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 Exubra was withdrawn from the market in 2007 due to slowdown in sales mainly because of issues revolving around product design.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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