Page 9 - Norgine Annual Report 2017
P. 9


            In May, Norgine launched ZIVEREL  in Austria, Belgium, Luxembourg
            and Switzerland, building on the previous launches in Spain, Australia
            and New Zealand. ZIVEREL  is designed to protect and repair
            oesophageal mucosa, offering relief from the symptoms of gastro-

 In March, Norgine entered into an agreement with Noventure S.L. to   oesophageal reflux.
 distribute GELSECTAN  in Spain, Portugal and Andorra. GELSECTAN  is
 a Class IIa marked medical device used as a treatment for irritable bowel
 syndrome (IBS).

            In June, Norgine launched LYMPHOSEEK  in Denmark, the
            Netherlands and the UK. LYMPHOSEEK  was launched in Italy in
            September. LYMPHOSEEK  has been specifically designed to target,
 In November, Norgine announced it had expanded its partnership with   bind to and be retained in sentinel lymph nodes, the first lymph node
 Apharm s.r.l. by entering into an exclusive distribution deal for ZIVEREL    (or group of nodes) to which cancer cells are most likely to spread from
 PLUS, a line extension of ZIVEREL .   a primary tumour.

            In June, Norgine announced that the US Food and Drugs administration
            (FDA) had accepted the New Drug Application (NDA) for its novel
            1 litre bowel preparation, PLENVU  (NER1006). In October, Norgine
            announced that the UK Medicines and Healthcare Regulatory Agency
            (MHRA) granted marketing authorisation for PLENVU  (NER1006)
            for bowel cleansing in adults prior to any procedure requiring a clean
            bowel. The approval was granted under the European Medicines
            Agency decentralised procedure, with the UK as the reference state.
            PLENVU  was subsequently approved for use in Austria, Australia,
            Belgium, Denmark, Finland, France, Iceland, Ireland, Italy, Portugal
            and The Netherlands. PLENVU  was made available in the UK in
            November 2017. PLENVU  is known as PLEINVUE in Austria and
            the Netherlands.


                                In 2017, Norgine continued to operate and meet the strict regulatory requirements which govern
                                the pharmaceutical sector. Norgine seeks to always remain compliant with relevant laws,
                                regulations and the Norgine Business Code. All Norgine employees are expected to conduct
                                their duties according to the highest ethical and professional business standards.

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