WPD Pharmaceuticals’ Annamycin Drug Received FDA Approval of Fast Track Designation
February 05 2020 - 3:05AM
WPD Pharmaceuticals Inc. (CSE: WBIO) (FSE: 8SV1) (the
“
Company” or “
WPD”), a clinical
stage pharmaceutical company, is pleased to provide an update on
its Annamycin Drug. Through its development partner, Moleculin
Biotech, Inc. (Nasdaq: MBRX) (“
Moleculin”),
Annamycin received approval from the U.S. Food and Drug
Administration ("
FDA") for Fast Track Designation.
Annamycin is currently being studied for the treatment of relapsed
or refractory acute myeloid leukemia
("
AML").
A drug that receives Fast Track Designation is
eligible for some or all of the following:
- More frequent meetings with FDA to discuss the drug's
development plan and ensure collection of appropriate data needed
to support drug approval
- More frequent written communication from FDA about such things
as the design of the proposed clinical trials and use of
biomarkers
- Eligibility for Accelerated Approval and Priority Review,
if relevant criteria are met
- Rolling Review, which means that a drug company can submit
completed sections of its New Drug Application (NDA) for review by
FDA, rather than waiting until every section of the NDA is
completed before the entire application can be reviewed. NDA review
usually does not begin until the drug company has submitted the
entire application to the FDA
Mariusz Olejniczak, WPD’s CEO
commented, "A Fast Track Designation is important for the
development of Annamycin as it is not only eligible for accelerated
approval and priority review, but it also serves as an important
validation of the significant unmet need that we are collectively
trying to address with our partners at Moleculin. We strongly
believe that Annamycin could become an important treatment for a
range of tumors and that ongoing AML studies are an important
milestone for both companies.”
About WPD Pharmaceuticals
WPD is a biotechnology research and development
company with a focus on oncology, namely research and development
of medicinal products involving biological compounds and small
molecules. WPD has 10 novel drug candidates with 4 that are
in clinical development stage. These drug candidates were
researched at institutions including MD Anderson Cancer Center,
Mayo Clinic and Emory University, and WPD currently has ongoing
collaborations with Wake Forest University and leading hospitals
and academic centers in Poland.
WPD has entered into license agreements with
Wake Forest University Health Sciences and sublicense agreements
with Moleculin Biotech, Inc. and CNS Pharmaceuticals, Inc.,
respectively, each of which grant WPD an exclusive, royalty-bearing
sublicense to certain technologies of the licensor. Such agreements
provide WPD with certain research, development, manufacturing and
sales rights, among other things.
On Behalf of the Board
‘Mariusz Olejniczak’
Mariusz OlejniczakCEO, WDP Pharmaceuticals
Contact:
Investor RelationsEmail: investors@wpdpharmaceuticals.comTel:
604-428-7050Web: www.wpdpharmaceuticals.com
Cautionary Statements:
Investors are cautioned that, except as disclosed in the
Company’s CSE listing statement, prepared in accordance with the
policies of the CSE, any information released or received with
respect to the transaction may not be accurate or complete and
should not be relied upon. Trading in the securities of the Company
should be considered highly speculative.
Neither the Canadian Securities Exchange nor the
Investment Industry Regulatory Organization of Canada accepts
responsibility for the adequacy or accuracy of this release.
This press release contains forward-looking
statements. Forward-looking statements are statements that
contemplate activities, events or developments that the Company
anticipates will or may occur in the future. Forward-looking
statements in this press release include the ability of Annamycin
to demonstrate safety and efficacy or to receive accelerated
approval. These forward-looking statements reflect the
Company’s current expectations based on information currently
available to management and are subject to a number of risks and
uncertainties that may cause outcomes to differ materially from
those projected. Factors which may prevent the
forward-looking statement from being realized is that competitors
or others may successfully challenge a granted patent and the
patent could be rendered void. Readers should refer to the risk
disclosure included from time-to-time in the documents the Company
files on SEDAR, available at www.sedar.com. Although the
Company believes that the assumptions inherent in these
forward-looking statements are reasonable, they are not guarantees
of future performance and, accordingly, they should not be relied
upon and there can be no assurance that any of them will prove to
be accurate. Finally, these forward-looking statements are
made as of the date of this press release and the Company assumes
no obligation to update them except as required by applicable
law.
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