Wk chg

11/18 cls

Alimera Sciences Inc. (NASDAQ:ALIM)


Simos Simeonidis


Neutral (from market outperform)



Simeonidis downgraded after FDA issued a second complete response for an NDA for Alimera's Iluvien to treat diabetic macular edema (DME) associated with diabetic retinopathy. According to Alimera, FDA said the "significant" risks of adverse events in the Phase III FAME trials were not outweighed by the benefits and asked the company to conduct two additional trials (see BioCentury, Nov. 14). Simeonidis believes the trials will take 3-5 years and a "significant amount of capital." He is not optimistic about an EU decision for the injectable insert that delivers fluocinolone acetonide, which he anticipates in 1H12. Alimera has rights from pSivida Corp. (NASDAQ:PSDV; ASX:PVA).

Amylin Pharmaceuticals Inc. (NASDAQ:AMLN)


Thomas Russo


Market outperform (from neutral)



Russo also raised his target to $15 from $13 after Amylin and Eli Lilly and Co. (NYSE:LLY) mutually ended a 2002 deal to develop diabetes therapy exenatide, which included two versions of the GLP-1 analog: twice-daily Byetta and once-weekly Bydureon (see BioCentury, Nov. 14). He said the termination "removes a conflicted partner" and improves Amylin's long-term economics. He expects the company to become cash flow accretive by year end 2013. Byetta is marketed in the U.S. and Europe for Type II diabetes, while Bydureon is marketed in Europe and has a Jan. 28 PDUFA date in the U.S.