Abbott has received marketing authorization from the European Commission for the use of Humira as a treatment for moderate-to-severe plaque psoriasis. In one clinical trial, more than 80%  of patients taking Humira achieved skin clearance of 75%  or better and in another, almost three quarters of patients achieved 75% clearance. In both trials, nearly half of the patients taking HUMIRA achieved 90% clearance as early as 16 weeks into treatment.

Psoriasis is the fifth approved indication for Humira in the EU. Humira is the first fully human, self-injectable biologic for the treatment of psoriasis. The FDA is reviewing the drug for the same indiciation.

Psoriasis is a non-contagious, chronic autoimmune disease that causes the body to attack itself. The most obvious physical symptom of the condition is raised, inflamed, scaly, red skin lesions known as plaques, which may crack and bleed. Psoriasis is more than painful skin lesions; data also suggest an association with other health conditions, including psoriatic arthritis.

BASi (Bioanalytical Systems)

4Q Revenues: $10.4 million (-3%)

4Q Loss: $203,000 (net loss of $736,000 in 4Q06)

FY07 Revenues: $45.2 million (+5%)

FY07 Earnings: $926,000 (net loss of $2.7 million in FY06)

Comments: Sales declined in 4Q07 due to a drop in bioanalytical revenues, partly offset by growth in toxicology services and sales of the company's Culex automated pharmacology systems. Net loss in the quarter included $354,000 in severance charges to several company officers and directors.

Richard M. Shepperd, BASi's president and chief executive officer, commented, "We are pleased that we can report progress in our performance for the fiscal year ended September 30, 2007, the company's first profitable year in four years. Had we not had the severance costs associated with completing our management change in the fourth quarter of this year, we would have shown profitable results in each quarter of the year. Our people worked hard to make this happen; however, major efforts remain to build consistently profitable operations in our Baltimore clinic and UK operations. Both of these operations have new management and new or renovated facilities where we will continue our effort to match their performance to the strength of the markets in which they do business. Our work is cut out for us, to build on the turnaround we began this past year."

Akorn, Inc. has received a satisfactory inspection from the FDA as part of a pre-approval inspection of the company's lyophilization facilities in Decatur, IL. Akorn had cGMP issues in the past, but the recent inspection led the Chicago office of CDER to conclude that Akorn's responses to the problems are acceptable.

As a result of the inspection, Akorn is now eligible for pending product approvals in its ophthalmic, ampoule, liquid vial and lyophilization production filling suites in the Decatur site.

Arthur S. Przybyl, Akorn's president and chief executive officer stated, "We are pleased to announce the results from the latest FDA inspection of our Decatur, IL manufacturing facility. Akorn remains committed to maintaining a comprehensive and robust quality system in order to remain in compliance with current good manufacturing practice regulations. This positive result is a significant event for Akorn. The results of this recent inspection allow us to commercialize our lyophilization manufacturing capabilities. We believe a shortage of lyophilization manufacturing capacity still exists in the market place."

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