Showdown Looms Over Arthritis Medications

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October 26, 2002

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Showdown Looms Over Arthritis Medications

With Humira, Abbott Laboratories plans to give real competition to Amgen's

popular but hard-to-get treatment Enbrel.

 

 By Gellene, Times Staff Writer

In large stainless-steel tanks that look as if they belong in a beer

factory, Abbott Laboratories Inc. is brewing what could become the next big

rheumatoid arthritis drug.

Abbott's Humira, already tested in 2,300 patients, poses a direct threat to

Enbrel, the rheumatoid arthritis treatment that is the crown jewel of Amgen

Inc.'s $9.6-billion acquisition of Immunex Corp. Though Humira is months

from market, the rivalry between Abbott and Amgen already is intense.

The competition for patients got off to an early start this month as Abbott

made Humira available to as many as 5,000 people with advanced disease

through a clinical trial. Abbott expects to grab some of the 32,000 patients

who are on a waiting list for Enbrel, a drug in high demand but in chronic

short supply.

The showdown with Abbott may decide whether Amgen's decision to buy Immunex

last December was a stroke of genius or a costly blunder. Amgen, based in

Thousand Oaks, grew into the world's largest biotechnology company chiefly

by protecting the monopoly held by its anti-anemia drug, Epogen.

With Enbrel, Chairman and Chief Executive W. Sharer is taking

conservatively run Amgen into one of the most competitive drug categories in

biotechnology. Amgen has lowered Enbrel sales forecasts twice since the

takeover.

Analyst Auster of SunTrust Humphrey said Amgen won't make

money on Enbrel until 2005, a year later than expected. " It is hard to

understand why they felt a need to do the deal, " he said.

Shares of Amgen rose $1.11 to close at $49.79 on Nasdaq on Friday. Abbott

rose 63 cents to $43.08 on the New York Stock Exchange.

The adversaries will square off this weekend in New Orleans at a medical

meeting attended by 8,300 arthritis specialists. For Abbott, the scientific

conference offers a critical opportunity to tout Humira, which it cannot

advertise because it is an unapproved drug.

Abbott executives predict patients will prefer Humira, a longer-lasting drug

that is taken less often than Enbrel. Humira is taken twice monthly; Enbrel

is a twice-weekly drug. The medications are injected, like insulin.

" For some patients, that will make a difference, " said Northwestern

University rheumatologist Ruderman. A consultant to Amgen and Abbott,

Ruderman said the drugs otherwise appear comparable. The drugs block TNF, a

molecule responsible for the joint inflammation of rheumatoid arthritis,

which affects 2.1 million Americans.

" There is going to be a big marketing battle, and no one knows how it is

going to play out, " Ruderman said.

The early outcome hinges on when Amgen can end a two-year shortage of Enbrel

that has driven the number of patients on the drug below 79,000 from 85,000

in March. Since Amgen closed the Immunex purchase in July, completion and

approval of an Enbrel factory in West Greenwich, R.I., has been its top

priority.

Teams of outside experts have poked around every corner of the plant in

preparation for a Food and Drug Administration inspection next month.

A clean review from the FDA would allow Amgen to open the factory before

Humira's expected launch in April.

At the same time, Amgen must rebuild the confidence of patients and doctors

who stopped using Enbrel as supplies tightened. A week after Abbott

announced its clinical trial, Amgen moved to blunt the effect by launching a

5,000-patient trial of its own for people with rheumatoid arthritis, using

supplies of Enbrel made in Rhode Island that have not been cleared for sale.

In advance of this weekend's medical meeting, Amgen took influential doctors

on a tour of its factory, hoping to create a buzz among rheumatologists.

Abbott, too, is courting physicians. For months now, it has sponsored dinner

meetings where clinicians who are consultants to Abbott lecture doctors

about rheumatoid arthritis and answer questions about Humira. Five hundred

doctors have expressed interest in offering the drug free to patients in

Abbott's clinical trial.

Leading a tour of Abbott's factory in Worcester, Mass., last week,

production chief Moesta showcased twin 6,000-liter tanks that can

produce enough Humira to supply 200,000 patients annually, more than twice

the number of people on Enbrel.

To build its stockpile, Abbott also is using a 3,000-liter tank to grow

colonies of cells programmed to produce Humira, an antibody drug.

By contrast, Amgen's new factory will use six 8,000-liter tanks to produce

enough medication for 100,000 patients, Moesta said. Amgen depends on

outside contractor Boehringer-Ingleheim for current supplies of Enbrel,

which is tricky to make.

After the tour, Abbott gathered 10 grateful rheumatoid arthritis patients

who received Humira in a clinical trial. Their doctor, Birbara, an

associate professor of medicine at the University of Massachusetts, said

three of the 75 patients he has treated with Humira have had serious side

effects: tuberculosis, an unusual lung infection and encephalitis.

Abbott released a study Friday showing that the infection rate among

patients on Humira was about the same as for patients taking only

traditional rheumatoid arthritis drugs, such as methotrexate. The study

didn't compare Humira with Enbrel.

The timing for FDA approval of Humira isn't certain. The agency has been

accused lately of dragging its feet, and Abbott's half-million-page

application for the drug, hauled to Washington from Chicago in an

18-wheeler, was the largest ever submitted to the FDA.

And Abbott has a history of manufacturing problems. It relaunched Abbokinase

this month after withdrawing the blood-clot buster in 1998 because of

quality lapses.

Still, Abbott isn't Amgen's only worry. Genentech Inc., Biogen Inc. and

Pharmacia Corp. are among a clutch of companies developing drugs for

inflammatory disease.

In June, a & drug knocked Enbrel from its perch as the

best-selling biotechnology drug for inflammatory disease. Until recently,

J & J's Remicade hadn't been viewed as competitive with Enbrel because it

causes allergic reactions in some patients and must be administered

intravenously by doctors.

Sales of Remicade, which also is used for Crohn's disease, a bowel disorder,

rose 63% to $293 million in the third quarter. Enbrel sales sank 7% to an

estimated $185 million during the same period.

Analysts and physicians doubt that Amgen will reclaim patients doing well on

Remicade, which should post more than $1 billion in sales in 2002, compared

with less than $800 million for Enbrel.

In the eyes of some, Amgen can afford to lose rheumatoid arthritis patients

to competitors because Enbrel is the only biotechnology drug approved for

psoriatic arthritis, which affects at least 500,000 people.

" Amgen's strategy is to press ahead in other indications, " said Deutsche

Bank . Brown analyst Dennis Harp.

Even so, Amgen must do everything right to make the Immunex purchase pay off

as promised, with Enbrel sales of $3 billion by 2005.

Recently, Lehman Bros. analyst Craig C. predicted that the market for

all drugs in Enbrel's class would total just $4 billion by 2006. If he's

right, Amgen needs to capture every penny that does not already go to J & J to

reach its previously stated goal.

Said Amgen Vice President Young, head of the company's Enbrel

business, " It is going to be an interesting spring. "

http://www.latimes.com/business/la-fi-amgen26oct26.story