IMNX
Drug Maker Immunex Expected to Expand Rhode Island Manufacturing Plant
Aug 10, 2001 (The Seattle Times - Knight Ridder/Tribune Business News via COMTEX) -- Immunex's biggest problem is its inability to make enough of its star drug Enbrel, and now the company is trying to solve it with another major manufacturing expansion.
Company spokeswoman Kris Greco said the Immunex officials would be "making an announcement next week about the possible expansion of our facility in Rhode Island." She would not discuss details or comment further.
Immunex is in the midst of a $450 million retrofitting of its Rhode Island pharmaceutical plant, which is planned to double its abilities to make Enbrel, the rheumatoid-arthritis drug that has become one of the fastest selling biotech drugs in history. Next week's announcement is expected to increase even more the plant's capacity to make Enbrel.
Immunex expects to have Food and Drug Administration approval and manufacturing capability by mid-2002.
That's a long wait for many with interest in the company. In North America, 75,000 patients are taking the drug, and 1,000 patients a week are being added to a waiting list, Immunex officials said. Immunex's contract manufacturer, Boehringer Ingelheim of Germany, has been running at full tilt for much of the past year.
In the meantime, competitors have seized an opportunity. Johnson & Johnson is supplying a competing drug, Remicade, and Abbott Laboratories expects to have its competitor ready for market in 2003.
Wall Street has begun to lose patience in Immunex, analysts say, because it is missing out on $200 million to $250 million in sales this year alone by not having enough of the drug to meet demand.
Immunex Chief Executive Ed Fritzky said the problem arose last year when the FDA unexpectedly approved Enbrel for patients with early stages of rheumatoid arthritis -- a move that swelled the potential market from 350,000 people with severe symptoms to about 1 million people with the disease.
"No one foresaw Enbrel to be as big as it is this quickly," Fritzky said.
Before Enbrel was approved for the market in 1998, Immunex expected to sell $500 million of the drug in its third year -- an estimate analysts considered optimistic.
It turned into a major underestimation: Immunex sold $652 million of Enbrel last year and is on pace to sell $750 million this year.
Although Immunex has been criticized as a one-hit wonder, Enbrel made the company profitable and enabled it to pile up more than $1 billion in cash.
The drug's success has enabled Immunex to expand the Rhode Island plant, to go forward on a $750 million headquarters on the Seattle waterfront and to position it to buy smaller companies.
Ragen MacKenzie analyst Andrew Heyward said the shortage could have a long-term effect because patients tend to stick with a treatment once it works.
But other analysts say patients may switch to Enbrel once it is more readily available because of its key advantages over Remicade: It doesn't require patients to also have chemotherapy, and it can be self-injected at home.
Despite the shortage, Immunex is trying to expand the market for Enbrel. It hopes to have FDA approval for use of Enbrel in psoriatic arthritis by next year, which will add another 300,000 potential customers.
American Home Products, a 41 percent owner of Immunex with European rights to Enbrel, is planning to complete a manufacturing plant in Ireland by 2005, largely to produce Enbrel. |