Cipla's Inhalable Insulin Project Suffers a Setback
Expert panel denies co permission to conduct trials on Indian
patients
Drug maker Cipla's plan of developing a
pump-delivered inhalable form of insulin has suffered a setback with an expert
committee denying it permission to conduct trials on Indian patients.The panel
has said the company's preliminary data on safety and efficacy of the trial drug
is insufficient.
Cipla had based its application to the panel
on the bioequivalence studies with Exubra, an inhalation drug and device
combination that was being marked by Pfizer. Exubra was withdrawn from the
market in 2007 due to slowdown in sales mainly because of issues revolving
around product design.
In November, the Subject Expert Committee -a
group comprising experts in diverse fields of endocrinology and metabolism -met
and noted: “The firm (Cipla) has presented BABE (bioavailability bioequivalence)
study data and requested for phase IV study which is not acceptable and not
scientifically justified with respect to inhaled insulin." Cipla declined to
comment on the development.
A year ago, Cipla's application was examined
by the same committee. It was directed to establish the safety, efficacy and
dose finding study (phase I and II) before carrying out phase III study. That
apart, Cipla was asked to provide safety and toxicological data from
experimentalanimal studies.
“The firm should also carry out the
coefficient of variation and stability of the device intended to be used for
delivering of inhaledpowder insulin,“ the committee had then said in its
report.
A veteran in clinical research told ET the
chances of Cipla getting a green signal appear slim given the issues related to
studies to establish safety, efficacy and immunogenicity of the product in the
new formulation. However, he said, carrying out large-scale studies and
improving on the product design would enable Cipla to prove that it has
bettered the safety and technology profile of the product.Although drug makers
have explored technological disruptions to deliver insulin in forms other than
needles and bring in convenience to the patients, those have met with little
success.
It was not just Pfizer's Exubra that was
junked. More recently, French drug maker Sanofi ended its deal with US-based
Mannkind which had developed Afrezza.
The product could not reach a scale due to
lower-than-expected response from prescribers. Novo Nordisk, the biggest
insulin maker in the world, recently dropped its project on oral insulin.
Instead, it is focusing on a non-insulin drug that can be had as a tablet.
Those failures, however, do not take away
from Cipla's capabilities in developing products using the inhalation
technology. It ranks among the best in the field with the largest portfolio of
28 molecules and their combinations in the respiratory drugs segment, say
experts. In a presentation made earlier this year, Cipla executives talked of
an insulin product under development, without elaborating on details.
Meanwhile, Bengaluru-based Biocon is making
steady progress in its oral insulin project. Earlier this year it announced key
data that it said can be the basis for further clinical development of its
product Tregopil.
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