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GSK ends muscular dystrophy deal

Terminates rare disease collaboration with Prosensa after trial disappointment
GSK GlaxoSmithKline house

GlaxoSmithKline (GSK) has terminated its collaboration with Dutch biopharma company Prosensa to develop a treatment for Duchenne muscular dystrophy (DMD).

GSK said that all rights for investigational antisense drug drisapersen will be transferred back to its original discovers putting an end to the pair's 2009 agreement to develop a treatment for the genetic condition which causes muscle weakness in boys.

The decision comes a few months after GSK posted disappointing phase III data for drisapersen after the drug demonstrated it was unable to significantly improve a patient's walking distance compared to placebo.

This results were especially disappointing considering earlier positive results in phase II trials, which helped GSK secure 'breakthrough' status from the US Food and Drug Administration (FDA), expediting the drug's development and review process.

Dr Carlo Russo, head of R&D for GSK's rare disease business, confirmed the termination of the deal but said the two companies had built up valuable data that would be shared with the scientific community.

“The value of this data to the scientific community's understanding of DMD should not be underestimated,” said Dr Russo.

Prosensa confirmed that it will continue the development of drisapersen as a treatment for DMD in its other trial programmes.

Breakthrough status for GSK's Tafinlar
GSK also announced that the FDA has granted breakthrough status to its personalised lung cancer drug Tafinlar (dabrafenib).

The designation applies to the drug's use in the treatment of patients with metastatic non-small cell lung cancer (NSCLC) who have the BRAF V600E gene mutation.

Tafinlar is already approved for the skin cancer melanoma but has demonstrated effectiveness in other oncology indications.

Article by
Thomas Meek

14th January 2014

From: Research

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