Updated from 3:05 p.m. EDT
were among the best-performing health and pharmaceutical stocks Monday, rising 13.6% after the Food and Drug Administration extended its review of the company's pancreatic cancer drug.
Orathecin is SuperGen's investigational drug for the treatment of pancreatic cancer for patients who have failed at least one other prior chemotherapy regimen. The company's first-line phase III trial originally failed to reach its endpoint of improving survival vs. gemcitabine. Still, according to the company, the subjects of that study fall outside the proposed use of Orathecin as a second- or third-line therapy. The extension gives the FDA until Feb. 26, 2005, to complete its review of the drug. SuperGen said the FDA requested additional data from its trial of Orathecin for use as a first-line pancreatic cancer treatment. "The additional clinical data submitted to the FDA provides additional support for the Orathecin NDA," the company said. Shares traded up 85 cents to $7.10.
rose 8.2% after the company said it submitted an application to the FDA for its Aryplase drug, which is used to treat mucopolysaccharidosis VI, a debilitating, life-threatening disease. If the Biologics License Application for marketing authorization is granted, the company will have a window of exclusivity to market the drug, since the drug has been granted orphan status by the FDA. As part of the BLA submission, BioMarin has also requested priority review. If the FDA grants the company priority review, the FDA is expected to complete its review and take action on the application within six months of submission, BioMarin said. Shares traded up 38 cents to $5.03.
fell 5% after the company posted a full-year loss that was wider than a year ago. Excluding items, the pharmaceutical company posted a loss of $181.5 million, or $4.53 a share, on sales of $42.8 million. Analysts surveyed by Thomson First Call were expecting a loss of $4.77 a share on sales of $49.9 million. A year ago, the company posted a loss of $149.9 million, or $4.02 a share, on sales of $32.4 million. Shares traded down $2.53 to $47.96
Other health care volume movers included
, up 17 cents to $27.33;
, down 3 cents to $27.67;
, up 60 cents to $3.23;
, up 53 cents to $60.74; and
, up 49 cents to $49.21.