Revenue on the Rise at Elan

The drugmaker has a much narrower first-quarter loss than Wall Street expected.
Publish date:

Updated from 9:34 a.m. EDT

Irish drugmaker



said its first-quarter revenue advanced 31% from a year ago, a gain attributable in part to strong showings from the infectious-disease treatments Maxipime and Azactam.

Elan had a quarterly loss of $33.3 million, or 8 cents a share, compared with a loss of $115.6 million and 29 cents a share in the year-ago period. Excluding costs of 3 cents a share for stock-based compensation, Elan would have shown a loss of 5 cents.

On average, analysts surveyed by Thomson Financial were expecting a loss of 20 cents a share.

Total revenue reached $134.3 million in the first quarter, up from $102.7 million last year. Sales from Maxipime more than doubled from last year to $44.7 million. Azactam sales were also more than twice last year's result, and rose to $19.9 million.

Azactam lost its patent exclusivity last October, and Elan expects its sales to take a hit if a generic version enters the market. To date, no generic Azactam has been approved.

Elan is often recognized as the company that marketed the multiple sclerosis drug Tysabri with

Biogen Idec

(BIIB) - Get Report

. The companies pulled Tysabri off the market early in 2005 after it was tied to an increased risk of a serious brain illness when combined with certain other drugs.

This past March, a Food and Drug Administration advisory panel

unanimously voted to recommend that the agency allow Tysabri back on to the market. The panel also voted in favor of using the drug, which the company says is twice as effective as any other MS treatment on the market, as a first choice treatment for patients.

The companies are working with the FDA to finalize proposed drug labeling and a risk-management plan, a "meaningful, challenging and important process," according to Elan CEO G. Kelly Martin during the company's conference call Thursday. Elan and Biogen expect the FDA to make a decision by June 28, and Tysabri should be available in the U.S. within the third quarter, the company says.

In Europe last week, the Committee for Medicinal Products for Human Use issued a positive opinion on the drug, recommending that regulators approve its marketing in Europe, specifically for the treatment of patients with recurring disease based on clinical-trial results, as well as results of safety analyses.

According to Elan, assuming Tysabri is approved, patients will be provided with safety information on the drug and the companies will gather post-marketing safety data from patients being treated with Tysabri. Depending on pricing and approvals, Elan says, it expects a rolling launch in Europe to begin this summer.

Once the companies receive some clarity on the status of Tysabri as a treatment for MS, Elan says, it will apply for regulatory approval to market the drug as a treatment for Crohn's disease, an inflammatory bowel condition.

Shares of Elan were trading 9 cents lower Thursday, at $14.59. Biogen Idec shares were up 48 cents to $46.57.