Alexion’s rebuilding plan has continued with another bolt-on acquisition, this time a $400 million upfront deal for rare disease specialist Syntimmune.

The takeover gives Alexion control of SYNT001—a neonatal Fc receptor (FcRn) inhibitor in phase 1b/2a trials for patients with warm autoimmune hemolytic anemia (WAIHA) and pemphigus vulgaris (PV) or pemphigus foliaceus (PF), all diseases characterized by high levels of immunoglobulin G (IgG) antibodies.

In addition to the upfront payment, Syntimmune shareholders are in line for milestone-dependent payments of up to $800 million.

It’s the second acquisition for Alexion this year after its $855 million takeover offer for Wilson Therapeutics was agreed upon in May, adding a phase 3 treatment for rare genetic disorder Wilson disease to its pipeline.

Syntimmune has proof-of-mechanism data for the antibody, showing it can rapidly reduce IgG levels, says Alexion CEO Ludwig Hantson, Ph.D., who is pitching at completing the takeover before the end of the year.

FcRn is thought to be a central mediator of IgG-related immunity and part of an important pathway that enables abnormal IgG responses in a large number of clinical settings, including autoimmune disease.

Both deals come after a difficult 2017 when Alexion took an ax to staff numbers, R&D programs and partnerships in preparation of an anticipated downturn in sales of Soliris, a 10-year-old paroxysmal nocturnal hemoglobinuria and myasthenia gravis therapy that has been its main source of revenue with sales of more than $3 billion in 2017.

Alexion has been working hard to beef up its pipeline as it faces the threat of biosimilar competition to Soliris from the likes of Amgen. The company is claiming protection for Soliris until 2027, but there have been suggestions it could face biosimilar competition in the U.S. from 2021, depending on the outcome of patent litigation.

"The acquisition of Syntimmune represents a critical step in rebuilding Alexion’s pipeline and further diversifying the company’s clinical-stage rare disease portfolio," commented Hantson. "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."

Not all of Alexion’s efforts to reduce its reliance on its cash cow have paid off, however. In 2015 it paid $8.5 billion for Synageva and its Kanuma drug for rare metabolic disorder LAL deficiency, but sales have disappointed and were just $41 million in the first six months of the year.

As well as bolstering its early-stage pipeline, Alexion is also hoping to switch patients from Soliris to late-stage candidate ravulizumab, which works in the same way as its predecessor but is administered every eight weeks rather than every two weeks.

For Syntimmune, the takeover offer comes just a few months after a change of CEO, with Jean-Paul Kress, M.D., taking over from Boehringer and Pfizer veteran David de Graaf, Ph.D., after just 13 months in the role. Since its founding in 2013, the biotech has raised around $78 million in two private rounds led by Apple Tree Partners.

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