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October 25, 2007

Exubera Inhaled Insulin Is No Longer Available

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Exubera Inhaled Insulin Is No Longer Available

Gone is the insulin bong as Pfizer announces they have spent 2.8 billion

on the marketing and development of the first inhaled insulin, but have

received

just 12 million in sales in 2007. This will be a great opportunity to

educate those patients using Exubera.

Pfizer

said last Thursday, that it would stop selling

Exubera

, its inhaled insulin, less than two years after introducing the drug.

Despite Pfizer's heavy promotion, Exubera's sales were minuscule, with

prescriptions

amounting to less than 1 percent of the insulin market.

Jeff Kindler, chairman and chief executive officer of Pfizer, said " we

made an important decision regarding Exubera, a product for which we

initially had

high expectations. Despite our best efforts, Exubera has failed to gain

the acceptance of patients and physicians. We have therefore concluded

that further

investment in this product is unwarranted. "

Kindler said the company would work with physicians to " transition

Exubera patients to other treatment options in the next three months. We

remain committed

to investing significant resources in the development of new and

innovative medicines to manage diabetes, including monitoring inhalation

technologies

and other innovative delivery systems for insulin and other medicines. "

The inhaled insulin was approved less than two years ago, but that

approval followed a long and rocky development process. Although

clinical trials had

demonstrated Exubera to have efficacy similar to that of short-acting

insulins, but without the needle stick, a host of concerns had cropped

up, including

worries about pulmonary toxicities, and questions about Exubera's

ability to achieve a reduction in glycosylated hemoglobin (HbA1c) levels

to below 7%,

the accepted gold standard.

Over the years, the developmental challenge had been to reduce insulin

to particles of just the right size to be inhaled by the lung and then

absorbed into

the bloodstream. Too small, and the particles would be exhaled. Too

large, and the particles would be filtered out.

In its approval statement, the FDA noted that the safety and efficacy of

Exubera have been studied in approximately 2,500 adult patients with

type 1 and

type 2 diabetes.

Exubera's end is another black eye for Pfizer, the world's biggest drug

company, which has sustained a series of recent reversals. The abrupt

discontinuation

also calls into question whether inhaled insulin - once viewed as a

potential multibillion-dollar market worldwide - will ever be able to

compete with

conventional injectable insulin as a treatment for

diabetes.

Several companies, including

Eli Lilly

, are investing in expensive programs to develop inhaled insulin. But

Pfizer said it would not try to develop a replacement for Exubera,

ending its inhaled

insulin research after more than a decade of work.

Many diabetes experts and longtime skeptics about Exubera, said that the

problems that bedeviled Exubera would probably plague other inhaled

insulin treatments

under development.

In a statement, Pfizer said it would work with physicians to move all

patients off Exubera within three months.. " Despite our best efforts,

Exubera has failed

to gain the acceptance of patients and physicians, " B. Kindler,

Pfizer's chairman, said in a statement.

When federal regulators approved Exubera in January 2006, analysts and

Pfizer predicted that the drug would become a blockbuster, easily

topping $1 billion

in sales annually. Pfizer was so bullish on Exubera's prospects that

just a few days before the approval, the company paid $1.4 billion to

Sanofi-Aventis

, the French drug maker, to buy out Sanofi's share of Exubera.

Even a few months ago, with Exubera's sales lagging badly, Pfizer

insisted that it still believed that the drug could reach blockbuster

status. And for

much of this year, Pfizer has heavily promoted Exubera to physicians and

patients.

But Exubera was not able to overcome questions about its safety,

efficacy, convenience and cost.

Clinical trials showed that Exubera marginally decreased patients'

breathing ability, although Pfizer said the declines reversed if

patients stopped taking

the drug. Further, regulators required that patients take a lung

function test before starting on Exubera, and another test after taking

it for six months.

The tests were an inconvenience for patients and for busy doctors.

Physicians also said that they worried about the possibility that

patients would receive more - or less - insulin than they expected

because of the natural

day-to-day variability of lung function. Too little insulin can lead to

uncontrolled high blood sugar, while too much can produce hypoglycemic

shock.

In addition, the needles that are used to inject insulin have shrunk

over the last two decades, making injections less painful. The size of

the Exubera

inhaler, variously described as looking like a tennis can or a bong for

smoking marijuana, was also an obstacle.

Finally, insurance companies were reluctant to pay for Exubera, or the

required lung function tests, since Exubera does not control blood sugar

better than

ordinary insulin. Exubera has cost about $5 a day, compared with $2 to

$3 a day for injectable insulin.

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