/R E P E A T -- Cipher Pharmaceuticals announces FDA approval of CIP-ISOTRETINOIN/
Product to be launched as Absorica™
Toronto Stock Exchange Symbol: DND
MISSISSAUGA, ON, May 27, 2012 /PRNewswire/ - Cipher Pharmaceuticals Inc. (TSX: DND; OTC: CPHMF.PK) announced today that the U.S. Food and Drug Administration (FDA) has approved Absorica™, Cipher's novel, patented brand formulation of the acne medication isotretinoin, for the treatment of severe recalcitrant nodular acne. Absorica is expected to be launched in the U.S. in Q4 2012.
"Approval of Absorica represents our third FDA approval and most important milestone to date, reflecting the great work by our Scientific Affairs team at Cipher and our partner, Galephar Pharmaceutical Research," said Larry Andrews, President and CEO of Cipher. "We look forward to working closely with our partner, Ranbaxy Laboratories Inc., in preparation for the upcoming U.S. launch of the product through its dermatology sales force."
"We are thrilled to make Absorica available as a valuable option for the dermatologist and patients who need treatment for severe recalcitrant nodular acne. Absorica is a critical milestone in our commitment to serve the dermatology community and will be the flagship brand for Ranbaxy's specialized dermatology sales force," said Venkat Krishnan, Senior Vice President and Regional Director, Americas.
As a result of the FDA approval of Absorica, Cipher will receive a US$9.0 million milestone from Ranbaxy, approximately US$4.5 million of which will be shared with Galephar. This milestone will be reflected in Cipher's cash balance at the end of Q2 2012. Going forward, Cipher will also receive royalties on net U.S. sales and is eligible for future milestone payments based on sales targets. Under the agreement with Ranbaxy, Cipher is responsible for product supply and manufacturing.
About Cipher Pharmaceuticals Inc.
Cipher Pharmaceuticals (TSX: DND; OTC: CPHMF.PK) 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 Ranbaxy Laboratories Inc.
Ranbaxy Laboratories Inc. (RLI) is a U.S. based wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL). RLI is focused on the promotion of branded prescription products in the U.S. RLI has been expanding and growing on the strength of Ranbaxy's R&D efforts, and continuing exploration of novel drug delivery systems (NDDS), licensing activities, mergers and acquisitions. RLI is expanding the visibility and presence of the Ranbaxy name by bringing value-added brand products to the market. For more information, please visit www. ranbaxyusa.com.
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.
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