Amgen Inc. continues to find new improvements and new markets to extend sales
of Enbrel, the blockbuster drug manufactured in West Greenwich.
Last week, investors cheered news that the Food and Drug Administration approved a once-a-week, 50-milligram dose of the injectible medication. Patients currently take two 25-milligram doses of Enbrel, spread three or four days apart.
Amgen, based in Thousand Oaks, Calif., says the new dosage will make it more convenient for patients. Enbrel is prescribed to rheumatoid arthritis patients, and also is approved as a treatment for psoriatic arthritis and ankylosing spondylitis, an inflammation of the spinal cord.
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The enhancement also is important in Amgen’s battle for market share with Chicago-based Abbott Laboratories, which early this year introduced its own rheumatoid arthritis drug, Humira. While Enbrel has a firm hold on the market, Humira is easier to use, with one 40-mg injection taken every other week.
Amgen officials during an Oct. 21 conference call said the green light for doctors to prescribe the once-a-week dose will help erode that competitive advantage.
“We think this first step to get once-weekly dosing will do a lot to neutralize the only advantage they have in the marketplace, which is more-convenient dosing,” said George J. Morrow, executive vice president of worldwide sales and marketing.
While patients can take the entire 50-mg Enbrel dose on the same day, it still comes in two injections. Company officials said they plan to file this quarter for FDA approval of a single 50-mg injection.
“That’s the advance that will substantially narrow the gap between Enbrel and Abbott’s Humira in terms of convenience,” said Eric Schmidt, a biotech analyst at SG Cowen Securities Inc. in New York.
Larry Bernard, a Rhode Island-based spokesman for Amgen, said changes in approved dosage levels for Enbrel – or approvals of the drug to treat other diseases – generally do not have an effect on operations at the West Greenwich facility.
Amgen now produces nearly all of its Enbrel supply at the 205,000-square-foot plant off Interstate 95, which employs 1,100 workers. A second, larger plant that will produce Enbrel and other medications is under construction and slated for completion in 2005.
The drug works by blocking inflammation-causing proteins, which stalls the structural damage suffered by rheumatoid arthritis patients. It has been used by more than 200,000 patients worldwide since hitting the market nearly five years ago. The FDA now is reviewing the drug as a treatment for psoriasis, a painful skin disease.
Enbrel reaped $342 million in revenue for the third quarter – a 116 percent increase over the same period last year. At that time, the West Greenwich plant had not yet come online, and the waiting list for Enbrel stretched to nearly 80,000 patients.
For the year, Amgen expects worldwide sales of Enbrel to hit $1.2 billion to $1.4 billion.
But the company’s third-quarter results received a cool reception from investors, with the company’s share price tumbled more than 5 percent on Oct. 22. The biotech bellwether reported a net gain of $612 million, or 46 cents a share, an increase of 53 percent.
For the year, Amgen said revenue should total $8.1 billion to $8.4 billion. Sales of the company’s flagship anemia drugs, Aranesp and Epogen, are projected to reach as much as $4 billion.
Schmidt said the drop in Amgen’s share price likely was more a result of a broad market sell off and a downgrade by an analyst at Morgan Stanley.
“I think Amgen had an excellent quarter and I think the outlook continues to be very bright,” Schmidt said.
Meanwhile, Amgen’s Rhode Island operation has a new general manager. Kathleen
Retterson, vice president and general manager of Amgen in Rhode Island, has
left the company and will be replaced by David Bengston, who has been serving
as the vice president of Amgen’s Colorado operations.
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