Biocon may start phase-III clinical trials for Tregopil insulin on type-2 diabetes patients1 min read . Updated: 28 Apr 2017, 11:02 PM IST
Biopharmaceutical company Biocon also plans to initiate a multiple ascending dose study for its oral insulin on patients with type-1 diabetes in the current financial year
Mumbai: Biocon Ltd’s long-standing oral insulin project is expected to move forward as the company may soon start phase-III clinical trials for its Tregopil in India on a few hundred patients with type-2 diabetes.
“We have already filed an application with the DCGI (Drug Controller General of India) to conduct pivotal phase-III study for insulin Tregopil to clinically validate its promise as an orally delivered, rapid acting prandial insulin in managing type-2 diabetes and we hope to soon start the trials," said Kiran Mazumdar Shaw, chairperson and managing director of Biocon.
The Bengaluru-based biopharmaceutical company also plans to initiate a multiple ascending dose study for its oral insulin on patients with type-1 diabetes in the current financial year.
Biocon had previously conducted a large scale phase III study in India for its oral insulin, which concluded in 2011. The study had met all secondary endpoints on efficacy and safety. However due to faulty study design, the primary endpoints of the trial could not be met.
Later on another phase-1 clinical study for the oral insulin was conducted in the US on over 100 subjects and the company announced a positive outcome from this study in January 2016.
The drug maker also plans to shortly file application for its insulin Glargine with the US Food and Drug Administration (FDA). The company has already launched insulin Glargine in Japan in partnership with FUJIFILM Pharma.
Biocon, along with partner Mylan, has also filed application for biosimilars trastruzumab and pegfilgrastim with the US regulator.
The company expects revenue from its biologics portfolio in regulated markets such as the US and Europe to kick in from financial year 2018-19 and has maintained its guidance of touching the $1-billion revenue mark in FY19.
However, for the current fiscal, Biocon is “cautiously optimistic" over its growth outlook as factors such as timelines of regulatory approvals for its biosimilars in emerging markets, appreciation of the rupee and roll out of the goods and services tax in India will have a bearing on the company’s financial performance, Shaw said.
In 2016-17, the company reported net profit of Rs612.1 crore, up 11% from a year ago, while sales grew by 16% to Rs3,921.6 crore.
On Friday, shares of Biocon ended down 1.3% at Rs1,105.35 on the BSE, while benchmark Sensex index closed 0.4% lower at 29918.40 points.