MESSAGE
| DATE | 2005-09-11 |
| FROM | Ruben Safir
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| SUBJECT | Subject: [NYLXS - HANGOUT] New Insulin without inject HUGE Tech Breakthrough
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Inhaled Insulin Raises Doubts
Expert panel is keen on Pfizer’s inhaled insulin product, but some
analysts are skeptical about its market impact.
September 9, 2005
After about half a decade in the final stage of clinical trials, a U.S.
Food and Drug Administration advisory committee has finally recommended
that Pfizer’s inhaled insulin product, Exubera, receive agency approval
for both type 1 and type 2 diabetes.
Seven of the nine experts delivered a positive decision Thursday.
However, their discussions highlighted key problems for Exubera’s
launch, causing some analysts to lower their revenue estimates for the
drug Friday.
“The panel physicians [endocrinologists and pulmonologists] and the
patient advocate did not appear to be excited about the availability of
inhaled insulin,” wrote Merrill Lynch analyst David Risinger. “As a
result, we could see a slow uptake curve that is primarily dependent on
patients new to therapy… rather than the switch of current injectable
users.”
The idea behind Exubera is simple. Diabetics don’t like injections.
Therefore, if insulin could be delivered through a device like an asthma
inhaler and cut out—or at least cut down—the need for injections, it
would probably make a lot of money.
‘[Some panelists] had concerns about
the durability and potential
frequency of repairs.’
-C. Anthony Butler,
Lehman Brothers
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“Given potential slow adoption, we are lowering our U.S. Exubera
estimates to $200 million from $400 million in 2006, $400 million from
$800 million in 2007, $600 million from $1.2 billion in 2008, and $828
million from $1.5 billion in 2009,” added Mr. Risinger.
Pfizer shares fell $0.18, closing at $26.33 on Friday.
The advisory panel’s recommendation is not binding. However, the FDA
almost always follows the advice of its expert panels.
Pessimistic Sentiments
Many of the reasons behind analysts’ pessimistic sentiments are
surprisingly mundane, given the complex problems of drug delivery. For
one, men tend not to carry purses, and they might not be bothered to
carry around an inhaler.
The device also counts insulin doses in milligrams, with which U.S.
patients are unfamiliar, and they are also likely to have to carry
around a backup inhaler, increasing the cost of treatment.
“The Advisory committee spent a great deal of time discussing the
potential problems with Pfizer’s pump/delivery device for the inhaled
insulin,” wrote Lehman Brothers analyst C. Anthony Butler. “[Some
panelists] had concerns about the durability and potential frequency of
repairs.”
Mr. Butler expects the FDA to approve Exubera by the end of the year,
and Pfizer likely will launch the product early in 2006.
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