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Ferrer pulls EU application for Egrifta in HIV patients with excess tissue

Comes after EMA committee was unable to determine positive benefit to risk balance on current data

Ferrer Internacional has withdrawn its application to market Egrifta (tesamorelin) in the EU for the treatment of patients with HIV who have a build-up of fat around their internal organs.

The European Medicines Agency (EMA) said the Spanish pharma company decided to pull its application after the regulator's advisory committee was unable to determine whether the drug had a positive benefit to risk balance based on available data.

The application, which was originally submitted to the EMA in May 2011, was for the drug's use in patients with visceral adipose tissue (VAT) levels greater than 130cm2.

Excess VAT, or lipodystrophy, is a known complication of HIV infection and has been linked to some antiretroviral drugs.

It can cause a patient's abdomen to protrude excessively, and there is concern it can lead to other problems, such as cardiovascular disease, type 2 diabetes and other obesity-related conditions.

Egrifta became the first drug available in the US to treat the condition in November, 2010, when it gained approval from the Food and Drug Administration (FDA).

It is marketed in the country by EMD Serono, an affiliate of Germany's Merck KGaA, who bought regional rights to the drug from its original developers Theratechnologies in a deal potentially worth up to $215m.

EMD Serono also has an option to participate in future indications in the US, with Theratechnologies maintaining the right to co-promote Egrifta in its additional uses.

The drug's US approval was based on placebo-controlled studies that demonstrated patients with HIV and excess abdominal fat treated with Egrifta experienced greater reductions in abdominal fat as measured by CT scan than were experienced by patients given a placebo injection.

The reasons why Ferrer failed in Europe where EMD succeeded in the US should become clearer next when when more information will be made avaialble after the next meeting of the EMA's Committee for Medicinal Products for Human Use (CHMP).

28th June 2012

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