AB2 Bio prepares market entry of its lead product

Lausanne-based AB2 Bio Ltd is specialized in developing innovative therapies for the treatment of severe systemic autoinflammatory diseases, including rare diseases with high unmet medical needs. The company is conducting a pivotal Phase 3 clinical trial of Tadekinig alfa in primary, interleukin-18 driven Hemophagocytic Lymphohistiocytosis (HLH). People with HLH usually develop symptoms within the first months or years of life. Symptoms may include fever, enlarged liver or spleen, cytopenia (decreased number of blood cells), and neurological abnormalities. All forms of HLH, including cases treated adequately, may have a high mortality rate.

Tadekinig alfa is also Phase 3-ready for two additional indications: Macrophage Activation Syndrome (MAS) and Still’s Disease. It has been granted Orphan Drug Designation by the US Food and Drug Administration (FDA) for the treatment of HLH and Still’s disease, including Adult-onset Still’s Disease and systemic Juvenile Idiopathic Arthritis, and by the European Medicines Agency (EMA) for the treatment of HLH. In addition, the FDA has granted Breakthrough Therapy Designation for the treatment of monogenic, IL-18 associated autoinflammatory conditions with ongoing systemic inflammation, and Rare Pediatric Disease Designation for the treatment of primary HLH.

Experienced CEO to prepare market entry

Today AB2 Bio has announced the appointment of the experienced pharmaceutical executive Michael Soldan, PhD, as its Chief Executive Officer. “I am very pleased to welcome Michael Soldan to AB2 Bio, where he will bring the benefit of his impressive and wide-ranging career in the pharmaceuticals industry. Dr. Soldan’s extensive experience in manufacturing and regulatory affairs is of direct relevance to prepare the next phase of development of AB2 Bio as we continue the pivotal Phase 3 trial of Tadekinig alfa in patients with monogenic, interleukin-18 driven autoinflammatory conditions and progress it towards market,” says Prof. Andrea Pfeifer, AB2 Bio’s Chairwoman.

Michael Soldan joins from global healthcare company Fresenius Kabi, where he was CEO of the Global Biosimilars Business located in Switzerland, responsible for the successful creation, development, launch and commercialization of biosimilars in the U.S., Europe and other parts of the world. He has an extensive background in general management, drug commercialization, business development and regulatory affairs as well as experience of integrating businesses.

Prior to Fresenius Kabi, Dr. Soldan was with Merck Group, where he spent two years heading the biosimilars business. He has also held a number of senior regulatory and clinical positions with companies including Boehringer Ingelheim, Biotest, Grünenthal and Aventis Behring. He holds a degree in Pharmacy and a PhD in Pharmacology from Philipps University Marburg, Germany.