Roche discontinue plans for nelfinavir 625mg formulation
Roche has taken the decision not to introduce its Viracept (nelfinavir) 625 mg film-coated tablets.
Recurrent manufacturing difficulties mean that an uninterrupted supply of this formulation could not be guaranteed for all patients. Roche believes that this is the most responsible decision to take and is in the best interests of patients and physicians.
The Viracept 250mg formulation is not affected by any manufacturing difficulties and remains an option in the therapy of HIV.
As a consequence of this decision we will be stopping all ongoing clinical trials. Patients in the UK receiving Roche Viracept 625mg via the Special Licence Scheme (SLS) should be transitioned to an alternative treatment, of which Viracept 250mg could be an option. This transition period of about 6 months (as agreed with the European regulatory body) should allow switching patients to an appropriate treatment without causing unnecessary inconvenience.
UK clinicians who currently have patients within the Viracept 625mg SLS or clinical trials are being informed of this decision and being asked to inform their patients at their next visit and switch them to an alternative treatment. All patients should have stopped taking Viracept 625mg by May 31st, 2005.
Roche is committed to continuing research, development and partnerships in HIV. We regret having to take this course of action and recognise that it could inconvenience patients and healthcare professionals but unfortunately it was not possible to overcome the problems involved in production.
For further information please contact Dr Cham Herath at Roche on 01707 366 7515 (firstname.lastname@example.org).
This news will be a disappointment to patients who have been waiting for a lower pill count formulation with improved tolerability.
Although Agouron/Pfizer independently developed a different 625 mg formulation for the US market, it was associated with poorer tolerability.
It is unlikely that the US formulation will be marketed in Europe.
Source: PR Statement from Roche