Letter to EMEA on the question of Biojector2000®

Patients taking Fuzeon® often face considerable difficulties due to its administration. Fuzeon® requires two subcutaneous injections per day, and injection-site reactions (ISRs) occur in almost all patients.

They can reduce the ability of HIV patients to cope with Fuzeon® injections and cause prejudice to patients whose viral load can rapidly grow without an optimal adherence, which in turn can lead to therapeutic failure.

Roche and Trimeris are well aware that ISRs caused by Fuzeon® are a major issue. Hence they decided to initiate – relatively soon after Fuzeon® received marketing authorisation – the development of a needle-free device to deliver Fuzeon®: the Biojector 2000®. Unfortunately, Roche and Trimeris recently decided to stop the co-development of Biojector 2000® with Fuzeon®.

We believe that the business decision made by Roche and Trimeris is life-threatening for some HIV patients facing very severe difficulties and therapeutic failure. Whilst we understand that a pharmaceutical company cannot be forced to develop a new method of administration for a drug, we do believe that the company has a moral obligation to do so when some patients’ lives are endangered in the short or longer term.

Thus, based on the available data, we consider this decision by Roche and Trimeris to be unacceptable.

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