• Abbott Laboratories, of Abbott Park, Ill., presented data from three studies demonstrating that Humira (adalimumab) treatment improved work productivity in rheumatoid arthritis patients. Humira, a tumor necrosis factor (TNF) antagonist, is approved for adult rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and Crohn's disease. The data were presented at the annual congress of the European League Against Rheumatism in Barcelona, Spain.

• Bristol-Myers Squibb Co., of New York, presented data demonstrating that Orencia (abatacept) re-established clinical benefit in patients with juvenile idiopathic arthritis after a treatment hiatus of up to six months. The selective T-cell co-stimulator is approved for adults with rheumatoid arthritis who have failed other medicines. The data were presented at the annual congress of the European League Against Rheumatism in Barcelona, Spain.

• Centocor Inc., of Horsham, Pa., said two-year data showed that patients with ankylosing spondylitis who received Remicade (infliximab) experienced significant improvement in spinal mobility, and also showed sustained reductions in spinal inflammation as detected by magnetic resonance imaging. Findings from the 279-patient study showed that those treated with Remicade had a greater improvement in the Bath Ankylosing Spondylitis Metrology Index (defined as a change of at least 1 in BASMI score) vs. placebo (-0.7 vs. -0.2). In percent change in chest expansion, which assessed the range of motion in patients, the Remicade-treated group had a rate of 44 percent compared to 19 percent in the placebo arm. Fifty-one percent in the Remicade group achieved a clinically meaningful improvement vs. 31 percent on placebo. Those data were presented at the European League Against Rheumatism meeting in Barcelona, Spain.

• Collegium Pharmaceutical Inc., of Cumberland, R.I., filed an investigational new drug application for its abuse deterrent sustained-released opioid formulation COL-003, and the company intends to start clinical development upon the FDA's acceptance of the IND. Based upon feedback from the agency, Collegium said, the product likely will qualify for fast-track review status. The product is based on the company's DETERx technology, which is designed to create dosages more resistant to tampering and abuse than traditional formulations of opioid drugs.

• Genmab A/S, of Copenhagen, Denmark, and GlaxoSmithKline plc, of London, reported positive 24-week efficacy data from a Phase II study of ofatumumab (HuMax-CD20) in patients with rheumatoid arthritis. Findings from the 224-patient intent-to-treat population showed that 46 percent of patients receiving the drug achieved ACR20, 24 percent achieved ACR50 and 6 percent achieved ACR70, compared to 15 percent, 5 percent and zero in the placebo group. In the subgroup (178 patients) receiving concomitant stable doses of methotrexate, results across the three dose levels showed that an ACR20 response was obtained by 42 percent in the 300-mg dose group, 56 percent in the 700-mg group and 50 percent in the 1,000-mg group, compared to 16 percent in the placebo group. Overall, 72 percent of patients treated with each of the ofatumumab doses experienced at least a moderate EULAR response compared to 40 percent on placebo. Data were presented at the European League Against Rheumatism meeting in Barcelona, Spain. In separate news, Genmab said it initiated a Phase I study of ofatumumab in combination with cyclophosphamide, doxorubicin, vincristine and prednisone in patients with previously untreated follicular non-Hodgkin's lymphoma. That trial will enroll 56 patients randomized into two dose groups to receive six infusions of the drug in combination with CHOP, with the primary endpoint of objective response from start of treatment until three months after last treatment assessed according to the standardized response criteria for NHL at 30 weeks. Genmab and GSK are collaborating on ofatumumab in multiple indications as part of a $2.1 billion worldwide deal signed in December. (See BioWorld Today, Dec. 20, 2006.)

• Neose Technologies Inc., of Horsham, Pa., said partner Novo Nordisk A/S, of Copenhagen, Denmark, started a Phase I trial of GlycoPEGylated factor VIIa, a long-acting version of NovoSeven Coagulation Factor VIIa (recombinant) in healthy volunteers. That news triggers an undisclosed milestone payment by Novo, which licensed rights to the product from Neose to develop for hemophilia.

• Solstice Neurosciences Inc., of Malvern, Pa., presented data from an open-label, dose-escalation study of Myobloc (botulinum toxin type B injectable solution) in cervical dystonia. Myobloc is approved in that indication at a recommended initial dose of 2,500 units to 5,000 units in patients with a prior history of tolerating botulinum toxin injections. The new data demonstrated that Myobloc was well-tolerated and efficacious at doses of 10,000 units, 12,500 units and 15,000 units, with no treatment-related, serious adverse events reported. The data were presented at the 11th International Congress of The Movement Disorders Society in Istanbul, Turkey.