court hearing gets under way today that one Wall Street analyst believes may significantly alter the fortunes of three big drug makers in the outsized market for cholesterol treatments.
Amgen is seeking a permanent injunction to prevent Sanofi and Regeneron Pharmaceuticals from selling their injectable cholesterol drug called Praluent. The move comes after a federal court jury last week upheld two Amgen patents on its own Repatha medication in response to a patent infringement lawsuit filed in late 2014. Both drugs, known as PCSK9 inhibitors, debuted several months ago to considerable fanfare because they can lower cholesterol considerably.
Sales for these drugs, however, have gotten off to a lower-than-expected start because insurers have pushed back on the cost — list prices for both injectables exceed $14,000 annually. Nonetheless, eagerly awaited cardiovascular outcomes data is expected to be released over the next year or so, and if the results are positive, the drugs could become important products for each of the companies.
This explains why the patent dispute has been closely watched. Wall Street, however, is largely discounting the likelihood that Amgen will win a permanent injunction and looks for a settlement to be reached that will involve Amgen receiving a royalty payment on sales. Leerink analyst Geoffrey Porges, for instance, believes such an injunction is a “remote possibility.”
But one analyst thinks otherwise.
Earlier this week, Gbola Amusa of Chardan Capital Markets released an investor note in which he took a contrarian view. He wrote that the Street is underestimating the likelihood of a permanent injunction being issued and predicted that it is “reasonably likely” that Sanofi and Regeneron’s Praluent will be taken off the market later this year.
As he views it, “when patent owners win (patent) infringement suits against products that are their sole competitors … such dynamics have historically led to a permanent injunction.” Since Praluent is the only current competitor to Amgen’s Repatha in this market, “precedents suggest that Praluent, too, will be removed from the US market.”
Moreover, he believes Sanofi and Regeneron will not win a stay — or a halt in the proceedings — while the companies simultaneously appeal last week’s verdict. Most Wall Streeters, however, believe the drug makers will win a stay so that the appeals process can be allowed to play out. And the appeals process is likely to take a year or more, which means Praluent will, meanwhile, remain available.
Amusa, though, writes that most investors “could be disappointed.” With a decision on a stay for a permanent injunction expected by May or June, he believes it is “possible that Praluent could come off the shelves in the US soon after.” And his outlook is boosted thanks to flubs that Sanofi has committed in the past with filing patents, he added.
As Amusa noted, the outcome of the hearing that began today will not be known for several weeks. But if he is proven to be correct, Amgen will be a big winner, especially since the company will soon face stiff competition for its key products from biosimilars. But another winner will be Amusa. Then again, he could also be one of the losers.