Amid a major executive shakeup, Alexion finds new R&D chief

Orloff joins from a brief stint at rare disease biotech Novelion

It’s not been a great six months for the leadership of Alexion as a sales scandal has forced a series of major changes at the top of the organization; one of these was Martin Mackay, who will “retire” this year, and will now be replaced by John Orloff, M.D.

He will work with Mackay (who retires at the end of the year) to take over as EVP and head of research & development and joins from a very short stint at rare disease biotech Novelion, where he had been head of research since November last year. Before then, was global head of R&D and CSO at Baxalta, with former roles at Baxter International (also the former home of Alexion's new CEO), Merck Serono, Novartis and Merck Research Laboratories.

Alexion said that Orloff will be focused on “strengthening the company’s clinical pipeline and research programs, enhancing R&D productivity, overseeing regulatory and medical affairs, and supporting business development.”

Mackay and Orloff will work together over the coming months to ensure “a smooth transition” of Alexion’s key pipeline programs, including the registration filings of its high-priced rare disease med Soliris (eculizumab) for patients with refractory generalized myasthenia gravis, as well as its FDA orphan-designated ALXN1210 development programs.

This med is designed as a longer-acting anti-C5 antibody that inhibits terminal complement, which is being tested in patients with paroxysmal nocturnal hemoglobinuria (PNH).

PNH is a debilitating, ultra-rare, life-threatening blood disorder in which uncontrolled activation of complement, a component of the immune system, results in hemolysis (destruction of a patient’s red blood cells).

ALXN1210 is in a phase 3 PNH and aHUS trial, as well as a phase 1 study looking at a new formulation of the experimental med when given subcutaneously in healthy volunteers.

This change comes amid a major shake-up at the top of Alexion, which has replaced its CEO and CFO late last year, and then kicked off a second round of changes in the past few weeks. The axing of personnel are being undertaken as the biopharma is embroiled in an ongoing sales probes around Soliris.

Related: Alexion's C-suite overhaul continues as CFO, R&D chief exit, new commercial head enters

Orloff will meanwhile stay on as a board member at Novelion, but the biotech is now on the hunt for a new R&D chief.

Jason Aryeh, Novelion’s chairman, said: “As Novelion strives to achieve its goal of becoming a leading rare disease company, we welcome Dr. Orloff’s continued contribution and will rely on his expertise in his new role as a board member.

“During his tenure at Novelion, Dr. Orloff has established a scientific platform for Novelion that positions the Company for growth in the near- and long-term. His guidance will continue to be invaluable as Novelion seeks to execute against multiple development opportunities.”

In a note to clients, analysts at Barclays said: “Overall he [Orloff] has more than 20 years of experience in biopharma. His background is clearly aligned with [new CEO] Hantson’s. According to the company, his responsibilities will be to not only continue clinical development of ALXN1210 and Soliris for rgMG, but also strengthen the company’s clinical pipeline and ‘enhance R&D productivity’—a key issue raised by Hantson.”

Analysts at Leerink however were less impressed: "Yesterday’s announcement of the wholesaler Baxter-ization of the management suite does little to reassure us the business outlook at the company is not impaired, or that growth can be maintained, at anything comparable to our prior expectations. We still believe in the myasthenia gravis (MG) indication and the value of the ALXN1210 line extension, but our confidence in the core business has been tested by the steady stream of disclosures and management missteps."