Panacea Biotec, one of India’s research-based health management companies has entered into collaboration with Rising Pharmaceuticals Inc in USA. Rajesh Jain, joint managing director, Panacea Biotec expects the USFDA approval for the collaborated drug by next year to early-2016.
Also read: Panacea enters into alliance with Canada based Apotex IncFurthermore, he says the potential of the product, an oral control release product, is to the tune of USD 300 million.
Below is the transcript of Rajesh Jain’s interview with CNBC-TV18\\'s Reema Tendulkar and Ekta Batra.
Reema: We understand that Panacea Biotec will receive an upfront research fee when you get the Food and Drug Administration (FDA) approval. What is going to be the quantum of this research fee, will it be fixed, walk us through the details?
A: This collaboration is for an oral control release product which uses Panacea Biotec’s platform oral drug delivery technology. The dossier has actually already been filed and is currently under review by USFDA and as per the agreement, we will be receiving an upfront research fee post close to USD 750,000 this month. Apart from that I believe the whole potential of this product is close to USD 300 million when we see the innovative sales as of now. I am sure we will have some competition in this line as well.
When you look at the total Panacea Biotec earnings on these R&D collaboration that we have done to date, we expect all these alliances to translate into a potential of USD 13 million as various milestone payments which will be received by the company over the next 18 months once we meet the timelines.
Ekta: When do you expect FDA approval for this drug?
A: This one should happen sometime next year or early 2016 and the second one should come out somewhere around July 2016 and the third one around September 2017.
Ekta: So, how much would you expect in terms of milestone payments beyond this R&D fee that you spoke about. What is the structure in terms of milestone payments or any sort of fee going forward from this particular agreement?
A: As I said that the total end-to-end potential of receiving USD 13 million is the total fee that we expect. However, out of that USD 2.5 million have already been received by us so far and USD 1 million would be received in the current quarter.
Ekta: What is the remaining contingent on?
A: These are basically dependent upon the undertaking of the bio studies and then putting together that dossier and filing. So those will be the two additional milestones that we need to achieve and if we get into the first to file opportunity, so that also is linked to milestone payment.
Reema: You have indicated in the release that profits will be shared in a predetermined ratio. What is this ratio?
A: The arrangement that the company generally does is we tend to manufacture the product and transfer the product at cost to the partner and then they sell the product. So, once the complete margins are arrived at which is profit for both the companies put together then we share the profits in ratios. For one company we have 50:50 as the profit sharing, for the other we have different ratios depending upon how much they share in terms of the upfront fees. So, you arrive at different models with different companies.
Ekta: This is not a new chemical entity, this is a generic version of drug that exists?
A: Yes, these are all generic drugs but they are very complex in terms of their complete development and therefore Panacea Biotec relies on its own platform oral drug delivery technologies to do that.
Ekta: So, how many competitors would you see if in case the drug is already genericised? You did already mention an First to File (FTF), so I am assuming it is not, but can you just give us a sense in terms of what the drug is, what the size of the market is?
A: Currently this is yet not available in the market as a generic drug. So, the patents will go off in times to come. So, we do expect that either we will be among the top three to launch or at least among the top six and currently the product about which we are talking about today under collaboration has a market size of close to USD 300 million in US market which is the innovator size. So as soon as the generic comes all of us will share the market.
Ekta: So, would this tie up be similar to what you had with Apotex which you signed a couple of days ago?
A: Yes, this is something very similar to Apotex but then the product range is completely different, that is more on injectible products and this is focussed on oral products.
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