Monday, July 28, 2003

FDA APPROVES BAXTER'S ADVATE HEMOPHILIA A THERAPY

Baxter International Inc.'s hemophilia A treatment Advate (factor VIII) received an approval from the Food and Drug Administration, according to the agency.

The therapy, a new recombinant DNA-derived clotting factor, is the first antihemophilic human factor VIII product produced without the use of additives derived from human or animal blood during the manufacturing process.

The health care brand Advate is indicated to prevent and control bleeding episodes or to prepare hemophiliacs for surgery.

Replacement therapy with any factor VIII product, which requires intravenous administration, enables patients with hemophilia to form blood clots. However, the effect of the treatments is only temporary, consequently requiring factor VIII products to be given several times per week or more, the FDA said.

Technological advances during the last two decades, including viral inactivation and removal steps in manufacturing to prevent transmission of diseases such as hepatitis B, hepatitis C or HIV, have made both plasma-derived factor VIII products and recombinant factor VIII treatments safe.

No factor VIII products have transmitted HIV, hepatitis B or hepatitis C since 1987, the FDA noted.

Monday, July 21, 2003

BAXTER REPORTS Q2 EARNINGS, ADDITIONAL JOB CUTS

Baxter International Inc. reported disappointing second-quarter earnings, announced that it will lay off 700 more workers than was previously planned and revealed it is being investigated by the Securities Exchange Commission.

Net earnings from continuing operations were $49 million, or $0.08 per diluted share, in the second quarter of 2003 compared with $204 million, or $0.33 per share, in the year-ago period.

The quarterly results include a $337 million after-tax charge related to the firm's previously announced restructuring plans, including severance costs for employees that were laid off. Baxter announced the elimination of 2,500 employees July 2, but said Thursday that the restructuring charge includes severance costs for 3,200 employees, or 6 percent of its workforce.

Net sales in the quarter totaled $2.16 billion, an 11 percent increase from $1.95 billion in the same period of 2002. For the full year, Baxter expects to achieve sales growth in the 8 to 10 percent range, with earnings from continuing operations totaling between $1.65 per share and $1.75 per share.

Separately, the Deerfield, Ill.-based drug maker said it is cooperating with the SEC in retrieving information related to recent downward revisions to the firm's growth and earnings forecasts for 2003. The commission's letter stated that its information request "should not be construed as an indication by the commission or its staff that any violations of law have occurred, or as a reflection upon any person, entity or security," according to Baxter.

Additionally, Baxter confirmed Thursday that it expects Food and Drug Administration approval for hemophilia drug Advate (Factor VIII) in the second half of 2003.

Shares of Baxter closed Friday at $26.00, up $1.49, or 6.1 percent, in heavy trading on the New York Stock Exchange.