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 [...]

Alitair builds value without outside investors

Dr. William W. Howard likes to say there’s a lesson to be learned in how closely held Alitair Pharmaceuticals has spent the first couple years of its existence developing a portfolio of respiratory therapeutics and a drug safety technology: make some money first and then go out and get investors. “We’ve been able to develop [...]

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 signs up Canadian distributor for Tramadol

Cipher Pharmaceuticals (TSX:DND) has entered into a distribution and supply agreement with Medical Futures, a closely held Canadian pharmaceutical company, for the marketing of Durela in Canada. Durela is Cipher’s once-daily capsule formulation of tramadol, which has both immediate-release and extended-release components for the treatment of moderate-to-moderately severe chronic pain in adults. “This agreement, coupled [...]

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 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 [...]

Labopharm’s new antidepressant to be ‘game-changer’

It’s game on for Labopharm (TSX:DDS; NASDAQ:DDSS). By February 11, the FDA is expected to approve the company’s antidepressant trazodone, a novel once-daily formulation that addresses many of the shortcomings of similar drugs on the market.  “I think it’s fair to say this drug could be a game-changer for us,” CEO James Howard-Tripp says in [...]