) announced that the U.S. Food and Drug Administration (FDA)
awarded orphan drug designation to gevokizumab for the treatment
of pyoderma gangrenosum (PG).
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We note that XOMA's gevokizumab already has orphan drug
designation in the U.S. for three other indications:
non-infectious, intermediate, posterior or pan uveitis, chronic
non-infectious anterior uveitis and Behçet's uveitis.
Orphan drug designation is granted to novel drugs or biologics
targeting rare diseases or conditions that affect less than 0.2
million patients in the U.S. Under this status, the company
developing the orphan drug enjoys a seven-year period of
marketing exclusivity in the U.S., receives assistance on studies
conducted on the drug and tax credits on costs related to such
studies, can apply for annual grant funding and is exempted from
paying fees under the Prescription Drug User Fee Act (PDUFA).
We remind investors that XOMA has a license and collaboration
agreement with Servier to jointly develop and commercialize
gevokizumab for multiple indications.
In Oct 2013, XOMA had said that it is looking to start a phase
III pivotal study on gevokizumab for inflammatory PG. XOMA will
discuss the requirements with the FDA for advancing gevokizumab
into the phase III study in this indication.
Meanwhile, gevokizumab is currently in a phase III program
(EYEGUARD). While the EYEGUARD-A study is being conducted to
evaluate gevokizumab for the treatment of non-infectious uveitis
(NIU), EYEGUARD-B is evaluating gevokizumab's ability to prevent
disease flares in patients with Behçet's uveitis. Another study,
EYEGUARD-C is being conducted to evaluate gevokizumab for the
prevention of disease flares in NIU patients who are controlled
with steroids and immunosuppressants.
XOMA holds a Zacks Rank #3 (Hold). Some better ranked stocks in
the biopharmaceutical sector include
Alexion Pharmaceuticals, Inc.
Biogen Idec Inc.
Acceleron Pharma, Inc.
). While Alexion and Biogen carry a Zacks Rank #1 (Strong Buy),
Acceleron holds a Zacks Rank #2 (Buy).