) gevokizumab recently received Orphan Drug Designation from the US
Food & Drug Administration (FDA) for treating non-infectious
intermediate, posterior, or pan-uveitis, or chronic non-infectious
uveitis (NIU). Notably, Orphan Drug Designation is granted to those
candidates that aim to treat rare diseases with unmet medical
Gevokizumab is an IL-1 beta modulating antibody. In June this
year, the company initiated patient enrollment in two clinical
trials to evaluate gevokizumab for treating interleukin-1
beta-mediated inflammatory diseases.
The first study (phase III) is evaluating the candidate's
potential in reducing the symptoms like vitreous haze in patients
suffering from non-infectious uveitis (NIU) involving the
intermediate and/or posterior segment of the eye. The primary
endpoint of the randomized, double-masked, placebo-controlled study
is the proportion of patients showing reduction in vitreous haze
score on day 56 following gevokizumab treatment.
The other study (phase II) is evaluating the potential of the
candidate to improve symptoms of pain, physical function and other
abnormalities in patients suffering from erosive osteoarthritis of
We note that, in January 2011, XOMA entered into a partnership
with Les Laboratoires Servier to develop and commercialize
gevokizumab. As per the agreement, XOMA received around $35 million
in upfront payment and can get up to $470 million in milestone
payments and tiered royalties. Moreover, XOMA retained development
and commercialization rights for NIU and other inflammatory and
oncology indications in the US and Japan.
Earlier this month, XOMA and its partner, Servier, entered into
a manufacturing agreement with Boehringer Ingelheim. The companies
joined forces to utilize XOMA's technology and process for the
commercial manufacturing of gevokizumab. Per the agreement,
Boehringer Ingelheim will be manufacturing gevokizumab in Biberach,
Germany, for XOMA. It was also discussed that XOMA and Servier will
be retaining their development and commercialization agreement for
Currently, we have a Neutral long-term stance on XOMA. The
company carries a Zacks #3 Rank (Hold rating) in the short run.
XOMA CORP (XOMA): Free Stock Analysis Report
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