Setback for anticoagulant drug

AstraZeneca has received a blow with the news that an FDA advisory committee raised concerns about the safety and efficacy of its anticoagulant ximelagatran (Exanta). The treatment, the first alternative to warfarin for more than 60 years, had been granted European approval in May 2004 for the prevention of blood clots in patients undergoing knee-replacement surgery, but briefing documents released by the FDA highlighted previously unheard-of problems. Trial data for the three indications in which AZ sought approval — prevention of blood clots in knee-replacement surgery, prevention of strokes in patients with atrial fibrillation, and long-term secondary prevention of blood clots following standard treatment of a clot — left too wide a margin in showing equivalence to warfarin. Concerns were raised about the previously reported increase in liver-enzyme levels with ximelagatran — including three deaths related to liver failure — and what seemed to be a signal of increased cardiac events with even short-term exposure.

Demands grow for clinical trials registry

Moves to establish an independent database for clinical trials have advanced. First, GlaxoSmithKline settled its case with New York Attorney General Eliot Spitzer for US $2.5 million, and it has agreed to publish results of its drug trials in a registry. The Pharmaceutical Research and Manufacturers of America (PhRMA) trade group announced plans for an online database starting 1 October 2004 (http://www.clinicalstudyresults.org/). This voluntary scheme will contain results of all controlled clinical trials — mainly Phase III and IV studies — completed since October 2002. But editors of 11 major medical journals say that this is not enough, and have announced that from July 2005 their journals would no longer publish any trial results that have not been registered in advance in an independent database that is freely accessible to the general public.

China revokes patent on Viagra

Another country has stepped up efforts to overturn its patent on sildenafil citrate (Viagra; Pfizer). The Chinese State Intellectual Property Office (SIPO) revoked patent protection for insufficient disclosure on the drug, arguing that Pfizer's application had failed to accurately explain the use of the drug's key ingredients. Pfizer has already lost patent protection for Viagra through similar challenges in Colombia and Venezuela. The patent in China, which expires in 2014, faces further pressure as a result of the announcement of an alliance between 17 Chinese pharmaceutical companies to produce a generic version of the drug.

Partnership struck between Bayer and Schering

Bayer and Schering-Plough announced an agreement under which Schering will have marketing rights to Bayer's primary care products, such as its antibiotics, in the United States. But the driving force behind the deal involves the company's biggest products. Schering will now have a Japanese marketing partner for its cholesterol absorption inhibitor, ezetimibe (Zetia), which is under regulatory review. Bayer now has help in the US commercialization of its erectile dysfunction drug vardenafil (Levitra), and in establishing an oncology business unit in the US, in which it will be able to commercialize its renal cell carcinoma drug, BAY 43-9006, that is currently in Phase III trials.

Initiative to apply nanotechnology to cancer

The US National Cancer Institute (NCI) has launched a new five-year initiative to develop engineered nanoparticles to treat cancer. Around $144 million will be spent on The NCI Alliance for Nanotechnology in Cancer, with the largest chunk — $90 million — going towards funding several Centers of Cancer Nanotechnology Excellence. NCI plans to release a call for applications for these centers this autumn, and expects to have at least five of them set up by summer 2005. NCI plans to collaborate with National Institute of Standards and Technology to work on the characterization of nanomaterials and with the FDA to define pathways to get nanotechnologies into clinical testing.

Society to assess potential of pharmacogenetics

The Royal Society, the United Kingdom's academy of science, will examine the potential of developing personalized medicines and how well equipped the UK is to proceed with it. The group, chaired by David Weatherall of the University of Oxford, will look at whether pharmacogenetics is, or when will it become, a scientifically achievable aim. It will also look at whether healthcare systems in the UK and other countries have the resources to implement such technologies, and what the pharmaceutical industry's assessment is of the significant investment needed to try and develop them in the first place. The Royal Society report will be published in summer 2005, and individuals and organizations are invited to provide evidence by 12 November 2004 (http://www.royalsoc.ac.uk/policy/pharmacogenetics.htm).