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 More than two dozen drugmakers are working on novel medicines to
treat the condition affecting about 20 million Americans, also known
as atopic dermatitis, and Pfizer's $5.2 billion deal positions it to
become a market leader.
Anacor's steroid-free topical ointment crisaborole is the first of
the new treatments to be reviewed by U.S. regulators. An injectable
therapy called dupilumab from Regeneron Pharmaceuticals Inc <REGN.O>
is expected to be submitted for U.S. approval later this year.
"Until a few years ago, I don't think we had any message of hope for
eczema patients who have tried everything," said Gil Yosipovitch,
chairman of dermatology at Temple University School of Medicine who
is a paid consultant for both companies. “Now we do.”
The two medicines greatly reduced eczema symptoms in late-stage
trials without side effects accompanying current treatments. They
could eventually see combined annual global sales of over $9 billion
and face no significant competition for years.
Yosipovitch said Anacor’s crisaborole could be a valuable option for
the 60 percent to 80 percent of patients with mild and moderate
eczema on localized areas of the body. Dupilumab would be used for
patients with more severe disease, he said.
The global eczema drug market is currently worth about $4 billion in
sales, mostly of topical steroids than can cause skin atrophy and
increase risk of glaucoma and cataracts. Doctors may also prescribe
oral drugs that suppress the immune system, such as cyclosporine,
but they are not approved for eczema and can cause infections,
shingles and cancer. There are no approved systemic drugs for the
condition.
However, the cost of the new treatments may limit patient access.
Regeneron's injectable dupilumab could cost $25,000 a year, similar
to psoriasis drugs, at a time when U.S. health insurers are
resisting rising drug prices. Analysts say it could eventually
capture annual sales of $6 billion, with Anacor's drug costing more
than $1,200 a year and having peak annual sales of up to $3 billion.
"Payers know this will be a big market and will put up a lot of
barriers and restrictions," said Yatin Suneja, an analyst with
Suntrust Robinson Humphrey.
Express Scripts Inc last month said it would scrutinize new eczema
treatments and their expected prices.
LONG-TERM EFFECTS
Crisaborole blocks an inflammation-causing protein called PDE-4. In
large clinical trials that included children and adults, it cleared
or almost cleared treated areas of skin in half of patients with
mild to moderate disease, with mild side effects.
"We badly need a nonsteroidal topical that can get around serious
steroid concerns and this drug showed no skin atrophy or other
significant side effects," said Dr. Lawrence Eichenfield of the
University of California San Diego and lead author of American
Academy of Dermatology eczema treatment guidelines. Regeneron and
Sanofi aim to seek approval for dupilumab this year for adults with
moderate to severe eczema. It blocks two proteins, IL-4 and IL-13,
believed to cause eczema and allergic conditions like asthma.
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In big trials, dupilumab led to an average 70 percent improvement in
rash area and severity. Fewer serious side effects, including
infections, were reported for dupilumab than for placebos. In
separate studies it reduced incidence of asthma.
One concern over drugs like dupilumab, which regulate the immune
system, is potential for serious side effects over time, including
lymphoma. Such problems typically do not show up until a patient has
used a medicine many years, said Dr. Cameron Rokhsar, a New York
dermatologist with no financial ties to the drugmakers.
Roche Holding AG and AstraZeneca Plc are developing injectable
eczema treatments several years behind dupilumab.
Data from mid-stage trials of the Roche drug, lebrikizumab, are
expected in the second quarter. AstraZeneca plans this year to
disclose data from a mid-stage trial of its tralokinumab in adults
with moderate to severe eczema.
Nemolizumab from Japan's Chugai is also being tested in a mid-stage
trial. The injectable drug targets IL-31, a protein associated with
itch, a hallmark of eczema.
"The main concept of our drug is to break the vicious itch-scratch
cycle because scratching damages the skin and causes more intense
inflammation," Dr. Michiaki Tanaka, a senior Chugai research
executive, said in an interview.
Celgene Inc recently tested its psoriasis drug apremilast in
about 200 patients with moderate to severe eczema.
It has not publicized the results, but researchers and analysts say
it could become the first approved oral treatment for eczema. The
pill has caused nausea and other gastrointestinal problems in
psoriasis patients. "I'm very excited about apremilast because we
have no approved oral drug for eczema," said Dr. Emma Guttman-Yassky
of Mt. Sinai Medical Center in New York. She helped conduct trials
of apremilast and dupilumab.
(Reporting by Ransdell Pierson; Editing by Michele Gershberg and
Bernard Orr)
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