WINNIPEG, June 27, 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 Barbados subsidiary, Waverley Pharma
International Inc., has submitted abbreviated new drug applications
(ANDAs) with the United States Food and Drug Administration
for two high value anti-cancer generic drugs. The
products were in-licensed and developed under a collaboration
between Waverley Pharma International Inc. and Reliance Life
Sciences Private Limited. The ANDA filings are the result of an
exclusive product supply and development agreement executed on
August 30, 2017, under which Waverley
Pharma holds all commercial rights to the products in the United States, Canada and the European Union (excluding the
United Kingdom, where Waverley
Pharma has non-exclusive rights).
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 effective and affordable
cancer therapeutics in the EU and North American markets. The
Company has recently acquired two generic drugs marketed in the
United Kingdom, Capecitabine and
Temozolomide. Furthermore, Waverley Pharma has filed
for marketing approval in selected countries of the EU and with the
United States FDA for two additional high value generic oncology
drugs and is currently evaluating other 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 the target filing and approval dates of ANDAs and other
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
potential product revenues, stage of development, additional
capital requirements, risks associated with the completion and
timing of clinical trials 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; 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.