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Fuzeon Biojector marketing application withdrawn

Roche and Trimeris withdraw a supplemental marketing application with the FDA for the needle-free injection device for use with Roche's HIV treatment Fuzeon

Swiss-based Roche and Trimeris have withdrawn a supplemental marketing application with the FDA for the needle-free injection device for use with Roche's HIV treatment Fuzeon (enfuvirtide).

Fuzeon, an HIV fusion inhibitor which prevents the virus from attaching to CD4 cells, was approved back in 2003. The injectable drug is indicated for use (in combination with other drugs) for the treatment of HIV in patients who have already tried anti-retroviral triple therapy which did not halt virus replication. The companies were seeking approval from the FDA to market the products together.

The Biojector 2000 device, which is manufactured by Bioject Medical Technologies, has been cleared by the FDA to deliver injections of liquid medicine under the skin and into muscle.

Both Roche and Trimeris have said they reached the decision to withdraw the application after a comprehensive assessment of the clinical programme, as well delays to US regulatory approval caused by the FDA request to generate more data.

Total net sales of Fuzeon for H1 FY07 were USD 126.3m, an increase of 12 per cent from USD 112.7m in H1 FY06. Net sales in the US and Canada for H1 FY07 were USD 62.2m, up six per cent from USD 58.5m in H1 FY06.

Sales have been disappointing as neuropathic pain and haematoma warnings caused by Biojector have been included on Fuzeon's label. Roche collected the data in two major studies of the device. The second study failed to show positive data. The device was also not designed for personal use and is expensive to manufacture and sell.

Roche's vice-president Michelle Zupancic said in a written statement: "While the device has shown potential benefit for some patients, we don't believe it's the ideal alternative delivery option for all treatment-experienced patients. We continue to review other options for administering Fuzeon."

SEC documents filed by Trimeris revealed that while the new Biojector device did reduce pain in many patients, its potential to create adverse effects led the FDA to seek more information before it would approve use with Fuzeon.

Biojector 2000 is manufactured by US-based Bioject Medical Technologies. The company's shares traded above USD 16 in 2000, but closed at USD 1.41 on 3 October 2007.

30th September 2008

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