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ADIENNE Pharma & Biotech to launch IPO on SIX Swiss Exchange

09/12/2016 | 01:05am EST

ADIENNE Pharma & Biotech to launch IPO on SIX Swiss Exchange

Lugano, September 12, 2016; ADIENNE Pharma & Biotech SA ("ADIENNE" or "the Company" or "the Group") announces today its intention to proceed with an initial public offering (the "Offering") of ordinary shares ("Shares") and seek a listing of its Shares on the SIX Swiss Stock Exchange.

ADIENNE is an integrated biopharmaceutical group of companies based in Lugano, Switzerland, with a proprietary portfolio consisting of an orphan-designated marketed medicinal product and clinical and preclinical product candidates focusing on critical conditions and high unmet medical needs. The Group aims to develop a range of product candidates for orphan diseases, for which existing treatment options are limited, the patient population is small and the clinical need for therapies is high. The Group is focused on orphan drug development for the treatment of various hematological and immunological diseases, in which the Group has high expertise and proven in-house capabilities from discovery to commercialization. In addition, the Group has its own Good Manufacturing Practice ("GMP")-approved manufacturing facility, which is authorized for the production of biotechnological sterile products for clinical trials and commercial use.

ADIENNE believes that it distinguishes itself by the following key competitive strengths:

  • Integrated innovative biopharmaceutical company with a proprietary product portfolio targeting life threatening conditions and high unmet medical needs.
  • Proprietary lead candidate Begelomab in Phase II/III FDA (Food and Drug Administration) and EMA (European Medicines Agency) registrative study for steroid-resistant acute Graft-versus-Host Disease.
  • Currently marketed orphan drug TEPADINA® indicated as a conditioning treatment in Hematopoietic Stem Cell Transplantation;
  • Historically profitable and cash generative business funding the product pipeline.
  • Pipeline expansion driven by a proven discovery engine that identifies and acquires unique opportunities, with three preclinical products candidates in development.
  • Capabilities across the value chain: from discovery to commercialization, with fully GMP-approved in-house monoclonal antibody production.
  • Deep leadership team with multidisciplinary expertise and commercialization skills.

ADIENNE's proprietary lead candidate Begelomab is currently running a Phase II/III FDAand EMA registrative study for steroid-resistant acute Graft-versus-Host Disease ("sr-aGvHD"), for which it has received orphan drug designation (ODD) in U.S., EU and Switzerland. Begelomab is an immunomodulatory monoclonal Antibody ("mAb") targeting the CD26 receptor on a subset of T cells associated with autoimmune conditions.

ADIENNE is the exclusive marketing authorization holder for TEPADINA® in EU, Russia, Israel, Hong Kong and Switzerland, as well as ODDs from FDA, EMA and Swissmedic. TEPADINA® is currently marketed in 42 countries worldwide, and is indicated, in combination with other chemotherapy medicinal products, with or without total body irradiation (TBI), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (HPCT) in haematological diseases in adult and paediatric patients and when high dose chemotherapy with HPCT support is appropriate for the treatment of solid tumours in adult and paediatric patients. With the successful marketing of TEPADINA®, ADIENNE has an existing international commercialization footprint which it can draw upon when commercializing its other product candidates.

ADIENNE is also developing three preclinical product candidates: ADN-LYS, ADN-MCL and MUBODINA® for Gaucher's Disease, Mantle Cell Lymphoma and typical Haemolytic Uremic Syndrome, respectively.

Dr. Antonio Francesco Di Naro, Chairman and President, started in 2004 to build the Group, which currently has 60 employees. The Company's headquarters are based in Lugano (Switzerland), its manufacturing site is based in Caponago (Italy) and a subsidiary is located in Barcelona (Spain).

Dr. Antonio Francesco Di Naro said: "I am very much looking forward to seeking a listing of ADIENNE on the SIX Swiss Exchange which will clearly enlarge the international footprint of the company. The proceeds from the planned IPO would further support the ongoing Phase II/III FDA and EMA registrative clinical trial of Begelomab for steroid-resistant acute Graft-versus-Host Disease, the scale up the Group's manufacturing, our commercialization capabilities ahead of the launch of Begelomab and the other trials of our clinical and preclinical development programs. I plan to retain a clear majority stake in the Company and will remain fully committed to develop ADIENNE into the next phase of its corporate development."

BofA Merrill Lynch and Jefferies International Limited are acting as Global Coordinators and Joint Book-Runners and Bank am Bellevue is acting as Co-Lead Manager in connection with the proposed Offering.

About ADIENNE

ADIENNE is an integrated biopharmaceutical group of companies based in Lugano, Switzerland, with a proprietary portfolio of orphan-designated marketed medicinal product, clinical and preclinical product candidates. ADIENNE is focused on orphan drug development for the treatment of various hematological and immunological diseases. In addition, the Group has its own Good Manufacturing Practice ("GMP")-approved manufacturing facility, which is authorized for the production of biotechnological sterile products for clinical trials and commercial use. More on www.adienne.com

ADIENNE's key personnel

Board of Directors as of the first trading day of the company:

  • Antonio Francesco Di Naro, Chairman and President
  • Antonio Lanzavecchia
  • Gilles Alberici
  • Silvana Minoretti

Executive Management:

  • Antonio Francesco Di Naro, Chairman and President
  • Andrea Berardi, Chief Financial Officer
  • Giovanni Amabile, Chief Scientific Officer
  • Federico Sanvito, Chief Manufacturing Officer and General Manager Italy
  • Alessandra Berardi, Chief Human Resources Officer
  • Silvia Nosari, Chief Regulatory Affairs Officer
  • Joseph O'Neill, Chief Commercial Officer USA/Canada/Latin America
  • Emanuele Vitari, Chief Commercial Officer Europe/International
  • Marco Sardella, Chief Pharmacovigilance Officer
  • Francesc Corpas Lara, General Manager Spain

For more information and CVs see www.adienne.com/about


For further details, please contact

Investors

Media

Dr. Antonio Francesco Di Naro

Chairman and President

Phone +41 91 210 47 26

E-Mail : ir@adienne.com

Martin Meier-Pfister

Press Officer

Phone +41 43 244 81 40

E-Mail: adienne@irfcom.ch




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