Cerimon Pharmaceuticals, Inc (SOUTH SAN FRANCISCO, California), a clinical-stage biopharmaceutical company engaged in the development and commercialization of therapeutics for autoimmune diseases, inflammation associated with autoimmune diseases, and pain management, announced that it has begun enrolling patients in a phase IIb clinical study of its lead product candidate basiliximab (Simulect®, Novartis Pharma AG) for the treatment of ulcerative colitis (UC). The randomized, double-blind, placebo-controlled study, titled ARREST UC-1 (Achieve Remission & Reduce or Eliminate Steroid Therapy in Ulcerative Colitis), will enroll a total of 135 patients to study the safety, efficacy, and pharmacokinetics of a 3-dose induction regimen of basiliximab in patients with moderate-to-severe UC, who are not responding to a standard course of oral corticosteroids.
Simulect has shown promising results in an open-label pilot study of UC patients conducted by the University of Bristol, in the UK. Data from this study led Cerimon to acquire the exclusive worldwide rights to develop and commercialize Novartis Pharma's Simulect, a monoclonal antibody that selectively blocks the receptor for interleukin-2 (IL-2) and subsequent T-lymphocyte activation, for the treatment of inflammatory bowel disease (IBD). Novartis Pharma AG currently markets Simulect, and will continue to do so, for the prevention of organ rejection in transplant recipients. Cerimon is responsible for the development and marketing of Simulect (for injection) for IBD and will share revenue from net sales with Novartis, following the regulatory approval of Simulect for this indication.
Cerimon employs a corporate strategy of in-licensing late-stage or marketed drugs to reduce the development and regulatory risk, decrease time to market, and expand the commercial potential of known drugs. Cerimon's pipeline consists of proven, marketed drugs that are being developed for expansion into North America or repurposed for new disease indications. Because the company's lead products already have been used in thousands of patients, their safety and initial efficacy profiles are well documented, which lowers Cerimon's development risk compared to earlier stage compounds.
In addition to basiliximab, Cerimon has a topical formulation of diclofenac sodium, a nonsteroidal anti-inflammatory drug (NSAID), for the treatment of osteoarthritis (OA) and musculoskeletal pain that will enter clinical testing in the US in 2007. Cerimon has acquired US rights to market and sell two topical formulations of diclofenac that are currently marketed in Japan. Other formulations of topical diclofenac are also marketed in Europe, but no topical NSAID is available in the US. Cerimon is developing a patch formulation of diclofenac for the US market with an initial focus on the treatment of mild-to-moderate pain associated with OA. The company's goal is to offer a topical formulation that can provide pain relief directly to the affected joint without accumulating high levels of the drug beyond the target area.
Cerimon is well financed, having closed a $70 million Series A financing in late 2005 with the premier investors MPM, Nomura Phase 4 Ventures, and OrbiMed Advisors.
—A. Techman
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