) recently announced that the U.S. Food and Drug Administration
(FDA) has granted orphan drug designation to its candidate OMS721
for the prevention of complement-mediated thrombotic
OMS721's orphan drug designation will not only accelerate its
development but will also benefit Omeros in various stages of
drug development, including faster approval process, seven years
of market exclusivity following marketing approval and tax
credits on U.S. clinical trials.
Shares of Omeros were up 18% on the news. Meanwhile, a phase I
study on OMS721 is underway to assess the safety and
pharmacokinetics of the candidate.
We note that Omeros announced positive data from the phase I
trial on OMS721 in Nov 2013. The data showed that a subcutaneous
administration of OMS721 achieved a high degree of lectin pathway
inhibition. The data also showed that the drug was well tolerated
and no adverse events were observed.
Omeros expects to report additional data from the phase I
study in early 2014. Omeros also plans to initiate enrolment for
a phase II study in the first quarter of 2014 to evaluate OMS721
for the prevention of complement-mediated TMAs.
We are encouraged by the pipeline progress at Omeros. Omeros
is looking to get its candidate, Omidria (OMS302), approved in
the U.S. and EU for the treatment of patients undergoing
intraocular lens replacement (ILR) surgery in 2014. Omidria
is Omeros' proprietary pharmacosurgery product.
Omeros will also initiate a phase II study on its other
pipeline candidate, OMS824, for the indication of Huntington's
disease. The company also expects to report phase II data on
OMS824, evaluated for the treatment of schizophrenia.
Omeros currently carries a Zacks Rank #3 (Hold). Stocks
that currently look attractive include
Vanda Pharmaceuticals Inc
). While Actelion and Vanda Pharma carry a Zacks Rank #1 (Strong
Buy), Affymetrix is a Zacks Rank #2 (Buy) stock.
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