S. Harachand, Contributing Editor03.09.16
Bharat Biotech surprised many when it came out with the news early last month that the company was in the process of seeking government approval to conduct pre- Clinical Trials for Vaccine candidates to fight Zika virus.
Zika virus, suspected to be linked to a serious birth defect that causes babies to be born with abnormally small heads, has now emerged a major threat to the world. The sudden outbreak of the virus in Latin America and its rapid spread prompted WHO declare stalling Zika virus transmission a global health emergency.
With WHO announcement, drug makers as well as academia world over swung into action exploring possibilities for a viable vaccine to deal with the Zika challenge.
Paris-based Sanofi said its vaccines unit Sanofi Pasteur was responding to the global call to action to develop a Zika vaccine. Japan’s Takeda Pharma set up an 8-member team to investigate how to make a vaccine. Pfizer said the company was analyzing its existing vaccines portfolio to find where it might be able to play a role.
Meanwhile, Merck put itself on the job working with public health partners to see how its expertise in developing world’s first Ebola vaccine could help. GlaxoSmithKline was concluding a feasibility study to see if its vaccine technology was suitable. Officials at Johnson and Johnson, said the company’s Janssen unit was evaluating if any of its available technologies could be directed to address Zika.
Among the academia, the U.S. National Institutes of Health, the Public Health Agency of Canada and the Butantan Institute in Brazil and University of South Australia partnering with Australian biotech Sementis are in hot pursuit of Zika vaccine, said reports.
Bharat BIO ’s announcement too came close on the heels of WHO call. However, what made the news different was that the company had started work on the vaccine a year ago and the leads already reached pre-clinical phase.
Experts consider outbreak of the current magnitude is rather new with Zika virus. Also, unlike dengue or West Nile viruses—the family in which Zika belongs to—scientific literature pertaining to the pathogen is far and few.
According to Bharat Bio, the company landed upon the potential leads while working on vaccines for dengue and chikungunya. The Hyderabad, south India-based firm is currently evaluating two Zika vaccine candidates: inactivated and recombinant versions. If they emerge successful in pre-clinical studies, the company specialized in vaccines, expects to commercially produce its Zika vac in two years time, provided the government fast-tracks the approvals. The company, which filed Patent applications for both of its experimental vaccines, claims Bharat Bio will be the first in the world to file for global patents for Zika vaccine.
Another manufacturer looking at Fast Track approval from the government is Serum Institute of India, located at Pune in the western state of Maharashtra. Asia’s largest vaccine maker, Serum has plans to launch a monoclonal Antibody treatment for dengue in India where infection from the mosquito-borne virus is, presently, a major public health issue. Serum acquired the rights of VIS513 from Visterra in a $39 million deal in September last year. The single-dose injection, using Visterra technology, would Hit the Indian market within 12 to 18 months of getting regulatory approvals. In that instance, Serum could potentially become the first company, globally, to launch a cure for dengue, reports said.
India’s vaccine market itself appears poised for a faster growth track. Rising number of MNCs vying to increase their footprint in India’s vaccine space illustrates this point further. Merck &Co, which parted ways with Sun Pharma on a JV to produce branded generics in February, is “hunting for customized partnerships for manufacturing and marketing” to gain access over the private market for vaccines, according to Patrick Bergstedt, Merck’s global head for vaccines.
In India the majority of the vaccines are distributed through government agencies. The opportunity to expand in India is huge as the penetration of new vaccines, like cervical cancer, is less than 1%. The U.S. drug maker has also started procuring bulk drugs from India for its global vaccine portfolio, Bergstedt added.
GSK is trying a different strategy to ramp up sales. The company went for a 40% cut in the price of its pneumococcal conjugate vaccine Synflorix, late last year, setting the platform for future launches. The British drug maker is the current market leader in several vaccines, even without being a part of India’s public-funded vaccination programs. In line with Merck, GSK also targets the non-government vaccines segment in India. Clearly, GSK intends to beef up offerings with more vaccine categories and enhanced sales force, which it augmented following the acquisition of Novartis’ vaccine business last year.
