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 [...]

Vertical Pharma to distribute Cipher’s tramadol in U.S.

Cipher Pharmaceuticals (TSX:DND) has entered into a distribution and supply agreement with Vertical Pharmaceuticals to market Cipher’s CIP-TRAMADOL ER in the U.S. for the treatment of moderate to moderately severe chronic pain in adults. “Completing a commercial supply agreement for our extended-release tramadol represents another important achievement for our organization and provides an additional revenue [...]

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 [...]

FDA clears Cipher pain pill

The FDA has approved Cipher Pharmaceuticals’ (TSX:DND) CIP-Tramadol ER drug to treat moderate to moderately severe chronic pain in adults. “We believe our product’s unique capsule formulation, comprising an immediate-release tablet and sustained-release beads, combined with having no food effect, will make it an attractive alternative for clinicians and chronic pain sufferers,” CEO Larry Andrews [...]

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 [...]

Cipher revenue jumps; new director added

Cipher Pharmaceuticals (TSX:DND) posted a 59% revenue gain to $1.1-million in the fiscal third quarter ended Sept. 30, driven mainly by continued market penetration of its Lipofen drug. The Mississauga-based company also appointed Dr. William Claypool to its board. Cipher chairman William Garriock said in a statement that Dr. Claypool previously led global clinical development at SmithKline Beecham and has [...]