The PCSK9 wars continue, but at what cost?

Amgen's aggressive legal pursuit of Sanofi and Regeneron's Praluent might work, but will the PCSK9 developers ever recoup their costs?

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The latest US legal case between the anti-PCSK9 antibody developers was won by Sanofi and Regeneron yesterday, with a federal judge ruling that two of Amgen’s Repatha patents were invalid. The decision, which overturned a previous jury verdict, means that Praluent stays on the market for now, though Amgen has no intention of giving up this fight.

The big biotech has made no secret of the fact that it wants to get Praluent pulled from sale, and it has aggressively pursued this end in courts in several countries. In July a regional German court ruled in Amgen’s favour and granted an injunction on the sale of Praluent. For this to go into effect Amgen had to post a bond, which it promptly did, enforcing the removal of the Sanofi and Regeneron product.

As such, it is clear that Amgen’s motivation is market dominance – another option would have been to negotiate a royalty payment, for example. After spending what must be a considerable sum on legal expenses, the company must reckon that removing Praluent from the market is the most efficient way to recoup those costs.

Still, such an aggressive and costly tactic is somewhat surprising when considering that sales of the PCSK9 antibodies have vastly disappointed. The developers are presumably keen for these drugs to start turning a profit as soon as possible, though the huge clinical development costs that were incurred means that these franchises are a long way from paying back this investment.

And Amgen has spent a lot more: up to the end of last year the Repatha clinical programme had cost the company $2.5bn, according to EvaluatePharma Vision. This is double the cost of Praluent’s trials to Sanofi and Regeneron; the difference is probably explained by the substantially bigger patient pool that Amgen recruited.

Expensive business… the cost of PCSK9 development 
Product Company Clinical trial costs to end 2018  Number of registered clinical trials Total recruitment  2018 sales 2024e sales
Repatha Amgen  $2.5bn 49 67,248 $573m $2.73bn
Praluent Sanofi/Regneron $1.2bn 63 35,831 $308m $738m
Source: EvaluatePharma Vision.

Respective sales figures for the two products show how Amgen has been much more successful commercially than its rivals, a result of pricing and contracting practices over the years, according to Salim Syed, a research analyst at Mizuho. He also believes that at certain points doctors were concerned that Praluent would get pulled from the market, which might put them off prescribing that product.

So perhaps Amgen’s aggressive legal stance should actually be considered a marketing strategy – when choosing between two largely similar drugs, why would a physician reach for the one that might become unavailable?

This fiercely competitive market could soon get even tougher, if The Medicines Company’s inclisiran delivers competitive data next week at the European Society of Cardiology meeting (ESC preview – Medicines Company hopes for a starring role, August 19, 2019).

This siRNA therapy also blocks PCSK9 but is administered via injection only twice a year, potentially offering patients a much more convenient option. Should safety data also impress, and a big marketing partner jump on board, the existing players would have a lot to worry about.

Some believe that Regeneron and Sanofi might even reconsider their involvement in the space, if this scenario eventuality unfolds. “Given Praluent’s lowered commercial potential now … Regeneron seems even more likely to consider scaling back its investment in Praluent,” Geoffrey Porges of Leerink wrote this week.

It is hard to see how Sanofi and Regeneron will ever recoup their investments in this space. It is far from certain that Amgen will manage it, though the company seems to believe that having the market to itself will improve its chances. But if the inclisiran data are a big hit next week the prospects for all three players will weaken significantly.

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