UPDATE 3-Affymax anemia drug shows weak heart data, shares tank

By Krishnakali Sengupta

BANGALORE, June 21 (Reuters) - Affymax Inc said its experimental anemia drug met the main goal of four late-stage studies, but showed heart-related adverse events in a sub-group, raising doubts about the drug getting approval.

Shares of the drugmaker plunged to their lifetime low of $7.12 Monday on Nasdaq, clocking more than 50-times higher volumes than its 10-day moving average.

Shares of Amgen Inc, whose drugs Epogen and Aranesp were compared with Affymax's Hematide in the trial, were up 3 percent at $56.76, Monday afternoon on Nasdaq.

News of higher cardiovascular events, including death and stroke, in a sub-group of patients who were suffering from chronic renal failure, triggered a sell-off in Affymax shares.

Data from the late-stage studies of the drug, Hematide, also prompted at least two brokerages to cut their ratings on the stock and several analysts to raise doubts of Hematide getting approval in the non-dialysis segment.

'This creates regulatory risk, in our view,' said Geoff Meacham, an analyst at J.P. Morgan. 'Particularly in non-dialysis, though there could also be read-through to the more important dialysis segment as well.'

However, filing for approval of the drug in the smaller dialysis segment could be one way out of the tough spot for the company, McNicoll, Lewis & Vlak analyst Christopher James said.

PiperJaffray analyst Ian Somaiya, who cut his rating on the stock to 'underweight' from 'overweight,' said he expects further downside to the stock, once regulators review data from the drug.

The trial showed that in the non-dialysis group, frequency of cardiovascular events for those taking Affymax's drug was 21.6 percent compared to 17.1 percent in those taking standard-of-care, epoetin and darbepoetin, Affymax said.

Hematide, which Affymax is co-developing with Japan's Takeda Pharmaceutical Co Ltd, showed non-inferiority in maintaining hemoglobin in the target range, compared to standard-of-care in each of the four late-stage studies, the company said.

The main goal of the study was to assess the mean change in hemoglobin (Hb) from baseline.

Affymax shares were down $15.80 at $7.20 Monday afternoon on Nasdaq.

(Additional reporting by Vidya L Nathan in Bangalore; Editing by Vyas Mohan, Aradhana Aravindan) Keywords: AFFYMAX/ ([e-mail]; within U.S. [phone]; outside U.S. [phone]; Reuters Messaging: [e-mail]) COPYRIGHT Copyright Thomson Reuters 2010. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.