Friday, 24 May 2019

Alexion to acquire Syntimmune

26 September 2018 | News

The deal gives Alexion clinical-stage anti-FcRn antibody SYNT001 with potential to address a number of rare IgG-mediated diseases

Alexion Pharmaceuticals and Syntimmune have entered into a definitive agreement for Alexion to acquire Syntimmune, a clinical-stage biotechnology company developing antibody therapeutics targeting the neonatal Fc receptor (FcRn).

SYNT001 – a humanized monoclonal antibody that inhibits the interaction of FcRn with Immunoglobulin G (IgG) and IgG immune complexes – has the potential to improve treatment in a number of rare IgG-mediated diseases.

SYNT001 is currently being evaluated in Phase 1b/2a studies in patients with warm autoimmune hemolytic anemia (WAIHA) and in patients with pemphigus vulgaris (PV) or pemphigus foliaceus (PF) and has demonstrated proof of mechanism showing rapid IgG reduction. Under the terms of the agreement, Alexion will acquire Syntimmune for an upfront payment of $400 million, with the potential for additional milestone-dependent payments of up to $800 million, for a total value of up to $1.2 billion.

“Targeting FcRn holds great promise in transforming the treatment of IgG-mediated diseases. SYNT001 has successfully demonstrated proof of mechanism – the ability to rapidly lower IgG levels – in early clinical studies and has the potential to treat a number of rare IgG-mediated diseases,” said Ludwig Hantson, Ph.D., Chief Executive Officer of Alexion. “The acquisition of Syntimmune represents a critical step in rebuilding Alexion’s pipeline and further diversifying the company’s clinical-stage rare disease portfolio. It offers a strong strategic fit with Alexion’s existing rare disease franchises and provides the opportunity to transform patient care in diseases like warm autoimmune hemolytic anemia, where SYNT001 is the first, and currently the only, anti-FcRn therapy in clinical development.”

“Since the company’s founding in 2013, the team at Syntimmune has been focused on developing transformative therapies for patients with autoimmune diseases. We see tremendous promise for SYNT001, which is being evaluated in multiple IgG-mediated autoimmune diseases in ongoing clinical trials,” said Seth Harrison, M.D., Chairman of Syntimmune and Managing Partner of Apple Tree Partners. “Alexion’s demonstrated rare disease expertise and development and commercial capabilities provide an ideal foundation for continued advancement of SYNT001 and, we believe, will ensure its broad potential is realized.”

Warm autoimmune hemolytic anemia (WAIHA) is a rare autoimmune disorder caused by pathogenic Immunoglobulin G (IgG) antibodies that react with and cause the premature destruction of red blood cells at normal body temperature. The disease is often characterized by profound, and potentially life-threatening anemia and other acute complications, including severe and life-threatening hemolysis, severe weakness, enlarged spleen and/or liver, rapid heart rate (tachycardia), chest pain, heart failure and fainting (syncope). There are approximately 65,000 patients across the United States, France, Germany, Italy, Spain and the United Kingdom. There are currently no approved treatments for WAIHA.

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