17.Sep.2009 | The Center for Drug Evaluation and Research of the Food and Drug Administration (CDER/FDA) has agreed in principle to accept our proposed product development plan, which entails the use of an abbreviated registration pathway, formally known as a 505(b)(2) New Drug Application (NDA), in order to obtain CDER/FDA approval of OphthalmoPharma’s Latanoprost CD Ophthalmic Solution product. Alpnach Dorf, Switzerland, September 17, 2009; Ophthalmopharma Ltd (OPPH) is pleased to report that the FDA has confirmed in a pre-IND meeting that an abbreviated registration pathway, the 505(b)(2) NDA, is an acceptable pathway for the registration of Latanoprost CD Ophthalmic Solution. This registration pathway includes a clinical development plan that begins with phase 2 and therefore considerably shortens development time for this product. Latanoprost CD Ophthalmic Solution is in advanced pre-clinical stage of development. This new formulation is based on a proprietary cyclodextrin. The use of this naturally-derived, sugar-based substance imparts significant advantages to this formulation. Preclinical testing has suggested that Latanoprost CD will have better stability, lower side-effects, and better penetration to the eye than the original product (Xalatan®, Pfizer). Furthermore, the Latanoprost CD can be stored at room temperature and presented in a unit-dose, non-preservative-container. OphthalmoPharma (OPPH) is a specialty pharmaceutical company incorporated in Switzerland and dedicated to the development of drugs, nutraceuticals and medical devices used in ophthalmology. OphthalmoPharma acquires or in-licenses projects with high market potential and a limited risk profile, usually at preclinical development stage. It is our strategy to move the projects along the critical development pathway with the objective to add maximum value within a limited time frame. We intend to out-license our products, at an appropriate point in time, to development and marketing partners, i.e., large pharmaceutical companies and ophthalmic specialty firms. We are interested in contact from potential commercialization partners for this and other products in development (www.ophthalmopharma.com). |
3. July 2008 | Motti Geron joins OphthalmoPharma as Global Projects Manager. OphthalmoPharma is pleased to announce that Motti Geron has joined the Company as Projects Manager. His outstanding operational experience will be of particular value to the Company. Motti will be in charge of the projects management and coordination with top management and external partners. Motti Geron has more than 20 years managerial experience in the Biotech and Pharmaceutical industries. He was responsible for successful process development and manufacturing of various Pharmaceutical and Diagnostic products, while serving as Process Development and Cell Culture Manager for Serono, Vice President of Operations for Procognia and Global Project Manager for Novartis. Prior to joining OphthalmoPharma, he has been an independent Project Management and BioProcessing consultant. Mr. Geron holds MSc degree in Applied Microbiology from Hebrew University of Jerusalem. |
17.Mar.2007 | Dr. Christian Suter joins the OphthalmoPharma as senior project manager and strategic advisor to the board of directors.
The Company has hired Dr. Christian Suter, an experienced pharmaceutical executive with extensive international experience, as senior project manager and strategic advisor. He will support OPPH to strengthen further its value creation efforts.
Christian Suter is Senior Partner in suterscience LLC, a consulting firm focused on life sciences. He has 30 years experience in the life sciences industries. He was a pharma researcher at Roche, directed Vitamins Research, was head of manufacturing of Roche Pharmaceuticals in the US and Head of Global Vitamins R&D. Christian Suter studied chemistry at Basel University and UC Berkeley; he is an alumnus of the Harvard Business School Advanced Management Program. | |
