The Burrill Report


AstraZeneca has entered into a $68.5 million multi-state settlement to resolve allegations that the pharmaceutical company deceptively marketed its anti-psychotic drug Seroquel. Some 36 states and the District of Columbia are party to the settlement, described as the largest-ever multi-state, consumer-protection-based pharmaceutical settlement. The states charged that AstraZeneca engaged in unfair and misleading practices when it marketed Seroquel for unapproved or off-label uses. The Complaint also alleges that AstraZeneca failed to adequately disclose the potential side effects of Seroquel to healthcare providers, and withheld negative information contained in scientific studies regarding the safety and efficacy of Seroquel. In addition to the financial settlement, AstraZeneca agreed to publicly post its payments to physicians on a website and put into place policies to ensure that financial incentives are not given to marketing and sales personnel for off-label marketing, among other measures.

ARYx Therapeutics said that it is winding down its operations following notice from the U.S. Food and Drug Administration that there will be an additional delay in providing needed guidance on the late-stage development of naronapride, the company’s experimental drug for the treatment of various gastrointestinal disorders. The agency informed the company that its response would come in July at the earliest. Initially, the FDA was expected to respond to the company in November 2010. The company said its board has determined that continued operations are not possible due to lack of funding, and that it will immediately begin the winding down of operations.

Sanofi-Aventis and Regeneron Pharmaceuticals said a late-stage clinical trial of its experimental cancer drug aflibercpet in combination with the chemotherapy drug docetaxel failed to meet the study’s primary endpoint as a second line treatment for non-small cell lung cancer. The data showed that adding aflibercept to docetaxel demonstrated activity as measured by the key secondary endpoint of progression free survival and an overall objective response rate of 23.3 percent in the aflibercept arm compared to 8.9 percent in the placebo arm. The companies said they will perform an analysis of the study. Separate trials of aflibercept in metastatic colorectal cancer and hormone-refractory metastatic prostate cancer are underway to determine the clinical potential of the drug in those cancers.

Tolerx and GlaxoSmithKline said that a late-stage study of otelixizumab, an experimental humanized anti-CD3 monoclonal antibody, failed to meet the primary efficacy endpoint as a treatment for type 1 diabetes. No new or unexpected treatment-related safety concerns have emerged during the study. GSK said it will continue to explore additional dosing regimens to inform decisions about the future clinical development program for otelixizumab. New recruitment and dosing in the second study, the ongoing confirmatory phase 3 study with a similar design to the failed study, has been suspended pending review of the results.

A British Orthopedists’ group says that a hip replacement made by Johnson & Johnson DePuy fails in the United Kingdom nearly half the time – four times what the company said when it recalled the device in 2010, Bloomberg reported. The British Orthopaedic Association and the British Hip Society said data on the ASR XL Acetabular System from four surgeons show the rate of second operations, or revisions, ranges from 21 percent after four years to 49 percent after six years. DePuy recalled both the ASR XL and an ASR hip resurfacing system in August. At the time, the company cited unpublished data from the National Joint Registry of England and Wales saying 13 percent of ASR XL patients required second surgeries in five years, and 12 percent of patients with the resurfaced hips needed such operations within five years.

A new study published in The Journal of Sexual Medicine reveals that, for the first time, a class of drugs commonly used to treat urinary problems in patients with benign prostatic hyperplasia or BPH and found in popular medications to treat hair loss can produce persistent erectile dysfunction, depression, and loss of libido, according to a study in The Journal of Sexual Medicine. The study found that the effects can persist even after the medication has been discontinued. Researchers at Boston University School of Medicine, examined data reported in various clinical studies concerning the side effects of the 5 alpha reductase inhibitors, finasteride and dutasteride. Prolonged adverse side effects on sexual function, such as erectile dysfunction, depression, and diminished libido, were reported by a subset of men, the study found. Drug-related reduction in libido occurred in 4.2 percent in the dutasteride compared to 1.8 percent for those using a placebo. Reduced ejaculation and semen volume were also reported and in some patients, these drugs were associated with depression.












March 11, 2011
http://www.burrillreport.com/article-astrazeneca_enters_into_68_5_million_multi_state_pharmaceutical_settlement.html