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 tramadol cleared by Health Canada

Cipher Pharmaceuticals (TSX:DND) has received Health Canada approval for its CIP-Tramadol ER, an extended-release treatment of moderate to moderately severe chronic pain in adults. “This represents the second regulatory approval for our extended-release tramadol and another important milestone for the company,” CEO Larry Andrews said in a statement. “We believe our product’s unique attributes, including [...]

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 gets U.S. patent for tramadol

The U.S. Patent and Trademark Office has issued a patent notice of allowance for Cipher Pharmaceuticals’ (TSX:DND) CIP-Tramadol ER, an extended-release product for the treatment of moderate to moderately severe chronic pain in adults. Cipher said that after the patent is formally issued, it will pursue an FDA Orange Book listing associated with its previously [...]

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 [...]