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FDA Okays Affymax Anemia Drug Omontys - Update

Affymax Inc. (AFFY) said Tuesday the U.S. Food and Drug Administration has approved its investigational injection Omontys for treatment of anemia in chronic kidney disease patients on dialysis. Following the news, Affymax shares surged more than 9 percent in later afternoon trade on the Nasdaq.

Omontys is a new erythropoiesis-stimulating agent, or ESA, that aids in the formation of red blood cells. It works by stimulating the bone marrow to produce more red blood cells to reduce the need for transfusions in patients with chronic kidney disease, or CKD. Affymax is co-developing Omontys (Peginesatide) with Japan-based Takeda.

The FDA approval was based on results of two trials that randomly selected a total of 1,608 patients with hemoglobin levels initially stabilized by ESA to receive either Omontys once monthly or to continue their current ESA (epoetin) treatment.

Results from the trials showed that Omontys was as safe and effective as epoetin in maintaining hemoglobin levels within the studies' pre-specified range of 10 to 12 grams per deciliter.

The most common side effects observed in 10 percent or more of dialysis patients treated with Omontys were diarrhea, vomiting, high blood pressure and joint, back, leg or arm pain.

Commenting on the FDA approval, Affymax CEO John Orwin said, "The approval of Omontys now provides a therapeutic alternative to treat anemia of CKD in adult patients on dialysis, one of the most common complications affecting this patient population."

"For over two decades, doctors have relied primarily on one erythropoietin-based treatment in the dialysis setting. With Omontys, doctors and patients will have access to a once-monthly alternative for the treatment of anemia in adult CKD patients on dialysis," added Orwin.

Meanwhile, the FDA has mandated an observational study and a randomized controlled trial for Omontys, with final reports to be submitted in 2018 and 2019, respectively. The study objective is to assess cardiovascular safety and evaluate safety of long-term use in adult patients on dialysis.

The first ESA approved by the FDA was in 1989 for Amgen Inc.'s (AMGN) Epogen (Epoetin alfa) for the treatment of anemia in renal disease. Epogen was approved in 1993 also as a supplemental indication for the treatment of anemia associated with cancer chemotherapy. Epogen recorded sales of $2.04 billion in 2011, down 19 percent from the prior year, while Aranesp sales dropped 7 percent to $2.30 billion.

Currently marketed ESAs in the U.S. are dosed between 1 to 3 times per week or up to every two weeks in CKD patients on dialysis. But Omontys is administered as a once-a-month injection, signifying a major edge over existing ESAs.

Following the FDA approval, Affymax is expected to receive additional milestones of $50 million related to the approval alone from Takeda.

In the U.S, Omontys 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 the drug.

AFFY is trading at $15.05, up $1.32 or 9.61%, on a volume of about 10.7 million shares. In the past year, the stock has traded between $3.93 and $14.15.

TKPYY.PK is trading at $22.14, down $0.66 or 2.85%.

by RTTNews Staff Writer

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