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GEN News Highlights : Jul 30, 2010

Formatech to Donate Fill/Finish Services to Femta for One Lot of Investigational mAb

FM101 is expected to begin clinical trials in 2011 as a treatment for RA.

Formatech will donate services required to aseptically fill and finish one lot Femta Pharmaceuticals’ FM101 under its Fillanthropy Program. The candidate is a mAb targeting interleukin 6 (IL-6) intended for evaluation as a treatment for rheumatoid arthritis (RA).

FM101 is Femta’s lead candidate and is currently in preclinical studies. Formatech’s services will be used to support upcoming clinical trials.

“FM101, which binds and neutralizes human IL-6 with a femtomolar binding affinity, has recently demonstrated positive animal data in nonhuman primate animal models,” notes Stephen F. Keane, president and COO of Femta. “Femta has recently started GMP manufacturing and IND-enabling toxicology studies with a target of initiating a Phase I clinical program in the first half of 2011.”

Each month Formatech donates services required to aseptically fill and finish one lot of drug product for selected therapeutic candidates that are entering clinical trials. The company says that it considers both the product’s potential therapeutic benefit and the financial need of the sponsor.