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 report that it has enrolled more than 700 patients in its 800-patient Phase 3 trial for its CIP-ISOTRETINOIN drug. The 18-month trial in the U.S. and Canada is “progressing well” and Cipher expects to complete enrolment towards the end of the third quarter.
During the second quarter, monthly prescriptions of Cipher’s Lipofen drug showed steady growth, as marketing partner Kowa Pharmaceuticals America increased coverage of primary care physicians in its targeted regions and expanded its sales force.
Cipher posted a profit of $743,000 or 3 cents a share in the second quarter, compared with a year earlier loss of $784,000 or 3 cents. Revenue jumped to $2.2 million from $678,000. For the first half, profit was $231,000 or 1 cent a share on revenue of $3.1 million, compared with a loss of $1.6 million or 6 cents on revenue of $1.3 million.