Friday's Health Winners & Losers
Elizabeth Trotta
12/28/07 - 03:42 PM EST
Blasé biotech stocks met the last weekend of the year with regulatory news, and not much else.
Mylan(MYL Quote) said Friday that it received approval from the U.S. Food and Drug Administration for its generic over the counter (OTC) version of Pfizer's zyrtec, or cetirizine hydrochloride tablets. Pfizer's Zyrtec harnessed U.S. sales of approximately $1.4 billion for the year ended Sept. 30.
Mylan's shares rose 19 cents, or 1.4%, to $13.99.
Perrigo(PRGO Quote) also announced that it has received final FDA approval for its Abbreviated New Drug Application (ANDA) for OTC generic Zyrtec. Its shares were trading down 29 cents, or 0.8%, at $35.80.
On the medical device side,
Boston Scientific(BSX Quote) received European regulatory approval for its new Livian implantable defibrillator to treat heart failure. The device is currently under review by the FDA. It monitors a patient's heartbeat, delivering small electrical pulses if necessary. Shares of Boston Scientific were up just 6 cents, or 0.5%, to $11.77.
Trying to navigate the approval process,
Theravance(THRX Quote) said Thursday after the close that an FDA panel will meet to review its new-drug application for skin-infection drug Telavancin.
The company said it recently learned that the agency's Anti-Infective Drugs Advisory Committee will soon meet to discuss the once-daily injection, which is intended to treat infections caused by Gram-positive bacteria, including resistant pathogens like MRSA. Shares gave up $2.52, or 12%, to $18.82 on Friday.
Also Thursday after the close,
Alexza Pharmaceuticals (ALXA Quote) said
Endo Pharmaceuticals(ENDP Quote) will pay it $10 million up front under a license-and-development agreement for AZ-003, a pain-treatment device in early-phase development.
AZ-003 uses Alexza's Staccato system inhalation technology to deliver fentanyl to treat cancer and non-cancer patients for breakthrough pain. Alexza may also get an additional $40 million in milestone payments. Alexza was trading up 13 cents, or 1.6%, at $8.25, while Endo Pharmaceuticals was down 17 cents, or 0.6%, at $26.69.
Theravance, Alexza and Endo Pharmaceuticals are all components of the Nasdaq biotechnology index, which was down 4.47, or 0.53%, at 842.41.