GBR 1302 could be an out-licencing opportunity: Glenmark

The antibody in this case can bind two targets whereas a normal molecule antibody which we produce in our body can only bind one target twice since the normal antibody is called monoclonal. Antibody monospecific and these antibodies are called bispecific.

If GBR 1302 succeeds in the clinic, it is going to be an innovative treatment for breast cancer and it is going to be a superior Herceptin. We all know that monoclonal antibodies have revolutionised cancer medicine, they are very effective and many patients profit from treatment from these monoclonal antibodies. However, there are short falls.

In case of Herceptin which is the established monoclonal antibody treatment for breast cancer, unfortunately only one-third of women who express the antigen that is targeted by Herceptin can be treated because this antibody Herceptin is exquisitely high expression of the target on the surface of breast cancer tissue.

Now with GBR 1302 because it is a bispecific antibody and it is so much more potent in Herceptin which we have shown in our preclinical work and we hope to treat the remaining two-thirds of women from breast cancer.

Anuj: What is the potential opportunity that this has in terms of market size and the kind of opportunity for Glenmark?

A: That is why I mentioned Herceptin as an example, Herceptin has annual sales of more than USD 6 billion and that can only target one third of patients affected. Now if you can target two third of them, plus patients who are resistant to Herceptin and that unfortunately occurs, it is obvious how big the opportunity will be.

Ekta: This molecule is just in discovery stages, once it goes into preclinical stages, where do you think the out-licensing opportunity could emerge and is Glenmark exploring such an opportunity?

A: We will look to explore this, we are working at all our molecules, we design in a way that we can out-license and that is a given for us because that is the way for us to work on several molecules in parallel and thereby minimizing our risk and optimizing our income. Hence, we don't need to spend as much for development.

Also, once we are at a right stage in the clinic, meaning that we have proof of concept in the clinic for this molecule, we will definitely out-license or look for out licensing partners. I can assure you that at this point in time we are speaking to companies already about this molecule.

I cannot tell you by when will the deal come because that is not entirely in our hand, we have worked very hard but the deal can never be planned, but it is our goal to out license any of the novel molecules we have in our pipeline.

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Ekta: Are you already investing a significant amount of your R&D cost towards this molecule? How much will you possibly spend for this molecule as well as others in terms of your entire R&D cost for this fiscal?

A: I cannot give you a precise number because this number changes with development. We are committed to this molecule and will provide all the funding necessary to bring this molecule to a stage where it is really attractive for partners. Having said that, it is true for all molecules we are working on and we are on a very strict budget. That is really important for a company like Glenmark. We only commit certain percentage of our sales to research and part of our research is innovative research and it is very important to be disciplined as risk and reward have to be carefully balanced.

You can look at our history, there are very few companies globally that have such a track record. Over the years we have out-licensed seven molecules through various big international pharma companies. If you look at our R&D investment versus just the upfront milestones we have received, we are cash positive. I don't know many companies that have achieved that.

Ekta: We did see a milestone payment which came in from Sanofi in the previous quarter. Can you apprise us of how GBR 500 is currently progressing and what will be the next milestone payment that we could possibly expect from Sanofi?

A: I cannot give you any precise number but Sanofi keeps investing in the molecules, they believe in it and they will start a new clinical phase two trial in multiple sclerosis patients which is great because that is a huge market. Sanofi is fully committed to that molecule and we can say that with confidence.

Also, all the other molecules are progressing according to what we have announced in the past.

Ekta: Can you tell us about crofelemer, when can we see a launch in the licensed markets that Glenmark had actually market the molecule in and where does it stand at this point in time and how much of an opportunity is it?

A: I cannot give you a precise number in terms of opportunity but I can give you an update within the limits I have of where we stand. We have an exclusive license for crofelemer in 140 countries and Salix is the license holder in the US and they got approval by FDA to market this molecule. That is great news for us because we can use this Salix knowledge and Salix experience to get regulatory approval of the molecule in our markets. We have achieved approval in several key markets already, I cannot tell you exactly which ones but that also looks very promising.

Ekta: If you had to bet on the most promising molecule right now which one would it be?

A: Nobody can tell you which molecule will eventually succeed or not because we do research, we do preclinical research, we do clinical research and we do research because we don't know certain things and that is why it is so important to have several molecules in parallel in the clinic. Only by doing that you can compensate for molecules that work and that don't work and this is why you need to have a very good pipeline.

If you look at the pipeline we have been at large, biologics or small molecules, all of them are either first in class opportunities or best in class opportunities, all address huge unmet medical needs and all of them have the potential to be useful not only in one indication but in several indications. So any of the molecule if they make it to the market will be really big.