- In-license agreement for the Betesil® Patch to treat inflammatory skin conditions -
Toronto Stock Exchange Symbol: DND
MISSISSAUGA, ON, Aug. 7, 2012 /CNW/ - Cipher Pharmaceuticals Inc., (TSX:
DND) (OTC: CPHMF) today announced it has reached agreement with Institut
Biochimique SA ("IBSA"), a privately-owned, global pharmaceutical
company headquartered in Lugano, Switzerland, to obtain exclusive
license and distribution rights in Canada to market the Betesil® Patch, a novel, patent-protected, self-adhesive medicated plaster
containing 0.1% betamethasone valerate, for the treatment of
inflammatory skin conditions such as plaque psoriasis.
"The Betesil® Patch is an innovative new pharmaceutical approach to the treatment of
inflammatory skin conditions. Based on initial feedback from Canadian
dermatologists, the Betesil® Patch is expected to provide distinct advantages over existing
treatment options, particularly for patients that suffer from plaque
psoriasis in hard to treat areas such as knees and elbows," commented
Larry Andrews, President and Chief Executive Officer of Cipher. "This
compelling new product opportunity represents an important step towards
our goal of establishing a commercial presence in Canada in selected
therapeutic areas including dermatology. Betesil® Patch is an excellent strategic fit that complements our existing
dermatology portfolio, which features CIP-Isotretinoin, our novel
formulation of isotretinoin, which is currently under Health Canada
review."
The efficacy and safety of the Betesil® Patch has been established in three successful phase III trials
conducted by IBSA. The product is currently marketed in several
European countries. Cipher intends to initiate the regulatory review
process for the Betesil® Patch in Canada in Q4 of this year.
The financial terms of the agreement include an upfront fee of $100,000
CAD, followed by other regulatory related milestone payments.
Commercial product will be supplied by IBSA.
About the Betesil® Patch
The Betesil® Patch is a patent-protected, 7.5x10 cm self-adhesive patch containing
2.25 mg of betamethasone valerate, a medium-potency corticosteroid that
is widely prescribed for the treatment of inflammatory skin conditions
such as eczema and plaque psoriasis. The Betesil® Patch is applied once-daily to the affected region and may be cut to fit
the particular size and shape of the psoriatic lesion thereby reducing
potential contact of the steroid with healthy areas of skin. The
occlusive format of the Betesil® Patch provides a consistent distribution, delivery and absorption of the
active ingredient and enhances the potency of the corticosteroid. The
patch also helps to moisturize the skin, which accelerates healing and
provides a protective barrier which reduces local trauma to the lesion
due to scratching and prevents transfer of fluids from the lesion onto
clothing. Due to its particular pharmaceutical format, the Betesil® Patch is ideal for the treatment of psoriatic plaques located in
difficult to treat areas such as the knees, elbows and other points of
flexion.
About Psoriasis
Psoriasis is a chronic, autoimmune disease that appears on the skin,
typically occurring in young adulthood and persisting for decades. It
is estimated that approximately 500,000 people in Canada are living
with psoriasis. It occurs when the immune system sends out faulty
signals that speed up the growth cycle of skin cells. The most common
form is plaque psoriasis, which appears as raised, red patches covered
with a silvery-white buildup of dead skin cells. Treatment of
psoriasis involves the application of topical corticosteroids for mild
cases, progressing to combination therapy with systemic
immunomodulators for moderate and severe disease. The goal of treatment
is to relieve the signs and symptoms of the disease by minimizing the
frequency and intensity of the plaques thereby improving the patient's
quality of life.
About Cipher Pharmaceuticals Inc.
Cipher Pharmaceuticals (TSX: DND) (OTC: CPHMF) is a growing specialty
pharmaceutical company that commercializes novel formulations of
successful, currently marketed molecules. Cipher's strategy is to
in-license clearly differentiated products, advance them through the
clinical development and regulatory approval stages, and out-license to
international marketing partners. The Company's first product is a
fenofibrate formulation marketed in the United States as Lipofen®. Cipher's second product, an extended-release tramadol, is marketed in
the United States as ConZip® and is marketed in Canada as Durela™. Cipher's third product, a novel
formulation of the acne treatment isotretinoin, was recently approved
by the FDA and is expected to be launched in Q4 2012 as Absorica™. The
product is also currently being reviewed by Health Canada. For more
information, please visit www.cipherpharma.com.
About IBSA Institut Biochimque SA
IBSA Institut Biochimque SA is a privately owned, pharmaceutical company
headquartered in Lugano, Switzerland. Founded in 1945 by a group of
Swiss biologists, IBSA started its activities at a national level but
rapidly became a consolidated company worldwide. Currently IBSA employs
1,800 people and sells its products covering 7 main therapeutic areas
in 4 continents and more than 70 countries. IBSA's main therapeutic
areas are: Human Reproduction, Rheumatology, Pain & Inflammation,
Respiratory, Endocrinology, Dermatology and Urology.
IBSA manufactures all in-house products under GMP conditions. The
manufacturing capabilities range from oral formulations to high-tech
injectables, with specific focus and specialization in the production
of topical formulations. For more information, please visit: www.ibsa-international.com
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limited to losses; the applicability of patents and proprietary
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Company's pipeline; marketing of products; meeting projected drug
development timelines and goals; product liability and insurance;
dependence on strategic partnerships and licensees; concentration of
the Company's revenue; substantial competition and rapid technological
change in the pharmaceutical industry; the publication of negative
results of clinical trials of the Company's products; the ability to
access capital; the ability to attract and retain key personnel;
changes in government regulation or regulatory approval processes;
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Except as required by Canadian securities laws, the Company does not
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