S. Harachand
Contributing Editor
S. Harachand is a pharmaceutical journalist based in Mumbai. He can be reached at harachand@gmail.com.
Zika virus, suspected to be linked to a serious birth defect that causes babies to be born with abnormally small heads, has now emerged a major threat to the world. The sudden outbreak of the virus in Latin America and its rapid spread prompted WHO declare stalling Zika virus transmission a global health emergency.
With WHO announcement, drug makers as well as academia world over swung into action exploring possibilities for a viable vaccine to deal with the Zika challenge.
Paris-based Sanofi said its vaccines unit Sanofi Pasteur was responding to the global call to action to develop a Zika vaccine. Japan’s Takeda Pharma set up an 8-member team to investigate how to make a vaccine. Pfizer said the company was analyzing its existing vaccines portfolio to find where it might be able to play a role.
Meanwhile, Merck put itself on the job working with public health partners to see how its expertise in developing world’s first Ebola vaccine could help. GlaxoSmithKline was concluding a feasibility study to see if its vaccine technology was suitable. Officials at Johnson and Johnson, said the company’s Janssen unit was evaluating if any of its available technologies could be directed to address Zika.
Among the academia, the U.S. National Institutes of Health, the Public Health Agency of Canada and the Butantan Institute in Brazil and University of South Australia partnering with Australian biotech Sementis are in hot pursuit of Zika vaccine, said reports.
Bharat BIO ’s announcement too came close on the heels of WHO call. However, what made the news different was that the company had started work on the vaccine a year ago and the leads already reached pre-clinical phase.
Experts consider outbreak of the current magnitude is rather new with Zika virus. Also, unlike dengue or West Nile viruses—the family in which Zika belongs to—scientific literature pertaining to the pathogen is far and few.
According to Bharat Bio, the company landed upon the potential leads while working on vaccines for dengue and chikungunya. The Hyderabad, south India-based firm is currently evaluating two Zika vaccine candidates: inactivated and recombinant versions. If they emerge successful in pre-clinical studies, the company specialized in vaccines, expects to commercially produce its Zika vac in two years time, provided the government fast-tracks the approvals. The company, which filed Patent applications for both of its experimental vaccines, claims Bharat Bio will be the first in the world to file for global patents for Zika vaccine.
Another manufacturer looking at Fast Track approval from the government is Serum Institute of India, located at Pune in the western state of Maharashtra. Asia’s largest vaccine maker, Serum has plans to launch a monoclonal Antibody treatment for dengue in India where infection from the mosquito-borne virus is, presently, a major public health issue. Serum acquired the rights of VIS513 from Visterra in a $39 million deal in September last year. The single-dose injection, using Visterra technology, would Hit the Indian market within 12 to 18 months of getting regulatory approvals. In that instance, Serum could potentially become the first company, globally, to launch a cure for dengue, reports said.
India’s vaccine market itself appears poised for a faster growth track. Rising number of MNCs vying to increase their footprint in India’s vaccine space illustrates this point further. Merck &Co, which parted ways with Sun Pharma on a JV to produce branded generics in February, is “hunting for customized partnerships for manufacturing and marketing” to gain access over the private market for vaccines, according to Patrick Bergstedt, Merck’s global head for vaccines.
In India the majority of the vaccines are distributed through government agencies. The opportunity to expand in India is huge as the penetration of new vaccines, like cervical cancer, is less than 1%. The U.S. drug maker has also started procuring bulk drugs from India for its global vaccine portfolio, Bergstedt added.
GSK is trying a different strategy to ramp up sales. The company went for a 40% cut in the price of its pneumococcal conjugate vaccine Synflorix, late last year, setting the platform for future launches. The British drug maker is the current market leader in several vaccines, even without being a part of India’s public-funded vaccination programs. In line with Merck, GSK also targets the non-government vaccines segment in India. Clearly, GSK intends to beef up offerings with more vaccine categories and enhanced sales force, which it augmented following the acquisition of Novartis’ vaccine business last year.
S. Harachand
Contributing Editor
S. Harachand is a pharmaceutical journalist based in Mumbai. He can be reached at harachand@gmail.com.
