Gilead in row with generics manufacturers over HIV drug in Ireland

A major row between global pharmaceutical giants Gilead, Mylan and Actavis over a life-saving HIV drug is about to spill over into the High Court in Dublin.

Gilead Sciences, which manufactures the HIV antiretroviral drug Truvada, is planning injunctive action next week against Mylan and Actavis over alleged plans to sell a cheaper generic version of the drug in Ireland.

Industry sources estimate that generic versions of the drug would be 60 per cent cheaper than Truvada, according to industry sources.

Truvada is used as part of a cocktail of drugs to treat patients with HIV, and also as a treatment immediately after possible exposure to HIV to prevent contraction, known as post-exposure prophylaxis (PEP).

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The Health Service Executive says it pays for Truvada use as a treatment and for PEP, but it did not immediately have a figure available for the cost to taxpayers. Industry sources said about €24 million is spent on Truvada in Ireland for HIV treatment and PEP, with most of this attributable to the HSE.

Prophylaxis

Truvada is also widely used globally as a pill to help prevent the contraction of HIV (pre-exposure prophylaxis – PrEP), and some studies have shown it reduces contraction rates among men who have sex with men by more than 90 per cent.

The HSE does not pay for Truvada’s use for PrEP, but users pay privately at least €400 per month.

The original European patent on Truvada is due to expire this year, but Gilead, the world’s largest manufacturer of HIV drugs, has sought an extension of its protection, which is due before European Court of Justice.

It has now moved to obtain Irish injunctions against Mylan and Actavis over their versions of Truvada. It has hired top corporate law firm McCann Fitzgerald to represent it, and will ask the High Court next week to accept the case on to its fast-track commercial list, which deals with cases involving more than €1 million.

Gilead declined to comment on the details of the case, but confirmed it was over Truvada and its use in Ireland. Medicines for Ireland, a trade group for generics drugs manufacturers, also declined to comment.

The case is sure to attract attention within Ireland’s gay and transgender community, where there is concern over access to affordable drugs for PrEP. More than 500 new cases of HIV were recorded in Ireland last year and contraction rates are increasing.