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 now being marketed in the U.S. and set for a Canadian launch in early 2012, we have multiple product revenue streams contributing to our performance for the first time,” CEO Larry Andrews said in Cipher’s third quarter report.
“Our balance sheet remains strong, and we believe the combination of increasing product revenues and future milestone payments from our marketing partners’ positions us well for future growth,” he added. At the end of the quarter, Cipher had $9.2 million of cash and no debt.
He said Cipher continues to actively pursue additional product candidates and advance out-licensing discussions for its current products in other territories.
In the third quarter, Cipher’s U.S. marketing partner, Vertical Pharmaceuticals, launched its extended-release tramadol, CIP-tramadol ER, under the name ConZip. The company also completed a Canadian distribution and supply agreement for the tramadol product with Medical Futures to be launched in the first quarter of 2012 under the name Durela.