WINNIPEG, MB, Nov. 12, 2020
/CNW/ - Waverley Pharma Inc. ("Waverley Pharma" or the
"Company") (TSXV: WAVE), an emerging Canadian pharmaceutical
company, is pleased to announce that the Company has obtained
tentative approval of its Abbreviated New Drug Application
(ANDA) for Pemetrexed for Injection, 100 mg and 500 mg (formerly
known as "WAV-101") in the United
States (US). The tentative ANDA approval indicates that the
technical requirements for approval have been met but approval can
not be made effective or marketing begin until the patent on the
reference listed drug has expired, which is projected to occur in
2022.
About Pemetrexed
Pemetrexed is an injectable chemotherapy product used in the
treatment of pleural mesothelioma and non-small cell lung cancer
along with other indications. In addition to obtaining tentative
ANDA approval in the US, the Company has obtained marketing
authorization for this product in numerous European countries and
is in the process of filing for market authorization in additional
countries across Europe.
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 European Union, United Kingdom and North American market. The
Company, through its subsidiary, is currently selling three generic
oncology products in the United
Kingdom, namely capecitabine, temozolomide and erlotinib. In
addition, the Company is developing two generic oncology products
in Europe, namely pemetrexed and
bortezomib and additional products in the
United States. 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 potential patent expiry date of the reference listed
drug and other 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 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.
