Pfizer's Oxbryta exit may hasten trials of rival experimental sickle cell drugs, analysts say

Fulcrum Therapeutics

26/09/2024 16:36

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      EMA raises concerns about deaths in Oxbryta trials
    

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      Shares of Agios and Fulcrum rise after Pfizer's decision
    

  
    By Kashish Tandon and Christy Santhosh
       Sept 26 (Reuters) - Pfizer's  PFE.N  decision late on
Wednesday to withdraw its sickle cell disease treatment due to
the risk of death could help speed up trials of new experimental
rivals, Wall Street analysts said.
    Oxbryta, one of at least six treatments for the disease, is
mostly used in patients with mild-to-moderate symptoms. The drug
received accelerated approved in the U.S. in 2019, requiring
further trials to confirm the benefits.
    In July, the European Medicines Agency posted online
concerns about deaths in two of those trials. The regulator,
after a meeting on Thursday to discuss the data, said that it
had serious concerns about the safety. It recommended an
immediate suspension of its authorization.
    At least three Wall Street brokerages said the withdrawal
could create an immediate need to accelerate trials of rival
drugs for the inherited condition, including Agios
Pharmaceuticals'  AGIO.O  mitapivat and Fulcrum Therapeutics'
 FULC.O  pociredir.
    Enrollment in an early-stage trial has been a hurdle for
Fulcrum, said analysts at Leerink.
    In case of Agios, it could create pressure on regulators to
speed up the review, Piper Sandler analysts said.
    If mitapivat shows benefit in reducing the painful episodes
that mark the disease, "we anticipate this will enable an easier
regulatory review, especially now considering the greater
demands from patients who can no longer access Oxbryta," said
Piper Sandler's Christopher J. Raymond.
    Shares of Agios rose 4% while Fulcrum jumped more than 20%
in early trading.
    Two recently approved gene therapies - bluebird bio's
 BLUE.O  Lyfgenia and Vertex Pharmaceuticals'  VRTX.O   and
partner CRISPR Therapeutics'  CRSP.BN  Casgevy - are reserved
for people with severe form of the disease.
    The removal of Oxbryta likely leaves the vast majority of
patients, who have mild-moderate symptoms, relying on
chemotherapy medicine hydroxyurea, said Stifel analyst Dae Gon
Ha on Thursday. 
    Sickle cell disease affects an estimated 100,000 people in
the U.S., most of whom are Black. 
    The withdrawal is the latest headwind for Pfizer and its CEO
Albert Bourla. Investors have punished the company as it
navigates sharply dropping sales for its COVID vaccines and
drugs, a weaker-than-hoped launch of its respiratory syncytial
virus (RSV) vaccine and disappointing clinical data for an
obesity pill it was developing.
    Pfizer's shares were marginally down on Thursday. The stock
is trading at around half its pandemic highs.
    Oxbryta was the centerpiece of Pfizer's $5.4 billion buyout
of Global Blood Therapeutics in 2022, one of a number of deals
bankrolled by the pandemic-era windfall. It also picked up two
other experimental sickle cell treatments, both of which remain
in clinical trials, according to Pfizer's website.
    In patients with the disease, red blood cells become sickle
or crescent shaped and can cause strokes, organ damage and early
death, as well as debilitating pain crises.

 (Reporting by Christy Santhosh and Kashish Tandon in Bengaluru;
Additional reporting by Michael Erman in New Jersey; Editing by
Sriraj Kalluvila)
 ((Kashish.Tandon@thomsonreuters.com; 8800437922;))