Pfizer has received orphan drug designation from the US Food and Drug Administration (FDA) for the autoimmune candidate GL-2045.
FDA has granted status for GL-2045, which is a recombinant intravenous immune globulin (IVIG)-mimetic, to treat chronic inflammatory demyelinating polyneuropathy (CIDP).
CIDP is a rare neurological disorder that is characterised by progressive weakness and impaired sensory function in the legs and arms.
Gliknik CEO David Block said: “This orphan drug designation is important in that it provides numerous incentives to develop GL-2045 to address an unmet need in CIDP, a rare neurological disorder.”
In September 2013, Pfizer signed an exclusive worldwide licencing agreement with Gliknik for GL-2045, a drug candidate designed to replace and improve on pooled human IVIG
Under the deal, Pfizer received an exclusive worldwide licence to GL-2045 for all therapeutic indications, while Gliknik received an upfront payment of $25m and is eligible for development, regulatory and commercial milestone payments
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In addition, Gliknik is eligible to receive tiered, double-digit royalties on net sales of any products that are commercialised pursuant to this licence agreement.
According to Gliknik, GL-2045 showed better results in a wide range of preclinical tests and is being developed as a potential treatment for different autoimmune diseases.
Gliknik also includes clinical compound GL-0817, which is being developed to prevent the recurrence of squamous cell cancer of the oral cavity.