EU approval for making Rosuvastatin a key milestone: Biocon

Biocon on Monday received its first generic formulation approval for making Rosuvastatin Calcium tablet in the European Union (EU). This will enable the company to address USD 1.2 billion market opportunity and it will launch the drug in FY17. In an interview to CNBC-TV18, Kiran Mazumdar-Shaw, Chairman of the company, says this is a very important milestone for Biocon as part of the company's change in strategy. This area means a big uptick in value creation, she adds.Further, she says the company will soon apply for Abbreviated New Drug Application (ANDA) for the same in the US as well.
However, she says the company will not get a 6-month exclusivity for this particular product.   Below is the verbatim transcript of Kiran Mazumdar Shaw’s interview with Ekta Batra & Anuj Singhal on CNBC-TV18.Ekta: If you could just take us through this opportunity that has emerged from the EU this formulation approval that you have received?A: This is a very important milestone for us because we had indicated a while ago that we were changing our business strategy and moving up the value curve from active pharmaceutical ingredient (API’s) to finished formulation. As you know we have a huge strength in statin and of course this is for a Rosuvastatin formulation which of course allows us to really rapidly go up the value curve. As you know this obviously paves the way for us to get our ANDA also approved in the US. So, this is a pretty large opportunity for us starting with Europe and before too long we should be able to get our ANDA approval in the US as well. So, a big milestone for us and we have a nice pipeline of similar chemist formulations for both the Europe and US markets.Anuj: When you say it is a large opportunity if you could give us any ballpark number and where you are sitting right now what kind of visibility do you see in revenue addition from here on?A: The generic business, if you look at the size of the market today it genericises very fast. The price point, the pricing should not be looked at as in terms of what the size of the Rosuvastatin market is in US and Europe, but rather what will it sort of fall down to. We are very well poised because we have been supplying our API’s to many generic companies. We believe that we will able to compete very effectively in this space. So, it is a multibillion dollar opportunity even when it genericises when you combine US and Europe. We hope that we can take a good share of this opportunity.  Ekta: When you spoke about the US market and a possible ANDA launch of your statin there, can you just give us more details on that? What would the market size be which would be the statin that be launching in the US?A: What I wanted to say was that this paves the way for the same molecule which we are also developing under an ANDA. So, the EU approval gives you some upticks on an ANDA filing for the same molecule which we hope to receive fairly soon. We are not the first to file, we are not going to get six months exclusivity for this, this was our first starting product in which we have some strengths in the API area. So, now we will be moving up the value curve so obviously this means a big uptick for us in terms of value creation. So, obviously we can capture a much better value for this molecule than before.