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Launch of Ipsen/Braintree’s Eziclen/Izinova in Europe expected by end 2013



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Eziclen® / Izinova® a new bowel cleansing preparation, is a sulphate-based formulation (sodium, magnesium and potassium sulphates).

The dose for cleansing the colon will require two administrations of about 0.5 litre / 16 ounces of the product diluted in water, each followed by about 1 litre / 32 ounces, of clear liquids, each.

The drug will be registered under the trade name Eziclen® in the large majority of the concerned EU countries and under the name Izinova® in the other few countries including France & UK

7  feb 2013

French drugmaker Ipsen  and US partner Braintree Laboratories yesterday announced today that Eziclen/Izinova (BLI-800) has successfully completed its European decentralized registration procedure involving 16 countries, paving the way for a launch of the product before the end of 2013.

The product will be indicated in adults for bowel cleansing prior to any procedure requiring a clean bowel (eg, bowel visualization including bowel endoscopy and radiology or surgical procedure). Each European Union member states (France [reference member state], Belgium, Czech Republic, Estonia, Germany, Greece, Italy, Latvia, Lithuania, Luxemburg, the Netherlands, Poland, Portugal, Romania, Spain and UK) should now adopt a national decision within 30 days. In practice, the grant of the national marketing authorization may vary from one to several months, Ipsen noted.

Jean Fabre, senior vice president Intercontinental Operations and Franchise “Primary Care” at Ipsen, stated: “The completion of the decentralized procedure for Eziclen/Izinova (BLI-800) is an important step forward to national marketing authorizations in Europe. The availability of Eziclen/Izinova (BLI-800) will provide physicians and patients with a valuable agent for pre-colonoscopy colonic cleansing, particularly in the screening of colorectal cancer. This decision gives also perspectives for our plant in Dreux where Eziclen/Izinova will be manufactured”.

In 2009, Ipsen acquired the exclusive manufacturing, marketing and distribution rights of Braintree’s proprietary formulation BLI-800. The agreement covers countries within the EU, Commonwealth of Independent States, selected Asian countries (including China) and some North African countries. This product was approved by US Food and Drug Administrtion in 2010 and is marketed as Suprep Bowel Prep Kit.

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DR ANTHONY MELVIN CRASTO, Born in Mumbai in 1964 and graduated from Mumbai University, Completed his Ph.D from ICT, 1991,Matunga, Mumbai, India, in Organic Chemistry, The thesis topic was Synthesis of Novel Pyrethroid Analogues, Currently he is working with GLENMARK PHARMACEUTICALS LTD, Research Centre as Principal Scientist, Process Research (bulk actives) at Mahape, Navi Mumbai, India. Total Industry exp 30 plus yrs, Prior to joining Glenmark, he has worked with major multinationals like Hoechst Marion Roussel, now Sanofi, Searle India Ltd, now RPG lifesciences, etc. He has worked with notable scientists like Dr K Nagarajan, Dr Ralph Stapel, Prof S Seshadri, Dr T.V. Radhakrishnan and Dr B. K. Kulkarni, etc, He did custom synthesis for major multinationals in his career like BASF, Novartis, Sanofi, etc., He has worked in Discovery, Natural products, Bulk drugs, Generics, Intermediates, Fine chemicals, Neutraceuticals, GMP, Scaleups, etc, he is now helping millions, has 9 million plus hits on Google on all Organic chemistry websites. His friends call him Open superstar worlddrugtracker. His New Drug Approvals, Green Chemistry International, All about drugs, Eurekamoments, Organic spectroscopy international, etc in organic chemistry are some most read blogs He has hands on experience in initiation and developing novel routes for drug molecules and implementation them on commercial scale over a 30 year tenure till date Dec 2017, Around 35 plus products in his career. He has good knowledge of IPM, GMP, Regulatory aspects, he has several International patents published worldwide . He has good proficiency in Technology transfer, Spectroscopy, Stereochemistry, Synthesis, Polymorphism etc., He suffered a paralytic stroke/ Acute Transverse mylitis in Dec 2007 and is 90 %Paralysed, He is bound to a wheelchair, this seems to have injected feul in him to help chemists all around the world, he is more active than before and is pushing boundaries, He has 9 million plus hits on Google, 2.5 lakh plus connections on all networking sites, 50 Lakh plus views on dozen plus blogs, He makes himself available to all, contact him on +91 9323115463, email, Twitter, @amcrasto , He lives and will die for his family, 90% paralysis cannot kill his soul., Notably he has 19 lakh plus views on New Drug Approvals Blog in 216 countries...... , He appreciates the help he gets from one and all, Friends, Family, Glenmark, Readers, Wellwishers, Doctors, Drug authorities, His Contacts, Physiotherapist, etc

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