UCB inches toward the FDA with its latest epilepsy contender I FierceBiotech
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`UCB inches toward the FDA with its latest
`epilepsy contender
`
`by Damian Garde I Jul 23, 2014 9:34am
`
`f
`
`in
`
`A new epilepsy treatment from Belgian drugmaker UCB helped reduce the
`rate of seizures in a Phase III trial, the company said, setting the stage for an
`FDA application and a shot at widening its footprint in the field.
`
`In a 12-week study, UCB's brivaracetam beat out placebo in cutting back
`partial-onset seizure frequency and improving response rates among 768
`patients whose disease isn't fully controlled despite taking one or two
`antiepileptic drugs (AED5). The treatment hit statistical significance on both
`measures, according to the company, although it is saving detailed data for a
`later medical congress.
`
`The positive results cap an 8-year, 3,000-patient clinical program for
`brivaracetam, and UCB now has the data to fuel global regulatory
`applications, the company said, planning to file with the FDA and the
`European Medicines Agency early next year.
`
`"Today's positive results with brivaracetam represent a significant milestone in
`our strategy to deliver new treatment options for people with severe
`diseases," incoming UCB CEO Jean-Christophe Tellier said in a statement. "...
`We are proud to provide AED options for the epilepsy community today, and
`remain committed to addressing the unmet needs of adult patients who
`continue to experience uncontrolled seizures."
`
`If approved, brivaracetam would be UCB's third marketed treatment in the
`company's banner epilepsy franchise. Keppra, UCB's top-selling drug, is on
`the decline after coming off patent in 2011, and sales fell another 15% to €712
`million ($959 million) last year. Vimpat, approved as an adjunctive therapy in
`
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`ARGENTUM Exhibit 1075
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`UCB inches toward the FDA with its latest epilepsy contender I FierceBiotech (cid:9)
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`10/8/16, 12:53 PM
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`About the Author
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`2008, is on the upswing, growing 23% in 2013 to bring in €411 million ($553
`million). UCB is working through a late-stage effort to get that drug OK'd for
`pediatric patients and as a monotherapy for adults.
`
`Tellier, poised to take over for longtime chief Roch Doliveux next year, is
`plotting to wean UCB off of its dependence on central nervous system
`treatments and build up a new franchise of biologics for immunology. Building
`off the success of Cimzia, a monoclonal antibody for arthritis and inflammatory
`bowel diseases, UCB is developing candidates for lupus, osteoporosis and
`other immunological diseases.
`
`- read the statement
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`UCB inches toward the FDA with its latest epilepsy contender I FierceBiotech
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