) has several late stage candidates including romosozumab in
osteoporosis in post-menopausal women, brivaracetam as adjunctive
therapy for the treatment of partial onset seizures in adults
with epilepsy, and epratuzumab in systemic lupus erythematosus
Vimpat (marketed product) as monotherapy was submitted as part
of the supplemental New Drug Application (sNDA) with the U.S.
Food and Drug Administration (FDA), which was accepted in Oct
2013. Vimpat is also being studied for monotherapy in the EU.
Vimpat is also under a phase III study for adjunctive epilepsy in
children. The initial results will be out in 2017.
Recently, UCB announced that it will return global rights to
tozadenant (SYN115) to Biotie Therapies Corp.
Tozadenant is an orally administered, selective inhibitor of
the adenosine 2a receptor, which is being developed for the
treatment of Parkinson's disease.
The decision to return the rights emerged from the company's
assessment of its early and late stage pipeline and also its
preclinical opportunities. However, it does not in any way
reflect concerns regarding the safety or efficacy of tozadenant.
As a result of this decision, UCB will write-off a non-recurring,
one-time item of intangible assets and costs amounting to roughly
We note that in Feb 2013, UCB had in-licensed exclusive global
rights to tozadenant for Parkinson's disease from Biotie
Therapies. UCB and Biotie had initially announced their
collaboration in 2010. UCB's decision to in-license the candidate
was based on encouraging results from a phase IIb study that
evaluated tozadenant as an adjunctive therapy in levodopa-treated
Parkinson's disease patients. The phase III program was to be
conducted by Biotie in return for milestone payments from
As earlier planned, the end-of-phase II meeting with the U.S.
Food and Drug Administration (FDA) will take place in the first
half of 2014. The phase III study is scheduled to start in 2015.
UCB will continue working with Biotie to make the candidate ready
for phase III development.
UCB carries a Zacks Rank #4 (Sell). Considering UCB's
priorities, it was a good decision from the company.
Investors looking for better-ranked stocks in the biopharma
sector may consider companies like
Questcor Pharmaceuticals, Inc.
), all of which carry a Zacks Rank #1 (Strong Buy).
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