FRAMINGHAM, MA -- (MARKET WIRE) -- February 28, 2007 -- Symbollon Pharmaceuticals, Inc. (OTCBB: SYMBA) announced that they recently met with the German regulatory authorities (the BfArm) seeking their input and guidance regarding the nonclinical and clinical issues on the development of IoGen™ as a treatment for moderate to severe cyclic breast pain and tenderness associated with fibrocystic breasts. Based on a review of Symbollon's current IoGen program, the BfArm agreed that the proposed indication for IoGen and the determination of the primary endpoint are acceptable. This will allow Symbollon to submit its ongoing Phase III study in support of regulatory marketing approval. Several suggestions were offered by the BfArm that Symbollon will consider for the next Phase III trial. Based on the BfArm comments, and consistent with the guidance from the FDA, Symbollon plans to submit the Mimetix data as part of its clinical data package required to meet the ICH Guidelines for human exposure. The BfArm has requested that Symbollon undertake a non-rodent species repeat dose toxicity study and a combined fertility and reproductive rodent development study. Symbollon plans to conduct these animal studies prior to its planned regulatory submission in 2009.
