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UCB-Amgen pull development of drug to heal fractures

But romosozumab remains on course in postmenopausal osteoporosis

UCB Amgen

UCB and Amgen have given up on the use of their investigational drug CDP7851/AMG785 (romosozumab) to accelerate the healing of fractures.

The two companies said the compound will not enter phase III development after under-performing in phase II trials, the results of which will be presented at a future conference, according to UCB.

The Belgium-based pharma company also confirmed that the decision to halt development in this indication was not based on the drug's safety and won't affect romosozumab's development for the separate bone disorder post-menopausal osteoporosis.

“We are very excited about the phase III programme in post-menopausal osteoporosis, which is on-going as planned and should provide first results at the end of 2015,” said Professor Iris Loew-Friedrich, chief medical officer at UCB.

“Safety and other data collected so far indicate the potential for a change of treatment paradigms in postmenopausal osteoporosis,” she added.

Postmenopausal osteoporosis is also known as type 1 osteoporisis, and is a condition that usually occurs in women when oestrogen levels drop, leading to bone loss.

It is a potentially more lucrative market for UCB and Amgen than the acceleration of the healing of fractures, and one the company will hope to capitalise on following that indication's discontinuation.

“At UCB, we strive constantly to allocate our funds and resources to the most promising activities for our pipeline projects to maximise sustainable and superior value for patients and all stakeholders," said UCB's Loew-Friedrich.

Romosozumab is a monoclonal antibody that is developed to work by targeting sclerostin, a protein secreted by bone cells that inhibits bone formation.

Amgen has previously said it expects its R&D costs during 2013 to rise due to continuing trials investigating the drug's use in postmenopausal osteoporosis.

13th February 2013

From: Research

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