New drug launches stalled by COVID-19 pandemic

[July 01, 2020]  By Carl O'Donnell and Manas Mishra

(Reuters) - The U.S. Food and Drug Administration has approved more than 30 new drugs since January. So far, five medicines have seen their commercial launches delayed by manufacturers until later in the year or 2021 because of the COVID-19 pandemic.

Here are the drugs that have been delayed:

PALFORZIA

Aimmune Therapeutics Inc paused the launch of the first peanut allergy treatment to be approved by U.S. regulators until later this year because of the widespread closure of allergists' practices. It is the company's only approved product, meaning Aimmune is unlikely to make the $48 million in annual revenue some analysts had previously projected.

ONGENTYS

Neurocrine Biosciences Inc has delayed the launch of its Parkinson's treatment, which analysts expected to generate nearly $9 million in its first year, until later this year, in part because it said neurologists had been busy helping treat COVID-19 patients.

XIAFLEX

Endo International PLC has delayed the launch of its drug Xiaflex as a cellulose treatment until later in 2020, even though the FDA is due to give a formal verdict on its approval in July. Xiaflex earned $89 million in the first quarter of 2020 for use in other conditions, such as painful erections. Endo executives told Reuters they expect to see a surge of patients starting new prescription drugs once social distancing measures lift.

SARCLISA

Sanofi SA launched its multiple myeloma treatment, Sarclisa, in March, but then paused the ramp up and delayed full commercialization until the COVID-19 pandemic subsides. Analysts projected the drug would earn $173 million in its first year.

ZEPOSIA

This treatment for relapsing multiple sclerosis was approved late March and was expected by some analysts to earn as much as $91 million in 2020. Bristol Myers Squibb Co delayed the product, citing a slowdown in new drug starts in the early days of the pandemic, but it moved forward with the launch in June because "physicians are beginning to actively initiate new therapies," said chief commercial officer Christopher Boerner during a recent investor call.

(Reporting by Carl O'Donnell and Manas Mishra in Bengaluru; additional reporting by Dania Nadeem in Bengaluru; Editing by Mark Potter)

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