Regulatory chatter and depressing clinical results, among other things, made for a fairly lifeless biotech sector at the start of the week.
Ahead of a Food and Drug Administration advisory panel for Avastin, when added to paclitaxel for breast cancer,
shares gave up $3.06, or 4.2%, to $73.07. The FDA indicated in a brief preceding the meeting that the panel will discuss whether a 5.5-month improvement in progression-free survival is enough to approve the drug given the data showed no improvement in overall survival.
said Sunday that they received an approvable letter from the FDA regarding a new-drug application for nebivolol, which is under review to treat hypertension. The companies said that they've agreed with the FDA on the product labeling text and the FDA didn't raise any questions about safety or efficacy of the drug. However, the companies said the agency indicated that a recent inspection of a backup manufacturing facility in Belgium uncovered deficiencies, and final marketing approval for nebivolol is contingent upon satisfactory resolution of those deficiencies.
Mylan shares edged down 15 cents, or 1%, to $14.23, and Forest Laboratories' shares were trading down $1.02, or 2.7%, at $37.53.
Amgen and Forest Laboratories are both components of the Amex pharmaceutical index, which was down 2.42, or 0.7%, at 353.46.
On the clinical end,
said Monday that a midstage trial on its TC2696 for acute post-operative pain didn't meet its primary endpoint. The company said it will continue to analyze the data for TC-2696, which it is jointly developing with
per an alliance in therapeutics announced earlier in the year.
Targacept shares gave up $2.30, or 24%, to $7.30.
closed at $55.24 on Friday, and opened at $53.70 on Monday. The company said Friday after the close that an
interim analysis of a phase III study showed no benefit to treatment of breast cancer from adding its anemia drug Aranesp to chemotherapy. Shares were trading down 22 cents, or 0.4%, at $55.03 in recent trading Monday.
said it expects fiscal 2008 earnings in the range of $2.77 to $2.95 and reiterated that its December quarter will be difficult. The company expects quarterly earnings of around 62 cents a share, similar to last year. The company said operating revenue in the quarter will be below the expectation for the rest of the year due to the negative impact from lower sales of anemia pharmaceuticals, loss of a large specialty customer and the loss of a large retail customer in January of 2007. Analysts surveyed by Thomson Financial were looking for 70 cents a share for the quarter and $2.88 for the year.
The company also said it signed a letter of intent with
Medco Health Solutions
, reaffirming its position as Medco's prime vendor for PBM mail-order wholesaler services. The company's contract, which was slated to end in March, 2008, represented 8% of AmerisourceBergen's $61.6 billion revenue and 90% of its $4.4 million in bulk revenue in fiscal 2007.
AmerisourceBergen's shares were trading down $1.37, or 3%, at $44.01.