- 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
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.
SOURCE: Cipher Pharmaceuticals Inc.
For further information:
Craig Armitage
Investor Relations
The Equicom Group
(416) 815-0700 ext 278
(416) 815-0080 fax
[email protected]
Larry Andrews
President and CEO
Cipher Pharmaceuticals
(905) 602-5840 ext 324
(905) 602-0628 fax
[email protected]
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