Affymax Inc (OTC:AFFY)

Affymax, Inc., incorporated on July 20, 2001, is a biopharmaceutical company engaged in developing drugs to improve the treatment of serious and often life-threatening conditions. Its product candidate, peginesatide, is for the treatment of anemia in chronic kidney disease patients on dialysis. Peginesatide is a synthetic peptide-based erythropoiesis stimulating agent (ESA), designed to stimulate production of red blood cells. The Company has a worldwide collaboration to develop and commercialize peginesatide with Takeda Pharmaceutical Company Limited (Takeda). As of December 31, 2011, over 2,600 patients have received peginesatide in clinical trials. As of December 31, 2011, The New Drug Application (NDA) for peginesatide is under review by the United States, Food and Drug Administration (FDA). As of December 31, 2011, the Company has suspended its development efforts to treat anemia in non-dialysis patients and chemotherapy-induced anemia.

The Company and Takeda Pharmaceutical Company Limited completed multiple Phase I and Phase II clinical trials of peginesatide at sites in the United States and the European Union in normal healthy volunteers, dialysis patients, non-dialysis patients and peritoneal dialysis patients. These Phase I clinical trials were designed primarily to demonstrate bioavailability or bioequivalence of product concentrations and formulations while these Phase II trials were designed to determine the safety, pharmacodynamics and pharmacokinetics of peginesatide when administered to patients suffering from anemia. Two of these Phase II clinical trials were conducted to evaluate the use of peginesatide to treat anemic patients in additional segments of the chronic kidney disease patient population. One of the studies focused on evaluating peginesatide in patients undergoing peritoneal dialysis, a special form of dialysis that allows the process to be performed in the patient's home. Another trial was designed to evaluate the conversion of Aranesp-treated chronic kidney disease patients (on dialysis and not on dialysis) to once-monthly peginesatide. As of December 31, 2011, the Company continues to conduct an ongoing Phase II clinical trial of peginesatide in a small number of patients with pure red cell aplasia (PRCA) in European Union.

The Company announced preliminary top-line results from the peginesatide Phase III clinical program for the treatment of patients with anemia associated with chronic kidney disease. Its Phase III clinical program included four open-label, randomized controlled clinical trials. Two of these trials, called PEARL 1 and PEARL 2, were conducted in non-dialysis patients and designed to evaluate the safety and efficacy of peginesatide compared to darbepoetin alfa to correct anemia and maintain hemoglobin in a corrected range over time. The other two trials, called EMERALD 1 and EMERALD 2, were conducted in dialysis patients and designed to evaluate the safety and efficacy of peginesatide and its ability to maintain hemoglobin levels in a corrected range compared to epoetin alpha or epoetin beta when switched to peginesatide. Analysis of efficacy and safety for all of the Phase III studies were primarily based on assessments of non-inferiority to the comparator drugs.