Affymax Gets A Gift From Investors: Time
This article was originally published in The Pink Sheet Daily
It’s not usually the case in biotech, but investors are showing patience for Affymax as it ramps up the launch of its long-acting erythropoiesis stimulating agent Omontys. The drug has yielded nominal sales since its launch in May but Affymax’s stock is up 25% since the drug was approved March 27.
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The market for kidney disease drugs is under pressure from Medicare cost containment policies. However, there is still room for new drugs – if they can demonstrate a cost-savings benefit.
With FDA’s March 27 approval of peginesatide to prevent anemia in CKD patients on dialysis, Affymax will focus initially on marketing to smaller, price-conscious dialysis providers. But the biotech also expects to do business with Fresenius and, to a lesser degree, Davita.
Delaying Inclusion Of Oral-Only ESRD Drugs In Bundled Payment Gives Short-Term Reprieve To Genzyme, Amgen
Although manufacturers and other stakeholders were unable to convince CMS to change its stance on including oral-only drugs to treat end-stage renal disease in a new prospective payment system, the agency's decision to delay that step for three years is being viewed as a somewhat positive result for Amgen and Genzyme in the short term