Pfizer Engaged in Outreach to 200,000 Healthcare Professionals About Use of
Exubera, the First Inhalable Form of Insulin
Exubera will be Introduced in the U.S. Starting in Mid-July
NEW YORK, June 9 /PRNewswire-FirstCall/ -- A New Medicine for People
With Diabetes: Exubera(R) (insulin human (rDNA origin)) is a rapid-acting
dry powder human insulin inhaled through the mouth into the lungs prior to
eating using the Exubera Inhaler. The patient inserts an Exubera blister
into the inhaler, and with the press of a lever and a button, an insulin
cloud is released into the inhaler chamber. The patient breathes in
normally, sending the insulin into the lungs and then the bloodstream.
Exubera was approved earlier this year in the United States and in the
European Union for adults with type 1 and type 2 diabetes.
New Long-term Safety and Efficacy Data:
* Two studies assessed the long-term safety and efficacy of Exubera in
patients with type 1 and type 2 diabetes. In these Phase III studies,
the level of sustained blood sugar control in patients taking Exubera
was compared to patients taking placebo. A similar comparison was made
regarding respective differences in weight gain.
(Saturday, June 10, 10:15-12:15, Washington Convention Center, Room 146
(Oral presentations 109, 110))
Analysis of Delay in Insulin Treatment in U.K. and U.S. Patients:
* Two studies reviewed a medical database of patients with type 2 diabetes
in the U.S. and the U.K., and examined the length of time it took
patients, who should have started taking insulin, to begin treatment.
Patients often delay taking insulin injections, which is necessary to
get their blood sugar in control, although delaying insulin can put them
at risk for developing devastating complications such as kidney failure,
heart disease and blindness. The results will be of interest to health
care professionals, health plans and government health care systems that
care for and manage patients with Type 2 diabetes.
(Sunday, June 11, 12:00-2:00 and 6:30-7:30 Hall C, Washington CC
(Poster: 535-P); Monday, June 12, 4:30-6:30, WCC, Room 151 (Oral
Presentation 324))
Pfizer Education:
* "Millions of patients are not achieving or maintaining acceptable blood
sugar levels, despite the availability of current therapies," said Dr.
Michael Berelowitz, Pfizer Worldwide Medical. "Exubera meets a critical
medical need by offering a highly effective and needle-free alternative
to diabetes pills and insulin injections to manage this complicated,
debilitating disease. That's why we are making a comprehensive
education campaign a priority."
* As part of its educational outreach, Pfizer will discuss the
introduction of Exubera with leading experts in diabetes care at ADA.
By September, Pfizer estimates it will have communicated with
approximately 200,000 health care professionals about Exubera, with
continuing outreach throughout 2006.
* The company will begin to make Exubera available in the U.S. in mid-July.
* When Exubera is available, a 24 hour toll-free customer support center
will be initiated to assist patients and physicians in the U.S.
Extensive Exubera education materials -- including CD-ROMs and patient
guides -- will be distributed to physician offices, pharmacies, health
clinics, and patient organizations.
Note to News Media:
* Exubera Media Briefing: Saturday, June 10th from 7-9 p.m. at the
Mandarin Oriental Hotel. The briefing will include overview of data and
product demonstrations.
* Background information on studies will be posted on
http://www.pfizer.com timed to presentations at ADA.
Important Safety Information about Exubera
Patients should not take Exubera if they have poorly controlled or
unstable lung disease, or if they smoke or have stopped smoking less than
six months prior to starting Exubera treatment. If a patient starts smoking
or resumes smoking, he or she must stop using Exubera and see a health care
provider about a different treatment.
Before starting treatment with Exubera, a health care provider will
carry out a simple test to check lung function. This will help to find out
if Exubera is the right treatment for individual patients. Once a patient
starts treatment, it is recommended that a health care provider check lung
function again at six months and yearly thereafter.
Like all medicines, Exubera can cause side effects. As with all forms
of insulin, a possible side effect of Exubera is low blood sugar levels.
Some patients have reported a mild cough while taking Exubera, which
occurred within seconds to minutes after Exubera inhalation. Coughing
occurred less frequently as patients continued to use Exubera.
In clinical trials, treatment with Exubera was associated with small,
nonprogressive declines in lung function relative to comparator treatments.
SOURCE Pfizer Inc
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CONTACT: Daniel Watts, +1-212-733-3835, or Vanessa Aristide, +1-212-733-3784, both of Pfizer Inc
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