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Politrate(Leuprorelin)
2015-01-30 16:09:15 来源: 作者: 【 】 浏览:643次 评论:0
PharmaMar Signs Licence Agreement with GP Pharm to market Politrate ® in Italy for Treating Prostate Cancer
Source Press Release
Company Grupo Zeltia, GP Pharm, Sigma-Tau Group
Tags Oncology, Licensing
Date July 01, 2014
Madrid, 1 July 2014 : Grupo Zeltia announced today that Pharma Mar, S.R.L., an Italian subsidiary of Pharma Mar, S.A., has signed a licence agreement with  GP Pharm under which Pharma Mar S.R.L. will distribute  GP Pharm's drug Politrate ® (Leuprorelin) in Italy. Politrate ®—marketed in other countries under the Lutrate® brand—has been approved by 23 countries of the European Union for the treatment of prostate cancer, and a reimbursement price has also been approved.
The agreement designates Pharma Mar S.R.L. as the sole distributor of Politrate ® in Italy; the product will be supplied to Pharma Mar S.R.L. by GP Pharm. PharmaMar plans to begin distributing Politrate ® in Italy in October. Initially the one-month dosage will be distributed, with plans to subsequently add the threemonth dose.
The agreement is synergic with PharmaMar's commercial activities in other EU countries and is part of the company's strategy of enhancing its sales network by adding other products to its portfolio. The agreement covers distribution of Politrate ® but not manufacture, which will be entrusted to GP Pharm. Accordingly, the agreement does not entail additional investment by PharmaMar and it will use its existing infrastructure in Italy to distribute the drug.
About prostate cancer
Prostate cancer is the second most frequent cancer in men, after lung cancer. About 1.1 million men were diagnosed with this disease in 2012 (Globocan) and it accounts for 15% of all male tumours.
Nevertheless, there are significant differences between more and less developed countries: whereas in developing countries it is the sixth-most preva lent cancer, after lung, stomach, liver, oesophagus and colon cancer, its preva lence has increased very rapidly in developed countries in the last decade with the result that, in many countries, it is the most frequent type of cancer among men, far ahead of lung cancer (mainly in North America, Australia and Northern Europe). However, it has one of the lowest mortality rates (307,000 deaths in 2012, ranking fifth as cause of death) because of early diagnosis and progress with therapy. This is the case in Italy, where over 44,000 cases are diagnosed annually and it represents 23% of tumours in men. Most cases are diagnosed between the ages of 60 and 80, peaking between 70 and 75, although there is a significant number of cases after the age of 50. It can be classified generally as a tumour of old age.
About GP Pharm
GP Pharm is a biopharmaceutical company located in Barcelona (Spain). Its activities are  focused on research, development, production and marketing of injectable products in the fields of Urology and Oncology, some of them based on proprietary drug delivery systems, including microspheres and liposomes. The company handles end-to-end development of the drugs, from clinical research to market. The drugs are marketed under the company's own brands or under licence.
About Politrate®/Lutrate®
Lutrate® (leuprolide acetate 3.75  mg) is an agonist of luteinizing-hormone-releasing hormone (LHRH), a class of drugs that reduce the secretion of testosterone (a sex hormone).  Lutrate® 1 month has been approved in 23 countries of the European Union, including Spain, Germany, the United Kingdom and Italy. It is expected to be available shortly in the United States (the registration dossier for Lutrate® Depot 1 and 3 months is expected to be submitted in the US in the second half of 2014) and many other countries. The registration dossier for Lutrate® Depot 3 months was submitted (DCP with Spain as the reference country) in April 2014.  GP Pharm is currently developing  Lutrate® Depot 6 months.
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