Health indices lacked luster Monday, while a few biotech stocks kicked off the week with a swath of regulatory news.
said Monday that the Food and Drug Administration has more questions for the company regarding its cervical cancer vaccine Cervarix before the product can be approved.
The agency's Center for Biologics Evaluation and Research issued Glaxo a "complete response letter" to its Cervarix application, signaling that the review is complete but questions have to be answered before the drug can be approved. Glaxo said it will submit a response to the FDA letter on Cervarix, which is already approved in markets outside the U.S., as soon as possible.
Glaxo shares fell $1.05, or 2%, to $51.95. The stock is a component of the Amex pharmaceutical index, which was down 3.57, or 1%, to 344.25.
Meanwhile, the European Commission granted marketing authorization for Atripla, an HIV drug that was joint-filed by
for commercialization in the 27 countries of the E.U., as well as in Norway and Iceland. The drug has been approved in the U.S. since 2006. Bristol was up just 3 cents at $28.11, Genentech was down $1.32, or 2%, at $67.11, and Merck was up 8 cents, or 0.1%, to $59.65.
In other regulatory news,
said Monday that it received Japanese regulatory approval on Dec. 10 for its Sprint Quattro lead, a wire used with implantable cardioverter-defibrillators (ICDs) that detect and treat rapid and potentially lethal heart rhythms. The company said it hopes to receive reimbursement for the lead by Jan. 1, in which case it would immediately begin the commercial launch in Japan. In October, the company recalled its Fidelis leads, sparking a shift to the use of its Quattro leads, but Quattro lead product hadn't been approved in Japan. Medtronic shares were down 25 cents, or 0.5%, at $49.15.
On the clinical side,
said Monday that it had positive results from its interim analysis of late-stage data from Rapinyl as a treatment for breakthrough cancer pain. The company said the primary and secondary endpoints were all met in the 61-patient study. The interim analysis was only intended to determine efficacy and not tolerability, but Endo said the adverse events that were reported were consistent with what is usually observed with other opioids. Endo shares rose 15 cents, or 0.6%, to $27.27.
said its tanespimycin demonstrated meaningful antitumor activity and tolerability in a small, midstage trial in patients with HER2-positive metastatic breast cancer, when administered in combination with Herceptin in patients whose disease progressed following treatment with Herceptin immediately prior to entering the trial. Of 20 evaluable patients, the company said 11 patients saw a clinical benefit to tanespimycin. Common toxicities were mainly mild to moderate and included fatigue and gastrointestinal symptoms.
The company licensed the exclusive rights to develop and market Rapinyl in North America from Orexo AB. Shares rose 8 cents, or 2.4%, to $3.36.
Elsewhere, UBS upgraded
to neutral from sell, sending shares up $1.41, or 6%, to $24.52.