Cipher Expands Dermatology Franchise
August 07 2012 - 8:00AM
PR Newswire (Canada)
- 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.,
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 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 Forward-Looking Statements Statements
made in this news release, other than those concerning historical
financial information, may be forward-looking and therefore subject
to various risks and uncertainties. The words "may", "will",
"could", "should", "would", "suspect", "outlook", "believe",
"plan", "anticipate", "estimate", "expect", "intend", "forecast",
"objective", "hope" and "continue" (or the negative thereof), and
words and expressions of similar import, are intended to identify
forward-looking statements. Certain material factors or assumptions
are applied in making forward-looking statements and actual results
may differ materially from those expressed or implied in such
statements. Factors that could cause results to vary include
those identified in the Company's Annual Information Form and other
filings with Canadian securities regulatory authorities. These
factors include, but are not limited to losses; the applicability
of patents and proprietary technology; possible patent litigation;
approval of products in the 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;
dependence on contract research organizations; third party
reimbursement; the success of the Company's strategic investments;
the achievement of development goals and time frames; the
possibility of shareholder dilution; market price volatility of
securities; and the existence of significant shareholders. All
forward-looking statements presented herein should be considered in
conjunction with such filings. Except as required by Canadian
securities laws, the Company does not undertake to update any
forward-looking statements; such statements speak only as of the
date made. Cipher Pharmaceuticals Inc. CONTACT: Craig
ArmitageInvestor RelationsThe Equicom Group(416) 815-0700 ext
278(416) 815-0080 faxcarmitage@equicomgroup.comLarry
AndrewsPresident and CEOCipher Pharmaceuticals(905) 602-5840 ext
324(905) 602-0628 faxlandrews@cipherpharma.com
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