Industry

Europe struck by heparin scare

EC admits patients are at increasing risk of noncompliant products

Heparin, already responsible for deaths in the US, has now been tied to several adverse reactions in Germany, and there are now concerns that the heparin scare could become a global problem. In the US, the deaths were linked to heparin produced by Baxter, which has no link to Rotexmedica, where the German batches originated. The German batches are now being analysed to identify whether they contain the same impurity as Baxter's contaminated heparin, which is believed to have originated from a Chinese factory. Although no other reactions have, as yet, been reported in other countries, heparin products worldwide are being subjected to additional testing. In Japan, supplies of heparin-based products are also being withdrawn as a precaution.

The situation has initiated a response from the European Fine Chemicals Group (EFCG), which advocates tougher enforcement of existing laws and new, harmonized international laws to combat substandard APIs, especially those originating from China. According to the group, the majority of global pharmaceuticals are now off patent and the industry is becoming increasingly competitive, which drives more risk in medicines. It says: "Weak enforcement has encouraged the growth of severely noncompliant manufacture and sourcing of substandard APIs with fatal effects not only to patients, but to the competitiveness of EU manufacturers of APIs."

Coincidentally, in early March, the European Commission (EC) announced that it accepts that the risks from noncompliant and counterfeit pharmaceutical products and APIs in Europe have worsened significantly, and that new legislations are urgently required to deal with the issue. EFCG applauded the EC's announcement, but believes that: "The 21st century demands a new approach to law-making and enforcement, one that is based on international cooperation by the major authorities, on joint enforcement actions at an international level and on strict sanctions that drive effective deterrence."

http://www.efcg.cefic.org/

Regulatory

Sanofi welcomes Swedish vaccine choice

The recommendation from health authorities in Sweden to vaccinate all young girls in Sweden against cervical cancer has been described as "great news" by Sanofi Pasteur. The Swedish National Board of Health and Welfare is pushing for the universal free vaccination of all girls in school aged 10–12 years, which will also help protect the girls against human papillomavirus-related genital diseases, as well as cervical cancer. In accordance with Sweden's administrative procedure, the recommendation is open for referral with final confirmation expected later this month, and implementation at country level from autumn 2008. Didier Hoch, president of Sanofi Pasteur MSD, says: "We hope that vaccination programmes will be implemented quickly so that girls and women will have full access to these programmes that will help save lives and protect girls' and women's health."

In May 2007, the Pharmaceuticals Benefits Board in Sweden included Sanofi Pasteur's Gardasil in the national Pharmaceutical Benefits Scheme for girls aged 13–17 years, marking the first time that the Board had granted a vaccine reimbursement status.

http://www.spmsd.com/

R&D

Swiss company eyes cancer treatment

Cancerous tumour growth can be reduced by 69% according to comparative preclinical studies by a company based in Geneva (Switzerland). Anavex 7-1037 is Anavex's lead candidate in its attempt to develop a treatment for a number of cancers, including cancer of the breast, colon, prostrate and melanoma, as it appears to exhibit a high-safety profile and disease-modifying potential. During advanced preclinical studies, the compound significantly delayed tumour growth in xenografts, which were developed in the lab using samples taken from patients suffering from clear cell sarcoma, a rare skin cancer that is difficult to treat.

"The results confirm the potent, anticancer activity and chemotherapeutic potential of Anavex 7-1037," says Dr Kontzalis, chief executive officer for Anavex. "We remain committed to developing cancer fighting therapeutics based on our Sigmaceptor discovery platform, which utilizes a new class of receptor molecules know as sigma ligands to influence the origin or development of a disease."

http://www.anavex.com/