Health Canada accepts Cipher acne filing for review

Health Canada has accepted for review a New Drug Submission by Cipher Pharmaceuticals (TSX: DND) for its CIP-Isotretinoin, a novel, patented formulation of the acne medication isotretinoin. The company expects a response from Health Canada in the first quarter of 2013. “Health Canada’s acceptance moves us a step closer to the commercialization of CIP-Isotretinoin in [...]

Zacks starts Cipher at outperform

Zacks Investment Research has initiated coverage of Cipher Pharmaceuticals (TSX:DND) with an “outperform” rating and 12-month price target of $2.25. The stock closed at 64 cents on Wednesday. “Based on our model, the stock is currently trading below the net present value of the cash flows from Lipofen and ConZip /Durela, plus the cash on [...]

Cipher gets complete response for amended NDA

Cipher Pharmaceuticals’ (TSX:DND) amendment to its New Drug Application for CIP-Isotretinoin, a novel, patented formulation of the acne medication isotretinoin, has been accepted by the FDA as a complete, class 2 response. The FDA’s goal date under the Prescription Drug User Fee Act (PDUFA) is May 29, 2012. Cipher will receive a $1 million milestone [...]

Cipher amends NDA for CIP-Isotretinoin acne drug

Cipher Pharmaceuticals (TSX:DND) has submitted an amendment to its pending new drug application to the FDA for CIP-Isotretinoin, its novel, patented formulation of the acne medication isotretinoin. Cipher’s NDA amendment provides additional clinical information requested by the FDA in support of obtaining approval to market CIP-Isotretinoin for the treatment of severe, nodular acne. Subject to [...]

Cipher readies regulatory filings for acne product

Cipher Pharmaceuticals (TSX:DND) is on track to file Health Canada and FDA submissions this quarter for its high-potential acne product, CIP-Isotretinoin, which is expected to trigger a $1 million milestone payment from its U.S. partner. The FDA review under PDUFA is expected to be six months. “With Lipofen generating steady revenue and our tramadol product [...]

Cipher’s isotretinoin yields positive trial results

Cipher Pharmaceuticals (TSX:DND) has reported top-line safety and efficacy results from the Phase 3 safety study of its CIP-ISOTRETINOIN treatment for severe, nodular acne. From a safety perspective, the top-line data was positive showing no overall statistical differences in the adverse event profile, comparing  CIP-ISOTRETINOIN to a commercially available isotretinoin product in the 925-patient study. The [...]

Cipher completes CIP-Isotretinoin enrolment

Cipher Pharmaceuticals (TSX:DND) has completed patient enrolment in a Phase 3 safety study of its CIP-Isotretinoin treatment of severe, nodular acne. A total of 931 patients were enrolled in the trial, of which 626 have completed treatment to date. Following an estimated six-month treatment period, the last subject enrolled should complete treatment in April, 2011, [...]

Cipher readying tramadol launch in first quarter 2011

Cipher Pharmaceuticals (TSX: DND) is “working diligently” to finalize a marketing partnership and is finalizing commercial manufacturing requirements for its extended-release tramadol drug, which was cleared by the FDA in the second quarter, as it prepares for a commercial launch expected in the first quarter of 2011. The company also disclosed in its second quarter [...]

Cipher plans to license-in new drug this year

For much of its six years as a separate company, Cipher Pharmaceuticals (TSX:DND) has been known for driving its three drugs toward the finish line.  That could change in 2010. “We ramped up our in-house resources last year to look at adding pipeline opportunities, and we’ve looked at over 100 to this stage,” CEO Larry Andrews [...]