![]() ![]() Our total sales have grown from €69.9 million (US$78.0 million) for the year ended December 31, 2014 to €88.6 million (US$98.9 million) for the year ended December 31, 2015 and from €43.0 million (US$48.0 million) for the six months ended June 30, 2015 to €54.6 million (US$60.9 million) for the six months ended June 30, 2016. We also manufacture and commercialize our broad portfolio of six diagnostic products, including Gluscan, for a number of clinical indications. The combination of NETSPOT and our product candidate SomaKit-TOC, which we refer to as our Somakit products, are agents which we believe will help improve diagnosis and staging of NET patients. ![]() In August 2016, NETSPOT was administered to its first patient in the United States. ![]() In June 2016, we gained approval from the FDA for NETSPOT™ (formerly known as Somakit-TATE), a novel, patent-pending, sterile and easy-to-use kit designed to diagnose the presence of somatostatin-receptor-positive NETs, which we believe will serve to further diversify our leadership position in the accurate diagnosis and treatment of NETs. In addition to our radiolabeled pharmaceuticals portfolio, we have also built a leadership position in nuclear medicine diagnostics in Europe. We are also developing additional radiopharmaceutical therapeutics and diagnostics and are planning clinical studies to evaluate their efficacy and safety. We also submitted a marketing authorization application, or MAA, to the European Medicines Agency, or EMA, for Lutathera for the same indications in April 2016. We have been assigned a Prescription Drug User Fee Act, or PDUFA, target action date of December 28, 2016. Food and Drug Administration, or FDA, in April 2016 for the treatment of gastroenteropancreatic NETs, including foregut, midgut, and hindgut NETs in adults. Following successful completion of pivotal clinical trials of Lutathera, we submitted a new drug application, or NDA, to the U.S. There are currently no approved radiotherapeutic products for the treatment of NETs and current therapeutic treatment alternatives are limited to symptom management. and European census data, we estimate that the overall incidence of NETs for the combined populations of the United States and the European Union was approximately 47,300 in 2013. Somatostatin is overexpressed in approximately 80% of NETs. Lutathera is designed to target somatostatin receptor positive NETs. ®, is a novel compound in development for the treatment of neuroendocrine tumors, or NETs, a heterogeneous group of tumors arising from cells of the endocrine and nervous systems. Our business, financial condition, results of operations and prospects may have changed since the date on the front cover of this prospectus. You should assume that the information appearing in this prospectus is accurate only as of the date on the front cover of this prospectus, regardless of the time of delivery of this prospectus or any sale of the ADSs. This offering is being made in the United States and elsewhere solely on the basis of the information contained in this prospectus. Neither we nor the underwriters are making an offer to sell the ADSs in any jurisdiction where the offer or sale is not permitted. We and the underwriters have not authorized any other person to provide you with different or additional information. We take no responsibility for, and can provide no assurance as to the reliability of, any other information that others may give you. We have not authorized anyone to provide any information other than that contained in this prospectus or in any free writing prospectus prepared by or on behalf of us or to which we may have referred you. ![]()
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