The weekly round-up of failed trials, missed targets, and other business mishaps.
Teva Pharmaceuticals has cut its profit and revenue forecasts for 2012, pegging weaker economies and healthcare spending cuts in Europe as the main culprits for the lowered estimates. The reductions were anticipated as new CEO Jeremy Levin had declined to affirm his predecessor’s outlook. Teva had assumed it would grow 4-6 percent in Europe in 2012, but growth in key markets Germany and France has so far been negative, while Italy has remained flat. In a call to analysts Levin said, “In Europe, our outlook has been impacted by more than $1 billion due to negative currency effects totaling $600 million and the ongoing macroeconomic conditions.” Despite the lowered estimates, Teva’s shares climbed slightly after the call.
Danish biopharma company Neurosearch A/S announced that it has been charged with share price manipulation. Neurosearch said the charges were related to an announcement in February 2010 in which the upper management of the company reported top-line results from a mid-stage study regarding the company’s Huntington’s disease candidate drug Huntexil. Two months later, the company released “corrected” top-line data from the study in a new announcement that may have allegedly worked to manipulate the share price of the company. “On the present basis, Neurosearch is denying the charge and is collaborating fully with the authorities in order to resolve the matter,” the company said in a statement.
Johnson & Johnson said that an advisory panel to the U.S. Food and Drug Administration has voted against the approval of Xarelto as a treatment for acute coronary obstruction. Xarelto has already been approved by the FDA as a blood thinner but J&J and its development partner for Xarelto, Bayer, had been hoping to expand the use of the drug to treat acute coronary obstructions, or individuals who have heart attacks or chest pain due to blocked arteries. Although the drug looked promising, concerns about missing data and the risk of bleeding led to the advisory board voting 6-4 against recommending the expanded use of the Xarelto.
Pfizer has recalled more than 650,000 bottles of Advil pain relief medicine due to the potential for a strong odor in the product. The Advil recall was issued because an element of the manufacturing process may have caused a stronger odor in the product. A Pfizer spokeswoman said that eight lots of Advil Liqui-Gels bottles were voluntarily recalled from retail-distribution centers only and that the recall wasn’t at the consumer level. The recalled lots had been manufactured by contract manufacturer Catalent Argentina S.A.I.C. in Argentina according to a notice on the U.S. Food and Drug Administration’s website.
MediciNova’s shares plunged 50 percent after the company said its mid-stage study of its experimental drug for the treatment of acute asthma failed to hit its primary endpoint. MediciNova’s CEO Yuichi Iwaki, however, did try to pull some positive news from the study. “We believe certain variables, such as administration of off-protocol therapies, especially in the standard-of-care alone group (placebo arm),” said Iwaki. Investigators in the study did note that patients taking the asthma medication experienced an improvement in lung function which helped reduce hospitalizations.