Health stocks were nothing to flirt with Thursday as the major biotech and pharma indices followed the broader markets into the red and regulators took a cautionary stance.
The Food and Drug Administration issued a notice Thursday that makers of TNF inhibitors, used to treat immune system-related diseases such as rheumatoid arthritis and Crohn's disease, must beef up their labels with regard to the risk of fungal infections.
The agency said the makers of Humira, Cimzia, Enbrel and Remicade must strengthen their existing warnings on the risk of developing opportunistic fungal infections.
, which makes Humira, and
, which market Enbrel, are among those affected. Abbott, Amgen and Wyeth traded down 2.4%, 3.5% and 3.6%, respectively.
The FDA, which said some patients with invasive fungal infections have died, used its new authority under the Food and Drug Administration Amendments Act of 2007 to mandate the label changes.
Meanwhile, U.S. regulatory staff members said in a pre-panel analysis Thursday that
bone drug Fablyn -- made with
technology -- was effective for preventing fractures in post-menopausal women with osteoporosis. However, they noted that patients who received the experimental osteoporosis drug had a higher death rate than those who took a placebo, though that outcome wasn't statistically significant. In their review of Fablyn, FDA staff members also noted concern that patients taking the pill had more than twice the chance of developing a blood clot in a vein.
An expert advisory panel will meet Monday to discuss the safety of the drug, which the agency rejected in 2005.
Pfizer's shares declined 2.8% to $18.67. The stock, in addition to Wyeth, Amgen and Abbott, is a component of the Amex pharmaceutical index, which was down 2.4%.
-- the only component on the Pharma index that saw positive territory -- was up 60 cents, or 5.5%, at $11.58.
In nonregulatory news,
continued to rise Thursday, a day after it announced a substantial deal with Pfizer -- including a $225 million upfront payment -- for its experimental Alzheimer's disease drug Dimebon. Shares were up $2.34, or 8%, at $31.37 after an 11% hike a day prior.
In analyst actions, UBS downgraded pharmaceutical company
to neutral from buy and lowered its price target to $35 from $46. This comes a day after the company announced results from two late-stage trials on its experimental drug for patients with moderate to severe chronic obstructive pulmonary disease. The results met Forest Labs' main goal but underwhelmed expectations. The stock, which dipped to a seven-year low Wednesday, was off another 2.7% at 30.25 on Thursday.