Newly-approved cold sore treatment helps minimize physical symptoms

XERESE™ is now available by prescription in Canada for the treatment of herpes labialis (a.k.a. cold sores)

LAVAL, QC, Oct. 23, 2013 /CNW/ - Valeant Canada today announced Health Canada's recent approval of XERESE™ (acyclovir 5% and hydrocortisone 1%) Topical Cream for the treatment and management of herpes labialis. XERESE works in two ways by helping stop the virus from spreading and targeting the inflammation that leads to the actual cold sore outbreak (the body's visible reaction to the herpes virus).1

Affecting an estimated one in five Canadians annually,2 cold sores are clusters of small blisters that usually appear on the lips, around the mouth (especially the corners), and occasionally inside the nose.3 The pain and stigmas associated with cold sore outbreaks can deeply impact a sufferer's quality of life - often causing embarrassment that can lead to depression, fear of rejection and even isolation.4 The emotional burden for those living with the virus often goes unrecognized.

A recent survey reported that 50 per cent of respondents identified that they have a negative self-image from cold sores, and that living with the virus limits their social lives when affected by a recurrent outbreak.5

"Herpes simplex is a complicated condition that, unfortunately, is highly transferable and affects a large number of individuals," says Christine Janus, Executive Director, Canadian Skin Patient Alliance (CSPA). "We often don't realize the sheer burden of living with such a contagious virus - where many of those affected are too embarrassed or self-conscious to open up. We hope that people with herpes simplex feel encouraged and supported in seeking the advice of their doctor or other healthcare professional, because we've learned that there are effective treatment options that can make a positive difference in their lives."

On average, 20-40 per cent of people living with the herpes simplex virus will suffer from a recurrent outbreak,3 typically two to three per year.2 These individuals largely resort to available over-the-counter options and home remedies. Yet, almost half of cold sore sufferers surveyed outlined that they would prefer a topical prescription to apply at the first signs of the outbreak, such as a tingling and burning sensation.5 Current available options, such as single-agent anti-viral therapies, do not address the inflammatory process that underlies lesion development, but focus primarily on reducing the healing time of a lesion.

"Cold sores undoubtedly have a profound impact on quality of life. As a medical community, we constantly hear of the multitude of ways sufferers try to cope with an outbreak - either to try to hide the physical appearance or speed up recovery," says dermatologist Dr. Gary Sibbald, MD and Professor of Medicine and Public Health, University of Toronto. "The reality is that we want to help people do more than just cover up the problem. With the introduction of Xerese, for instance, patients now have a treatment option that works to help prevent the development of the blister, as well as reduce healing time."1

XERESE is available by prescription. For more information, consult your healthcare practitioner.

XERESE is a newly approved treatment option for managing cold sores, available through a doctor's prescription. XERESE is indicated for the treatment of early signs and symptoms of recurrent herpes labialis (cold sores) to reduce the progression of cold sore episodes to ulcerative lesions in immunocompetent adults and adolescents (12 years of age and older).1

XERESE combines antiviral acyclovir with anti-inflammatory hydrocortisone to provide early cold sore symptom relief.1 Its unique dual mode of action helps stop the virus from replicating and causing an infection, while also reducing inflammation.1 Typically, outbreaks are caused by a reaction to the virus, and not to the virus itself; therefore, it makes sense to decrease inflammation by adding corticosteroids to the antiviral.7

About the PIVOTAL Study
The approval of XERESE was based on the PIVOTAL study. This multicenter, randomized, double-blind, active and placebo-controlled study evaluated XERESE in approximately 2,437 patients with a history of HSL.6It was conducted at 55 sites in the Unites States and Canada from July 2006 to December 2007.6

The primary efficacy endpoint for the PIVOTAL study was the prevention of ulcerative HSL lesions, defined as the frequency of patients with non-ulcerative recurrences. Key secondary efficacy endpoints included "episode duration" (i.e., from study drug initiation "to loss of hard crust" and "skin normalization").6

About Valeant Canada
Valeant Canada is a subsidiary of Valeant Pharmaceuticals International, Inc., a multinational specialty pharmaceutical company that develops manufactures and markets a broad range of pharmaceutical products primarily in the areas of dermatology, eye health, neurology, and branded generics. More information about Valeant Canada can be found at

Forward-Looking Statements
This press release may contain forward-looking statements, including, but not limited to, statements regarding the launch of XERESE™ in Canada, the ability of XERESE to position the Company to meet unmet needs and the prescribing practices of healthcare practitioners. Forward-looking statements may generally be identified by the use of the words "anticipates," "expects," "intends," "plans," "should," "could," "would," "may," "will," "believes," "estimates," "potential," "target," or "continue" and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, the uncertainty associated with the launch of a new product and the risks and uncertainties discussed in the Company's most recent annual or quarterly report and detailed from time to time in Valeant's other filings with the Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. Valeant undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this press release or to reflect actual outcomes.

1 Xerese Canadian Product Monograph. Valeant Canada. March 2013.
2 Kuel, B. Cold Sores - How to Prevent and Treat Them. Accessed  July 2013.
3 Cold Sores Guide. What are Cold Sores? Accessed July 2013
4 Sibbald, G., Andriessen, A. Evaluation on quality of life aspects of early cold sore treatment.
5 Survey: A New Perspective on the Management of Cold Sores. 2013. Sponsored by Valeant Canada.
6 Hull, C.M., et al. Early treatment of cold sores with topical ME-609 decreases the frequency of ulcerative lesions: A randomized, double-blind, placebo-controlled, patient-initiated clinical trial. J Am Acad Dermatol.. Volume 64, Issue 4 , Pages 696.e1-696.e11, April 2011.
7 Tyring, S., Sibbald, G. Managing Cold Sores: A New Perspective. Dermatology Times, March-April 2013.

Managing cold sores: a new perspective

Video with caption: "Video: The fight against cold sores". Video available at:

Image with caption: "Cold sores in Canada (CNW Group/Valeant Canada)". Image available at:

PDF available at:

SOURCE: Valeant Canada

For further information:

Sebastien Beauchamp

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Valeant Canada

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