Biocon oral insulin seems to be coming up short

Biotechnology firm Biocon’s ambitious oral insulin project has failed to live up to its hype, thereby putting a question mark over the market entry of insulin in oral form in the near future.

In a trial in India involving 264 patients across multiple centres, the molecule — IN 105 — failed to meet the primary goal of reducing HbA1c levels by 0.7%.
HbA1c indicates the level of blood glucose in a person.

The molecule did, however, meet parameters concerning safety and efficacy, and further assessment of the data is currently on, the company said.

Biocon CMD Kiran Mazumdar-Shaw said they will continue global development of the molecule by partnering a global company, for which discussions will be initiated.

Experts, though, aren’t enthused.

Reducing HbA1c is the primary objective, Dr AK Jhingan, chairman, Delhi Diabetes Research Centre, pointed out. “If that key objective is not met, then what is the point of bringing out a product which will be costlier than existing insulin, which most patients are used to?”

According to a diabetologist in Mumbai, though the medical community is excited about non-injectable ways of delivering insulin, it is highly wary of actually prescribing such products. “So many patients are on insulin. It’s a tough call for doctors to actually ask patients to use insulin in a different format, when little is known about its side effects in the long run.”

A pharmaceutical industry expert also made light of the claim about global development of the molecule. “Which global firm will come forward and be ready to partner in this project, where the risks are so high? Without a partner, it’s impossible at a financial level to continue with the development.”
Ranjit Kapadia, vice-president, institutional research, HDFC Securities, said there were no major upsides from this result.

“They used the product along with another diabetes product metformin. There needs to be studies on how it works as a singular product and in a larger patient population.”

Experts say insulin in non-injectable form is a mechanism that quite a few companies, including behemoth Pfizer, have experimented with and failed.
In 2007, Pfizer’s Exubera, one of the world’s first non-injectable insulins, was withdrawn due to poor sales, as it didn’t gain acceptance amongst the medical and patient community. The product, which delivered a powdered form of insulin through an inhaler into the lungs, was also difficult to handle because of its huge size, and was said to reduce lung function in some patients.

In 2008, US-based Generex Biotechnology introduced ‘oral recosulin’, a delivery device that worked by placing it in the mouth, and a pre-set quantity of insulin would be sprayed into the mouth cavity, below the tongue.

This product faced controversy for not having adhered to guidelines pertaining to stringent regulatory approvals, and its marketing licence was suspended.
“With the Exubera failure, MNCs are skeptical about venturing into this territory. In the US, the regulatory authorities are much more stringent than in India. So any optimism at this point on IN 105 is premature,” said the pharma expert.

“Exubera is something stuck at the back of most doctors’ minds when it comes to asking patients to use non-injectable insulin,” said Dr Jhingan.