Kiran Mazumdar Shaw, CMD of Biocon says, the agreement with PiSA of Mexico to develop insulin for the US market is important, as US commands 40 percent of global insulin market. Biocon has long standing relationship with PISA, she adds.
As per the agreement, PISA will manufacture the drug while Biocon will provide the drug substance.
Highlighting that the insulin market currently has just a handful of players and provides huge scope for growth, Shaw says, Biocon will be filing its first insulin analogue dossier in FY17.
On the government’s recent ban on fixed dose combination drugs, Shaw says, there may be some rationale to the move but a process needs to be followed as it is very difficult to recall drugs overnight.
Below is the verbatim transcript of Kiran Mazumdar Shaw's interview with Latha Venkatesh & Reema Tendulkar on CNBC-TV18.
Latha: What this agreement with PiSA of Mexico is going to mean for you in terms of profit and loss (P&L)?
A: This is an important opportunity for Biocon because the US market commands 40 percent of the global insulin's market which is right now around USD 5 billion in size and therefore the USD 2 billion opportunity which is in the US is a large opportunity for us. It is at an attractive price point and therefore we believe that it is important for us to develop this asset for the US market.
We have a long standing relationship with PiSA, where we have a very dominant share of the insulin market in Mexico which PiSA is partnering us in and PiSA has a partnership with Biocon where Biocon provides the insulin drug substance and they manufacture the drug product in Mexico and we will be using the same model for US co-development partnership that we have entered into because we believe that this partnership will give us very optimal supply chain efficiency because of its proximity to the US market and its North American Free Trade Agreement (NAFTA) membership.
Reema: Could you tell us what will be the revenue share between you and PiSA?
A: I am not able to disclose that but suffice to say that Biocon has a very attractive commercial interest in this partnership
Reema: By when will the product be ready and when the commercial sales will begin and you indicated that the market opportunity is USD 2 billion in the US? What percentage of that are you hoping to garner?
A: It is very early days to forecast that the market share that we can expect to attain but at this point in time I can say that Biocon has strong focus on insulin market share globally and we will try and garner as much market share as we possibly can in the US.
Latha: Is this a start of more such a partnership, will you deepen the partnership with this company itself?
A: We have already partnered in insulin analog with Mylan and as you also have heard before from me that we are in the process of filing our first insulin analog Glargine dossier coming fiscal. So I think we are in good shape. I think this is an important space for Biocon. There are very few players in the insulin market and Biocon is in that select group of companies which includes a handful like Novo, Lilly and Sanofi. So we are in very good company, we have a good presence in the insulin market globally and we want to strengthen this position.
Latha: The big development of the government banning the fixed-dose combinations. What is your take on this?
A: My view is that there can be a rational in terms of why they are banning these fixed-dose combinations but having said there needs to be a proper process followed because taking sudden decisions on approved products is what I think the industry is concerned about and there needs to be a greater dwell into how we go about banning any product in the future because you cannot do an instantaneous recall of everything on one particular day.
Reema: Is this a limited competition drug and also tell us what the status of the drug is. Has it completed, what trail stage is it, when can we expect the commercial sales of it?
A: Biocon's bio similar insulin is marketed in over 40 countries right now. So as a product it has been developed but we have to follow certain bio similar guidelines as prescribed by the US FDA and European Medicines Evaluation Agency (EMEA). So in the US FDA guideline, we will have to go through the entire process and we expect that it will take us at least two years to complete the process.
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