FDA review triggers jittters in Amgen and J&J

Yesterday Amgen (AMGN) dropped by as much as 2%, to a low of $54.65 before rebounding and finishing the day at $56.27 (-0.92%) as the U.S. Food and Drug Administation (FDA) announced plans to consult outside experts to re-evaluate the use of Amgen’s Aranesp and Johnson u& Johnson ‘s Procrit anemia drugs when given to patients with chronic kidney disease

An article published in the New England Journal of Medicine on Wednesday, said the agency "anticipates convening a public advisory committee meeting in 2010 to re-evaluate the use of drugs known as erythropoiesis-stimulating agents (ESAs) in people with chronic kidney disease. Amgen's Aranesp and Epogen and J&J's (JNJ) Procrit are both ESA’s.

The drugs came under scrutiny two or three years ago after studies showed high doses could lead to heart complications or in very rare cases even death. An FDA spokeswoman said an "important question" for the advisory panel would be what level of haemoglobin doctors should try to achieve with the drugs . In the journal article, they said "optimal haemoglobin targets have never been established" for patients with chronic kidney disease and clinical trials had raised "major concerns regarding the use of ESAs to increase hemoglobin concentrations" in chronic kidney disease patients above levels needed to avert blood transfusions. But the studies "do not rule out the possibility, however, that modest increases in the hemoglobin level could be beneficial," they added.

Sales of ESA drugs are a significant contributor to earnings, particulary in the case of Amgen. Amgen reported third-quarter Aranesp sales of $675 million. Sales of J&J's Procrit and anemia drug Eprex were $542 million in the quarter.

Given that both Amgen and J&J have aggressively tightened the labelling of their ESA products to minimise risks which has hit earnings from their drugs signnicantly, it is likely that these products will contain to be mainstay of therapy in patients with Chronic Kidney disease given the lack of viable alternatives at the current time. Thought the FDA hearings will undoubtedly hit sentiment, especially for Amgen, it is considered unlikely that Aranesp, Epogen and Procrit will be withdrawn from the market. Additional monitoring may be requested which may further hinder sales, but forthcoming news on new products from both J&J and Amgen makes any downside likely to be covered by these new innovations.

Position increased in Amgen at $55 and position initiated in J&J at $63.