Q BioMed's Uttroside-B Receives U.S. FDA Orphan Drug Designation in the Treatment of Liver Cancer

NEW YORK, Jan. 27, 2021 /PRNewswire/ -- Q BioMed Inc. (OTCQB: QBIO), announced today that the U.S. Food and Drug Administration's Office of Orphan Products Development has granted Orphan Drug Designation to Uttroside-B, a small molecule chemotherapeutic for the treatment of hepatocellular carcinoma (HCC), the most common form of liver cancer. In preclinical studies, Uttroside-B was up to 10-times more potent against HCC cells than Sorafinib, the standard of care drug at the time.

As an Orphan Drug, Uttroside-B may benefit from a seven-year market exclusively following marketing approval, grant funding for clinical trials that contribute to marketing approval, protocol assistance, and tax credits. Preclinical testing is now underway to support an FDA Investigational New Drug (IND) application expected this year.  

Q BioMed has the exclusive rights to the technology through an agreement with the Rajiv Gandhi Centre for Biotechnology, an autonomous Institute under the Department of Biotechnology, Government of India and the Oklahoma Medical Research Foundation.

"Orphan Drug Designation gives our Uttroside-B program a substantial boost, and we expect it will significantly accelerate development and reduce costs. We are pleased that the FDA recognizes the urgent need for effective treatments for HCC, and that the agency sees the potential of Uttroside-B to address this difficult to treat cancer," stated Q BioMed CEO Denis Corin.

With very limited approved first-line pharmaceutical therapies for HCC available today, challenges include drug resistance, adverse side effects, and high costs. An estimated 700,000 people are diagnosed with HCC each year, with the global market for liver cancer drugs expected to grow to $3.9 billion by 2027.

About Q BioMed Inc.

Q BioMed Inc. is a biotech acceleration and commercial stage company focused on licensing and acquiring undervalued biomedical assets in the healthcare sector. Q BioMed is dedicated to providing these target assets the strategic resources, developmental support, and expansion capital needed to ensure they meet their developmental potential, enabling them to provide products to patients in need‏.

Please visit http://www.QBioMed.com and sign up for regular updates.

Forward-Looking Statements:

This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs and any other statements that are not historical facts. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated are: risks related to our growth strategy; risks relating to the results of research and development activities; our ability to obtain, perform under, and maintain financing and strategic agreements and relationships; uncertainties relating to preclinical and clinical testing; our dependence on third-party suppliers; our ability to attract, integrate, and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions, or circumstances on which any such statement is based, except as required by law.

Q BioMed Media Contact:

Denis Corin
CEO

Investor Relations:
Keith Pinder
+1(404) 995-6671
[email protected]

SOURCE Q BioMed Inc.

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