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UCB targets regulatory filing for its osteoporosis drug in 2016

Published on 03/03/16 at 10:49am
UCB chief executive, Jean-Christophe Tellier, revealed drug met primary endpoints in Phase III trials

Belgian drug company UCB says it is looking at a regulatory filing for its trial drug romosozumab to treat osteoporosis in postmenopausal women. The company recently announced late-stage trials for the drug candidate met the primary end point and is looking at announcing further data in September.

Romosozumab is a trial stage bone-forming monoclonal antibody and is not approved by any regulatory authority for the treatment of osteoporosis. It is designed to work by inhibiting the protein sclerostin, and has a dual effect on bone, both increasing bone formation and decreasing bone breakdown. The company said this process is effectively the opposite of osteoporosis.

The drug is being studied for its potential to reduce the risk of fractures in an extensive global Phase III program.

Romosozumab is a product that really “illustrates our initiative in the UK,” chief executive Jean-Christophe Tellier told the reporters at a media briefing in London, adding, “we build bones faster than anyone else.”

Frame study

The data from the Frame study showed the drug candidate met the co-primary endpoints by reducing the incidence of new vertebral fracture through months 12 and 24 in postmenopausal women with osteoporosis treated with romosozumab. The study also met the secondary endpoint of reducing the incidence of clinical fractures (composite of vertebral and non-vertebral fractures) in postmenopausal women with osteoporosis through 12 months.

Sean Harper, executive vice president of research and development at Amgen, commented: "A vertebral fracture due to osteoporosis can be a life-altering event, and the risk of these kinds of fractures will be a growing burden as our society ages. These data show that romosozumab reduced new vertebral fracture risk as soon as 12 months."

Results from the Frame study showed that women receiving monthly subcutaneous injections of romosozumab experienced a statistically significant 73% reduction in the relative risk of a vertebral (spine) fracture through 12 months compared to those receiving placebo.

"Deeper understanding of the results will help us to sharpen the profile of romosozumab in postmenopausal women with osteoporosis," Iris Loew-Friedrich, chief medical officer at UCB, said in a statement.

Regulatory filing/ launch plans

The company plans for a regulatory filing for later this year, Mr Tellier revealed, saying the company was looking at a “relatively early launch” for the product, adding that UCB plans to push the drug as first-line treatment.   

The company will start the product launch with the US markets going on to Japan. The European region launch for romosozumab is scheduled for the second round, after the product is rolled out in the US markets.

Refraining from commenting on the pricing range for the drug, Mr Tellier said: “We look at pricing as a component of value created.”

UCB partners with US biotech firm Amgen for all development and marketing of the drug. We have a 50-50 market global partnership with Amgen,” Mr. Tellier said, adding “We’ll be doing all of it [development, marketing] jointly with them.

The company is looking at announcing further data on the drug following the Bridge study in September.

The UCB-Amgen drug will be competing with Eli Lilly’s Forteo (teriparatide) and Radius Health’s abaloparatide.

Financial forecast

Last week, the company reported full-year results ahead of estimates and said it sees further growth for numbers in FY 2016.

UCB said it expects 2016 revenue between €4.0 and €4.1 billion, recurring core profit (EBITDA) of €0.97 to €1.01 billion and core earnings per share of €2.90 to €3.20.

For the full year 2015, core profit rose 35% to €821 million. Combined sales for its three key drugs are estimated at €3.1 billion.

Anjali Shukla

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