Allergan Announces Agreement to Acquire Aczone(R) Gel 5% I Business Wire
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`Allergan Announces Agreement to Acquire Aczone® Gel
`5%
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`- - Acquisition Will Address Unmet Medical Need in Acne Therapies and
`Strengthen Allergan's Medical Dermatology Product Portfolio - -
`
`June 09, 2008 07:00 AM Eastern Daylight Time
`
`IRVINE, Calif. -- (BUSINESS WIRE) -- Allergan, Inc. (NYSE:AGN) today announced that its wholly -
`owned subsidiary, Allergan Sales, LLC, has entered into an agreement with QLT USA, Inc., a wholly -
`owned subsidiary of QLT Inc. (NASDAQ:QLTI) (TSX:QLT), to acquire QLT's Aczone® (dapsone) Gel
`5% product, a topical treatment for acne vulgaris.
`
`Aczone® Gel 5% is indicated in the United States and Canada for the treatment of acne vulgaris in
`patients 12 years and older. In two randomized, double -blind, vehicle controlled clinical studies
`involving approximately 3,000 patients, Aczone® Gel 5% achieved a statistically significant reduction in
`the number of acne lesions and a better success rate relative to vehicle use alone on the Global Acne
`Assessment Score, a 5 -point scale designed to assess the severity of facial acne vulgaris ranging
`from no or minimal to significant acne lesions. Aczone® Gel 5% is the only acne treatment harnessing
`dapsone in a topical formulation to provide patients with a convenient and effective therapy.
`
`"Aczone® Gel 5% is the first new chemical entity approved by the FDA for the treatment of acne in
`several years, and represents an important clinical advance in dermatology with a robust safety and
`efficacy profile demonstrated in more than 3,000 patients," said Scott Whitcup, M.D., Allergan's
`Executive Vice President of Research and Development. "We are excited to make Aczone® Gel 5%
`widely available to dermatologists and their patients in North America, underscoring our commitment
`to continue to invest and respond to unmet medical needs in dermatologic therapies and building upon
`our more than 10 years of success with TAZORAC ®."
`
`Allergan expects to launch Aczone® Gel 5% in the fourth quarter of 2008 to dermatologists in the
`United States and Canada.
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`Under the terms of the agreement, Allergan will pay approximately $150 million for all assets relating
`to Aczone® Gel 5% upon closing, which is expected to occur in the third quarter of 2008. Closing of the
`transaction is subject to antitrust clearance under the Hart- Scott- Rodino Act and other customary
`closing conditions. Allergan estimates that Aczone® Gel 5% could reach peak year revenue in excess
`of $75 million. Allergan anticipates the transaction will not be dilutive in 2008. Therefore, Allergan's
`financial guidance provided on May 7, 2008, remains unchanged.
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`AMN1041
`Amneal v. Almirall, LLC
`IPR2019-00207
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`https: / /www.businesswire.com/ news / home / 20080609005407 /en/Allergan- Announces- Agr...
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`10/7/2019
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`Allergan Announces Agreement to Acquire Aczone(R) Gel 5% I Business Wire
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`About Acne
`
`Acne vulgaris, or acne, is a common skin disorder with an estimated 80 percent of all people between
`the ages of 11 and 30 years old experiencing outbreaks at some point.' Acne treatment depends on
`whether a patient has a mild, moderate, or severe form. Fortunately, acne is also one of the most
`treatable skin conditions once a physician and patient find an appropriate product and dosage.
`
`About Aczone® Gel 5%
`
`Aczone ®Gel is an aqueous topical gel formulation containing 5% dapsone developed by QLT, Inc.'s
`wholly -owned subsidiary, QLT USA, Inc., for the treatment of acne vulgaris. Combining dapsone in a
`Solvent Microparticulate gel enables dapsone to be applied topically and safely. Aczone ®Gel 5% was
`originally approved by the U.S. Food and Drug Administration (FDA) in July 2005 and by Health
`Canada in June 2006. On March 17, 2008, and on June 5, 2008, the Aczone ®Gel label was updated
`by the FDA and Health Canada respectively to remove certain restrictive requirements. The most
`common adverse events reported with Aczone ®Gel 5% in controlled clinical trials included
`oiliness /peeling, dryness, and erythema. There were no significant differences in the adverse event
`rates between Aczone ®Gel 5% and vehicle control treated patients.
