FDA-APPROVED DRUGS THAT DISAPPOINTED IN 2013: AFFYMAX’S OMONTYS
Though 2013 looked to be a good year for Affymax (AFFY), it quickly spiraled downward when the Cupertino, CA-based biotech and its partner, Japanese drug maker Takeda (TKPYY), announced in late February of last year a nationwide suspension of all promotional and sales activities for the anemia treatment Omontys due to post-marketing reports of serious hypersensitivity reactions, including life-threatening or fatal anaphylaxis. Sadly, even an enterprise value of $20.3 million overvalues a company with little cash, no products and few prospects.
Approved in March 2012 to treat anemia, a condition in which the body does not have enough healthy red blood cells, in adult dialysis patients who have chronic kidney disease (CKD), both Wall Street analysts and investors were optimistic that Omontys (peginesatide) had a good shot at loosening Amgen’s (AMGN) stranglehold – Epogen (epoetin alfa) and increasingly Aranesp (darbepoetin alfa) – on the $11 billion CKD drug market (U.S. and other G7 countries). Being the first new FDA-approved and marketed erythropoiesis-stimulating agent (ESA) for this condition since 2001, analysts like Piper Jaffray’s Ian Somaya predicted peak sales for Omontys of $700 million by 2017.
Investors responded in-kind, pushing AFFY’s stock price and market cap to a historical high of $27.46 per share and $1.03 billion in October 2012.
A functional analog of the glycoprotein hormone erythropoietin (EPO), Omontys worked like ESAs by aiding in the formation of red blood cells by stimulating the bone marrow to produce more red blood cells, thus reducing the need for transfusions in patients with CKD. Additionally, a mean half-life of 47.9 (± 16.5) hours following intravenous administration in dialysis patients meant Omontys only had to be taken through a once-a-month injection.
The longer EPO-receptor binding activator activity of Omontys was marketed as a clinically compelling and compli
Just sums up what I have been posting quite some time now. AFFY longs will probably grasp at the NOLs, as did Maxdad, to suggest that the $138B NOLs are worth something. As a retired lawyer who knows something about tax law, the NOLs are not available to new shareholders as a result of a buyout. My prior posts explained why, and Maxdad just flat out lied about it being otherwise. Interesting that Maxdad is no longer around after he and EXP teamed up for 4 successful AFFY pumps and dumps. I agree with Propthink that AFFY is not even worth 66 cents a share.