Page 8 - Norgine Annual Report 2017
P. 8


                                                                                                                                   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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