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TRIALS AND TRIBULATIONS

Novartis Faces Federal Claims of Kickbacks in Civil Court

The weekly round-up of failed trials, missed targets, and other business mishaps.

The Burrill Report

The United States has filed a civil healthcare fraud lawsuit against Novartis Pharmaceuticals under the False Claims Act, alleging that the company gave kickbacks in the form of rebates and discounts to at least 20 pharmacies in exchange for their switching kidney transplant patients from a competitor’s immunosuppressive drugs to Novartis’ Myfortic. The government’s Civil Frauds Unit is pursuing the case in the Southern District of New York’s Federal Court, where it is trying to recoup tens of millions of dollars in reimbursements paid out by Medicare and Medicaid to the pharmacies. The FBI’s Major Provider Response Team, the Office of Inspector General in the U.S. Department of Health and Human Services, and the Commercial Litigation Branch of the Department of Justice all participated in the investigation.

Ceregene’s gene therapy for Parkinson’s disease failed to reach its primary endpoint in a mid-phase double-blind, randomized trial. The adeno-associated virus delivery vector containing the neurotrophic factor, neurturin, did not significantly improve a measure of Parkinson’s disease-related disability and impairment. According to Ceregene, a substantial placebo effect was observed, in that both the sham-surgery-control patients and the treated patients showed significant improvement following surgery. The gene therapy did, however, meet statistical significance for one of the key secondary endpoints related to patient’s personal daily diaries, and the company says it is continuing to analyze trial data. The study involved 51 patients at 11 clinical sites and was funded by the Michael J. Fox Foundation for Parkinson’s Research.

Roche will halt development plans for its sequencing tools, a decision that will lead to 170 job cuts within the company. Roche will return a semiconductor-based sequencing system project back to its originator, DNA Electronics, because the company believes it will be unable to disrupt the market at product launch. It is also ending a partnership with IBM for development of a nanopore-based sequencing platform, due to what it characterized as high technical risks. Roche’s entire Applied Science Business Area will be dissolved and existing products will be integrated within its other diagnostics business areas. The reorganization will eliminate 110 positions in Germany and 60 positions at the company’s Connecticut site.

Cook Medical initiated a global voluntary recall of its Zilver PTX Drug Eluting Peripheral Stent, telling hospitals to stop using the device, quarantine any inventory, and return it for credit. The problem lies not with the stent itself but with the delivery system for implanting it into the vein. One patient died and the company has received 13 complaints of the catheter tip separating during implantation of the stent. The defective units were distributed to 84 medical institutions in the United States between December 13, 2012 and April 16, 2013. Cook’s notice indicates that when the inner delivery catheter breaks possible adverse events include the need for additional surgery to remove the catheter tip, vascular occlusion, thrombosis, amputation, and possible cardiac arrest. Patients with stents already installed are not at risk.

The development of combination antibiotic treatments for methicillin-resistant Staphylococcus aureus hit new roadblocks with findings reported in PLoS Biology. Doctors often prescribe combination antibiotics to treat the serious infection since two antibiotics can disrupt two different parts of the bacteria’s protein-building machinery, improving the chance of killing the bacteria. Researchers wanting to know how antibiotic pairs work over several days found that after an initial day of decline, treated test bacteria of a different strain skyrocketed in number. Sequencing data showed that the flourishing bacteria had rapidly duplicated genes, including those for chemical efflux pumps, involved in four different drug resistant pathways.

South Africa’s parliament is considering extensive intellectual property reforms that include closing a loophole known as “ever-greening,” whereby drug companies slightly modify a drug facing near term patent expiry so they can claim it as new and thus extend patent protection and profits, according to Reuters. By making it more difficult for drugmakers to register and extend their drug patents, the South African government hopes to bring cheaper therapies for cancer and HIV/AIDS to its citizens. “South Africans are missing out on affordable versions of life-saving medicines because generic competition is blocked by frivolous patents that prevent or delay generic competition,” says Julia Hill of Médecins Sans Frontières, the humanitarian aid group known in the United States as Doctors Without Borders.



April 26, 2013
http://www.burrillreport.com/article-novartis_faces_federal_claims_of_kickbacks_in_civil_court.html

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