From Parkinson's to peanut allergy, pandemic puts brakes on new drugs
Send a link to a friend
[July 01, 2020]
By Carl O'Donnell and Manas Mishra
(Reuters) - Treatments for peanut allergy
and Parkinson's disease are among U.S. drug launches that have been
postponed by the COVID-19 pandemic as drugmakers struggle with
disruptions to business, a Reuters review of filings and interviews with
executives show.
The Food and Drug Administration (FDA) has approved more than 30 new
medicines since January, but at least five drugmakers including Bristol
Myers Squibb <BMY.N>, Sanofi <SASY.PA>, Neurocrine Biosciences <NBIX.O>,
Endo Pharmaceuticals <ENDP.O> and Aimmune <AIMT.O> have changed their
launch plans.
More may be delayed as authorities battle to control a pandemic that has
already claimed more than 125,000 U.S. lives.
"We don’t believe there will be any kind of 'new normal' until there are
effective (COVID-19) vaccines," said Barry Greene, president of Alnylam
Pharmaceuticals Inc <ALNY.O>, which makes treatments for genetic
disorders.
"We are going to be in this interesting world for quite a while."
Launching drugs is an expensive and complicated process that includes
sales representatives talking to doctors, coordinating supplies and
treatment with pharmacies and clinics, and advertising campaigns - many
of which have become harder during lockdowns or other restrictions to
tackle the pandemic.
That's bad news for patients and drugmakers.
Delays altogether could cost companies over a quarter of the originally
estimated more than $1 billion in 2020 sales for the products approved
by the FDA since January, according to a Reuters estimate based on
company and analyst sales forecasts.
Hold-ups are mainly affecting treatments for diseases that are less
acute, or less profitable for drugmakers, as the industry prioritizes
its most promising new medicines.
"Clearly diseases that are less severe will have more impact to sales,"
Eli Lilly Chief Executive David Ricks said in an interview.
Lilly and rival Pfizer Inc <PFE.N> have moved forward with launches of
recently approved cancer drug Retevmo and heart disease treatment
Vyandeqel, respectively, the only available treatments for two rare and
potentially deadly conditions.
That's little consolation for patients waiting for delayed drugs, such
as Neurocrine's Parkinson's treatment Ongentys.
[to top of second column]
|
A view shows the U.S. Food and Drug Administration (FDA)
headquarters in Silver Spring, Maryland August 14, 2012.
REUTERS/Jason Reed/File Photo
NEW WORLD
"The sooner we get a new option, the better," said Rachel Dolhun,
vice president of medical communications at the Michael J Fox
Foundation, an advocacy group for patients with Parkinson's disease.
There are already Parkinson's drugs, but they don't work well on all
patients, she said.
The first U.S.-approved treatment for peanut allergy, Palforzia from
Aimmune, was put on hold after COVID-19 stalled its launch in March.
The launch of multiple sclerosis medicine Zeposia was delayed by
Bristol Myers Squibb by about three months before the company
launched it in June.
For a list of affected drugs see FACTBOX.
Neurocrine Chief Executive Kevin Gorman said in an interview that
many neurologists had been redirected to fighting the pandemic,
leading to delaying Ongentys until later in 2020. The delay to
Palforzia, Aimmune's sole approved drug, means the company will not
generate any revenue until later this year, prompting it to halt new
hires in a bid to preserve its $370 million of cash. "We assume that
there is some kind of return to normal some point this year and that
the launch will actually take place in late summer, early fall, and
that we will start to generate revenues from then on out," said Eric
Bjerkholt, Aimmune's chief financial officer, during an investor
call.
Around half a dozen more drugs are scheduled to be reviewed by the
FDA in the coming month, including Ultragenyx Pharmaceutical Inc's <RARE.O>
therapy for a group of genetic disorders and Endo's skin-treatment
Xiaflex, which it said it would delay launching until later in the
year.
But their prospects may depend in part on the progress of the
pandemic.
Prescriptions across the board have fallen as doctors offices have
closed for non-emergency business, and the process of approving
treatments for patients could also slow down. For some products,
"every patient requires reams of prior authorizations and lots of
tests to be done, and lot of paperwork to be shared. In the old
world, that was hard. In this world, that would be impossible," said
Alnylam's Greene.
(Reporting by Carl O' Donnell in New York and Manas Mishra in
Bengaluru, additional reporting from Dania Nadeem in Bengaluru;
editing by Peter Henderson and Mark Potter)
[© 2020 Thomson Reuters. All rights
reserved.] Copyright 2020 Reuters. All rights reserved. This material may not be published,
broadcast, rewritten or redistributed.
Thompson Reuters is solely responsible for this content. |