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Merck stops osteoporosis trial early on positive results

Marketing applications for odanacatib expected in early 2013

Merck & Co has halted a phase III trial of its candidate osteoporosis drug odanacatib early after seeing "robust efficacy and a favourable benefit-risk profile" in an interim analysis and will now begin marketing applications in the first half of 2013.

Odanacatib (formerly MK-0822) is an inhibitor of cathepsin K (cat-K), an enzyme thought to play a central role in the breakdown of the organic matrix of bone.  The drug reduces bone resorption but unlike other therapies for osteoporosis does not affect the viability of the cells involved in maintaining bone structure.

The 16,000-patient study looked at the safety and efficacy of odanacatib in reducing fracture risk in post-menopausal women with osteoporosis who were receiving vitamin D and calcium treatment, and has been ongoing since 2007.

It had been due to continue until 237 of the enrolled patients suffered a hip fracture, with an interim analysis triggered when 70 per cent of that tally had been reached.

One issue still to be addressed in the study is that the Data Monitoring Committee (DMC), which took the decision to stop ahead of schedule, has indicated that safety issues remain "in certain areas", according to Merck.

As a result, the company is following up on a previously-announced plan to carry out a blinded extension trial that will allow these issues to be monitored further.

Merck is leading the pack among pharma companies developing cat-K inhibitors for osteoporosis, with filings scheduled in the US, Japan and Europe next year, but the class as a whole has suffered a number of setbacks.

Other companies that have tried to develop such treatments include Novartis, whose balicatib (AAE581) had reached phase II testing but was discontinued on safety issues, with Ono Pharmaceuticals' also electing to drop its own candidate ONO-5334 last year blaming competitiveness and marketing conditions in the osteoporosis sector.

Odanacatib is claimed to offer greater selectivity for cathepsin K which limits its tendency to cause side effects.

The challenge for Merck is to position odanacatib, if approved, against a new generation of fast-growing therapies, notably Amgen/GlaxoSmithKline's Prolia/Xgeva (denosumab), which has been tipped to reach multibillion dollar sales at peak, and Eli Lilly's parathyroid hormone-based Forteo (teriparatide), which had sales of almost $1bn last year.

"We are encouraged by the DMC's recommendation to close the trial early … and look forward to reviewing the data with the scientific community to bring forward this innovation," commented Peter Kim, president of Merck Research Laboratories.

12th July 2012

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