Paladin Labs Announces the Canadian Launch of Veregen®
MONTREAL, CANADA—July 16, 2014 - Paladin Labs Inc., a subsidiary of Endo International plc (Nasdaq: ENDP) (TSX: ENL) and a leading Canadian specialty pharmaceutical company, today announced the launch of Veregen® (sinecatechins) Ointment, 10%, a topical treatment for external genital and perianal warts (condylomata acuminata) in immunocompetent patients aged 18 years and over.
Clinically visible warts are present in approximately 1% of sexually active adults, making genital warts the most common sexually transmitted infection¹. Studies have demonstrated that for individuals with external genital warts, the reduction in their quality of life is of similar magnitude to that seen in people with moderate to severe asthma or osteoarthritis².
"We are pleased to announce the launch of Veregen® in Canada," said Mark Beaudet, President of Paladin Labs Inc. "Sexually transmitted infections (STIs) such as external genital warts can cause tremendous psychological stress³. Canadians who suffer from external genital warts now have a new, non-invasive and effective topical treatment option with a demonstrated tolerability profile.”
Paladin obtained the exclusive rights to market Veregen® in Canada from Medigene AG in May 2014.
About Veregen: Veregen® (sinecatechins) Ointment 10% is a topical treatment for external genital and perianal warts (condylomata acuminata) in immunocompetent patients aged 18 years and over. It is available in a 15g tube. The drug substance in Veregen® is sinecatechins, which is a partially purified fraction of the water extract of green tea leaves from Camellia sinensis (L.) O Kuntze and is a mixture of catechins and other green tea components. The most common side effects with Veregen® Ointment are local skin and application site reactions, but these should decrease over time⁴.
Sinecatechins 10% & 15% Ointment (Veregen®) has been included in the 2012 European Guideline for the Management of Anogenital Warts. In addition, in its current treatment guidelines for sexually transmitted diseases, the US Center for Disease Control and Prevention recommends Sinecatechins 15% Ointment (Veregen®) as a possible option for treating genital warts.
About Paladin Labs Inc.: Paladin Labs Inc., headquartered in Montreal, Canada, is a specialty pharmaceutical company focused on acquiring or in-licensing innovative pharmaceutical products for Canadian and select emerging markets. Paladin has a focused marketing and sales organization that has helped it evolve into one of Canada’s leading specialty pharmaceutical companies. Paladin is an operating company of Endo International plc, a global specialty healthcare company focused on improving patients’ lives while creating shareholder value. Learn more at www.endo.com.
1. Society of Obstetricians and Gynaecologists of Canada. Canadian consensus guidelines on human papillomavirus. J Obstet Gynaecol Can 2007;29(8 Suppl 3):S1-56.
2. F. Marra, G. Ogilivie, L. Colley, E. Kliewer, C.A. Marra. Epidemiology and costs associated with genital warts in Canada. Sex Transfm Infect 2009;85:111 – 115.
3. G. Mortenson, H. Larsen. The quality of life of patients with genital warts: a qualitative study. BMC Public Health 2010, 10:113.
4. Veregen® Product Monograph. Triton Pharma Inc., August 27, 2013.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and Canadian securities legislation. Statements including words such as “believes,” “expects,” “anticipates,” “intends,” “estimates,” “plan,” “will,” “may,” “look forward,” “intend,” “guidance,” “future” or similar expressions are forward-looking statements. Because these statements reflect Endo's current views, expectations and beliefs concerning future events, these forward-looking statements involve risks and uncertainties. Although Endo believe that these forward-looking statements and information are based upon reasonable assumptions and expectations, readers should not place undue reliance on them, or any other forward-looking statements or information in this news release. Investors should note that many factors, as more fully described in the documents filed by Endo and Endo Health Solutions Inc. (“EHSI”) with securities regulators in the United States and Canada including under the caption “Risk Factors” in EHSI’s Form 10-K, and Endo’s Form 10-Q and Form 8-K filings, as applicable, with the Securities and Exchange Commission and by Endo with securities regulators in Canada on the System for Electronic Document Analysis and Retrieval (“SEDAR”) and as otherwise enumerated herein or therein, could affect Endo's future financial results and could cause Endo's actual results to differ materially from those expressed in forward-looking statements contained in EHSI’s Annual Report on Form 10-K. The forward-looking statements in this press release are qualified by these risk factors. These are factors that, individually or in the aggregate, could cause Endo's actual results to differ materially from expected and historical results. Endo does not assume any obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise, except as may be required under applicable securities law.
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