represents a large unmet medical need in which meaningful improvements in treatment outcomes may be attainable with the introduction of new medicines. The Company is developing ANA598, a non-nucleoside polymerase inhibitor for the treatment of hepatitis C. The Company has also investigated the potential of ANA773, an oral, small-molecule inducer of endogenous interferons that acts via the Toll-like receptor 7, or TLR7, pathway in hepatitis C.
Safe Harbor Statement
Statements in this press release that are not strictly historical in nature constitute "forward-looking statements." Such statements include, but are not limited to, references to Anadys' restructuring plans, its focus of operations, management of its ANA773 programs, its plans regarding the planned ANA598 Phase II trial, the potency, safety and tolerability profile of ANA598, which may not be duplicated in future clinical studies of longer duration, the planned timing for initiating the Phase II trial of ANA598, the proposed design of the ANA598 trial, the expected timing and occurrence of projected ANA598 Phase II data milestones, the Company's reduction of its workforce, its ability to retain personnel, its ability to achieve cost-savings in connection with the restructuring and costs associated with the restructuring. Such forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause Anadys' actual results to be materially different from historical results or from any results expressed or implied by such forward-looking statements. For example, the restructuring may result in additional costs or other negative results not currently anticipated. Moreover, the results of preclinical and early clinical studies may not be predictive of future results, and Anadys cannot provide any assurances that ANA598 will not have unforeseen safety issues or will have favorable results in the planned Phase II trial. Also, Anadys cannot provide any assurances that the FDA will concur with Anadys' proposed ANA598 Phase II trial design. In addition, Anadys' results may be affected by risks related to competition from other biotechnology and pharmaceutical companies, its effectiveness at managing its financial resources, its ability to enter into collaborations around its product candidates, its ability to successfully develop and market products, difficulties or delays in its preclinical studies or clinical trials, difficulties or delays in manufacturing its clinical trials materials, the scope and validity of patent protection for its product candidates, regulatory developments involving its product candidates and its ability to obtain additional funding to support its operations. Risk factors that may cause actual results to differ are more fully discussed in Anadys' SEC filings. All forward-looking statements are qualified in their entirety by this cautionary statement. Anadys is providing this information as of this date and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.
|SOURCE Anadys Pharmaceuticals, Inc.|
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