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Amgen Q3 report focuses on pipeline, Kai purchase

LINDA A. JOHNSON, AP Business Writer
Friday, 19 Oct 2012 | 10:51 AM ET

TRENTON, N.J. -- Amgen Inc., the world's biggest biotech company, will update on progress on its experimental drugs when it reports its third-quarter results after the stock market closes Tuesday.

WHAT TO WATCH FOR: CEO Robert A. Bradway, who took over in late May, will note the appointment of a new corporate compliance officer and the closing of a deal for a company developing a treatment for a common complication of kidney disease. He'll also mention the latest product approval for Amgen, based in Thousand Oaks, Calif.

In July, Amgen completed its $315 million acquisition of Kai Pharmaceuticals of South San Francisco, Calif. It's developing a treatment for secondary hyperparathyroidism, in which poor functioning of the parathyroid gland allows blood levels of calcium and phosphorous to get too high. This frequently happens to patients with chronic kidney disease who are on dialysis. If approved, the drug could become an additional treatment to Amgen's Sensipar, which is for secondary hyperparathyroidism and excessive calcium levels.

Osteoporosis drug Prolia, one of Amgen's newest products, got a second approval in late September, for building bone mass in men at high risk of fractures. It's a shot given just under the skin every six months. Prolia and Xgeva, a different dose of the same active ingredient that's for preventing fractures in cancerous bones, already have a combined $540 million in sales in the first half of 2012.

But prospects are dimming for ganitumumab, for advanced pancreatic cancer, after a late-stage trial was stopped in early August because it wasn't working. Amgen is still testing it against two other types of cancer.

Executives will discuss progress in late-stage testing programs for a drug for ovarian cancer called trebananib and one for melanoma called talminogene laherparepvec, or TVEC for short.

Meanwhile, at a medical conference last week, researchers presented limited data from Amgen's midstage study of a new treatment for postmenopausal osteoporosis, called romosozumab. After a year of treatment, all five dosing regimens tested _ shots of different strengths given either once a month or every three months _ increased the women's bone density more than two comparison drugs in the study.

Amgen research head Sean Harper will tell analysts about some upcoming research results.

Those include four mid-stage studies on a drug still known as AMG 145, part of a new class of drugs for lowering bad cholesterol, to be presented at the American Heart Association conference in early November. The company has already reported it met all the studies' main goals.

Harper likely will note that detailed results will be presented at a conference of kidney specialists later this month on a late-stage study of Sensipar in which the drug didn't meet the primary goals. The large study tested whether it reduced chances of heart attacks and death in kidney patients on dialysis who have secondary hyperparathyroidism.

WHY IT MATTERS: In July, Amgen raised its 2012 financial forecast significantly, citing strong performance in the first half, momentum from rising sales and promising drugs in development. Investors will want to see whether the latest sales and research results continue that trend.

Revenue from newer drugs is important because sales for two top sellers, anemia drugs Aranesp and Epogen, have been declining since federal health programs put limits on dosing and reimbursement amounts amid safety concerns.

WHAT'S EXPECTED: Analysts polled by FactSet, on average, expect earnings per share of $1.48, excluding one-time items, and sales of $4.24 billion.

LAST YEAR'S QUARTER: Amgen reported profit of $454 million, or 50 cents per share, down more than 60 percent due to a huge charge for settling multiple federal and state investigations of marketing and other practices. Revenue was $3.94 billion.

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Linda A. Johnson can be followed at http://twitter.com/LindaJ_onPharma

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