| Nektar Therapeutics said on Monday a clinical trial
showed its inhaled insulin product did not significantly hurt
patients' ability to breathe, a safety concern that had delayed the
drug's progress toward regulatory review.
Shares of Nektar, which is developing the medicine with large
drugmakers Pfizer Inc. and Aventis, jumped as much as 23 percent on
hopes the new data would help the drug win approval.
Most diabetics (news
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web sites) give themselves an insulin injection daily, an often
painful ritual that can discourage patients from sticking with their
course of treatment. An inhaled form of insulin would be more
convenient and help patients comply with their regimen, industry
analysts say.
Nektar, previously known as Inhale Therapeutics, also said the
treatment, called Exubera, reduced blood sugar levels in diabetics
more than a commonly used therapy in the late-stage, or Phase III
trials.
The inhaled product was originally expected to be submitted to
the U.S. Food and Drug Administration (news
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web sites) in 2002 or even earlier, but was delayed because of
concerns that it might hurt lung function, or patients' ability to
breathe. Nektar did not announce a new filing timeline in its
statement Monday.
The results of the trial were presented at an annual meeting of
the American Diabetes Association in New Orleans. They showed that
Exubera significantly reduced blood glucose levels in more patients
than GlaxoSmithKline Plc.'s Avandia.
Avandia is designed to make the body's natural stores of insulin
do a better job.
Many diabetics have a combination of two problems: insufficient
production of insulin, which controls levels of glucose in the
blood, and ineffective batches of the hormone in the body.
As a result, many diabetic patients take one drug for each
problem, including insulin injections for the lack of insulin and an
"insulin sensitizer" such as Avandia to make existing insulin work
better.
Nektar, Pfizer and Aventis are racing other companies to reach
the market first with an inhaled form of insulin.
Aradigm Corp., along with Denmark's Novo Nordisk, has a product
in Phase III clinical trial testing, and Alkermes Inc. and Eli Lilly
and Co. are in mid-stage, or Phase II, testing with a drug. |