Washington Editor

Amgen Inc. and partner Wyeth Pharmaceuticals believe the Enbrel supply will double on FDA approval of the Rhode Island manufacturing facility.

Meanwhile, sales of Amgen's Aranesp could be impacted by a U.S. district court judge's decision to dismiss the company's recently filed complaint against the government for reimbursement provisions contained within the Medicare hospital outpatient prospective payment system. (See BioWorld Today, Nov. 4, 2002.)

In terms of money, increased availability of Enbrel could push U.S. sales to $1.2 billion to $1.4 billion in 2003, but U.S. sales of Aranesp could drop about 10 percent, according to some analyst estimates. According to Amgen, Enbrel's U.S. sales in the first three quarters of 2002 were $567 million and Aranesp's were $209 million worldwide.

Nevertheless, Bill Tanner, managing director with Leerink Swann & Co. in Boston, said, "In my mind, the Enbrel plant is far more positive than the court decision is negative."

Enbrel (etanercept), a fully human anti-TNF receptor launched in 1998, was discovered by Immunex Corp., of Seattle, and is marketed for rheumatoid arthritis (RA), juvenile rheumatoid arthritis and psoriatic arthritis. Amgen acquired Enbrel, and the partnership with Wyeth, of Madison, N.J., when it merged with Immunex last summer in a deal valued at $10.3 billion. (See BioWorld Today, July 17, 2002, and Dec. 18, 2001.)

Prior to the Amgen-Immunex merger, Immunex was in the process of constructing a facility to meet the increasing demand for Enbrel.

"[Immunex] had basically been in a position where demand outstripped supply," Rebecca Hamm, Amgen spokeswoman, told BioWorld Today. "They were getting supply from a contract manufacturer in Germany [Boehringer Ingleheim GmbH] and there just was not enough Enbrel being produced, so they went to work on trying to build basically a new facility to produce Enbrel, and it became Amgen's when the acquisition went through."

Amgen filed for FDA approval of the facility in August. Amgen's prepared statement described the facility as a 250,000-square-foot structure that houses eight 8,000-liter bioreactors, the tightly controlled vessels needed to produce large quantities of Enbrel through recombinant DNA technology. The facility will employ more than 550 people.

And while Amgen hasn't released specific details about the capacity of the plant, Tanner told BioWorld Today it should allow the company to sell twice as much Enbrel. Furthermore, he said, "We believe Amgen is going to be able to more aggressively market it for the treatment of psoriatic arthritis, which is different from RA. We think there is a sizeable market revenue opportunity there as well."

But the real contest, according to Tanner, has been the race to "relaunch" Enbrel before Abbott Laboratories' Humira, an anti-TNF MAb for RA, makes it to market.

"Remember, there's still competition from Remicade [Johnson & Johnson], but if you were to look for new competition coming in that is a fairly direct competitor to Enbrel, it would be Humira," he said.

Humira, which is available through the expanded use program, could make it to market during the first quarter, Tanner said.

"Some physician consultants we work with think the efficacy data for Humira might be a bit superior [to Enbrel], but they have not been tested head to head, so it is impossible to make that claim," he said. "One of the real issues comes down to frequency of dosing."

He added that Enbrel is dosed twice a week, and it is contemplated that Humira could be dosed once a week or once every two weeks.

Enbrel also is in Phase III trials for psoriasis, ankylosing spondylitis and Wegener's granulomatosis.

In the reimbursement issue, a U.S. District Court for the District of Columbia, citing Amgen's lack of standing, dismissed the company's challenge to prevent the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services (HHS) from implementing certain provisions of a new rule that impacts some Medicare payments for Aranesp (darbepoetin alpha).

At issue here is CMS's reimbursement rule, scheduled to take effect Jan. 1, which considers Aranesp "functionally equivalent" to Procrit, a similar product made by Johnson & Johnson. In the eyes of the government, Aranesp is not a new therapy and does not qualify to be reimbursed at a higher rate, as is common with most new or innovative therapies. The reimbursement applies only in the Medicare hospital outpatient setting.

"The only thing we have is the judge's ruling," Jeff Richardson, spokesman for Amgen, told BioWorld Today. "The judge has not yet issued the opinion, so we don't know the rationale of why he dismissed the case."

Considering the holidays, Amgen is not sure when the opinion will be issued, but expects it "soon," Richardson said. "[The opinion] will help us decide which steps to take, including whether we will appeal. But we can't make a decision until we see his rationale."

Aranesp, the second generation of Amgen's blockbuster Epogen (epoetin alfa), was first approved in September 2001 as a red blood cell booster for dialysis and nondialysis patients with chronic renal failure. In July, the FDA approved Aranesp for use in patients with non-myeloid malignancies who have chemotherapy-induced anemia. (See BioWorld Today, July 23, 2002.)

Of the lawsuit, Tanner said, "We were thinking that they were not likely to succeed, and it is only a small part of Aranesp revenues. Some of our physician consultants have told us over the last few weeks that Amgen has been talking about price discounts, so we are thinking that Amgen is either trying to cover their bases or was of the opinion or belief that they weren't going to prevail, and are trying to create a demand for the drug by offering a discount."

Richardson wouldn't comment on whether price reductions are in the future.

The Enbrel news came out late Monday and the Aranesp news was released late Tuesday. Amgen's stock (NASDAQ:AMGN) fell 19 cents Tuesday and 77 cents Thursday to close at $50.68.