Alexion Redefines R&D Strategy, Discontinues Programs and Kills Deals With Moderna, Blueprint and Arbutus Biopharma

Alexion is Under Investigation by the HHS Office of Inspector General

July 27, 2017
By Mark Terry, Breaking News Staff

While reporting strong earnings, New Haven, Conn.-based Alexion Pharmaceuticals also indicated it plans to retool its research-and-development strategy.

Alexion, at its second-quarter financial report, announced total revenues for the quarter of $912 million, an increase of 21 percent from the same period last year. Revenue was driven by strong sales of Soliris (eculizumab), generating $814 million for the quarter, up from $701 million in the second quarter of 2016, an increase of 16 percent. Other product sales were strong as well. Strensiq (asfotase alfa) brought in $83 million for the quarter, almost double its $45 million in the same period last year, and Kanuma (sebelipase alfa) brought in $15 million compared to $7 million in the second quarter of 2016.

“Alexion delivered strong performance in the second quarter of 2017 while also executing on several initiatives to position the company for the future, including strengthening the Soliris patent portfolio, reaching a funding agreement for Strensiq in England, advancing the late-stage pipeline, enhancing compliance and culture and building a strong leadership team,” said Ludwig Hantson, Alexion’s chief executive officer, in a statement. “Our strategy for the next phase of growth will focus on our strengths to deliver sustainable long-term performance and increased value for shareholders. We will achieve this by growing our rare disease business, leveraging our expertise in complement, pursuing disciplined business development to expand the pipeline, and taking steps to optimize our infrastructure and operating model.”

The company plans to halt development of ALXN1101, a cPMP replacement therapy and ALXN6000 (samalizumab), and put them up for sale. It plans to discontinue its preclinical programs with mRNA therapies in addition to other preclinical programs outside its core complement franchise. As a result, it’s ending its partnerships with Moderna Therapeutics, Blueprint Medicines and Arbutus Biopharma (ALXN).

John Carroll, writing for Endpoints News, notes, “Alexion paid Moderna $100 million upfront to partner on up to 10 programs, which now revert back to the Cambridge, MA-based biotech. Alexion tied up with Blueprint on a 2015 discovery deal, anteing up $15 million and promising up to $250 million more. Arbutus came into the picture much more recently, signing on to an $82.5 million deal in March.”

Alexion is not the only company at this year’s halfway point to announce R&D restructuring. GlaxoSmithKline ’s Emma Walmsley announced it planned to kill more than 30 preclinical and clinical programs and allocate 80 percent of its research-and-development budget to respiratory and HIV/infectious diseases. Biogen ’s Michel Vounatsos indicated he is reviewing the company’s capital deployment strategy and will likely focus on mergers and acquisitions. And Eli Lilly ’s David Ricks has developed a new decision-making framework that has it prioritizing seven of its drug candidates and looking to rid itself of seven Phase II candidates and potentially partnering with another 10 of its mid-stage cancer drugs.

“Alexion’s new management effectively cleaned house on their prior development portfolio,” Geoffrey Porges, an analyst with Leerink, wrote in a note to investors this morning, “terminating two non-complement and non-core development programs, and re-focusing the company’s strategy….Alexion has now fully enrolled the ALXN1210 Phase III treatment-naïve PNH study, and expects data in Q2 2018. The company’s Soliris NMO trial, which has faced recent delays, has also been confirmed to finish enrollment in 2017 for data in early 2018.”

Hantson joined the company in March after a series of scandals shook the company. He took over from David Brennan, who was named interim chief executive officer after chief executive officer David Hallal and chief financial officer Vikas Sinha stepped down in December, the results of various investigations by the U.S. Securities and Exchange Commission (SEC) related to grant-making activities and compliance with the Foreign Corrupt Practices Act (FCPA) in several countries.

Carrol writes, “Hantson, who briefly ran Baxalta before Shire stepped in with a buyout, has been grumbling about the pipeline at Alexion ever since his arrival, leaving plenty of writing on the wall to point to his revamp. The company is hugely dependent on Soliris, its expensive rare disease drug, for most of its revenue.”