Mega News wie Partner deal und Phase 3 Daten werden bis spätestens ende juni veröffentlicht .
Perfekter einstiegspunkt bevor die Top News kommen .
Mein Kursziel liegt bei 4-6 dollar bis Jahresende .
Upcoming Milestones :
Partnerdeal für Once a day Tramadol in 2Q11
Isotretinoin Phase 3 daten in 2Q11
Canada Zulassung für Tramadol in 3Q11
Tramadol US markteinführung in 3Q11
Cipher Pharma (DND.TO) oder (WKN: A0B85L)
Marktkap: 27 M
Cash: 9.1 M
Shares Out: 24 M
Presentation from late 2010
Product Update 5/12/2011
Lipofen® monthly prescriptions remained steady in Q1 2011 relative to the prior quarter. The product continues to be actively promoted by Cipher's U.S. distribution partner, Kowa.
During Q1 2011, Cipher entered into the final stages of its Phase III safety trial for CIP-ISOTRETINOIN. Subsequent to quarter end, the trial was completed, with more than 900 patients enrolled. Cipher expects to report top-line results in late Q2 2011 and complete its FDA and Health Canada submissions by Q4 2011. The FDA review of this submission under PDUFA is expected to be six months, and the Company is targeting the second half of 2012 for the U.S. commercial launch of the product.
During Q1 2011, the Company continued with pre-commercial activities for CIP-TRAMADOL ER, including the completion of the manufacturing validation batches and out-licensing discussions with potential U.S. distributors. The Company is hopeful of completing out-licensing negotiations in Q2 2011 and is targeting late Q3 2011 for the commercial launch. In addition, Cipher expects a response from Health Canada concerning regulatory approval in Q3 2011.