Sanofi has agreed to acquire Ablynx for €3.9 billion ($4.8 billion) in a deal designed to expand the buyer’s R&D pipeline and rare blood disorders portfolio with a late-stage candidate and its underlying technology based on therapeutic proteins, or Nanobodies®.

The deal marks Sanofi’s second multi-billion-dollar acquisition of a rare-blood disorder drug developer in as many weeks, and third move to expand in blood treatments in three weeks.

On January 22, Sanofi announced plans to expand its portfolio in rare blood disorders, hemophilia, and other specialties by acquiring Bioverativ for approximately $11.6 billion. That deal was disclosed on January 8, two weeks to the day Sanofi obtained global development and commercialization rights to fitusiran through a restructuring of a rare disease global alliance with Alnylam Pharmaceuticals launched in 2014.

Ablynx would bring to Sanofi its first-in-class acquired thrombotic thrombocytopenic purpura (aTTP) candidate caplacizumab (anti-von Willebrand factor [vWF] Nanobody), a wholly owned development program. Ablynx has already filed for approvals for caplacizumab in the European Union, with plans to do likewise in the U.S. during the first half of this year.

Caplacizumab is an anti-vWF Nanobody that has received Orphan Drug designation in the U.S. and E.U. in 2009. Caplacizumab is designed to work by inhibiting the interaction between vWF and platelets by targeting the A1 domain of vWF—and thus has the potential, says Ablynx, to immediately block the ultra-large (UL) vWF-mediated platelet interactions and the formation of the string-like clots in the blood of patients with acquired TTP.

In October, Ablynx reported positive topline results from the Phase III HERCULES study, saying that caplacizumab met its primary endpoint and key secondary endpoints by delivering a statistically significant reduction in time to platelet count response, with patients treated with caplacizumab 50% more likely to achieve platelet count response at any given time.

Ablynx also reported a 74% relative reduction in the percentage of patients with aTTP-related death, a recurrence of aTTP, or at least one major thromboembolic event during the study drug treatment period, and a 67% relative reduction in the percentage of patients with aTTP recurrence during the overall study period.

Caplacizumab is Ablynx’s lead candidate among its Nanobodies, which are based on single-domain antibody fragments that contain the structural and functional properties of naturally occurring heavy chain only antibodies. Ablynx says its proprietary Nanobody platform allows for rapid generation and large-scale production of novel biological therapeutics that have potential in a wide range of human diseases.

Eight Clinical-Phase Nanobodies

Ablynx’s pipeline includes more than 45 proprietary and partnered Nanobody candidates in therapeutic areas that include hematology, inflammation, immuno-oncology, and respiratory diseases. Of those Nanobodies, eight have entered clinical development.

Among the eight, in addition to caplacizumab, is ALX-0171, a Phase IIb inhaled anti-respiratory syncytical virus (anti-RSV) Nanobody that the companies say represents a potential breakthrough for the symptomatic treatment of RSV infections—for which there is no widely used therapy available. ALX-0171 would be “very” complementary to Sanofi Pasteur RSV-associated programs, according to the buyer.

“With Ablynx, we continue to advance the strategic transformation of our R&D, expanding our late-stage pipeline and strengthening our platform for growth in rare blood disorders. This acquisition builds on a successful existing partnership,” Sanofi CEO Olivier Brandicourt, M.D., said in a statement.

The two companies have been collaboration partners and are in preclinical phases for the development of up to eight programs for immunoinflammation indications.

“Since our founding in 2001, our team has been focused on unlocking the power of our Nanobody technology for patients. The results of our work are validated by clinical data,” said Ablynx CEO Edwin Moses, Ph.D. “As we look ahead, we believe Sanofi's global infrastructure, commitment to innovation, and commercial capabilities will accelerate our ability to deliver our pipeline. Our Board of Directors feels strongly that this transaction represents compelling value for shareholders and maximizes the potential of our pipeline to the benefit of all stakeholders.”

In agreeing to be acquired by Sanofi, Ablynx has rejected two offers to be acquired by Novo Nordisk—the latest one a €2.6 billion ($3.2 billion) proposal that would have given Ablynx shareholders €28 ($34.63) upfront and €2.50 ($3.09) in contingent value rights.

The transaction was unanimously approved by the boards of both companies. Sanofi plans to acquire all outstanding ordinary shares of Ablynx—including shares represented by American Depositary Shares (ADSs), warrants and convertible bonds of Ablynx—at €45 ($55.65) per share cash.

The offers are expected to be launched by the beginning of the second quarter, when the deal is expected to close—subject to customary conditions that include the tender of securities representing at least 75% of Ablynx’ outstanding shares at the end of the initial acceptance period of the Belgian Tender Offer, as well as required regulatory approvals.

To comply with a Belgian regulation requiring certainty of funds, Sanofi has entered into a bank credit facility, BNP Paribas Fortis SA/NA, acting as the sole credit facility arranger.

Dr. Brandicourt said in the statement that Sanofi would reaffirm its commitment to Belgium by maintaining and supporting the Ablynx science center in Ghent, as well as retaining its biologics manufacturing facility in Geel.

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