Amgen Gets OK for Kidney Disease Drug
Amgen Inc. won regulatory approval Monday of a drug for dialysis patients -- the first new product from the Thousand Oaks biotech in two years.
Designed to prevent bone loss in patients with kidney disease, Sensipar represents a milestone for Amgen because it is the company’s first oral medication. Amgen until now sold only injectable drugs such as Epo, a successful anemia treatment.
Sensipar sales could eventually reach $500 million, analysts said, spurred by new treatment guidelines from the National Kidney Foundation for dialysis patients. Experts said those guidelines will discourage use of vitamin D, the drug typically used to prevent bone loss -- in large numbers of dialysis patients.
“Clinicians will be casting about for therapeutic alternatives,” said William Goodman, a medical professor and kidney specialist at UCLA. “The timing is good for cinacalcet.” Cinacalcet is the generic name for Sensipar.
Amgen didn’t announce a price for the drug, which it expects to begin shipping in the next several weeks.
The Food and Drug Administration approved Sensipar to treat excessive levels of parathyroid hormone, the substance that regulates calcium levels in the blood. Dialysis patients produce so much of the hormone that calcium leaches from their bones, putting them at risk for fractures.
Physicians currently reduce hormone levels by giving patients intravenous vitamin D. However, excess vitamin D can increase blood levels of calcium and phosphorus, which in extreme cases leads to calcification of blood vessels.
Amgen’s new drug regulates hormone levels in a manner that does not increase calcium and phosphorus levels.
Side effects include nausea and vomiting. Because Sensipar can lower calcium levels, patients on the drug must be regularly monitored, the FDA said.
Some on Wall Street said Sensipar could face marketing challenges, at least initially. Dialysis centers derive much of their profit from insurance reimbursement on intravenous drugs, including vitamin D. So if Sensipar reduces the need for vitamin D, dialysis centers could see lower profits.
Jennifer M. Chao of RBC Capital Markets said Sensipar was unlikely to replace vitamin D entirely. Dialysis patients will continue to need the vitamin because they don’t produce enough of it, she said.
“I don’t see this as mutually exclusive,” she said.
Amgen licensed the drug from NPS Pharmaceuticals, a Salt Lake City-based biotechnology company which will receive royalties on sales of Sensipar. On Nasdaq on Monday, Amgen shares closed down 79 cents to $62.46 and NPS fell $1.08 to $31.70.
