Pfizer said that two subsidiaries of Pharmacia reached separate settlements with the US Department of Justice to address charges stemming from the off-label marketing of human growth hormone medicine Genotropin and the inappropriate use of a vendor contract to increase the sales of other Pharmacia medicines. Both settlements cover activities that occurred at Pharmacia before the company was acquired by Pfizer in 2003. The subsidiaries have agreed to pay fines totaling $34.7 million.One subsidiary — Pharmacia & Upjohn Company Inc. — will plead guilty to a single count of offering to an outside vendor remuneration in the form of an award of a contract to manage a Genotropin patient assistance program as an inducement for recommending the purchase of Pharmacia medicines. The contract was awarded in 2000. The subsidiary, which has no operational role in Pfizer today, was assessed a fine of $19.7 million and will be disqualified from participation in government healthcare programs. The disqualification will have no impact on current or future Pfizer medicines approved for use in the US and will not affect the continued marketing of Genotropin. A second Pharmacia subsidiary — Pharmacia & Upjohn Company LLC — has entered into a Deferred Prosecution Agreement with the Department of Justice (DOJ) that includes a fine of $15 million to address the improper promotion of Genotropin, which Pfizer discovered and self-reported to the Department of Justice, the FDA and the Office of the Inspector General within the first month following completion of the Pharmacia acquisition. Under the agreement, no criminal charges will be filed against Pharmacia in return for compliance with the terms of the agreement.
Novo Nordisk announced new diabetes self-management tools are now available on its updated Web site, ChangingDiabetes-us.com. These resources were developed in response to findings from the DAWN (Diabetes Attitudes, Wishes and Needs) Study, a 5,426-patient global survey commissioned by Novo Nordisk, and are designed to individualize and help optimize patient care. The new tools may be useful for people in every stage of diabetes. Visitors to the newly enhanced site can utilize the interactive diabetes care plan to help identify personal barriers to diabetes care and help alleviate fears about advancing to insulin therapy. By registering at the ChangingDiabetes-us.com Web site, diabetes users can immediately access critical information about diabetes, utilize the online tools, and receive regular e-mail communications on timely diabetes-related topics.
GlaxoSmithKline has been fined $156,000 for misleading advertising after two New Zealand high school science students found the company’s black currant soft drink Ribena contained no detectable vitamin C, the Associated Press reported. The company admitted to 15 charges of misleading advertising between 2002 and 2006 in a suit filed by the Commerce Commission, a consumer watchdog, after a 2004 school science project exposed the false claims. Ribena has long been sold in the UK, Australia and New Zealand as a healthy drink based on advertisements that black currant juice has more vitamin C than orange juice. Its New Zealand ads claimed Ready to Drink Ribena had 7 milligrams of vitamin C per 100 milliliters (0.25 ounce per 3.4 fluid ounces). In 2004, high school students Anna Devathasan and Jenny Suo, then 14, found the drink contained almost no trace of vitamin C after testing it as part of a science based project. Auckland District Court Judge Phil Gittos fined GlaxoSmithKline and ordered the company to run corrective advertisements, in addition to a message on its Web site.
Sanofi-Aventis and UK gene-therapy developer Oxford BioMedica, have announced a joint-collaboration agreement to develop and market the pipeline cancer treatment TroVax. Under terms of the deal, Sanofi-Aventis will pay Oxford BioMedica, the owner of TroVax, up to $690 million if all development and registration targets are met for certain uses, the companies said. Additional payments will be made to Oxford BioMedica if regulatory milestones are achieved in other cancer types. Oxford BioMedica will receive an initial payment of $39 million and further payments of $25 million as targets are reached TroVax is Oxford BioMedica’s main cancer immunotherapy. Early research suggests TroVax has potential for applications in a wide range of solid tumors, including renal, colorectal, lung, breast and prostate cancer. A Phase III trial in renal cancer is ongoing. Both companies will co-fund the renal cancer study, while Sanofi-Aventis will fund all future research, development, regulatory and marketing. Oxford BioMedica has an option to develop TroVax for other cancer types in exchange for enhanced financial returns under terms where Sanofi-Aventis would keep all commercial rights.
Avanir Pharmaceuticals announced that it has ended two drug development collaboration deals -- one with AstraZeneca and one with Novartis -- and is exploring the sale of certain assets. Novartis, which was developing inflammatory disease treatment AVP-28225 with Avanir, will further develop the compound on its own. Avanir will receive a milestone payment if the compound reaches the next stage of development. Avanir also said it would return to AstraZeneca the drug the companies were co-developing for cardiovascular diseases. Avanir would also return all related rights to AstraZeneca, Avanir said in a statement. Additionally, Avanir said it plans to exit its San Diego research facility later this year and move clinical development and support resources to its Orange County, CA, headquarters. Avanir is also evaluating options including sale of several investigational compounds and its schizophrenia drug FazaClo, which contributed $6.3 million to Avanir’s sales in the first quarter.
An Illinois jury last Tuesday ruled Merck’s withdrawn painkiller Vioxx was not responsible for causing a 52-year-old woman’s fatal heart attack and awarded no damages in the case. Plaintiff Frank Schwaller sued Merck after his wife, Patricia, took Vioxx for 20 months for shoulder pain before dying from a heart attack in August 2003. Schwaller’s lawyers alleged that Vioxx was defectively designed, inadequately tested, dangerous to human health, and lacked proper warnings, which subjected users to risks of heart attack, stroke and other illnesses. Merck argued Schwaller’s pre-existing risk factors – a family history of heart disease, morbid obesity, diabetes, high blood pressure, and sedentary lifestyle – were responsible for her sudden cardiac death. In trials that have reached a jury verdict, Merck, so far, has won 10 and lost five.