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Alexion, AstraZeneca secure backing of EMA panel for key drugs

  • Nine drugs received the backing of the European Union’s drug review committee this month, setting them up for full approval in new or expanded indications within weeks.
  • Alexion’s Ultomiris, a follow-on medication to the company’s blockbuster drug Soliris, secured a positive vote in the rare condition paroxysmal nocturnal hemoglobinuria (PNH), an indication which would accelerate the company’s plans to switch patients from the older product. Biosimilar competition for Soliris could emerge in Europe next year.
  • AstraZeneca’s Lynparza, meanwhile, won the panel’s backing as a first-line maintenance treatment for BRCA-mutated ovarian cancer following chemotherapy. This follows a Food and Drug Administration approval in the same indication in December, making it the only PARP inhibitor to be used in that early treatment setting.

Alexion hasn’t exactly been a single-product company, but it derives 84% of its sales from one product, Soliris (eculizumab). Once famous for being the world’s most expensive drug at a half-million dollars a year, Soliris is due to lose patent protection in Europe in 2020. The key composition of matter patent runs out in the U.S. in 2021, although other patents could keep U.S. biosimilars on the sidelines for years.

Alexion’s response has been to develop Ultomiris (ravulizumab), which relies on a similar mechanism of action but has a longer dosing interval than Soliris. Ultomiris received FDA approval in December 2018, and achieved sales of $25 million in the first quarter of 2019.

The European market represents about 27% of Soliris sales, so Alexion will not want to risk losing that when biosimilars do emerge to compete for business in nationalized health systems. The decision by the Committee for Medicinal Products for Human Use (CHMP) sets up an approval decision by the European Commission, which in turn would allow Alexion to begin persuading national insurers to cover Ultomiris.

Because PNH is such an ultra-rare disease, with patients numbering in the hundreds, Alexion’s strategy will need to rely primarily on persuading new patients to switch from Soliris to Ultomiris, rather than expecting new patients to drive growth. That could prove challenging as patients may not wish to switch if they are stable on Soliris.

Stateside, AstraZeneca has benefited from Lynparza (olaparib) becoming the first PARP inhibitor to win approval, and has remained ahead of Clovis’ Rubraca (rucaparib) and GlaxoSmithKline’s Zejula (niraparib) in many settings. A first-line maintenance approval in Europe would allow Lynparza to be used to prevent ovarian cancer from recurring after an initial round of chemotherapy induces a remission.

The FDA approved Lynparza in the first-line maintenance setting in December.

AstraZeneca’s oncology business has helped return the company to sales growth, with the company recently reporting first quarter cancer drug sales of $1.9 billion, or 59% growth year over year.

Another PARP inhibitor, Pfizer’s Talzenna (talazoparib), received CHMP backing in patients with germline BRCA1/2 mutations who have HER2-negative locally advanced or metastatic breast cancer. So far Pfizer has not competed with AstraZeneva, Clovis or GlaxoSmithKline in ovarian cancer.