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Sixteen States, DOJ Join Whistle-Blower Lawsuits Alleging Wyeth Defrauded Medicaid Programs
The U.S. Department of Justice and 16 states have joined two whistle-blower lawsuits filed in federal District Court in Massachusetts alleging that Wyeth defrauded the government by not offering the same discounts on two medications to Medicaid that it offered to hospitals, the Wall Street Journal reports. The lawsuits were initiated following a grand-jury investigation by the U.S. Attorney"s Office in Massachusetts (Johnson, Wall Street Journal, 5/19). The other states included in the lawsuits are California, Delaware, Florida, Illinois, Indiana, Louisiana, New York, Michigan, Nevada, New Hampshire, Tennessee, Texas, Virginia, Wisconsin and the District of Columbia (Barrett, AP/Austin American-Statesman, 5/18).According to the lawsuits, Wyeth from 2000 to 2006 sold hospitals a bundled package called the Protonix Performance Agreement, which included its acid-reflux drugs Protonix Oral and Protonix IV. The suits allege that Wyeth gave hospitals up to a 94% discount for the oral version under the deal, with the understanding that when patients were released from hospitals they would be switched from the intravenous version of the drug to the oral version. According to the complaint, Wyeth hoped to gain an edge in a competitive market for acid-reflux pills by taking advantage of its standing as the only company offering an IV acid-reflux drug. The Journal reports that Wyeth charged hospitals $20 per vial for the IV version of Protonix and $3 for the oral version.Medicaid rules stipulate that the program is entitled to the lowest price on prescription drugs, and drugmakers are required to pay states rebates if they offer discounts to any other entities. The lawsuits state that Wyeth avoided paying hundreds of millions of dollars to state Medicaid programs because it did not offer the programs the same discounts or provide rebates (Wall Street Journal, 5/19).The lawsuits are seeking financial penalties against Wyeth of up to three times the amount lost by Medicaid. Assistant Attorney General Tony West said, "By offering massive discounts to hospitals, but then hiding that information from the Medicaid program, we believe Wyeth caused Medicaid programs throughout the country to pay much more for these drugs than they should have." Wyeth spokesperson Doug Petkus said that Wyeth "believes that its pricing calculations were correct and intends to defend itself vigorously in these actions" (AP/Austin American-Statesman, 5/18).
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Amarillo Biosciences Announces Completion Of Screening Process For Influenza Study In Australia
Amarillo Biosciences, Inc. (ABI) (OTCBB: AMAR) announced that the screening of volunteers for inclusion in a Phase 2 clinical study of the company"s oral interferon product at the University of Western Australia is now complete. The investigators met their target of screening at least 200 healthy adults for participation in the trial. A total of 215 volunteers were evaluated and 134 of them have been enrolled into the study to date. About 90% of the screened subjects have been found to qualify for the study, so additional enrollments are expected over the next 2 weeks to bring the total number of study participants up to or above the targeted 160 subjects.
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Earlier Commencement Of Antiretroviral Therapy Yields Better Clinical Outcomes
A clinical trial has demonstrated that HIV-infected adults in a re-limited setting are more likely to survive if they start antiretroviral therapy (ART) before their immune systems are severely compromised.
Medical Devices

ABRAXANE Approved For Advanced Breast Cancer Patient Treatment In Quebec

Abraxis BioScience, Inc. (NASDAQ:ABII), an integrated biotechnology company, announced the listing of ABRAXANE® for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) 100 mg in Quebec for the treatment of metastatic breast cancer with a recommendation from the Quebec Conseil du Mç©dicament and approval from the Quebec Ministry of Health. ABRAXANE is approved and commercially available in Canada for the treatment of metastatic breast cancer, including first-line disease. The listing of ABRAXANE in Quebec offers an important new treatment option to Quebec women with advanced breast cancer. "Based on clinical study results to date and my first-hand experience, I believe that ABRAXANE represents a very important and needed new treatment option for breast cancer," said Dr. Andrç© Robidoux, Director of the Breast Cancer Research Group of the CHUM Research Center. "ABRAXANE is the only taxane that is solvent free and is approved to treat metastatic breast cancer." The Conseil"s approval was based upon comparative clinical trials demonstrating the tumor response rate of ABRAXANE was nearly double for patients who received ABRAXANE compared to those who received solvent-based paclitaxel. Patients treated with ABRAXANE experienced a significant improvement in progression-free survival and prolonged time to tumor progression compared to patients treated with solvent-based paclitaxel.i Additionally, a recently published Phase II study demonstrated that ABRAXANE (administered weekly at 150 mg/m2) nearly doubled progression-free survival over docetaxel injection (14.6 months versus 7.8 months respectively p=0.012).ii ABRAXANE is indicated in Canada at a dose of 260 mg/m2 every three weeks for the treatment of metastatic breast cancer. ABRAXANE uses the natural properties of a human protein, albumin, to deliver the drug more effectively to tumors. By wrapping the albumin around the active drug, ABRAXANE can be administered to patients at higher doses without the use of toxic solvents - often the cause of significant treatment-related side effects with other taxane chemotherapies. Unlike most taxane chemotherapies, ABRAXANE eliminates the patient"s need for premedication during treatment to avoid allergic reactions caused by solvents . Additionally, patients can receive treatment in as little at 30 minutes compared to more than three hours needed for solvent-based paclitaxel. "With this approval, Quebec doctors and patients now have another effective treatment option to help women in their fight against advanced breast cancer," said Lyndal Walker, Vice President and Managing Director, Abraxis BioScience Canada. According to Canadian Cancer Society statistics, an estimated 5,900 Quebec women were diagnosed with breast cancer in 2008.iii With an average of 437 women diagnosed with breast cancer every week, breast cancer is the second leading cause of cancer mortality among Canadian women.iv ABRAXANE has now been approved in 36 countries across Europe, North America, Asia and Australia. Abraxis is continuing to expand its clinical experience with ABRAXANE and its potential in treating a variety of tumor types at multiple stages of disease as a single agent and in combination. About ABRAXANE® ABRAXANE is a solvent-free chemotherapy treatment option for metastatic breast cancer which was developed using Abraxis BioScience"s proprietary nab® technology platform. This protein-bound chemotherapy agent combines paclitaxel with albumin, a naturally-occurring human protein. By wrapping the albumin around the active drug, ABRAXANE can be administered to patients at higher doses, delivering higher concentrations of paclitaxel to the tumor site than solvent-based paclitaxel. ABRAXANE is currently in various stages of investigation for the treatment of the following cancers: expanded applications for metastatic breast, non-small cell lung, malignant melanoma, pancreatic, gastric and head and neck. In June 2006 ABRAXANE was approved by Therapeutic Products Directorate of Health Canada under a Notice of Compliance for the treatment of metastatic breast cancer in Canada. The U.S. Food and Drug Administration approved ABRAXANE for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in January 2005 for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. References i Gradishar WJ, Tjulandin S, Davidson N, et al. Phase III trial of nanoparticle albumin-bound paclitaxel compared with polyethylated castor oil-based paclitaxel in women with breast cancer. J. Clin Oncol. 2005;23(31):7794-803. ii Gradishar et al. Significantly Longer Progression-Free Survival With nab-Paclitaxel Compared With Docetaxel As First-Line Therapy for Metastatic Breast Cancer. J Clin Oncol. 2009; 0: JCO.2008.18.5397v1. iii Canadian Cancer Society. Breast cancer: the facts. October 2008. Available here. iv Canadian Cancer Society. Breast Cancer Stats. 16 April 2009. Available here. Abraxis BioScience, Inc.


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