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.
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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.
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