The Burrill Report


Novartis Pharmaceuticals said it reached a $422.5 million agreement with the U.S. Attorney's Office for the Eastern District of Pennsylvania regarding civil and criminal allegations of the off-label promotion of Trileptal, as well as civil allegations relating to five other products. Novartis said the payments are in line with provisions made for a potential agreement. As part of the settlement, the company will enter a Corporate Integrity Agreement with Office of the Inspector General. It will require the company to implement for five years additional compliance-related measures, which include additional monitoring, auditing, training, education, reporting and disclosures.

Johnson & Johnson officials told a Congressional committee that it had misled consumers and regulators in its effort to quietly remove its Motrin painkiller from the market, Reuters reported. J&J is facing a criminal probe. During the hearing, the lawmakers charged that the company had placed profits over the welfare of its customers. The company, which had sought to buy back its supply of Motrin through the use of contractors posing as customers, said its McNeil unit should have alerted stores and the U.S. Food and Drug Administration to the 2009 recall.

Pfizer said it is halting a late-stage trial of its cancer drug Sutent in combination with prednisone for men with advanced castration-resistant prostate cancer that had progressed despite treatment with a chemotherapy regimen. The decision followed a scheduled interim analysis in which an independent Data Monitoring Committee found that the combination of Sutent with prednisone was unlikely to improve overall survival when compared to prednisone alone. No new or unexpected safety issues were identified. Sutent is currently approved for both gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate, and advanced/metastatic renal cell carcinoma.

GlaxoSmithKline said it will not pursue further worldwide development of Simplirix, its experimental vaccine intended to prevent genital herpes disease in women. The company said it made the decision following receipt of the results of a late-stage trial evaluating efficacy of Simplirix, which was conducted collaboratively with the U.S. National Institute of Allergy and Infectious Diseases, part of the U.S. National Institutes of Health.
The trial, which began in 2002 and included 8,323 women ages 18-30, showed that the vaccine failed to meet its primary endpoint of prevention of genital herpes disease. It did, however, demonstrate an acceptable safety profile. GSK and NIH continue to evaluate data from the trial and plan to present details of the analysis in the near future in an appropriate scientific forum.

Palatin Technologies said it will eliminate about half its workforce as part of a restructuring. The company said it will focus its resources on clinical trials of bremelanotide for male and female sexual dysfunction and PL-3994 for acute severe asthma. It is also discontinuing research activities relating to the discovery of new compounds. With the changes, the company said it is implementing a one-for-ten reverse stock split of its common stock.

The U.S. Food and Drug Administration has notified Teva Pharmaceutical Industries that it would not approve the application to begin market for Neutroval, the company’s competitor for Amgen’s Neupogen, without additional data. A letter from the agency said it did not require additional clinical trials. Teva is seeking approval for Neutroval for the reduction in the duration of severe neutropenia and the incidence of febrile neutropenia in patients treated with established myelosuppressive chemotherapy for cancer.

AstraZeneca said its experimental drug Zibotentan as a treatment for castration resistant prostate cancer failed to show a significant improvement in overall survival in a late-stage trial. The safety and tolerability profile of zibotentan in this trial was in line with previous studies. Based on this study result, AstraZeneca plans no regulatory submissions for zibotentan at this time. The full results of study will be published in 2011.

SemBioSys Genetics plummeted around 60 percent on the Toronto Exchange following news that the company will pursue a corporate sale or merger, an accelerated strategic partnering transaction, an asset sale, a significant restructuring and recapitalization, or an orderly wind down of the company’s business. The company said it has sufficient assets to satisfy its obligations as they come due, but it is unable to continue its existing business at current levels or to take on new commitments without additional financing. In an effort to stretch its available cash, the company is terminating an unspecified number of employees.


September 30, 2010
http://www.burrillreport.com/article-novartis_to_pay_422_5_million_to_settle_criminal_and_civil_allegations_with_u_s_attorney%e2%80%99s_office.html