Biocon plans new drug applications in US

Move part of plans to explore developed markets like US with generic finished dosages

Pharmaceuticals maker Biocon is planning to file abbriviated new drug applications or ANDAs for its finished dosage products (medicines that have completed all stages of production including packaging) in the US. The company is working on developing over 20 ANDAs to grab a share of a market for therapeutic medicines that is worth $30 billion.

The company is also expecting to complete studies on an oral insulin drug in three to four years.

Speaking to the media on the sidelines of the launch of Women2Women (W2W) healthy awareness intiative, Kiran Mazumdar-Shaw, chairman and managing director, said, “We will be starting by filing a few ANDAs in 2015.” She refused to reveal the details of the products.

The new applications are part of the company’s strategy for moving up the value chain to the generic finished dosages business in developed markets from the active pharmaceutical ingredients (API) business.

According to the company’s annual report for 2013, it created a new ANDA sub-unit that would be vertically integrated with the API units for this.

“The ANDA initiative aims to build a robust pipeline of difficult-to-make, technology-intensive molecules that can be commercialised, primarily in the US as well as other global markets. We currently have over 20 ANDA programmes under development,” the report said. The focus is on therapeutic segments such as oncology, diabetology, cardiology, dermatology, ophthalmology and inflammatory diseases.

“As part of this plan, Biocon has identified over 20 molecules for developing ANDAs that address a market opportunity of nearly $ 30 billion,” it added. The move is aimed at using Biocon’s expertise in APIs to vertically integrate into making branded formulations for emerging markets and generic finished dosages for the developed markets.

It is expecting its oral insulin drug candiate to go through the third phase of studies and would see the trials completed in three-four years for the global market. However, the molecule would be launched in India before this, Mazumdar-Shaw said.

The company in 2011 said the late-stage clinical trials of its oral insulin drug under experiment to treat Type-II diabetes had not met the desired results. The annual report said though an unexpected placebo effect prevented some results from being achieved in the clinical trial conducted in India, other results fulfilled indicated the drug worked in lowering the blood glucose level.

Biocon has entered into an agreement with Bristol-Myers Squibb (BMS) for research on the drug candidate. The agreement stipulates BMS to provide financial and development assistance to establish efficacy through a number of Phase-I and -II clinical trials and at the completion of the studies, it would have an exclusive option to further develop and commercialise the drug worldwide, added the report.