BALTIMORE, Aug. 10, 2015 /PRNewswire/ -- Gliknik Inc.,
a privately held biopharmaceutical company, today announced that
its licensee Pfizer Inc. (NYSE: PFE) has received notification from
the U.S. Food and Drug Administration (FDA) that its autoimmune
candidate drug GL-2045, a recombinant Intravenous Immune Globulin
(IVIG)-mimetic, has been granted orphan drug designation for
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). CIDP is a
rare neurological disorder characterized by progressive
weakness and impaired sensory function in the legs and arms.
GL-2045 received the Orphan Drug designation for CIDP under the
U.S. Orphan Drug Act following a review by the FDA of a package of
data submitted by Pfizer. The FDA Office of Orphan Products
Development grants orphan drug designation to novel drugs or
biologics that treat a disease or condition affecting fewer than
200,000 patients in the U.S.
Gliknik entered into an exclusive licensing agreement with
Pfizer for GL-2045 in September 2013.
David Block, CEO of Gliknik, 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."
Several brands of the pooled human blood product IVIG have
previously received orphan drug designation for CIDP. In contrast,
GL-2045 is a recombinant (not blood derived) drug candidate under
development. GL-2045 may eventually provide patients an alternative
that is at least as effective as IVIG but potentially more
convenient and safer without the risk of blood-borne pathogens.
About Gliknik Inc.
Gliknik is creating new therapies
for patients with immune disorders and cancer. Gliknik's expertise
is in modulation of the immune system to fight disease. The
company's lead clinical compound is GL-0817 for prevention of the
recurrence of squamous cell cancer of the oral cavity. Learn more
at www.gliknik.com.
This press release contains "forward-looking statements"
concerning the development and commercialization of Gliknik
products, the potential benefits and attributes of such products,
and Gliknik's expectations regarding its collaboration with Pfizer.
Forward-looking statements are subject to risks, assumptions and
uncertainties that could cause actual future events or results to
differ materially from such statements. These statements are made
as of the date of this press release. Actual results may vary.
Gliknik undertakes no obligation to update any forward-looking
statements for any reason.
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SOURCE Gliknik Inc.