TiGenix : licenses exclusive marketing and distribution rights for ChondroCelect to Sobi

TiGenix : licenses exclusive marketing and distribution rights for ChondroCelect to Sobi                                             Regulated information 3 April, 2014                                                                                 TiGenix licenses exclusive marketing and distribution rights for ChondroCelect                                    to Sobi    oSobi to assume responsibility for the commercialisation of ChondroCelect     in existing and new markets in Europe and beyond   oSobi's considerable expertise and resources will enhance the availability     of ChondroCelect to many more patients in many more countries   oTiGenix to focus its resources on developing its pipeline of allogeneic     treatments using expanded adipose-derived stem cells (eASC's)  LEUVEN, Belgium,  April  3, 2014  (GLOBE  NEWSWIRE) --  TiGenix  NV  (Euronext  Brussels: TIG), the European leader in  cell therapy, announced today that  it  has licensed the marketing and  distribution of ChondroCelect, the  cell-based  medicinal product for  the repair  of cartilage defects  of the  knee, to  the  international specialty healthcare company dedicated to rare diseases, Swedish Orphan Biovitrum AB ('Sobi', NASDAQ OMX Stockholm: SOBI).  ChondroCelect was the first cell-based product to be approved in Europe. It is currently available for  patients and reimbursed  in Belgium, the  Netherlands  and Spain. Sales of ChondroCelect in 2013  were Euro 4.3 million, a growth  of  25% on a like-for-like basis over 2012.  Sobi will continue to market and distribute the product where it is  currently  available and has also acquired the  exclusive rights to expand the  product's  availability to  patients in  multiple additional  territories, including  the  rest of the European Union, Norway, Switzerland, Turkey, and Russia, plus  the  countries of the Middle East and North Africa.  TiGenix will receive a royalty of 22% of the net sales of ChondroCelect in the first year  of  the agreement,  and  20% of  the  net sales  of  ChondroCelect  thereafter. There will be no upfront or milestone payments. The agreement will take effect on 1 June 2014, and has a duration of 10 years.  "We are delighted to reach this agreement with Sobi", said Eduardo Bravo,  CEO  of TiGenix.  "With  its experience  of  marketing and  distributing  specialty  products, and with its human and financial resources, Sobi has the ability  to  bring ChondroCelect  to  a  far  greater  number  of  patients  in  many  more  countries. This then allows TiGenix to focus its human and financial resources on the development of its platform and pipeline of allogeneic treatments using expanded adipose-derived  stem  cells (eASC's)  for  the benefit  of  patients  suffering from a range of inflammatory and immunological conditions."  "ChondroCelect is an exciting therapy, and we are proud to expand our  support  for orthopaedic patients",  said Anders  Edvell MD,  PhD, Vice-President  Sobi  Partner Products. "This partnership is an excellent fit with Partner Products' strategy for  achieving sustainable  patient access  to innovative  treatments  with a pan-European scope."  While  TiGenix  will  initially  maintain  responsibility  for  manufacturing,  logistics and regulatory affairs, the costs of these activities will be  borne  by Sobi. TiGenix employees currently engaged in the marketing and distribution of ChondroCelect are expected to transfer to Sobi, thereby ensuring continuity of know-how.  For more information  For TiGenix: Richard Simpson Senior Consultant, Comfi sprl T: +32 494 578 278 richard@comfi.be  For Sobi: Oskar Bosson Head of Communications T:            +46            70             410            71             80   oskar.bosson@sobi.com  Jörgen Winroth Head of Investor Relations T: +1 347-224-0819, +46 8 697 2135 jorgen.winroth@sobi.com  About ChondroCelect  ChondroCelect, indicated  for cartilage  repair  in the  knee, was  the  first  approved cell-based product in Europe  that successfully completed the  entire  development track  from  research  through clinical  development  to  European  approval through the centralised  procedure. ChondroCelect received  Marketing  Authorisation in October 2009 as the first Advanced Therapy Medicinal Product, and was  approved  for reimbursement  in  Belgium  in February  2011,  in  the  Netherlands in June 2012 (retroactively to January 2011) and in Spain in March 2013. In addition to  these three countries,  ChondroCelect is also  currently  being commercialised in the UK through TiGenix's commercial team as well as in Finland through the Finnish Red Cross Blood Services with which TiGenix has  a  distribution agreement.  