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Safety concerns bring Ipsen haemophilia trial to halt

Development partner Inspiration Biopharmaceuticals begins investigation after high levels of antibodies found in patients taking IB1001

US regulators have told Ipsen to suspend two late-stage clinical trials of its investigational treatment for haemophilia after safety concerns were raised.

Biopharma company Ipsen said that the Food and Drug Administration (FDA) had notified its development partner Inspiration Biopharmaceuticals that both phase III trials of IB1001 had to be put on hold after patients taking the drug were found to be more likely to develop certain antibodies.

These antibodies target the Chinese hamster ovary (CHO) protein contained in the bleeding disorder treatment, with Ipsen reporting a “higher than expected rate of anti-CHO antibody development in people treated with IB1001” that could potentially cause side effects in patients.

Inspiration is currently leading an investigation into the matter, although no adverse events related to the development of such antibodies have been reported in the 86 people who have received IB1001 in clinical studies to date.

In addition, Ipsen said: “[N]o evidence suggests a change in the current overall clinical benefit and risk profile of IB1001.”

Of the two studies, one was evaluating the safety and efficacy of IB1001 to treat and prevent bleeding episodes in adults with haemophilia B, while the other was evaluating the drug in children with the condition.

Haemophilia B is a genetic disorder caused by a deficiency in the enzyme factor IX. It impairs the body's ability to control blood clotting and is estimated to occur in one out of every 30,000 males.

The investigation will delay Ipsen's attempts to launch the drug into a global haemophilia market worth $8bn a year, and concerns about the effect this would have on the company were reflected in Ipsen's shares, which dropped by 12 per cent after the news was released.

Ipsen and Inspiration entered a partnership to develop haemophilia products in January 2010, creating a haemophilia business unit structure in August 2011 that will act as the exclusive sales organisation for all haemophilia products commercialised as part of the agreement.

11th July 2012

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