With shares of AMAG Pharma (AMAG) declining by about 11% in the past five days and after listening to the conference call from late December again, I am adding to my long position in the Company on the potential for FDA approval of Feraheme (ferumoxytol) during 1Q09.
The complete response letter from the FDA in late December outlined the following three outstanding issues before approval could be granted:
1.) data to clarify a specific chemistry, manufacturing and controls (CMC) question
2.) resolution of the deficiencies observed during the pre-approval inspection of the Company’s manufacturing facility
3.) finalization of labeling discussions with the FDA
CEO Brian Pereira stated on the conference call that the CMC issue is a straightforward response that is technical in nature which AMAG would address promptly. Issue number two on the manufacturing deficiencies is just a matter of waiting for the FDA to review and approve AMAG's response to these issues, which was previously submitted in October after the initial complete response letter.
Moreover, no new manufacturing issues were raised by the FDA in the latest complete response letter, suggesting the agency simply did not complete the review process by the Class I deadline of December 30, which is reasonable given the holiday season. AMAG does not believe its existing inventory of Feraheme will be impacted by the outstanding manufacturing issues while the Company continues to build inventory and is ready to immediately launch the product upon approval.
The finalization of the label represents the last step in the process of approval for Feraheme and the CEO stated that he is pleased with these discussions thus far. This suggests that Feraheme is poised to receive a broad approval for the treatment of iron deficiency anemia in patients with chronic kidney disease, whether or not they are receiving dialysis.
During the conference call, the CEO stated that AMAG would be discussing the outstanding issues with FDA in the coming weeks and would provide an update to investors once clarity is achieved. Importantly, AMAG may not be required to submit a response to the agency and go through another formal Class I or II review because no new issues have been raised by the FDA in the second complete response letter.
AMAG
will be presenting at the 27th Annual J.P. Morgan Healthcare Conference on Monday 1/12/09 at 12:30 pm ET. While AMAG may not be able to provide clarity on Feraheme at this time; it appears that a first or second quarter approval is likely this year, depending on how quickly the FDA can complete its review of the manufacturing issues and conduct another inspection of AMAG's facilities (if deemed necessary by the agency).
$32.12 (01/09/09)
