Staff Writer

Amgen Inc. soundly beat estimates for the second quarter, led by a boost in product revenue, including a 26 percent increase in sales of the anemia drug Aranesp.

The Thousand Oaks, Calif.-based company reported total revenue of $3.6 billion for the three months ending June 30, a 14 percent increase over the second quarter of 2005. Net income rose 12 percent to about $1.2 billion, or $1.01 per share. Analysts' predictions had estimated revenues of about $3.5 billion and earnings per share of 94 cents.

The company ended the quarter with nearly $5 billion in cash.

"Clearly, it was a strong and, importantly, a high-quality financial quarter," Amgen's Chairman and CEO Kevin Sharer said during the company's earnings call after markets closed Thursday. He added that the firm raised its 2006 EPS guidance by 15 cents, now anticipating a range of $3.75 to $3.85.

Shares of Amgen (NASDAQ:AMGN) gained $2.23 Friday to close at $66.15.

Total product sales for the quarter increased 14 percent over last year to about $3.5 billion - U.S. sales rose 13 percent to nearly $2.9 billion, and international sales jumped 17 percent to $630 million.

For the first time, worldwide sales of Aranesp (darbepoetin alfa) broke the $1 billion mark for a single quarter with sales totaling nearly $1.1 billion, a 26 percent increase over last year. U.S. sales totaled $713 million, up 33 percent, and international sales came in at $342 million, up 14 percent.

Aranesp was approved in 2001 to treat anemia in chronic renal failure patients and approved for anemia induced by chemotherapy in 2002.

The company believes that the growing demand for Aranesp contributed to the 5 percent decline in Epogen (epoetin alfa) sales, which totaled $613 million for the quarter.

Combined worldwide sales of Neulasta (pegfilgrastim) and Neupogen (filgrastim), approved in chemotherapy-induced neutropenia, also hit $1 billion for the second quarter, an increase of 12 percent over last year. U.S. sales rose 12 percent to $785 million, due in part to demand and to a 2 percent price increase in April, and international sales rose 9 percent to $220 million.

North American sales for the anti-TNF therapy Enbrel (etanercept) totaled $724 million, up 13 percent, driven in part by a 4.9 percent price increase in May. And Sensipar (cinacalcet HCl), approved for secondary hyperparathyroidism in chronic kidney disease patients, posted worldwide sales of $79 million, a 119 percent increase. The price of Sensipar also increased by 4.9 percent in May.

By the end of the third quarter, Amgen hopes to have FDA approval of Vectibix, formerly panitumumab, which completed a rolling biologics license application in March in third-line metastatic colorectal cancer. The PDUFA date is Sept. 28, 2006.

Vectibix, which Amgen gained full rights to following the $2.2 billion acquisition of Fremont, Calif.-based Abgenix Inc. earlier this year, also is in late-stage development as a first- and second-line treatment in metastatic colorectal cancer.

However, planned Phase III studies in head and neck cancer will be delayed one or two quarters in order to "respond to changes in the competitive marketplace," Sharer said, referring to the March approval of Erbitux (cetuximab) in that indication. Erbitux was developed by ImClone Systems Inc. and Bristol-Myers Squibb Co., both of New York.

Elsewhere in the pipeline, Amgen has completed enrollment in two Phase III studies of AMG 531 in immune thrombocytopenic purpura, and expects to lock the database by early 2007. AMG 531, a peptide designed to stimulate the thrombopoetin receptor to increase platelet production, has received fast-track status from the FDA.

The company also reported promising efficacy data from a Phase II trial of AMG 706, a multi-kinase inhibitor, in patients with gastrointestinal stromal tumors receiving AMG 706 alone or in combination with other therapies, though it intends to amend the safety protocol after a small percentage of patients developed cholecystitis. That news is expected to delay the start of Phase III studies of the drug in first-line breast cancer and in first-line non-small-cell lung cancer.

Another oncology product, denosumab, is in three Phase III studies targeting skeletal-related events in prostate cancer, breast cancer and solid tumors. The product, a monoclonal antibody designed to specifically target the receptor activator of nuclear factor kappa B ligand, also is in Phase II testing in rheumatoid arthritis.

Overall, "our business performance is rock solid," said George Morrow, Amgen's executive vice president of global commercial operations. "We don't see any insurmountable obstacles to future growth."

Though faced with the impending prospect of biogenerics, Morrow said the firm is anticipating guidelines that will prevent the "automatic substitution" of existing drugs.

The company doesn't expect to see any biogeneric competition to any of its products this year, but biogenerics could swipe market share from Neupogen, Neulasta and Aranesp perhaps as early as 2007.

In the meantime, Amgen is working to keep F. Hoffmann-La Roche Ltd. from selling a pegylated version of recombinant human erythropoietin in the U.S.

In November 2005, Amgen filed suit against the Basel, Switzerland-based company alleging that Roche infringed on six Amgen patents relating to Epogen and Aranesp. (See BioWorld Today, Nov. 10, 2005.)

Sharer told investors on the call that no clinical data have emerged demonstrating any benefit of Roche's peg-EPO product over Amgen's.

"We have a firm conviction that Roche will be judged to infringe our U.S. EPO patents," he added, "and we're eager to get to the merits of that case in court."

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