Just a little less than a month is left for a panel of U.S. cancer experts to review Peginesatide, co-developed by Affymax Inc. (AFFY) and Takeda Pharmaceutical Co. for the 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.
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.
Affymax and Takeda submitted the Peginesatide New Drug Application to the FDA on May 31, 2011. As part of the companies' exclusive global agreement to develop and commercialize Peginesatide, Affymax received a $10 million development milestone payment from Takeda on August 10.
The NDA was based on data from two phase III studies - EMERALD 1 and 2, that evaluated the efficacy and safety of Peginesatide, dosed once every four weeks, compared to Epoetin alfa or Epoetin beta, dosed more frequently in maintaining hemoglobin (Hb) levels. The findings suggest that once-monthly Peginesatide was similar to Epoetin in maintaining Hb levels in chronic renal failure patients on dialysis with anemia with a similar adverse event rate.
The NDA for Peginesatide is slated to be reviewed by the FDA's Oncologic Drugs Advisory Committee on December 7, 2011. The regulatory agency's final decision on Peginesatide is scheduled to be announced on March 27, 2012.
If approved, Peginesatide will be the first once-monthly ESA available for the treatment of anemia associated with chronic kidney disease patients on dialysis in the United States.
Roche's Mircera, approved by the FDA in September 2007, is also a once-monthly treatment for renal anaemia in patients with chronic kidney disease. However, Roche is enjoined from marketing Mircera in the U.S. until mid-2014 as the drug was found to infringe Amgen's patents.
A quick look at Affymax balance sheet...
Affymax has generated no revenue from product sales to date. The company has incurred significant operating losses since inception in 2001, and at June 30, 2011, had an accumulated deficit of $411.0 million.
During the three months ended June 30, 2011, the company recognized $14.1 million of collaboration revenue compared to $54.3 million in the year-ago quarter.
Affymax and Takeda will be presenting Peginesatide data at the American Society of Nephrology Kidney Week 2011 on November 11th and November 12th.
In the last 52 weeks, Affymax shares have traded in a range between $3.93 and $8.50. The stock closed Monday's trading at $4.91.
Will Peginesatide clear the penultimate regulatory hurdle of panel review and also pass FDA muster? Stay tuned...
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