On a holiday-induced shortened day for stock trading, little news except a bird flu vaccine and a few FDA actions budged biotech stocks.
climbed Monday after announcing that in a mid-stage trial its avian influenza vaccine, H5N1, proved to be safe and prompted immune responses in humans. Share rose 60 cents, or 14.8%, to $4.66.
Another stock on the uptick,
, said on Monday that it has commercially launched Pantoprazole, the generic version of
acid reflux drug Protonix. Based on prescription data, Teva estimated that Wyeth has seen about $2.5 billion in sales from the drug in 2007. Subsequent to the launch, Teva upped its 2007 earnings guidance to a range of $2.34 to $2.36, compared to previous estimates of $2.20 to $2.30.
The FDA approved Teva's version of Protonix in August. Teva's launch announcement on Monday comes after a court denied a preliminary injunction filed by Wyeth and partner Altana regarding Protonix patents. The companies are now in settlement discussions and have entered into a standstill agreement for which Teva agreed not to ship additional product for 30 days, according to the company.
Teva's shares rose $1.41, or 3.1%, to $46.57, while Wyeth was trading down $1.74, or 3.7%, at $45.12.
Separately, Wyeth said Monday that the FDA issued a second approvable letter for its bazedoxifene for the prevention of postmenopausal osteoperosis. An approvable letter dictates that the FDA could approve the drug only if certain questions are answered or criteria, such as additional data or analyses, are met.
Wyeth said the FDA had several remaining questions regarding issues that were identified earlier but not resolved in its response to a first approvable letter earlier in the year. Specifically, the agency wants the company to provide more analyses and discussion on the incidence of strokes and blood clots.
Wyeth said the regulators didn't ask for new studies. The data from a large Asian study that was submitted in November and December of this year weren't reviewed by the FDA prior to the letter. The FDA and Wyeth will meet to discuss the drug.
Teva and Wyeth are both components included in the Amex pharmaceutical index, which was down six cents, or 0.02%, at 346.52.
Also dealing with an approvable letter from the FDA,
said Friday after the market close that the agency wants more information before it will approve the company's extended release Luvox for social anxiety disorder.
Jazz and partner Solvay Pharmaceuticals received approval for the drug for obsessive compulsive disorder earlier last week The companies said Friday that the FDA didn't raise any questions related to safety and efficacy for the social anxiety indication in the letter. Jazz gave up $1.36, or 7.6%, to $14.30 on Monday.