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Biotech / Medical : Amgen Inc. (AMGN) -- Ignore unavailable to you. Want to Upgrade?

To: mopgcw who wrote (1297)	10/14/2006 1:43:40 PM
From: tuck	Read Replies (3) \| Respond to of 1906

AMGN gets approvable on two week & monthly dosing for CKD patients not on dialysis. It already has approval for weekly and every three week administration, which allows it to be more easily synchronized with chemotherapy. The idea with the two week and monthly dosing was to provide even greater flexibility. This shouldn't be a big setback, one that substantially affects sales. AMGN was down slightly after hours. If there is follow through on Monday because of this, I might add to my position, as I see strong support in the low $72 area, and expect earnings to be at least solid. Amgen reports on the 23rd after the bell, with EPS expected to be 97 cents/share. I doubt they'll lower guidance, either. I do not know if Pani is in anyone's model for this quarter. It was approved with only three days left in the Q, so I doubt it. It could be a slight wild card. Lucentis garnered $10 million with just one day left in the quarter in which it was approved. A running start like that for Pani could maybe add a penny to earnings. Guidance for Pani will be interesting, if given. Guidance, in general, is always interesting. >>THOUSAND OAKS, Calif.--(BUSINESS WIRE)--Amgen (NASDAQ:AMGN - News) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter, commonly referred to as an "approvable" letter, for Aranesp® (darbepoetin alfa) de novo once every-two-week and maintenance once-monthly dosing regimens for chronic kidney disease (CKD) patients with anemia not on dialysis. In December 2005, Amgen submitted a biologics license supplement to the FDA for these Aranesp dosing regimens for CKD patients with anemia not on dialysis. The FDA has requested additional clinical data for the once-monthly dosing regimen, including an additional clinical study. The FDA has also requested additional label language and clarification of submitted data for the de novo once every-two-week dosing regimen. Amgen is committed to working closely with the FDA to resolve these questions in a timely and efficient manner. About Anemia and Chronic Kidney Disease (CKD) According to the National Kidney Foundation, CKD affects 20 million Americans (one in nine adults) and more than 20 million others are at increased risk for developing kidney disease. CKD is an irreversible condition characterized by kidney damage and impaired function that often progresses over time. Patients with CKD often suffer from serious complications such as anemia, which occurs when failing kidneys no longer produce sufficient erythropoietin, a hormone that stimulates the production of oxygen-carrying red blood cells. Red blood cells contain hemoglobin, a red, iron-rich protein that carries oxygen from the lungs to all of the body's tissues. Oxygen provides the energy the body needs for normal activities. Anemia occurs when the number of red blood cells (or the hemoglobin in them) falls below normal (12 to 18 g/dL of blood). Therefore, the body gets less oxygen and does not have enough energy to function properly. About Aranesp Amgen revolutionized anemia treatment with the development of Epoetin alfa, a recombinant erythropoietin (a protein that stimulates the production of oxygen-carrying red blood cells). Building on this heritage, Amgen developed Aranesp, a unique erythropoiesis-stimulating protein that can be dosed less frequently. Aranesp was approved by the U.S. Food and Drug Administration (FDA) in September 2001 for the treatment of anemia associated with chronic renal failure (CRF), also known as CKD, for patients on dialysis and patients not on dialysis. In 2002, Aranesp was approved for the treatment of chemotherapy-induced anemia in patients with nonmyeloid malignancies in the U.S. and European Union (EU). Today, Aranesp is the only erythropoiesis-stimulating protein approved in the U.S. and EU for weekly and every-three-week administration, which allows physicians to synchronize anemia treatment with the majority of chemotherapy schedules. Since its introduction in 2001, more than 2 million CKD and chemotherapy patients with anemia have received treatment with Aranesp.<< snip Cheers, Tuck