Illumina shares sank nearly 35 percent to $27.01 Friday morning on news that the company’s forecasted third-quarter revenue of about $235 million fell short of consensus estimates of $278.3 million. The maker of tools for genetic analysis said the uncertainty related to unknown levels of research funding has resulted in purchasing delays for both instruments and consumables, particularly among large-volume sequencing centers. Companies selling DNA sequencing systems like Illumina and Life Technologies get 20-40 percent of their revenue from U.S. government-backed research and could be hurt by the potential budget squeeze on research funding. Illumina’s ratings were dropped by major brokerages as well, with CitiGroup stating that “[though] there has been ongoing concern over a weakening environment for the tools sector, the magnitude of Illumina's miss was a surprise.”
A New Zealand Court ordered GlaxoSmithKline to pay a pharmacyin suburb of Auckland for the costs of recalling a suspected faulty medication. GSK had asked all community pharmacies to recall their Marevan brand of blood-thinning medicine warfarin in January. Ian Johnson Pharmacy filed suit, seeking payment for expenses incurred by the recall. Despite GlaxoSmithKline’s objections, Manakau District Court Judge Andree Wiltens ordered that the pharmaceutical company should pay a reasonable and proper price to the pharmacy for its services, stating that the “desirability of complying with an ethical or moral obligation cannot be the basis for disentitling a claim for compensation for the time and effort involved in such a compliance.”
The Takeda subsidiary Millennium said that it would be withdrawing its new application to expand the use of Velcade for injection in combination with rituximab. Millennium had hoped to use Velcade, which is approved in the United States for use in patients with multiple myeloma and for patients with mantle cell lymphoma, in combination with rituximab to treat patients with relapsed follicular lymphoma. Though pivotal clinical trial demonstrated a 1.8 month improvement in median progression-free survival compared with rituximab alone, external advisors and evaluations from the FDA led Millennium to withdraw its application.
Sangamo BioSciences shares plummeted on news that a mid-stage study of their diabetic neuropathy drugfailed to meet its primary or secondary clinical endpoints in patients with moderate severe diabetic neuropathy as compared to placebos. Sangamo said it would halt further clinical development of the drug, known as SB-509, and focus instead of other drugs in development. Shares dropped $1.59, or 36 percent to $2.80 on Monday following the announcement.
Johnson & Johnson’s subsidiary Scios will pay $85 millionas part of guilty plea for misdemeanor violations for promoting off-label use of its heart failure drug, Natrecor, the U.S. Department of Justice said. In 2001, U.S. Food and Drug Administration approved Natrecor for the intravenous treatment of patients with acutely decompensated congestive heart failure who suffer from shortness of breath when resting or engaging in minimal activity. The vasodilator opens up the blood vessels, which reduces the heart’s workload and may help to improve the acutely decompensated patient’s shortness of breath. As part of its plea, Scios admitted that it intended Natrecor to be used off-label for non-acute congestive heart failure patients on a scheduled, serial basis and that it understood that this was not an approved use of the drug. The United States has sued Scios and Johnson & Johnson in an on-going related civil case under the False Claims Act over claims submitted to Medicare and other federal healthcare programs for off-label use of Natrecor.
AstraZeneca will cut 400 jobs from its U.S. commercial business to streamline operations, the Associated Press reported. Company representatives stated that the cuts are needed to build a “leaner, more efficient organization.” The cuts include 70 positions that were already vacant, so approximately 330 employees will actually be affected. AstraZeneca will give employees the option of voluntarily leaving, and those who do so will receive the same severance package as those who will be cut.
Teva Pharmaceutical Industries failed to persuade a court that its drug Propofol wasn’t responsible for an outbreak of hepatitis C in 2008, Bloomberg reported. The court ordered Teva to pay a $20 million fine to compensate three plaintiffs for damages. Robert Eglet, a lawyer defending patients who contracted the hepatitis C virus, said that “Teva, along with distributors, Baxter international and McKesson Corp marketed Propfol in ‘jumbo-sized vials’ enticing doctors to reuse the containers and in turn increase the spread of blood-borne diseases.” Teva is still in an on-going fight with Baxter over how much of the $500 million each is to pay in punitive charges levied against them during the first trial. Teva says that they will appeal the latest ruling and maintains that the allegations against them are without merit.
Tolerx has decided to wind down operations by cutting staff and auctioning off assets after announcing the failure of a late-stage trial, FierceBiotech reported. Tolerx’s fortunes mostly rested on the success of their only late-stage contender in their pipeline, Otelixizumab. Those chances vanished in March on news that it had failed the late-stage trial. In the interim, GSK has taken over development of the drug, while Tolerx continues to liquidate earlier-stage candidates in its pipeline through an auction. Tolerx completed two rounds of layoffs in March and May.
Takeda Pharmaceutical reported on Friday that they would discontinue development of their insomnia drug ramelteon in Europe, Reuters reported. Though the drug, marketed as Rozerem, is approved in the United States and Japan, feedback on development requirements from the European Medicines Agency prompted them to drop further development.
October 06, 2011
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