WINNIPEG, March 12, 2018 /CNW/ - Waverley Pharma Inc.
("Waverley Pharma" or the "Company") (TSXV:WAVE), an emerging
Canadian pharmaceutical company, is pleased to announce that its
wholly-owned Irish Subsidiary – Waverley Pharma Europe Limited, has
submitted a Marketing Authorization application through the
European Union's De-Centralized Procedure for an
anti-cancer generic drug. The product was in-licensed and
developed under a collaboration between Waverley Pharma
International Inc. (a wholly owned Barbados subsidiary of Waverley Pharma Inc.)
and Reliance Life Sciences Private Limited ("RLS"). The Marketing
Authorization filing is part of an exclusive product supply
and development agreement executed on August
30, 2017, under which Waverley Pharma holds all commercial
rights in the United States,
Canada and the European Union
(excluding the United Kingdom,
where Waverley Pharma has non-exclusive rights). Regulatory filings
in additional jurisdictions are expected to take place in Q2
2018.
About Reliance Life Sciences
Reliance Life Sciences (RLS) is part of the Promoter Group of
Reliance Industries Limited. RLS was established to develop
business opportunities in medical biotechnology with key
initiatives in biopharmaceuticals, pharmaceuticals, regenerative
medicine, clinical research and molecular diagnostics. The Reliance
Group is India's largest private
sector enterprise, with annual revenues of US$ 66.8 billion. The Group's flagship company,
Reliance Industries Limited is India's largest private sector company and a
Fortune Global 500 company. RLS is a fully-integrated life sciences
industry player with in-house capabilities in research,
pre-clinical and clinical development, process development,
commercial-scale manufacturing and marketing. For further
information on Reliance Life Sciences please visit
http://www.rellife.com/index.html
About Waverley Pharma
Waverley Pharma is an emerging pharmaceutical company focused on
the development and commercialization of safe, effective and
affordable cancer therapeutics in the EU and North American market.
The Company has two lead products that have entered the market
authorization filing stage, and is currently evaluating a number of
injectable products in different stages of development. Waverley
Pharma is committed to providing patients with affordable
prescription medicines that lower healthcare costs and provide a
better quality of life. For more information on Waverley Pharma
please visit www.waverleypharma.com.
Neither the TSX Venture Exchange nor its Regulation Services
Provider (as that term is defined in policies of the TSX Venture
Exchange) accepts responsibility for the adequacy or accuracy of
this release.
Forward Looking Information: Statements contained in this
press release that are not statements of historical fact,
including, without limitation, statements containing the words
"believes", "may", "plans", "will", "estimates", "continues",
"anticipates", "intends", "expects" and similar expressions, may
constitute "forward-looking information" within the meaning of
applicable Canadian and U.S. federal securities laws (such
forward-looking information and forward-looking statements are
hereinafter collectively referred to as "forward-looking
statements"). Forward-looking statements, include expected
submission dates and timelines of future regulatory filings,
estimates, analysis and opinions of management of the Company made
in light of its experience and its perception of trends, current
conditions and expected developments, as well as other factors
which the Company believes to be relevant and reasonable in the
circumstances. Inherent in forward-looking statements are known and
unknown risks, uncertainties and other factors beyond the Company's
ability to predict or control that may cause the actual results,
events or developments to be materially different from any future
results, events or developments expressed or implied by such
forward-looking statements, and as such, readers are cautioned not
to place undue reliance on forward-looking statements. Such risk
factors include, among others, the Company's future product
revenues, stage of development, additional capital requirements,
risks associated with the completion and timing of regulatory
filings and obtaining regulatory approval to market the Company's
products, the ability to protect its intellectual property,
dependence upon collaborative partners, changes in government
regulation or regulatory approval processes, and rapid
technological change in the industry. Such statements are based on
a number of assumptions which may prove to be incorrect, including,
but not limited to, assumptions about: general business and
economic conditions; the impact of changes in Canadian-US dollar
and other foreign exchange rates on the Company's revenues, costs
and results; the timing of the receipt of regulatory and
governmental approvals for the Company's research and development
projects; the availability of financing for the Company's
commercial operations and/or research and development projects, or
the availability of financing on reasonable terms; results of
current and future clinical trials; the uncertainties associated
with the acceptance and demand for new products and market
competition. The foregoing list of important factors and
assumptions is not exhaustive. The Company undertakes no obligation
to update publicly or otherwise revise any forward-looking
statements or the foregoing list of factors, other than as may be
required by applicable legislation. Additional discussion regarding
the risks and uncertainties relating to the Company and its
business can be found in the Company's other filings with the
applicable Canadian securities regulatory authorities.
SOURCE Waverley Pharma Inc.