|Roche set to acquire small-cap biotech Anadys Pharmaceuticals|
|By Staff and Wire Reports|
|Monday, 17 October 2011 02:04|
The BioMedReports FDA Calendar and Catalyst Tracker shows that the clinical trial milestones for both those products from Anadys were on the board and in play for 4Q 2011. The first was announced in a news release in late May and indicated that Anadys was advancing the development of ANA773 in a separate indication, chronic hepatitis C virus infection, or HCV. Anadys was expecting to receive 28-day data from the Phase IIa HCV study during the fourth quarter of 2011.
ANA773 is Anadys' oral, small-molecule inducer of endogenous interferons that acts via the Toll like receptor 7, or TLR7, pathway. Both the prodrug and its active substance were discovered by Anadys scientists. Animal pharmacology studies have shown that ANA773 can elicit desired immune responses and that components of the response can be modulated by both dose and schedule of administration. The Company showed in their Phase I HCV clinical study that ANA773 can stimulate the immune system at a tolerated dose.
Because interferon-alfa is the foundation of the current standard of care for hepatitis C and the current approval strategies of direct-acting antivirals, or DAAs, are based on the addition of such DAAs to interferon-based regimens, we believe that an oral agent that stimulates interferon production with improved tolerability could potentially displace interferon from future regimens that contain DAAs. We believe that ANA773 may offer the opportunity to be such an oral interferon replacement.
The second catalyst involved that Phase IIb study of Setrobuvir (ANA598). The Company had announced early in the year that it expected to receive Week 24 antiviral response data in the fourth quarter of 2011. In the trial, approximately 100 treatment-naive HCV patients are expected to receive ANA598 in combination with SOC and 33 treatment-naive HCV patients are to receive placebo plus SOC.
Jean-Jacques Garaud, Global Head of Roche Pharma Research and Early Development, said: "This acquisition augments Roche's already strong HCV portfolio. Our aim is to offer physicians and hepatitis patients a powerful combination of therapies that bring us closer to a cure, even without the use of interferon. Anadys' compounds provide additional modes of action that could lead to interferon-free treatment regimens without viral resistance."Anadys Pharmaceuticals was engaged in improving patient care by developing novel medicines for the treatment of hepatitis C. The company was founded by Stelios Papadopoulos and Kleanthis G. Xanthopoulos, with an objective to contribute to an improved treatment outcome for patients with this serious disease.
The Company has 61.5M shares outstanding of which 22.39% are owned by insiders and 49.50% are owned by institutions. The stock closed Firday's session trading at a 40% discount from its 52-Wk High ($ 1.75), but had traded as low as $ 0.60 in early September.