This summer, while
action movies compete for top billing, Pfizer will be
angling for a blockbuster of its own — Exubera, an
inhaled insulin. The drug was recently approved in
both the United States and Europe for type 1 and type
2 diabetes in adults. Manufacturing has begun, and
Pfizer’s massive marketing force will likely start
promoting Exubera sometime this summer. This ouchless
protein delivery method’s market performance won’t
just impact diabetes. Soon, inhaled forms of other
proteins, from a variety of companies, will be
available.
Will inhaled insulin
catch on? Some analysts are predicting a
multibillion-dollar market for these products, but big
questions remain about how well patients and
physicians will accept them. Pfizer reports that many
of the clinical trial patients preferred Exubera over
insulin injections. Some physicians are more
skeptical. “It’s a technical breakthrough, but
I’m not sure yet it’s a clinical breakthrough,”
says Richard Jackson, a physician at the Joslin
Diabetes Center. Jackson argues that the inhaled
insulin is harder to dose, more cumbersome to take,
and has unanswered long-term safety questions.
Meanwhile, insulin injections have become much less
onerous.
Exubera is the first
inhaled insulin approved by FDA, but will soon face
competition. Both Eli Lilly (with Alkermes) and Novo
Nordisk (with Aradigm) have such products in Phase III
development. “Inhaled insulin removes a major
barrier to treating diabetes,” says Douglas Muchmore,
a fellow at Eli Lilly. “Market research tells us
that injections are a major reason type 2 diabetics
delay treatment.” Muchmore says a deciding factor in
the insulin market will be precision of delivery.
Diabetics need very precise doses, and need to be able
to change their dose by small increments.
Exubera uses Nektar
Therapeutics’ technology. Other methods are
following quickly behind, opening the way for
additional inhaled protein products. Eli Lilly is
collaborating with Alkermes on inhalable human growth
hormone and parathyroid hormone. These therapies are
both in earlier stages of development than the insulin
product. Startup Momenta Pharmaceuticals, meanwhile,
is working on inhaled forms of interferon beta,
erythropoietin, insulin, and human growth hormone.
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