Aurobindo Pharma is set to up the focus on its peptide business and will be filing its first set of drug master files (DMFs) by the end of this fiscal. A DMF is a submission to the Food and Drug Administration (FDA) used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.
“We are planning to file our first set of DMFs by the end of the financial year. We will be filing at least two products and two more products will be filed six months from then,” N Govindarajan, MD, said during the recent Q2FY15 earnings call.
“So, clearly, we have created a facility where we have two modules; now we are expanding it to a third module because there is pressure in terms of filing more number of products,” he said. The company expects the regulatory inspection in the next 18 months.
“Once we file the DMFs by the end of this financial year, we expect inspection to happen within 15-18 months while, parallelly, DMFs are also reviewed; so from there the business would kick in. But there is a good amount of excitement because there are enough customer requirements.
From a technology perspective, we are among the top 3-4 in the global arena in terms of capability, which has been established by supplying samples and being qualified through the sample evaluation,” he said.
“From a commercial perspective, we hope FY17 or FY18 is when these two products will start performing. Further, during the filing phase of DMF, we will be supplying enough quantity of validation batches as well. So, from a revenue perspective, we do not need to necessarily wait till the product gets commercialised,” he added.
“We are right now focusing on the US and Europe but, interestingly, even now there is some sale happening in the domestic market and some non-regulated countries,” he said.
The company is looking at a capex of Rs 600 crore for FY15 for various capacity expansions, including developing the peptide business and spreading out across APIs and the formulations business.
On market potential, he said that of the 30 products, if they reach 15-20, it can result in at least $70-80 million in top line or, even, $100 million.
Peptides are one of the most profitable businesses in the entire spectrum.
Govindarajan had earlier said during an analyst call that, globally, there were two large companies in peptides — one based out of Europe and the US, and the other in the US. And peptide companies were at this juncture in the $100-$300 million range.
“By 2018, the peptide industry itself could be $15-18 billion. In the next few years, we should be reaching the range of $100-$200 million,” he had said.
According to estimates, the worldwide market for peptide therapeutics was valued at $14.1 billion in 2011 and is expected to grow to $25.4 billion in 2018 at a CAGR of 8.7%. The prevalence of cancer, Alzheimer’s and Parkinson’s disease and metabolic disorders have grown in recent years, which has propelled the peptide therapeutics market.
By BV Mahalakshmi