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Hab vorhin ein paar von meinen Labopharm aktien verkauft und in Cipher Pharma reingesteckt . Produkte von Cipher : 1. Cip-Fenofibrate in Kanada und USA zugelassen seit knapp 15 monaten auf dem Markt erhältlich 2. Cip-Tramadol die Zulassung in USA ist schon seit ein paar Tagen fällig kann also jeden Tag kommen .War auch der grund für meinen einstieg . 3. Cip Isotretinoin hat schon 2 approvable letter bekommen muss noch eine Phase III Studie dürchführen dann sollte auch hier die Zulassung erfolgen . Alles in allem kriegt man die Aktie so gut wie Geschenkt . Cipher Pharma (DND.TO) Marketcap: 11 million C$ Cash: 10,3 million C$ Price: 0,46 C$ Präsentation Sep 2008 http://cipherpharma.com/downloads/DND_September_2008.pdf Pipeline http://cipherpharma.com/web/main.cfm?docID=11 Insider http://canadianinsider.com/coReport/allTransactions.php?tick… Q3 2008 results Summary --------------- - Entered into a definitive development, distribution and supply agreement with Ranbaxy Pharmaceuticals Inc. ("Ranbaxy") for CIP-ISOTRETINOIN in the United States. - Recorded licensing revenue of $672,000. - Achieved net income of $0.2 million for the quarter. - Solid balance sheet with cash of $10.3 million and no debt at quarter end; during Q3 2008, cash increased by $0.4 million. - Subsequent to quarter end, strengthened management team with the appointment of John MacInnis as Vice President, Portfolio Development and Licensing. "The third quarter was highlighted by the out-licensing agreement for CIP-ISOTRETINOIN with Ranbaxy, which we believe is an excellent partner for the product," said Larry Andrews, President and CEO of Cipher. "With their financial support, we are moving forward with the pivotal Phase III safety study, with enrolment expected to begin in early Q1 2009. The third quarter also saw continued growth in Lipofen(R) prescriptions under Kowa, resulting in steadily increasing royalty revenue, which contributed to positive net income during the quarter. With more than $10 million in cash, no debt and limited spending required for our current products, we are in a solid financial position from which to build our pipeline and expand distribution of our current products in selected markets." Product Update -------------- In July 2007, Cipher entered into a licensing and distribution agreement with ProEthic Pharmaceuticals under which ProEthic was granted the exclusive right to market, sell and distribute Lipofen(R) (Fenofibrate) in the United States. In Q3 2008, ProEthic was acquired by Kowa Company, Ltd. and changed its name to Kowa Pharmaceuticals America, Inc. ("Kowa"). During Q3 2008, weekly prescriptions continued to show steady growth, and Cipher expects this trend to continue as Kowa increases penetration of the primary care physicians in its targeted regions and expands its sales force. In Q2 2007, Cipher received a second approvable letter from the FDA pertaining to its CIP-ISOTRETINOIN NDA. In the letter, the FDA indicated that Cipher's application is approvable subject to the resolution of two remaining issues. In addition to one question related to chemistry, manufacturing and controls, which the Company responded to, the FDA requested that Cipher provide additional clinical safety data. The Company appealed the position taken by the FDA in its approvable letter using the formal dispute resolution process. After subsequent discussions, the representative from the FDA agreed with the Division of Dermatology and Dental Product's original view that a Phase III safety study was needed to further demonstrate the safety of CIP-ISOTRETINOIN. During Q3 2008, Cipher and its advisors met with the Division regarding the appropriate design of a safety trial. The Company expects to finalize the study protocol shortly under a Special Protocol Assessment ("SPA") and plans to begin trial enrolment in early Q1 2009. Subsequent to quarter end, another important milestone was reached with notice that the United States Patent and Trademark Office issued a patent for CIP-ISOTRETINOIN. During the third quarter, the Company entered into a definitive development, distribution and supply agreement with Ranbaxy Pharmaceuticals Inc. ("Ranbaxy"), a wholly owned subsidiary of Ranbaxy Laboratories Limited, under which Cipher has granted Ranbaxy the exclusive right to market, sell and distribute CIP-ISOTRETINOIN in the United States. Under the terms of the agreement with Ranbaxy, Cipher received an initial upfront milestone payment of US$1 million. The agreement includes additional pre- and post-commercialization milestone payments of up to US$23 million, contingent upon the achievement of certain milestone targets. Once the product is successfully commercialized, Cipher will also receive a royalty in the mid-teens on net sales. In addition, Ranbaxy will reimburse Cipher for all costs associated with any remaining clinical studies required to obtain FDA approval, up to a predetermined cap. Any additional development costs associated with initial FDA approval will be shared equally. After product-related expenses are deducted, approximately 50% of all milestone and royalty payments received by Cipher under the agreement will be paid to Galephar. In May 2007, Cipher received an approvable letter from the FDA pertaining to its NDA for CIP-TRAMADOL ER, the Company's extended-release formulation of tramadol. In December 2007, Cipher announced that it had appealed the position taken by the FDA using the FDA's formal dispute resolution process. In the written response, the Acting Director of the Office of Drug Evaluation II, Center for Drug Evaluation and Research supported the original approvable action. During Q2 2008, Cipher submitted a revised NDA to the FDA, which the Company concluded was the most expeditious path to final regulatory approval. Cipher's revised NDA includes data from additional pharmacokinetic studies conducted by the Company comparing CIP-TRAMADOL ER to Ultram(R) ER. The revised NDA was accepted for review in Q2 2008, and the Company originally expected the review to be completed by mid-October 2008. Subsequent to quarter end, Cipher was informed that additional time will be required for the FDA to complete its review of the NDA as the FDA has indicated that it plans to inspect the facilities of the Company's manufacturer and packager in Puerto Rico. No other outstanding issues have been identified. It is possible that the submission could trigger patent infringement litigation and a stay of up to 30 months under the Hatch-Waxman Act. Out-licensing discussions with potential commercial partners are ongoing |
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| aus der Diskussion: | Labopharm ....Nur geschenkt ist noch billiger |
| Autor (Datum des Eintrages): | StaatsKnecht (22.12.08 22:29:21) |
| Beitrag: | 51 von 324 (ID:36255549) |
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