A further  distribution agreement  is in  place  with  Genpharm for the Middle-East region.  ChondroCelect  is  a  cell-based  medicinal  product  for  use  in  autologous  chondrocyte implantation in which cells are taken from the patient's own knee, multiplied to reach a large quantity, and then re-implanted at the site of the defect. ChondroCelect  is  indicated  for the  repair  of  single  symptomatic  cartilage defects of the femoral condyle of the knee (International  Cartilage  Repair Society grades III or IV) in adults.  Treatment with ChondroCelect comprises a  two-step surgical procedure. In  the  first step,  a  cartilage biopsy  is  obtained arthroscopically  from  healthy  articular cartilage from a lesser-weight  bearing area of the patient's  knee.  Chondrocytes are  isolated  from  the  biopsy, expanded  in  vitro  through  a  process based on  cell characterisation,  and delivered as  a suspension  for  implantation in the same  patient. ChondroCelect can  be delivered nine  weeks  from the day of biopsy.  About Sobi  Sobi is  an  international  specialty healthcare  company  dedicated  to  rare  diseases. Its  mission is  to  develop and  deliver innovative  therapies  and  services to improve the lives of patients. The product portfolio is  primarily  focused on inflammation and genetic diseases, with three late stage biological development projects within haemophilia and  neonatology. Sobi also markets  a  portfolio of specialty and rare  disease products for partner companies.  Sobi  is a  pioneer  in  biotechnology  with  world-class  capabilities  in  protein  biochemistry and biologics manufacturing. In 2013, Sobi had total revenues  of  SEK 2.2 billion (€253 million) and about 550 employees. The share (STO:  SOBI)  is  listed  on  NASDAQ  OMX  Stockholm.  More  information  is  available   at  www.sobi.com.  About TiGenix  TiGenix NV  (Euronext  Brussels:  TIG)is  a  leading  European  cell  therapy  companywith a marketed  product for cartilage  repair, ChondroCelect®, and  a  pipeline of  clinical  stage  allogeneic adultstem  cell  programmesfor  the  treatment ofautoimmune and inflammatory diseases.TiGenixis based in  Leuven  (Belgium)  and   has  operations   in  Madrid   (Spain),  and   Sittard-Geleen  (theNetherlands). For more information please visit www.tigenix.com .  Forward-looking information  This document  may  contain  forward-looking  statements  and  estimates  with  respect to the  anticipated future performance  of TiGenix and  the market  in  which it operates. Certain of these statements, forecasts and estimates can be recognised by  the  use of  words  such as,  without  limitation,  "believes",  "anticipates", "expects",  "intends",  "plans", "seeks",  "estimates",  "may",  "will" and "continue" and similar  expressions. They include all matters  that  are not historical facts. Such  statements, forecasts and estimates are  based  on  various  assumptions   and  assessments  of   known  and  unknown   risks,  uncertainties and other factors,  which were deemed  reasonable when made  but  may or may not prove to be correct. Actual events are difficult to predict and may depend  upon factors  that are  beyond the  Company's control.  Therefore,  actual results,  the  financial  condition,  performance  or  achievements  of  TiGenix, or industry results, may turn out to be materially different from any future results,  performance  or achievements  expressed  or implied  by  such  statements,  forecasts   and   estimates.  Given   these   uncertainties,   no  representations  are   made  as   to  the   accuracy  or   fairness  of   such  forward-looking   statements,    forecasts   and    estimates.    Furthermore,  forward-looking statements, forecasts and estimates only speak as of the  date  of the  publication of  this  document. TiGenix  disclaims any  obligation  to  update any such  forward-looking statement, forecast  or estimates to  reflect  any change in the Company's expectations with regard thereto, or any change in events, conditions or circumstances on  which any such statement, forecast  or  estimate is based, except to the extent required by Belgian law.  HUG#1773704  
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