Biocon -Mylan on Wednesday initiated the global phase-3 trails for the insulin Glargine which targets around USD 8 billion market globally and has a size of around USD 3-4 billion. Speaking to CNBC-TV18 on the impact going ahead, Kiran Mazumdar Shaw, CMD, Biocon says the company is looking to commercialise Glargine by 2018.
The Indian research and development pharma company that developed this biosimilar drug and later on partnered Mylan to develop it further, will start receiving royalties once the insulin Glargine gets completely commercialsed post all necessary trials.
Shaw believes diabetic market has huge opportunity and is currently under-served with very players catering to this problem. According to her, the insulin analogue opportunity is a USD 20 billion space and the market is growing in double-digits.
The company will be able to address a larger global market due to the tie-up with Mylan, which exists on a profit-share agreement.
Below is verbatim transcript of the interview:
Q: The news that Biocon is reacting to is that Mylan has announced the initiation of two phase three trials for glargine which is Lantus or Sanofi’s Lantus. Can you take us through the details of this?
A: This is an important milestone for the two partners because glargine or Insulin Glargine which is important basal insulin analog is a very large global opportunity for the two partners.
This is a big announcement for Mylan and Biocon because the phase three clinical trials on both type one and type two diabetics is extremely important because it is now a signal that this product is going to closely follow Eli Lilly’s very successful approval that they have got for their insulin Glargine. Therefore, we as partners now are very confident that we will make it to the market before too long.
Q: Can you give us a sense in terms of the details of this, for example the phase three trials will be for the European as well as for the American markets and by when or what would be the timeline in terms of completion of the phase three trials? When could Biocon see some amount of financial accretion to the profit and loss (P&L) on account of this?
A: The phase three trials for these two types of diabetics that is type one and type two diabetic, is a harmonised approach that we have taken which will allow us to pursue a global clinical strategy that we expect to be completed by the end of 2016. If you then look at the review process then we should be able to commercialise this opportunity by 2018.
Q: What is the competitive launch space by then because Eli Lilly already has an approval for similar product, if you could throw some more light on that?
A: Eli Lilly is an innovator. Their approach in terms of commercialising a bio similar Glargine will have a very different positioning compared to what Mylan will be doing in terms of its commercial opportunity for the same product.
The space is not at all crowded. Diabetes is a growing pandemic. Diabetics need both basal and other forms of insulin in a very incremental way and Biocon and Mylan will be able to expand the diabetes market in a significant way in terms of insulin analogs that we are jointly developing between us.
Therefore, this is a huge opportunity, it is underserved at the present time and we will be able to make a huge global opportunity of this particular product.
Q: Could you also quantify because you said 2017-18, in terms of the kind of money that you expect by FY17-18?
A: I will not be able to comment specifically on this particular question but the insulin analog opportunity is now approaching USD 20 billion and this is only growing in double digits, so by the time we get to the market, the opportunity is going to be sizeable and both partners are very focused on maximising this opportunity between us.
Q: I wanted to get two clarifications from you – when you say clinical trials for global basis and you say possibly commercialisation by 2018 – that would include developed markets such as the US as well as the European Union (EU)?
A: This whole trial is focused on EU and US as the primary target markets but in the interim we also hope to market these products in the developing economies and in the emerging economies.
We already have Glargine registered in nearly ten countries globally now, which itself is a huge opportunity but the real big opportunity where the optics is focused is on US and Europe and what we have done, to conduct one trial which will allow us to enter both EU and US.
In the past we have segregated these two markets but this is a new approach where we will get approvals both in the US and in Europe by doing this kind of harmonised trials.
Q: While you cannot comment on the financials of this particular deal, can you tell us would it entail Biocon receiving royalties post commercialisation or would it also be some amount of milestone payments during the trial phase as well?
A: We have disclosed the fact that this is a profit share arrangement with Mylan. Therefore, it’s very important deal for us.
Q: A word on Syngene. What is happening on that because you reacquired some stake and if that could mean that you have a potential timeline in mind for Syngene’s listing?
A: We are very focused on very well worked out strategic plan for Syngene which will lead to an initial public offering (IPO) and listing in the market. So, all this is as a part of that strategic plan, so you will see what is happening along the way as we eventually prepare for listing.
Q: Any specific timeline in terms of possible listing. When could you file a Draft Red Herring Prospectus (DRHP) or anything of that sort that you could share?
A: At this point in time I do not think I will be able to give you much more than I have just said but in due course I will be happy to shed more light on this particular subject.