When Pfizer won FDA approval for Vyndaqel to treat ATTR cardiomyopathy last year, it took the relatively new market by storm, putting significant pressure on a rival drug from Alnylam as well as a second contender from Ionis affiliate Akcea.
Now, COVID-19 is threatening to put the brakes on the fast-growing market for ATTR drugs, analysts at SVB Leerink warned in a report to investors Wednesday. The halt may be temporary, they said, but it’s enough to change sales forecasts for the products in the near term.
“Given social distancing and measures against elective medical procedures in the US and EU, we expect growth in TTR diagnosis rates to pause” in the first quarter, SVB Leerink said, adding that the drop in new diagnoses could be even more precipitous in the second quarter. And that “will flatten the ramp of new patient starts” for all three drugs, the analysts said.
ATTR is a rare disease that has historically been underdiagnosed—a challenge all of the players in the emerging market have been working to overcome. Pfizer garnered kudos from the Street for its marketing approach, which involves educating physicians about the value of diagnosing ATTR cardiomyopathy with the imaging technology scintigraphy, rather than using genetic testing.
In the third quarter of last year, its first full quarter on the market, Pfizer’s Vyndaqel scored $79 million in sales, blowing away the consensus estimate of $21 million. Sales of Alnylam’s Onpattro came in at $46.1 million, which was in line with estimates.
Ionis’ Tegsedi was approved in 2018 to treat ATTR polyneuropathy and boasted what seemed like a significant selling point: Patients can dose themselves subcutaneously once a week. Then Vyndaquel came along as a once-daily pill for ATTR cardiomyopathy, and now Pfizer is working to get it approved in ATTR polyneuropathy, too. Onpattro can be given every three weeks, but it requires an infusion in a medical facility.
Because of COVID-19’s effect on new diagnoses, SVB Leerink lowered its estimates for Vyndaquel sales from $2.34 billion this year to $1.55 billion. The analysts dialed down their expectations for Tegsedi from $158 million in sales to $118 million, and the analysts predicted “lower market share in 2021 and beyond” for the product.
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As for Alnylam’s Onpattro, SVB Leerink expects sales to slip just a bit this year and come in at $298 million, versus the $304 million they had been expecting.
Onpattro and Tegsedi are both oligonucleotide drugs, but the latter’s sluggish launch has the analysts concerned that it won’t weather COVID-19 interruptions as well as Onpattro will. Ionis is working on a next-generation version of its drug, and “it appears increasingly likely” that the company will have to wait for it to be approved “to capture substantial share in this market,” they wrote.
So, can any of the players in the ATTR market make up for lost sales after the COVID-19 pandemic ends? Yes, SVB Leerink said. “We expect this slowdown to be relatively short-lived,” they said in the report. Because ATTR cardiomyopathy and polyneuropathy are progressive diseases, “the great majority of patients who would have otherwise been diagnosed this year will remain under care and represent a source of catch-up growth,” they said.
At that point, though, all three major players could be facing a new challenge: yet more competition. Eidos Therapeutics is rushing its ATTR candidate AG-10 through clinical trials, fueled by the $106.3 million it raised in an initial public offering in 2018.