7/29/2016
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`Valeant Pharmaceuticals Announces FDA Approval Of Jublia® for the Treatment of Onychomycosis - Valeant
`
`VALEANT
`
`Valeant Pharmaceuticals Announces FDA Approval
`Of Jublia® for the Treatment of Onychomycosis
`
`June 09, 2014
`
`LAVAL, Quebec, June 9, 2014/PRNewswire/-- Valeant Pharmaceuticals International, Inc.
`(NYSE: VRX) (TSX: VRX) today announced that that its wholly owned subsidiary, Valeant
`Pharmaceuticals North America LLC, received notice that the U.S. Food and Drug
`Administration (FDA) has approved the New Drug Application (NDA) for Jublia® (efinaconazole
`10% topical solution), the first topical triazole approved for the treatment of onychomycosis of
`the toenails.
`
`"We acquired Jublia® through our purchase of Dow Pharmaceutical Sciences in 2008 and
`advanced Jublia® from pre-IND stage through Clinical Phases 1, 2 and 3," said J. Michael
`Pearson, chairman and chief executive officer. "We are working quickly to get this important
`product launched in the U.S. and Canada in the third quarter of 2014. We anticipate favorable
`managed care coverage in the U.S., similar to other branded antifungal agents, with peak sales
`of $300-$800 million in the U.S. alone and we are also working with other regulatory agencies
`around the world on further approvals. This is the fourth product, sourced from our acquisition
`of Dow Pharmaceutical Sciences, for which we have received FDA approval - the other three
`being 1% clindamycin and 5% benzoyl peroxide gel (IDP 111), Acanya® and Retin-A Micro
`(tretinoin) Gel microsphere 0.08%. We have also filed a new treatment for acne, OnextonTM,
`which has a PDUFA date of November 30, 2014. All these compounds came through our Dow
`acquisition, bringing with it the full set of R&D capabilities from preclinical through regulatory."
`
`Onychomycosis is a common and destructive nail infection that is currently undertreated largely
`because of the limitations of available treatments. Currently, over-the-counter or prescription
`topical treatments provide limited efficacy and are often administered in conjunction with
`frequent debridement, or the scraping, cutting or removal of the nail. Prescription oral
`treatments are limited by drug interactions and serious safety concerns.
`
`"Onychomycosis is not only embarrassing and uncomfortable, but can lead to permanent nail
`damage and limited mobility in the general population," said American Podiatric Medical
`Association Executive Director and CEO Glenn B. Gastwirth, DPM. "We welcome the approval of
`Jublia® and encourage people with onychomycosis of the toenails to discuss their condition
`with their podiatrist, or other healthcare professional to find a treatment that’s right for them."
`
`The licensor and business partner for efinaconazole, Kaken Pharmaceutical, has also agreed to
`supply Valeant with the finished dosage form of Jublia for the U.S. market.
`
`http:llir.valeant.com/news-releases/2014/09-06-2014
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`ACRUX DDS PTY LTD. et al.
`EXHIBIT 1003
`IPR Petition for
`U.S. Patent No. 7,214,506
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`7/29/2016
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`Valeant Pharmaceuticals Announces FDA Approval Of Jublia® for the Treatment of Onychomycosis - Valeant
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`Information about Jublia® (efinaconazole 10% topical solution)
`
`Jublia® (efinaconazole 10% topical solution), is the first topical triazole antifungal agent
`developed for distal lateral subungual onychomycosis (DLSO).
`
`Being a solution, Jublia® is applied daily to the nail with a novel bottle that has a built-in flow-
`through brush applicator. It dries quickly and there is no need to remove excess product. There
`are no concerns for systemic side effects such as drug-drug interactions or acute liver injury.
`
`Jublia® has been extensively studied prior to its approval. The two positive pivotal studies that
`were the basis for approval were published last year in the prestigious Journal of the American
`Academy of Dermatology. These international studies were conducted in 1,655 subjects with
`onychomycosis, including subjects in Canada.
`
`For the pivotal studies, the primary endpoint was complete cure at Week 52, which required
`that the target nail show no clinical involvement and no evidence of fungus present by both
`KOH testing and a negative fungal culture. In Study 1, 17.8% of subjects treated with Jublia®
`were completely cured, compared to only 3.3% of subjects treated with vehicle. In Study 2,
`15.2% of subjects treated with Jublia® were completely cured, compared to only 5.5% of
`subjects treated with vehicle.
`
`Adverse events that were reported were generally mild and transient and were similar between
`subjects treated with Jublia® and vehicle. The most commonly reported adverse events in
`patients treated with Jublia® were application site dermatitis and application site vesicles.
`
`About Onychomycosis
`
`Onychomycosis is a common nail infection caused predominantly by dermatophyte fungi that
`typically occurs under the toenail, though fingernails may also be affected. Approximately 35
`million Americans suffer from onychomycosis, most of whom are men between 50 and 70 years
`of age. The fungi that cause onychomycosis live in warm, moist environments, including
`swimming pools and showers, and may invade the skin through tiny cuts or small separations
`between the nail and nail bed.
`
`The condition typically begins as a small white or yellow spot beneath the nail, and causes nail
`discoloration, thickening and/or distortion, pain, detachment of the nail from the nail bed and
`irregular surface changes. Once onychomycosis begins, it can persist indefinitely if not treated
`and may cause permanent nail damage. Currently 85 percent of onychomycosis patients are
`untreated.
`
`[Sou rce:
`http : //www.may~clinic.~rg/diseases-c~nditi~ns/nail-fungus/basics/definiti~n/c~n-2 ~~19 319
`]
`
`About Valeant Pharmaceuticals International, Inc.
`
`Valeant Pharmaceuticals International, Inc. (NYSE/TSX: VRX) is 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 can be found at
`
`http:llir.valeant.com/news-releases/2014/09-06-2014
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`Valeant Pharmaceuticals Announces FDA Approval Of Jublia® for the Treatment of Onychomycosis - Valeant
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`www,valeant,com
`
`Forward-looking Statements
`
`This press release contains forward-looking statements regarding, among other things, that
`Jublia® is a milestone in the treatment of onychomycosis, that Jublia® is an effective treatment
`of onychomycosis and the potential launch of Jublia®. 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 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.
`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, except as required by law.
`
`Contact Information:
`Laurie W. Little
`Valeant Pharmaceuticals International, Inc.
`949-461-6002
`lau rie.little@valeant.com
`
`.~....Valeant Pharmaceuticals International, Inc.
`
`Logo -
`http ://photos.prnewswire.com/prnh/20101025/LA87217LOGO
`
`SOURCE Valeant Pharmaceuticals International, Inc.
`
`http:l/ir.valeant.com/news-releases/2014/09-06-2014
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