WINNIPEG, MB, Aug. 2, 2023
/CNW/ - Waverley Pharma Inc. ("Waverley Pharma" or the
"Company") (TSXV:WAVE), a Canadian pharmaceutical company,
is announcing a business update.
The business opportunity Waverley Pharma envisioned of expanding
its focus beyond the development of novel oncology drugs, to
marketing recently off patent generic oncology drugs with
significant brand sales, like Bortezomib and Pemetrexed, has not
materialized as planned. The main reason has been the unprecedented
discount in pricing relative to brand that is now occurring in the
generic industry as soon as a brand comes off patent. This price
erosion is a direct result of the significant increase of
aggressive generic companies entering the market early on.
Both Pemetrexed and Bortezomib had over 15 early generic
entrants, as indicated in the Food and Drug Administration
Orange Book Database, and the competition has been fierce, with
prices dropping to as little as 5% of brand. Waverley Pharma
has been awarded a few tenders in the United Kingdom, but the prices are so low that
it is next to impossible to make a profit.
Even the largest generic companies have been surprised and
severely challenged by the extreme price competition that has
recently characterized the generic markets in Europe and the United States. One of the
global leaders in the generics business recently outlined plans to
stay away from products where it expects to face competition from
10 or more companies and to reduce the number of generics it
introduces to the market going forward due to the intense
competitive pressures the generic industry has experienced in
recent years.
Based on the current generic business environment as
outlined above, Waverley Pharma is shifting focus back to the
development of novel drugs, like the existing PARP-1 inhibitor
project, for which an update was provided on January 11, 2023.
As major shareholder, Dr. Albert
Friesen remains fully committed to the success of Waverley
Pharma Inc., demonstrated in no small way, by his commitment to
personally guarantee the $3,000,000
credit facility that was announced in August
2021.
About Waverley Pharma
Waverley Pharma is a pharmaceutical company focused on the
development and commercialization of safe, effective, and
affordable cancer therapeutics in the EU, United Kingdom and North American markets. The
Company, through its subsidiary, is currently selling two generic
oncology products in the United
Kingdom, namely capecitabine and temozolomide. In addition,
the Company has developed two generic oncology products in
the United States and Europe, namely pemetrexed and bortezomib.
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 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.
