Biotech Values

[DewDiligence]

ANA975 R.I.P.

[With the demise of Actilon from COLY in January (#msg-16403804) and now ANA975 from ANDS and NVS, TOL-like-receptor drugs are batting .000 as treatments for HCV. ANA975 had been on clinical hold since June 2006 due to safety issues seen in animal testing.

ANDS’ other drug in the clinic, ANA380 for HBV, was already on life support (#msg-19355016). With the termination of ANA975, ANDS will likely trade down to cash value or perhaps less, making it an appealing asset play for those with a soft spot for that kind of thing. CC today (Fri) at 8:30 am.]

http://biz.yahoo.com/prnews/070726/lath194.html?.v=1

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Development Discontinued for ANA975, an Early Stage Compound for Treatment of Hepatitis C Virus Infection

Thursday July 26, 6:55 pm ET

SAN DIEGO, July 26 /PRNewswire-FirstCall/ -- Anadys Pharmaceuticals, Inc. (Nasdaq: ANDS ) today announced that it and Novartis have decided to discontinue the development of ANA975, a phase 1b compound for the treatment of hepatitis C virus (HCV) infection. The parties have determined that the results received to date from the ongoing 13 week toxicology study together with the results observed in the previous 13 week toxicology study do not support further clinical evaluation of chronic daily dosing of ANA975 in hepatitis C patients.

"Although we are disappointed to discontinue development of ANA975, our animal toxicology results have convinced us that chronic daily dosing of this compound is inappropriate for further clinical development," said Lawrence C. Fritz, Ph.D., president and chief executive officer of Anadys. "However, we remain optimistic that TLR7 agonists offer therapeutic potential as effective immunomodulators in multiple disease areas, albeit using alternative dosing schedules, and our plans to develop ANA773 for cancer treatment continue unabated," Dr. Fritz said.

Anadys continues its development of ANA773, another TLR7 agonist prodrug distinct from ANA975, and expects to file an IND by the end of 2007. Anadys plans to evaluate ANA773 in Phase 1 clinical trials for the treatment of advanced cancer. This program is independent of the Novartis collaboration and is not affected by the decision to discontinue development of ANA975.

First and Second Toxicology Study Results

In June 2006, Anadys and Novartis suspended dosing in their 28-day phase 1b clinical trial of ANA975 in HCV infected patients due to then recently obtained information from pre-clinical 13-week toxicology studies. No clinical observations contributed to this decision. Preliminary analysis of the toxicology information revealed various new observations which appeared consistent with intense immune stimulation in animals. Subsequently, the FDA put the ANA975 IND on full clinical hold. In November 2006, Anadys and Novartis initiated a second 13-week toxicology study to understand better the observations from the first toxicology study and to assist in determining a future course of action for the program.

Analysis of available data from the second 13-week toxicology study, together with the results from the initial 13-week toxicology study led the parties to determine that: 1) chronic daily dosing of ANA975 was unlikely to provide an adequate therapeutic index; and 2) additional preclinical evaluation would be necessary to determine if alternate dosing schedules of ANA975 would support a safety margin sufficient for further development of this compound for the treatment of patients chronically infected with hepatitis C.

About TLR-7

Toll-like receptor 7 (TLR7) is a pattern-recognition receptor that activates the innate immune response. Stimulation of TLR7 induces the release of interferon-alpha and other type I interferons from immune cells, the release of various pro-inflammatory cytokines, the upregulation of co-stimulatory molecules and the development of an adaptive immune response. Small-molecule TLR7 agonists have been shown to have broad antiviral and anticancer effects in preclinical models and in some clinical settings.

Webcast of Conference Call

Anadys will host a conference call tomorrow at 8:30 a.m. Eastern Daylight Time to discuss the discontinuation of ANA975 development in HCV. A live webcast of the call is available online at http://www.anadyspharma.com. A telephone replay will also be available approximately one hour after completion of the call. To access the telephone replay, dial 888-286-8010 (domestic) or 617-801-6888 (international), passcode 38857175. The webcast and telephone replay will be available through August 10, 2007.

About Anadys

Anadys Pharmaceuticals, Inc., http://www.anadyspharma.com, is a biopharmaceutical company committed to advancing patient care by discovering, developing and commercializing novel small molecule medicines for the treatment of viral diseases and cancer. The Company's programs focus on Toll-Like Receptor-based small molecule product candidates and direct antiviral compounds that inhibit key steps in viral proliferation. The Company has core expertise in medicinal chemistry coupled with cell biology and structure-based drug design, and is developing compounds for the treatment of hepatitis C infection, hepatitis B infection and cancer.
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