NEW YORK (AP) — Shares of MannKind Corp. surged to a new 52-week peak Monday after the company reported positive study data for its inhalable insulin candidate Afresa and said it started developing a new inhalable medication system. The stock gained $1.06, or 15 percent, to $8.12 in afternoon trading. The shares blew past their previous 52-week high of $7.60, reaching $9.25 earlier in Monday’s session. The new system is aimed making powdered versions of pharmaceuticals inhalable and will be used in the development of the inhalable insulin Afresa. In a late-stage study, the Valencia, Calif.-based company said Afresa showed to be comparable to injectable insulin. The Food and Drug Administration is reviewing the company’s marketing application for Afresa. Rodman & Renshaw analyst Simos Simeonidis reaffirmed a “market outperform” rating on MannKind and $14 price target, citing the likelihood that Afresa will be a top inhalable insulin on the market, with blockbuster potential. He also expects the company to secure a worldwide partner for the drug over the summer and that Afresa will likely be approved next spring. Meanwhile, he brushed off any impact Sanofi-Aventis’ purchase of a Pfizer Inc. insulin plant may have on MannKind. MannKind had agreed to buy the plant, but that was pending Sanofi-Aventis’ decision to exercise certain rights to it. The plant is not a necessity for MannKind, Simeonidis said, and the deal does not effect MannKind’s purchase of $3 million worth of insulin. Last year, Pfizer started switching its Exubera inhaled insulin patients to MannKind’s experimental product. The company’s had been partners until Pfizer pulled Exubera from the market in 2007 after it posted dismal sales. Eli Lilly & Co. has also struggled with inhaled insulin. The company ended its development program in 2008, citing regulatory uncertainty.
