- On Thursday, the European Patent Office rejected a pair of patent applications on Alexion Pharmaceuticals' top-selling drug Soliris, intensifying the potential threat of biosimilar competition.
- Wall Street analysts said the rejection was widely anticipated, but nevertheless "solidifies Soliris' lack of IP protection in Europe," as Stifel analyst Paul Matteis wrote Thursday to investors.
- Alexion's patent applications were respectively for the biologic's pharmaceutical composition and composition of matter. The New Haven, Connecticut-based drugmaker said it will consider appealing the decision after receiving and reviewing the written decision.
The office's rejection could set up Soliris (eculizumab) to face a competing biosimilar launch in Europe in 2022.
The exact timing for a launch would also depend on when Amgen finishes a pivotal study for its copycat biologic. That clinical trial, dubbed DAHLIA, is still recruiting patients and requires 18 months of follow-up for some of the endpoints, according to clinicaltrials.gov.
Pressure on Soliris' IP isn't limited to Europe. Just last week, the U.S. Patent Trial and Appeal Board agreed to review a challenge from Amgen over three of the drug's U.S. patents.
If Amgen's challenge is successful, stripping those patents could expose Soliris to biosimilar competition in the U.S. several years ahead of expectations, beginning in 2021 in the indication of PNH, or paroxysmal nocturnal hemoglobinuria.
Analysts have been taking that possibility more seriously since PTAB accepted the review. Earlier this week, SVB Leerink's Geoffrey Porges upped the probability of success for Amgen's challenge to 50%, subsequently dropping the bank's per share price target approximately 9% to $157. Alexion shares opened Friday at about $100 apiece.
Soliris makes up the vast majority of Alexion's income. The rare disease drug posted global sales of nearly $2 billion in the first half of 2019, accounting for more than 85% of the biotech's total product sales.
The patent challenges on both sides of the Atlantic will increase pressure on Alexion's strategy of switching patients from Soliris to its next-generation drug, Ultomiris (ravulizumab).
Ultomiris brings a less frequent dosing interval and was approved in late 2018 to treat PNH, the first of Soliris' three rare disease indications. Analysts said the IP challenges put more focus on how fast the company is converting PNH patients in Europe from Soliris to the newer drug.
Alexion's stock opened relatively flat Friday before rising about 3% in morning trading hours.