`
`Forward- Looking Statements
`
`This press release contains "forward- looking statements," including the statements by Dr. Whitcup,
`certain statements regarding the timing of the closing and subsequent product launch, the dilutive
`effect of the transaction and 2008 guidance, and other statements regarding the safety, efficacy and
`market potential of Aczone® Gel 5 %. These statements are based on current expectations of future
`events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize,
`actual results could vary materially from Allergan's expectations and projections. Risks and
`uncertainties include, among other things, general industry, economic and pharmaceutical market
`conditions; technological advances and patents attained by competitors; challenges inherent in the
`research and development and regulatory processes; challenges related to product marketing, such
`as the unpredictability of market acceptance for new pharmaceutical products; inconsistency of
`treatment results among patients; the potential for product failures; potential difficulties in
`manufacturing new products; and governmental laws and regulations affecting domestic and foreign
`operations. Among other risks, the transaction may not close, or close on the schedule anticipated, the
`product may not launch on schedule and we may not achieve the anticipated financial results from our
`acquisition of the product. Allergan expressly disclaims any intent or obligation to update these
`forward- looking statements except as required by law. Additional information concerning these and
`other risk factors can be found in press releases issued by Allergan, as well as Allergan's public
`periodic filings with the Securities and Exchange Commission, including the discussion under the
`heading "Risk Factors" in Allergan's 2007 Form 10 -K and Allergan's Form 10 -Q for the quarter ended
`March 31, 2008. Copies of Allergan's press releases and additional information about Allergan are
`available on the World Wide Web at www.alleroan.com or you can contact the Allergan Investor
`Relations Department by calling 1- 714 -246 -4636>
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`About Allergan, Inc.
`
`Founded in 1950, Allergan, Inc., with headquarters in Irvine, California, is a multi -specialty health care
`company that discovers, develops and commercializes innovative pharmaceuticals, biologics and
`medical devices that enable people to live life to its greatest potential - to see more clearly, move
`more freely, express themselves more fully. The Company employs more than 8,000 people
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`Allergan Announces Agreement to Acquire Aczone(R) Gel 5% I Business Wire
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`worldwide and operates state -of -the -art R &D facilities and world -class manufacturing plants. In
`addition to its discovery-to- development research organization, Allergan has global marketing and
`sales capabilities with a presence in more than 100 countries. For more information, visit Allergan's
`Web site at www.allergan.com.
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`About QLT Inc.
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`QLT Inc. is a global biopharmaceutical company dedicated to the discovery, development and
`commercialization of innovative therapies. QLT's research and development efforts are focused on
`pharmaceutical products in the fields of ophthalmology and dermatology. In addition, QLT utilizes
`three unique technology platforms, photodynamic therapy, Atrigel® and punctal plugs with drugs, to
`create products such as Visudyne® and Eligard® and future product opportunities. For more
`information, visit QLT's Web site at www.altinc.com.
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`QLT Plug Delivery, Inc. is a wholly -owned subsidiary of QLT Inc.
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`Aczone and Atrigel are both registered trademarks of QLT USA, Inc.
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`Visudyne is a registered trademark of Novartis AG.
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`Eligard is a registered trademark of Sanofi- aventis.
`
`National Institute of Arthritis and Musculoskeletal and Skin Diseases. National Institutes of Health.
`What is acne? Fast facts: an easy -to -read series of publications for the public. Available at:
`http: / /www.niams.nih.gov /health info /acne /default.asp #acne d. Accessed November 13, 2007
`
`Contacts
`Allergan Contacts
`Caroline Van Hove, (714) 246-5134,,,
`(media)
`Heather Katt, (714) 246 -6224.
`Jim Hindman, (714) 246 -4636;;.: (investors)
`Joann Bradley, (714) 2464766.;:
`(investors)
`Emil Schultz, (714) 2464474,
`(investors)
`or
`QLT Contacts
`QLT Inc.:
`Vancouver, Canada
`Therese Hayes
`Telephone: (604) 707-7000%
`Fax: (604) 707 -7001:
`or
`The Trout Group:
`New York, USA
`Brandon Lewis
`
`1- 800 -663 -5486
`
`https: // www.businesswire.com /news/home/ 20080609005407 /en/Allergan- Announces- Agr...
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`10/7/2019
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`Telephone: (646) 378 -2915.;
`or
`Marcy Strickler
`Telephone: (646) 378 -2927
`
`