EU nod for cholesterol drug to help Biocon move up value curve

Biocon has received approval from the European Directorate for the Quality of Medicines (EDQM) for cholesterol-controlling drug Rosuvastatin Calcium, opening the doors to over 15 European countries and will enable the company to address a $1.2-billion opportunity starting FY17. Speaking to Bloomberg TV India , Biocon Chairperson and Managing Director Kiran Mazumdar Shaw says the EU approval is an indication of US ANDA approval in the near future, which will then enable the company to really move up that value curve. This also enables Biocon to get faster registration of the product in other regions of the world such as West Asia and South East Asia.

What is the size of the addressable market for which you got the cholesterol-control drug approval? Well, as you know, the size of the generic market is obviously a fraction of what the current size of Rosuvastatin’s market is. But I think, more than anything else, this is about our business strategy of moving up the value curve. And as you know, we have been a very large player in this statin business, and Rosuvastatin off course has been in the API market all these years. And I think this enables us to move up the value change and create far creative value from this product. The EU approval is an indication of a US ANDA approval in the near future, which will then enable us to really move up that value curve.

Talking about the USA API market, can you clarify if there was an import ban in the USA as far as your API business goes? Completely wrong. We have had no ban on any of our plants. I don’t know where you got that wrong information. But, I would like to vehemently correct that perception. We have passed all our US audit to date, we have absolutely no ban on any of our manufacturing sites and I think I would like to again reemphasise that we are one of the largest producers and exporters of Rosuvastatin.

The EU approval offers you opportunities of close to $1.2 billion. So what is the kind of incremental revenue gain that you are looking at for this product? Obviously, it is about the number of players in the market and the way we basically strategise to get good market share. So, obviously there is no such optics I can provide you with at this stage, but I think the important message that we are giving is that we have arrived on the generic stage.

If you could just tell us when can we expect the launch of the product? Very shortly. In Europe, for sure it will in the near future. And hopefully, the bigger market opportunity is in the US.

What is the size of the revenue contribution you see from markets such as Europe as well as US than going forward? At this point in time, it will be very difficult for me to give you clarity on the actual addressable size for Biocon because this is our first generic. But, I think we will be able to give you far better optics when we enter the market.

You have mentioned that you would be looking to collaborate with regional partners as well. If you could give us details in terms of what kind of collaboration are you looking at? Europe is not a homogenous market. It is a market that has country-wise opportunities. And in certain key markets, we will also look at regional partners. And, this also enables us to get into other regions of the world — in Middle East and South East Asia — because European approvals do enable us to get into certain markets and register in an expeditious manner.

How is the launch pipeline looking going forward? We have a very good generic pipeline in development and I think this is first of the block. I think you can expect to see a stream of such molecules from our stable over the coming years.

When do you plan to launch all of this in terms of our emerging markets are concerned? This is the first of the block and for us, speed is the essence. So, we will try and see how soon we can launch these products in every possible market opportunity.