AMAG Pharmaceuticals' Ferumoxytol meets Phase III clinical trial end point.
On May 31st, AMAG Pharmaceuticals (NASDAQ: AMAG, Stock Forum) announced results from a randomized phase III study of Ferumoxytol, an intravenous (IV) iron replacement therapy, in 31 patients with chronic kidney disease (CKD) stages 1-5 with functioning kidney transplants. The primary endpoint was the mean change in hemoglobin from baseline at Day 35.
The following results were obtained (copied from business wire press release at Yahoo.com)
For the primary endpoint, the mean change in hemoglobin from baseline at Day 35, there was a statistically significant greater mean (± standard deviation) increase in hemoglobin in patients receiving ferumoxytol compared with patients receiving oral iron (ferumoxytol 1.45 ± 1.27 g/dl vs. oral iron -0.09 ± 1.47 g/dl, p=0.035). There was also a statistically significantly greater mean increase in hemoglobin from baseline at Day 21 in patients receiving ferumoxytol compared with patients receiving oral iron (ferumoxytol 1.04 ± 0.97 g/dl vs. oral iron 0.23 ± 0.52 g/dl; p=0.035). A higher proportion of ferumoxytol-treated patients compared with oral iron-treated patients achieved a 1.0 g/dL or greater rise in hemoglobin at Day 21 (47.8% vs. 12.5%; p=0.108) and Day 35 (60.9% vs. 25.0%; p=0.113).
These results may look good at first glance but there may be some analysts who argue that the limited number of patients, as well as a lack of long-term follow-up data and the overall trial not representing actual clinical use patterns, may cause the FDA to ask for more data before approving the drug.
Nevertheless, the company has signed a development and commercialization agreement granting 3Sbio Inc. (NASDAQ: SSRX, Stock Forum) the rights to the Chinese market for $1 million upfront payment and double-digit royalties, tiered up to 25%.
Interestingly, two analysts have "buy" ratings and price targets of $99 and $80 on shares of AMAG. There is definitely a large worldwide potential market for Ferumoxytol; however, had the company designed the pivotal trial differently, it would have increased its chances of approval. Right now it is prudent to consider a higher chance for the FDA to ask for more data.
Financially, the company is in decent shape with over $200 million in cash. It is noteworthy to mention that the company has had significant losses in its auction rate security portfolio that may or may not continue to hurt its liquid assets.
Shares of AMAG have been trading as low as $34.10, or a little over twice the amount of cash on hand.
Disclosure: The author has no positions in AMAG Pharmaceuticals.
