From the last few years, almost every Indian company worth its name is talking of having novel molecules — new chemicals entities (NCEs) and a few new biological entities (NBEs) — in its kitty. But the process to discover and develop and to bring to market a novel medicine is fraught with huge risks of failure, costs, etc.
At the DNA Conversations forum, pharma sector experts — Neelima Joshi, vice-president, biological research, Glenmark Pharma, Raj Kamboj, president, novel drug discovery & development, Lupin, S M Sapatnekar, dean, Clinical Research Education & Management Academy (Crema) and Hitesh Sharma, partner & national leader, health sciences practice, Ernst &Young — discussed the risks and rewards of pharma R&D. DNA moderated the discussion. Excerpts:
With so many NCEs, is it a deliberate attempt by the Indian pharma to wash away the ‘generics only’ tag?
Joshi: When a company decides to go in for innovation, it’s a huge commitment, both scientific and financial. There is a big regulatory component involved. It needs clinical development expertise. It’s a big commitment in terms of developing infrastructure, hiring talent and developing expertise, which is cost intensive. And second commitment is financial. Bringing a new drug from the lab to the market costs a phenomenal $1 billion and it may reach $2 billion shortly. We have a very rich clinical pipeline, with dozens of compounds in phase I trials, double the number in phase II and a few compounds in advanced phase III trials.
Kamboj: It’s not by choice that all key pharma companies in India or globally can’t just rely on generics or branded generics. They have to advance to the high value chain—NCE/NBEs. Cost advantage of India will help. Intellectual property behind it gives a boost. To become a global player, Indian pharma has to do it.
Sapatnekar: Six months back AstraZeneca did not have anything in its pipeline after 2009. Companies can’t run like this. It acquired another company. This is a juggernaut. You can’t simply say I don’t have molecules, buy them, but the juggernaut has to go on.
Sharma: In order to get to the next level, you have to meet this particular level. Industry recognises that it’s a high risk, high reward game. Although no successful molecule has reached commercialisation stage, but at various stages companies have encashed on value. That itself is a good kind of indicator for the industry. I think in the regulated markets, there are a lot of processes which drive research in a particular way. That’s another area where Indian scientists are trying to see if they can play that role and eventually tie up with multinational companies to see successful commercialisation.
What are the factors which decide the therapeutic area a company wants to do its research in?
Kamboj: You have to look at it from the unmet need point of view. Generally, market size is driven by how successful the treatments are. I give you an example of neuropathic pain. People feel that there are so many pain drugs. Not true. Neuropathic pain, or chronic pain, actually has no drug that successfully treats it. Most drugs in that segment are either sedative in nature or do something to make it less. But they are actually not treating it. So, neuropathic pain has huge unmet need. You have to look at the disease pathology.
Joshi: By definition, research on innovation means looking for something which is not there. Industry would focus research in areas where there is unmet medical need. Unmet doesn’t only mean total lack of drugs in the market. There may be new diseases appearing.A classic example is neuropathic pain where not much suitable treatment is available. Many of the drugs show huge side effects. There is unmet medical need to make efficacious drugs. There may be drugs in market which are costly. Obesity, diabetes, mainly the complex diseases with increasing incidences globally or nationally, need focus from industry.
Sapatnekar: It’s a question of addition. Notwithstanding the efforts that have gone in, in 75% of cases success has come by accident. You are looking at something and something else pops up accidentally. This is the reason NCEs are money guzzlers. You have to keep sowing the seeds, which will become saplings. The fruition is generally witnessed by the next generation. That is the next generation of scientists.
Sharma: Any research looks at a 10-15 year horizon. You are taking a call on something today, and you don’t know what will develop tomorrow. So you look at what the competition is like. How many other companies are looking at this field, what is the level of progress they have made. What is the efficacy. And what is that you have which is unique and that which you want to push through. Because you are not going to spend 8-10 years of time and money if you don’t see something which would be the differentiator and for which you can get an IP that you will commercialise.
The NCE pipeline has a clear focus on cancer and diabetes, both in India and overseas. With much focus on these areas,will it increase chances of more of ‘me-too’ drugs coming out?
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