S&P/TSX
09.06.2008 11:00:00
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Allergan Announces Agreement to Acquire Aczone(R) Gel 5%
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.
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.
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.1 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.allergan.com
or you can contact the Allergan Investor Relations Department by calling
1-714-246-4636.
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 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.
About QLT Inc.
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.qltinc.com.
QLT Plug Delivery, Inc. is a wholly-owned subsidiary of QLT Inc. Aczone and Atrigel are both registered trademarks of QLT USA, Inc. Visudyne is a registered trademark of Novartis AG. Eligard is a registered trademark of Sanofi-aventis. 1 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
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