UPDATE 2-AMAG says FDA accepts anemia drug response; shares soar

(Adds analysts' comments, updates stock movement)

By Anand Basu

BANGALORE, Nov 13 (Reuters) - AMAG Pharmaceuticals Inc (AMAG.O) said U.S. health regulators accepted the complete response for its experimental anemia drug, ferumoxytol, sending its shares soaring 86 percent.

"We believe that AMAG's prompt response to the FDA and the resultant Class 1 Response decreases timeline uncertainty, places the application under active review, and provides for timing consistent with an expected ferumoxytol launch in 1Q09," Needham & Co analyst Mark Monane said.

In a statement, the company said the U.S. Food and Drug Administration (FDA) has set Dec. 30 as a target action date to complete the review of the drug.

"This (ferumoxytol) will be a significant driver for the company," said Canaccord Adam analyst Adam Cutler, who expects the drug to contribute revenue of $84 million in 2009 and $191 million in 2010.

The company, which received a complete response letter from the FDA in October, is seeking approval for ferumoxytol to treat iron deficiency anemia in patients with chronic kidney disease.

The FDA has designated the resubmission as a complete, Class 1 response, which typically means it will review the drug within a 60-day period.

Leerink & Swann analyst Joseph Schwartz said a Class 1 response from the FDA implies the issues raised in the initial complete response are minor and the FDA believes the remaining evaluation of ferumoxytol will be straightforward.

"AMAG is close to topping off its commercial organization in advance of an expected 1Q09 launch," he said.

Shares of the Lexington, Massachusetts-based company were up $15.05 at $33.42 in morning trade on Nasdaq. They touched a high of $34.22 earlier in the session. (Additional reporting by Esha Dey; Editing by Saumyadeb Chakrabarty, Himani Sarkar)