After a favorable advisory panel vote on its experimental anemia drug last December, Palo Alto, California- based Affymax Inc. (AFFY) is set to hear the FDA's final decision next week.
The investigational drug - Peginesatide, co-developed by Affymax and Takeda Pharmaceutical Co. is awaiting FDA decision for the proposed treatment of anemia in chronic kidney disease patients on dialysis.
Peginesatide, formerly known as Hematide, is a synthetic peptide-based erythropoiesis stimulating agent, or ESA, designed to stimulate production of red blood cells. Erythropoiesis, the process by which red blood cells are developed within the red bone marrow, is aided by erythropoietin, a protein produced by the kidney. Sometimes, due to illnesses such as cancer, kidney disease and HIV, the rate of erythropoiesis is reduced below the normal resulting in anemia. This anemia is treated by synthetic ESAs, which are an artificial version of the natural protein erythropoietin.
Last December, the FDA Oncologic Drugs Advisory Committee, voted 15 to 1, with 1 abstention, recommending approval of Peginesatide. The FDA's final decision is set for March 27, 2012.
Amgen Inc.'s (AMGN) Epogen (Epoetin alfa) was the first ESA approved by the FDA in 1989 for the treatment of anemia in renal disease. In 1993, Epogen was approved for a supplemental indication for the treatment of anemia associated with cancer chemotherapy. Some of the other FDA-approved ESAs include, Amgen's Aranesp, Johnson & Johnson's (JNJ) Procrit (Epoetin alfa) and Swiss drug major Roche's Mircera (Methoxy polyethylene glycol-epoetin beta). Roche's NeoRecormon (Epoetin beta) approved in the EU is also an ESA.
The currently marketed ESAs in the U.S. are dosed between 1 to 3 times per week or up to every two weeks in chronic kidney disease patients on dialysis. But Peginesatide is designed to be dosed once every four weeks, which is a significant advantage over the existing ESAs due to the less frequent dosage requirement.
In clinical studies, Peginesatide was found to be non-inferior to Epogen, Aranesp and Procrit, and also had a similar safety profile. In 2011, Epogen sales were down 19 percent to $2.04 billion and Aranesp sales dropped 7 percent to $2.30 billion.
According to the Centers for Medicare and Medicaid Services, more than 95 percent of patients on dialysis in the U.S. are currently receiving ESA treatment for anemia of chronic kidney disease.
If Peginesatide is approved in the U.S., Affymax expects to receive additional milestones of $50 million related to the approval alone from Takeda.
In the U.S, Peginesatide is co-developed and will be co-commercialized by Affymax and Takeda. Outside of the U.S., Takeda holds an exclusive license to develop and commercialize Peginesatide.
The Peginesatide application was accepted for review in the European Union last month, which triggered a $5 million milestone payment to Affymax from Takeda Pharma.
In December of 2011, Takeda announced its decision of not to market Peginesatide in Japan. A majority of phase II and phase III clinical trials with Peginesatide have been completed in Japan, and the investigational drug has been found to hold promise for treating Japanese renal anemia patients. It is believed that other options will be explored for the commercialization rights for Peginesatide in the Japanese market, including potentially licensing it out to a third party.
The stock was profiled on our site last November on the basis of the pending regulatory catalysts, when it was trading around $4. Had you bought this stock then, you would have made a gain of over 160% in just 5 months, based on yesterday's closing price of $12.30.
The FDA is not required to follow the advice of its panels, though it usually does. Now, with less than a week for the FDA decision on Peginesatide, it will be interesting to see how the stock plays out as the big day approaches.
For comments and feedback contact: editorial@rttnews.com
June 05, 2026 16:18 ET A busy week for economic news flow saw a slew of reports being released that reflected the trends in the U.S. labor market. In Europe, economic growth and inflation data gained attention as the European Central Bank and Bank of England head for policy session later in the month. In Asia, the monetary policy session of the Indian central bank was in focus as the country, a major oil importer, reels under the pressures of a weaker rupee and rising inflation.