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Our mission has been to offer even our innovative molecules at an affordable price.
-Dr Rajiv Modi, CMD, Cadila Pharmaceuticals

Mycidac-C is priced at about a tenth of the cost of those made by multinational competitors. Dr Rajiv Modi, CMD, Cadila Pharmaceuticals in an interview with Ananya Sen discusses Cadila’s innovation Mycidiac-C and their new research partnership.

What prompted Cadila Pharmaceuticals Ltd to enter into an R&D agreement with Helperby specifically to work out antibiotic resistance?
Cadila Pharmaceuticals Ltd as one of the leading R&D companies in India is focusing on providing innovative solutions for human health care by indigenous efforts as well as collaborative research. We have already successfully addressed some of the areas like cardiovascular diseases (Polycap), TB (Risorine) and cancer (Mycidac-C).

Antibiotic Resistance has emerged as a major public health problem globally. The world has run out of the pipeline of new antibiotics and we run the risk of returning to pre-antibiotic era if no solution is found very soon. The world used to make new antibiotics to cope with resistance, but this lifeline has now almost dried up. Like tuberculosis, antibiotic resistance, though a major public health problem, is now a neglected area of research. Recognising the need and practically dry pipeline of new antibiotics, we are looking at providing solutions.

This need prompted us to look for solution and the science pursued by Helperby made us enter into the agreement with them.

Please elaborate on the concept of Antibiotic Resistance Breakers (ARB). How will this prove beneficial?
Our partner, Helperby Therapeutics has developed a new way to tackle the problem of antibiotic resistance. The idea is to rescue old antibiotics and Helperby does this by discovering new compounds using novel cutting edge technology which it has developed. These new compounds are called Antibiotic Resistance Breakers. When an Antibiotic Resistance Breaker is combined with an old obsolete antibiotic, it can rejuvenate it and make it active against highly resistant bacteria.

Helperby has Antibiotic Resistance Breakers which can potentially rescue several different classes of antibiotics. It is shown that it is feasible, at least in early stage preclinical and clinical development. Furthermore, this approach requires the development of fewer novel compounds, is less risky and less costly than the traditional ‘one antibiotic’ route.

The other perceived added advantage of this approach is the least chance of developing future resistance. If this comes out true in real life then patients with recurrent infections may not need to change antibiotics. They may be treated using same antibiotic for subsequent episodes.

To what extent will this help to solve the problem of antibiotic resistance?
The laboratory findings are promising indeed. We will confirm this through our clinical development programme at Cadila Pharmaceuticals. If the approach meets expectations, problem of antibiotic resistance will be significantly reduced.

We believe that this approach can bring in a paradigm shift in the way we fight antibiotic resistance. There will be significant savings due to decrease in morbidity and mortality due to antibiotic resistance. This will also result in significant savings in health care costs related to prevention and treatment infections with resistant organisms.

The novel products are likely to be effective against the bacteria for much longer. We believe that our research on ARB will address the antibiotic resistance developed by number of bacteria including multi-drug resistance gram negative strains including NDM1.

How affordable will this newly developed treatment be?
Cadila Pharmaceuticals has always believed in ‘affordable’ medication. Our mission, as established by our Founder Chairman I A Modi is to offer our innovative and even ‘world’s first’ molecules at an affordable price. Polycap (for secondary prevention of cardio vascular disease), Risorine (a novel Anti TB medicine) are such examples. This demonstrates our commitment to the cause of affordable medicines. Very recently, we launched Mycidac-C for lung cancer management. This is also first-in-class therapy for lung cancer (NSCLC) in the world – however we priced it at a fraction of the cost compared to similar drugs sold by multinational companies in India. So going by this track record, our future pricing strategy for the molecules with ARB can be anticipated. I remain quite optimistic that Cadila would be able to continue to maintain the tradition of affordable pricing for our innovative products.

Is the lung cancer drug Mycidiac-C launched by Cadila a result of the organisation’s indigenous research?
Definitely. The entire basic and clinical development leading to its approval is an indigenous effort. Our scientists at Cadila were successful in finding a novel target Desmocollin-3 for this drug and have worked for over a decade to come out with this first-in-class active immunotherapy for lung cancer. The entire innovation is hundred per cent indigenous.

Why do you call it unique/ innovative?

Mycidac C is unique in several ways. This is ‘world’s first’ Active Immunotherapy for management of any cancer. The target Desmocollin 3 is a novel target. The drug offers novel treatment for squamous non small cell lung cancer (NSCLC). This was an unmet medical need as there has been no advancement in squamous NSCLS since 1983. Mycidac-C offers survival benefit of over 43 per cent which is significantly higher when compared to benefit offered by recently introduced similar molecules. Yet it is priced at a fraction of the cost to identical novel therapies marketed by MNCs in India. Mycidac C is the world’s first ever innovative drug in cancer therapy from an Indian company and that underlines our R&D strength.

Have you obtained a patent for this product?
Yes, we have obtained patent for Mycidac-C.

How do you plan to price Mycidac-C in India?
Mycidac-C is priced at about a tenth of the cost of those made by multinational competitors. The cost of Mycidac-C therapy to Indian patients will be just ` 40,000 for a 10-course injection - compare it against ` 37,000 per vial cost of recently introduced innovative MNC products for Lung cancer.

When does it hit the Indian market?
Mycidac-C has already been made available in Indian market since the beginning of December 2013 and has been used in NSCLC patients in India.

Has it been tried on subjects in India?
Yes. The pivotal trial of Mycidac-C was conducted at about 17 leading cancer hospitals spread across India and that showed over 43 per cent survival benefit to NSCLC lung cancer patients. This is indeed remarkable for a new drug in lung cancer.

Do you intend to launch it in other countries as well? Do you have plans of partnering with other companies to market the product outside India?
We have plans to launch Mycidac-C in several countries across the world in a time bound manner. We have an active IND with USFDA for this product. We have also received an ‘Orphan Drug’ status for Mycidac-C from USFDA for treatment of Desmocollin-3 expressing lung cancers.

Could you brief us on the product pipeline of CPL Biologics?
We have a very exciting range of biologicals at CPLB. We have several prophylactic and therapeutic vaccines at different stages of development. We expect our Influenza vaccine to be the first one, out of our basket, to hit the market.