Paul F. Truex, Anthera's President and Chief Executive Officer, commented:
The extensive data in the target severe population from our Phase 2 clinical program supports the initiation of a much smaller yet differentiated Phase 3 registration plan with the selected dose of blisibimod in patients with severe systemic lupus erythematosus. We have prospectively demonstrated for the first time the possibility for a subcutaneously administered BAFF inhibitor to be used in the treatment of a severe lupus population. The subgroup of severe patients from our Phase 2 study clearly identifies those patients most in need of therapy and most likely to benefit from our potent BAFF inhibitor blisibimod. Feedback from the EMA Scientific Advice process combined with an End of Phase 2 meeting in the third quarter will form the basis of our final phase 3 study designs.
Market was definitely overreacted on this news; Anthera has confirmation from the European Medicines Agency (NYSEMKT:EMA) for the acceptability of the Company's proposed Phase 3 design for the treatment of severe systemic lupus erythematosus patients as a basis for a marketing authorization application (NYSE:MAA). The EMA feedback confirms that Anthera's development program, including the heightened SRI-5 endpoint, is acceptable and that positive results from Phase 3 clinical studies in a severe lupus population would support approval of the product.
As of 11:45 a.m. EST ANTH stock traded one third of its floating shares and gave a nice opportunity to join it for the price below its cash/value.
Anthera Pharmaceuticals‚ Inc.
25801 Industrial Blvd, Suite B
Hayward‚ CA 94545
Tel: (510) 856-5600
Fax: (510) 856-5597
Anthera Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing products to treat serious diseases associated with inflammation, including cardiovascular and autoimmune diseases.
Disclosure: I am long ANTH.