Ebb & Flow
Amgen's blockbuster second quarter earnings were driven by its homegrown products. In contrast, Enbrel, the rheumatoid arthritis drug acquired in the merger with Immunex, continued to have manufacturing problems that are leading patients to seek treatment elsewhere. This could really hurt if another anti-TNF drug, D2E7 from Cambridge Antibody (LSE:CAT; CATG) and Abbott (ABT), is approved soon. Ineed, FDA action on the BLA could come by year end.
In reporting its earnings last week, AMGN ratcheted back '03 Enbrel sales guidance, attributing most of the shortfall to a second quarter manufacturing snafu (see "Earning Attention?"). If D2E7 is approved this year, that would precede AMGN's current goal of getting its Rhode Island manufacturing facility on line in the first quarter.
While AMGN acknowledged that D2E7 is on its radar, it threw water on a suggestion that added competition was the key driver for its reduction in Enbrel estimates. "D2E7 wasn't the biggest effect," said President and CEO Kevin Sharer on the company's conference call. "The biggest change to the run rate was the problem with manufacturing." The company now expects to sell $1.2-$1.4 billion of Enbrel next year, down from previous estimates of $1.6 billion.
Second quarter Enbrel sales were $192 million, down from $217 million in the first quarter, due to the manufacturing shortfall. The problems pushed 5,000 patients off Enbrel, with 79,000 patients on the drug at the end of the quarter compared to 84,000 at the beginning of April.
AMGN isn't saying how many patients it expects to be on the drug at the beginning of next year, but it hopes to begin taking patients off the wait list - which now stands at 23,000 patients - in the fourth quarter.
Despite the pull-back in '03, AMGN said it still believes that Enbrel could