by Marshaneil Soumi D’ Rozario | 06 APR 2018
In WHO’s 70th anniversary year, World Health Day will focus on “Universal health coverage: everyone, everywhere” - ensuring that everyone, everywhere can access essential quality health services without facing financial hardship. The major focus of this year is to inspire, motivate and guide Universal Health Coverage stakeholders to make commitments towards UHC. Epygen Biotech Pvt. Ltd. is an emerging Biotechnology company in the country, headquartered in Dubai Science Park, Dubai, with offices, labs and manufacturing facilities in Dubai, India and USA. It is trying efficiently to create a difference in the research and manufacture of a wide range of Recombinant Proteins for the Biopharmaceutical space. The company follows the soul of its corporate slogan “Building Future Strand by Strand”.
Mr. Debayan Ghosh, President and Co-Founder Epygen Biotech Pvt. Ltd. provides his inputs from Health perspective. His aim is to produce this Life-Saving drug to address the mid income strata and bottom of the pyramid and his target launch date is in 2018.
Discuss some major health issues which need immediate attention?
Some of the major health issues that plagues the country is in the areas of cardiovascular and oncology.
Around 17 lakh people die from heart attacks every year in this country. Although the cost of catheterization laboratories and surgical procedures has been subsidized in the recent past, they are still largely unaffordable by the many. While Tissue Plasminogen Activator (tPA) is quite expensive, Streptokinase which is the conventional biological drug for thrombolysis is not very widely available because of restricted productivity of the product and low expression levels. Several research papers show hardly any difference in mortality between the two treatments, but there is vast difference between the number of vials required versus vials available. This is one area that will be addressed aggressively by Epygen. The Biosimilar recombinant Streptokinase drug developed by Epygen scientists have high expression levels to make this injection affordable. In addition, patient safety profile of this injection has been improved drastically over the previous versions.
Another area that needs to be addressed with innovations is treatment for Oncology. Nearly all cancers are critical and it is not easy to determine which disease is more severe than the other, based on prognosis, especially when it progresses. When the patient reaches 3rd or 4th stage, they run out of options as conventional chemotherapy drugs stop working. The rapidly multiplying cancer tissue finds its way to outsmart chemical drugs and keep on proliferating. However, Biological drugs are much more adept to deal with these cells, as a result of which, later stages for cancer patients can be treated with these. This is one area which still needs a lot of work to be done around the world.
India does not rank amongst top 5 nations for cancers like breast, colon, liver and lung. But in the head and neck cancer area, India ranks at the top, owing to the indiscriminate use of tobacco. Lot of patients in this continent suffers from head and neck and oral cancer. In these cases, it is observed that small molecule Cytotoxin chemotherapy treatments result in quite a few side effects. Finding more tolerable treatment for late stage cancers and some versions of more common cancers like the triple negative breast cancer, are few amongst the most critical areas, which needs to be handled aggressively.
What is the primary focus of your company?
The primary focus for Epygen is to develop and produce Biosimilar drugs. Being a Biotechnology company, our primary focus had been to make a plethora of therapeutic proteins using the recombinant path. We identify proteins for critical use in cardio vascular and oncology patients and express them in recombinant organisms to produce in large quantities, making it affordable for the masses. Our focus is to maintain purity profiles of international standards, so that these products can reach across the globe and benefit millions of patients who need them.
In terms of disease areas, we are focusing on cardiovascular, oncology and recombinant human hormones. In cardiovascular, we are into biosimilar for thrombolytic protein drugs and in oncology we are into monoclonal antibodies for targeted therapies. We produce recombinant human Parathyroid hormones (PTH) for postmenopausal osteoporosis, which poses a large problem for women all over the world. Most postmenopausal osteoporosis is untreatable in the current scenario and is a common comorbidity in elderly woman in our part of the world, which needs to be addressed. Recombinant human Parathyroid hormones produced by E. coli route by Epygen, will definitely provide an answer for that.
Tell us about your recent endeavors in the healthcare sector?
We are into biosimilar drugs. Biological drugs offer the most efficient treatment for critical ailments such as cardio vascular, immune disorders and oncology, being some of the top killers in the world. However, producing these biological drugs are often very expensive and as a result, unaffordable by the masses. The innovator molecules present a high cost barrier as they attract billions of dollars spent on them for invention. Once they are launched, for the period of their patents, prices mostly tend to remain high and unaffordable. Once they cross the patent cliff, biosimilar drugs can be produced to match the innovator biological product and application quality and hence these drugs can me made affordable for more people. We are in the process of producing a range of critical biosimilar drugs, in highly advanced state of the art biopharmaceutical facility, rendering them affordable for the people in the country.
What are the future plans of the company?
We are working on a thrombolytic biosimilar molecule for cardiovascular, followed by biological molecules for oncology, the entire first group of proteins to be expressed through the E.coli route.
Currently our proteins are undergoing regulatory approvals through pre-clinical and clinical stages. We shall be efficiently expressing antibodies through mammalian cell culture route, expression titers of which are being optimized for maximum deliverables.
How does the company plan to reach the lower income group?
Biological therapeutic proteins are expressed using host organisms. By using the tools of genetic engineering and genomics, we are manipulating these microbial hosts to express proteins in large quantities; in its purest form. By further harnessing our tools of process engineering and bioprocess optimization, we purify these bulk quantities of relevant proteins, making it affordable for the masses.
Message for world health day ?
“Critical treatment can be affordable” which is contrary to the common belief that critical treatments are unaffordable and irrationally expensive! By harnessing the tools of modern biotechnology, genomics and proteomics, we can make critical therapeutic proteins more and more affordable…
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