Gemesis bercaplermin regulatory update

EMEA's CHMP issued a final negative opinion on BioMimetic's MAA for Gemesis bercaplermin (GEM 21S) to regenerate tissue in adults with defects around the teeth, including defects within the surrounding bone and receding gums. The decision confirms CHMP's initial negative opinion from July, in which the committee said BioMimetics failed to show that Gemesis was effective in treating periodontal defects and did not sufficiently demonstrate that the clinical product was comparable to the intended commercial product. The company also said EMEA raised concerns that it had only conducted a single trial in Europe. ...