Healthcare Industry News: BD
News Release - February 28, 2007
Symbollon Pharmaceuticals Receives Regulatory Guidance From EuropeFRAMINGHAM, MA--(Healthcare Sales & Marketing Network)--Feb 28, 2007 -- Symbollon Pharmaceuticals, Inc. (OTC BB:SYMBA.OB ) 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(TM) 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.
Paul Desjourdy, President and CEO of Symbollon Pharmaceuticals, remarked, "The guidance received from the BfArm was very encouraging. This input and guidance was the first we have received from a European agency, and the fact that the structure of our ongoing placebo-controlled study is generally acceptable to the BfArm indicates that the IoGen program is on target to submit for regulatory approval in 2009. Symbollon has additional meetings with regulators in Sweden and the United Kingdom in April for further European input and guidance concerning IoGen."
About Symbollon Pharmaceuticals, Inc. (OTC BB:SYMBA.OB ) is a specialty pharmaceutical company focused on the development and commercialization of proprietary drugs based on its molecular iodine technology. Symbollon is conducting a Phase III clinical trial evaluating IoGen as a potential treatment for moderate to severe periodic pain and tenderness (clinical mastalgia) associated with fibrocystic breast disease (FBD). FBD is a condition that affects approximately 20 to 33 million women in the U.S., and there are approximately 7 to 13 million women suffering from clinical periodic mastalgia. The Company believes IoGen also may be useful in treating and/or preventing endometriosis, ovarian cysts, and premenopausal breast cancer. Symbollon is also in preclinical development of antimicrobial products based on the same molecular iodine technology, and intends to investigate the potential effectiveness of its technology in applications such as dermatology, oral care, upper respiratory tract conditions, urinary tract infection and wound care. For more information about Symbollon, please visit the company's website at http://www.symbollon.com.
Forward-Looking Statement: This news release contains statements by the Company that involve risks and uncertainties and may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements reflect management's current views and are based on certain assumptions. Actual results could differ materially from those currently anticipated as a result of a number of factors, including, but not limited to, the risks and uncertainties associated with whether (i) future clinical trial results will support the use of IoGen for the treatment of fibrocystic breast disease, (ii) the clinical data acquired from Mimetix Inc. will be acceptable exposure data for IoGen, (iii) Symbollon will be able to obtain the resources necessary to continue as a going concern, (iv) IoGen will successfully complete the regulatory approval process, (v) competitive products will receive regulatory approval, (vi) the Company's ability to enter into new arrangements with corporate partners and (vii) such other factors as may be disclosed from time-to-time in the Company's reports as filed with the Securities and Exchange Commission.
Source: Symbollon Pharmaceuticals
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