Immunex Says Enbrel Shortage Worse Than Anticipated

Immunex Corp. is telling doctors that continued production problems could prevent it from delivering its rheumatoid arthritis drug Enbrel to the nearly 20,000 patients on its waiting list until next year, much later than expected.

The news, though anticipated on Wall Street, caught some doctors and patient advocates off guard. Immunex has not added patients since December but told doctors and patients as recently as March that the medicine would be available in early summer.

However, the letters said Immunex would not accept new patients until “late in the year at the earliest.” The letters also said the 82,000 current users of Enbrel will continue to experience delays in getting their prescriptions filled “at least through the month of June.”

Enbrel is the crown jewel in Amgen Inc.’s $15.3-billion acquisition of Immunex, and the production delays could cost the combined company $150 million in sales this year and $500 million next year, said Fariba Ghodsian, an analyst with Roth Capital Partners.

“They are not keeping us current,” said Nicola Cutsforth of the National Psoriasis Foundation after learning about the delay from a reporter. “This is very unfortunate.”

Enbrel also has been approved for treating psoriatic arthritis and is being tested for psoriasis.

Northwestern University rheumatologist Eric Ruderman said the letters confirmed rumblings among doctors that the Enbrel shortage had worsened. He said doctors who had been putting patients on the waiting list probably will prescribe Remicade, a competing drug. The medications have a similar effect on the disease, which results in joint destruction.

The shortage “is a big issue and a big problem,” said Ruderman, a member of Immunex’s academic advisory board. “When we thought supply would open up in July, we thought patients could muddle along and wait. But now, six more months is a long time to wait.”

Doctors already have started prescribing Remicade more often. The drug from Centocor Inc., a unit of Johnson & Johnson, surpassed Enbrel in sales during the first quarter and is expected to widen its lead over the Immunex drug, although Remicade is used not only for rheumatoid arthritis but also for Crohn’s disease. Doctors said patients who do well on Remicade won’t switch to Enbrel.

The shortage could affect doctors’ prescribing habits as well.

“Physicians are human beings and get used to doing things a certain way,” said UC San Diego rheumatologist Gary Firestein, a member of the Food and Drug Administration’s arthritis drug advisory committee. “If they get into the habit of having only Remicade around, they will be in that mind-set and give that drug to patients.”

The letters arrived in doctors’ offices on the heels of shareholder votes last week approving Thousand Oaks-based Amgen’s acquisition of Immunex. Amgen said its first priority is fixing Immunex’s supply mess, a chronic situation that drove Immunex’s shares to the mid-$20s from a high of $80 two years ago, making it a takeover target. The transaction needs government approval, which could come next month.

Enbrel supplies have been tight since November 2000, when Immunex initiated a waiting list for the drug. But doctors said the current shortage is the worst in memory.

Immunex warned its then 85,000 Enbrel users in March that their prescriptions could be delayed by “a few days to weeks” in April and May. But doctors said some patients have waited up to a month to have their prescriptions filled.

Hope Reed said she was worried during the two weeks that her 13-year-old son went without Enbrel. The boy fatigued easily and developed a vision problem related to his arthritis, his mother said.

Reed said her son improved when he went back on the drug, which patients must take twice a week. “But I am worried about the future,” said Reed, who lives in Chino Hills. “Will we get it on time? Or will there be another problem down the road?”

Immunex has fallen “down in our eyes in terms of its ability to take care of patients,” said Allan Metzger, a rheumatologist at Cedars-Sinai Medical Center in Los Angeles. Enbrel won’t regain the momentum it had with physicians, he said.

“This isn’t flag-waving against Enbrel,” Metzger said. “They made a terrible tactical error.”

Amgen Chairman and Chief Executive Kevin Sharer, in a brief interview after the company’s annual meeting, acknowledged the firm’s next potential blockbuster drug may have an image problem. The shortage “can’t be good for the brand,” he said, adding Amgen plans to “relaunch” Enbrel as soon as there is more drug to sell.

Seattle-based Immunex has blamed the shortage on its inability to forecast demand and on a series of production problems.

In March, the company said its contract manufacturer in Germany, Boehringer Ingelheim, produced less drug than expected. Last month, Immunex said it fell behind schedule on plans to open a factory in Rhode Island, and pushed the deadline to the end of the year from mid-2002. (Amgen has consistently said the factory won’t be ready until the beginning of 2003.)

Immunex also hit snags at a contract “fill and finish” plant in North Carolina where drug produced in Rhode Island is packaged in vials. Compliance issues at that plant also delayed government approval of a cancer drug from Idec Pharmaceuticals Corp. this year.

Immunex executives in recent weeks began backing away from previous supply forecasts in interviews and calls with analysts. Immunex Chief Operating Officer Peggy Phillips said in a telephone interview three weeks ago that Enbrel shipments to current patients “are returning to normal.” She could not predict when patients would come off the waiting list.

However, some patient advocacy groups and doctors complained Immunex has not kept them as well informed as Wall Street.

Cutsforth, membership director of the National Psoriasis Foundation, said a company representative told her in March that the drug would become available for new patients in July. Since that conversation, Cutsforth said, she has not been able to get anyone from Immunex on the phone.

The foundation plugged Enbrel in January when the drug received FDA approval as a treatment for psoriatic arthritis, Cutsforth said. It is the only drug approved for the condition, which affects the skin and joints.

“We touted this and it is not even available to us,” she said. “There is definitely a sense of frustration from patients that there was all this hype about a new treatment and they can’t get it.”

“Every time I get a letter from them, it says, ‘two more weeks.’ I’ve stopped opening their letters,” Firestein said.

Immunex spokeswoman Robin Shapiro said the firm has discussed its supply problems “in conference calls with analysts” and sent letters to physicians after getting “greater clarity on the situation.”

She added: “I don’t see [the letters] as a great departure from what we’ve said.”