Affymax, Inc. ( AFFY ) recently
announced that it will reduce its total workforce by approximately
75% (230 employees). The company took this decision after it
recalled all lots of Omontys (peginesatide) voluntarily along with
its partner Takeda Pharmaceutical Company Limited
( TKPYY ) in Feb
The recall was prompted by data from post-marketing studies which
revealed that fatal reactions including anaphylaxis were found to
be associated with the use of Omontys. The decision is in
conformity with the US Food and Drug Administration's (FDA) views.
A letter was also issued to doctors by the company stating that no
patient (new or existing) should be on Omontys.
We remind investors that Omontys received approval in the US, in
Mar 2012, for the treatment of anemia due to chronic kidney disease
(CKD) in adult patients on dialysis.
The drug received approval on the basis of randomized,
controlled, open-label, phase III EMERALD studies (EMERALD 1 and 2)
which evaluated Omontys in 2,606 patients. At that time, the
company reported that the most common side effects associated with
Omontys were shortness of breath, diarrhea, nausea, cough and
arteriovenous fistula site complication.AFFYMAX INC (AFFY): Free Stock Analysis ReportCYTOKINETCS INC (CYTK): Free Stock Analysis
ReportLANNETT INC (LCI): Free Stock Analysis ReportTAKEDA PHARMACT (TKPYY): Get Free ReportTo read this article on Zacks.com click here.Zacks Investment
However, data from post-marketing studies revealed that
hypersensitivity reactions were observed in approximately 0.2% of
the patients receiving Omontys and approximately one-third of these
patients experienced severe reactions, necessitating immediate
medical care and even hospitalization.
Affymax and Takeda are currently examining the data. Affymax is
also evaluating other strategic options including sale, merger,
restructuring, wind-down of operations and filing for
Affymax and Takeda Pharma both carry Zacks Rank #4 (Sell).
Lannett Company, Inc. ( LCI ) and
Cytokinetics, Incorporated ( CYTK ) look more
attractive in the pharma sector. Both carry a Zacks Rank #1 (Strong