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Alexion adds to pipeline with $1.2bn Syntimmune buy

As company prepares for possible loss of patent protection for Soliris

Alexion Pharmaceuticals

Alexion has agreed a $1.2bn takeover of US biotech Syntimmune that will add another clinical-stage rare disease drug to its R&D pipeline.

The deal – which includes an upfront payment of $400m and another $800m tied to various milestones – gives Alexion control of Syntimmune’s antibody therapeutics targeting the neonatal Fc receptor (FcRn), including lead candidate SYNT001 which is in phase 1b/2a studies.

SYNT001 inhibits the interaction of FcRn with immunoglobulin G (IgG) and is being tested for various IgG-driven disorders, including warm antibody autoimmune haemolytic anaemia (WAIHA) as well as pemphigus vulgaris and pemphigus foliaceus, which cause painful blisters and sores on the skin and mucous membranes such as the mouth and genitals.

According to Alexion chief executive Ludwig Hantson, SYNT001 is “the first, and currently the only, anti-FcRn therapy in clinical development” and has shown proof-of-concept as a way to quickly reduce IgG levels in the body.

Alexion is in the midst of a concerted effort to build its pipeline as it prepares for the possible loss of patent protection for Soliris (eculizumab), its biggest-selling product. Used to treat paroxysmal nocturnal haemoglobinuria (PNH) and myasthenia gravis, Soliris brought in sales of more than $3bn last year, far and away Alexion’s biggest product.

With patents due to expire in the US and Europe in the next three years – and new drugs such as lysosomal acid lipase deficiency treatment Kanuma and Strensiq for hypophosphatasia still in the early stages of growth – Alexion has been fixated on bolstering its pipeline.

A lot of its efforts have been directed at bringing forward ravulizumab (ALXN1210), a Soliris follow-up with improved dosing frequency which has cleared phase 3 testing and is already submitted for approval. Alexion used a priority review voucher from an earlier rare disease therapy approval to accelerate the FDA’s deliberations and bring forward a possible approval date.

In the meantime, however, it’s also been adding to its earlier-stage pipeline and the Syntimmune acquisition comes a few months after it snapped up Swedish biotech Wilson Therapeutics for $855m, adding orally-active copper binder WTX-101 in phase 3 testing for genetic disorder Wilson’s disease.

The acquisition of Syntimmune "represents a critical step in rebuilding Alexion's pipeline and further diversifying the company's clinical-stage rare disease portfolio" according to Hantson, who expects the transaction to close in the fourth quarter.

Article by
Phil Taylor

27th September 2018

From: Research, Healthcare

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