• 4SC AG, of Planegg-Martinsried, Germany, said the last patient was released from the current Phase IIa trial with SC12267 for rheumatoid arthritis, as scheduled. The drug is described as SC12267 is a new small molecule in the disease-modifying antirheumatic drug class. In the three-tiered and placebo-controlled study, about 120 patients were given two doses of SC12267 per day over a three-month period. Results are expected later this quarter.

• Accentia Biopharmaceuticals Inc., of Tampa, Fla., completed enrollment of a target 300 patients in its Phase III trial of SinuNase (intranasal amphotericin B) for chronic sinusitis. The company expects to unblind the data in 18 weeks and announce top-line results shortly afterward. Pending positive results, Accentia plans to file for conditional accelerated approval, which would allow a confirmatory Phase III trial to be conducted after launch, although the company projects the second trial would be completed and a filing for full approval would be submitted before the end of 2008. Separately, Accentia said it is working on an investigational new drug application for a pivotal Phase III trial of Revimmune in refractory, relapsing-remitting multiple sclerosis.

• Alimera Sciences Inc., of Atlanta, and pSivida Ltd., of Perth, Australia said enrollment is complete for the FAME (Fluocinolone Acetonide in Diabetic Macular Edema) Phase III study of Medidur FA for the treatment of Diabetic Macular Edema. FAME is a double-masked, randomized, multicenter study that is following more than 900 patients in the U.S., Canada, Europe and India for 36 months with safety and efficacy assessed at two years. Alimera and pSivida are jointly developing Medidur FA under a collaborative research and development agreement.

• Cerimon Pharmaceuticals Inc., of South San Francisco, has initiated a Phase I clinical study of a novel diclofenac sodium patch. The study will evaluate safety, tolerability and systemic pharmacokinetics of a topical patch formulation of diclofenac sodium, a nonsteroidal anti-inflammatory drug in 16 healthy volunteers. The study is expected to be completed this quarter. Following the completion of the study, Cerimon plans to rapidly initiate late-stage efficacy and safety studies in patients with acute musculoskeletal pain.

• EpiCept Corp., of Tarrytown, N.Y., completed its Phase I trial with EPC2407, a novel small-molecule vascular disruption agent and apoptosis inducer for the treatment of patients with advanced solid tumors and lymphomas. EpiCept has identified the maximum tolerated dose of EPC2407 in the Phase I study, and that dose is well below the dose that produced the expected toxicity in preclinical work. Started in December 2006, the study was conducted at three cancer centers in the U.S.

• Horizon Therapeutics Inc., of Palo Alto, Calif., has initiated a Phase III follow-on safety study (protocol HZ-CA-304) of its lead product candidate HZT-501, an investigational prescription NSAID (nonsteroidal anti-inflammatory drug) designed to be GI-friendly. HZT-501 is a proprietary formulation of ibuprofen combined with famotidine and is designed specifically to relieve pain while reducing stomach acidity during the peak time of risk for gastric ulceration. The safety study will support the two ongoing pivotal Phase III trials involving a total of 1,400 patients with mild to moderate pain, including patients with osteoarthritis.

• Noven Pharmaceuticals, of Miami, said its Phase III clinical study of its developmental once-daily lithium carbonate product did not meet its primary endpoint with statistical significance, sending its shares down 22 percent Monday. The Phase III trial was a multicenter, double-blind, randomized, placebo-controlled, parallel-group study of Lithium QD involving approximately 240 randomized subjects. The primary objectives of the four-week study were to determine the efficacy and safety of Lithium QD compared to placebo in treating acute symptoms of mania in subjects with Bipolar I disorder. The primary efficacy endpoint was change from baseline compared to placebo using the Young Mania Rating Scale. The company said it planned to complete its analysis of the data and consult with the FDA about the next steps to advance development. Shares of Noven (NASDAQ:NOVN) dropped $3.64, to close at $13.05.

• Ocera Therapeutics Inc., of San Diego, has completed patient enrollment in its Phase III study in fistulizing Crohn's disease. The pivotal, double-blind, placebo controlled study, FHAST1 (Fistula Healing with AST-120), is designed to determine the efficacy and safety of oral AST-120 in 240 patients with Crohn's disease suffering from perianal fistulas. Initial data from the trial will be available in the first quarter of 2008.

• UCB Inc., of Brussels, Belgium, presented data from two clinical trials that showed Neupro (Rotigotine Transdermal System), a once-daily nonergolinic dopamine agonist patch, effectively controlled early morning motor impairment, improved sleep quality and was generally well tolerated for long-term use in patients with Parkinson's disease. In the open-label, single-arm, exploratory 18-week study, 54 patients with mostly advanced-stage Parkinson's disease received Neupro in doses from 4 to 16 mg/24 hours during a four-week maintenance period. Forty-nine percent of patients treated with Neupro showed considerable improvement in early morning motor function sufficient to meet response criteria (=30% improvement of UPDRS III score). Nocturnal akinesia - inability to move at night - was reduced by 56 percent, and improvement also was noted in nocturnal dystonia - painful muscle contraction - and cramps. Neupro improved sleep quality, reduced excessive daytime sleepiness, decreased night-time urinary symptoms (nocturias) and appeared generally well tolerated. The most frequently reported adverse events in patients treated with Neupro were application site reactions (20 percent), nausea (19 percent), and somnolence (11 percent).