Amgen has given an upbeat R&D presentation to analysts in New York saying that the recent problems and loss of revenue it has suffered with the anaemia drugs Aranesp and Epogen will soon be behind the firm as its pipeline, driven by denosumab, starts to deliver.
George Morrow, Amgen’s executive vice president for global commercial operations, said that although “we expect an additional decline of 10%-20% in US Aranesp(darbepoetin alfa) sales”, as a result of safety concerns and reimbursement changes, ”relative stability” will be achieved in the first half of 2009 for the drug and the older erythropoiesis stimulating agent Epogen (epoetin alfa). The decline in sales of the drugs corresponds to around $1.5 billion a year in earnings.
However Amgen is extremely enthusiastic about its pipeline. Roger Perlmutter, executive vice president for R&D, noted that in 2001, Amgen had about 20 molecules in there and now there are more than 50.
Most of that enthusiasm surrounds denosumab, which is expected to be filed with the US Food and Drug Administration for post-menopausal osteoporosis by the end of 2008 or early 2009. The company added that it should report 17 key Phase II and III study results in 2009 and 2010, including data for denosumab in oncology, plus AMG 386 and AMG 655 for “various cancer indications”.
Amgen is also expected to report its findings soon from EVOLVE, a major global study of Mimpara/Sensipar (cinacalcet) its first-in-class treatment for secondary hyper-parathyroidism, in chronic kidney disease. Chief executive Kevin Sharer said that “over the next five years we could have three more drugs achieve blockbuster status”, ie Sensipar and denosumab in osteoporosis and cancer.
Robert Bradway, Amgen’s chief financial officer added that the firm’s restructuring programme is paying off and “we remain focused on optimising both our cost and capital structures”. He noted that the company “aspires to be among the top three biopharmaceutical companies in growth over the next five years”.
Investors seem to think that Amgen is on the right track and after the presentation, shares climbed 4% to $58.87.
