Word on the street is that Amgen's (Nasdaq: AMGN ) preliminary drug for kidney disease-related bone loss has shown effectiveness in Phase III trials, according to Reuters Thursday. The results of the trials are due to be released at the American Society of Nephrology conference.
Being first to treat a specific aspect of a disease is a great boon in the pharmaceutical business, and this drug has that potential. The drug, cinacalcet, comes in pill form, and is the first in a class of drugs called calcimimetics.
Amgen's drug prevents bone loss by controlling production of a hormone that regulates calcium and phosphorous, the production of which tends to go into overdrive in those with kidney disease. When this happens, calcium dissolves into the bloodstream, leaving bones more brittle and prone to breakage.
According to the article, one of the studies showed that between 36% and 48% of dialysis patients taking the drug experienced hormone levels in the desired range, as compared to 4% to 7% taking a placebo. Another study, which involved non-dialysis patients, showed a 30% decrease in the hormone, as opposed to 19% in those who took placebos.
End-stage renal disease affects 360,000 Americans, and that figure increases 7% every year, according to the American Society of Nephrology. The U.S. incidence rate of the disorder is 210 per million. That number is on the rise, too, as the population gets older and at-risk populations grow in number. For example, diabetes and high blood pressure put people at risk of developing kidney disease, and, unfortunately, such factors as diet and weight gain have made these ailments more prevalent.
In September, Amgen applied for FDA approval of this drug, and successful Phase III trials, which go in depth to test a drug's effectiveness and safety, are, of course, a good omen on the road to bringing a new drug to market.
Amgen has had lots to celebrate lately, as Jeff Hwang discussed in October. Considering it may be one step closer to adding a first-mover drug to its portfolio of popular medications -- which include Aranesp, Epogen, Neulasta, and Enbrel -- this is a potential prescription for additional success.
What do you think the outlook is for Amgen? Let us know on the Amgen discussion board.
Alyce Lomax welcomes your feedback at [email protected].