Express Pharma

‘Our next vaccine will be a three-dose rabies vaccine based on nano-particle technology’

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Dr Rajiv Modi, CMD, CPL Biologicals, elaborates on the vaccines developed by his company, the huge positive impact they can have on healthcare delivery, the company’s role in facilitating and drive adult vaccination in India and more, in an interaction with Usha Sharma

Can you explain the JV model of CPL Biologicals? How does it work?

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Dr Rajiv Modi

Based in Ahmedabad, India, CPL Biologicals is an independent joint-venture biotechnology company established in 2009 by Novavax Inc, US and Cadila Pharmaceuticals, one of India’s largest privately held pharma companies. The company develops vaccines based on Novavax Inc’s Virus Like Particles (VLPs), recombinant nanoparticles and adjuvant technologies, which are groundbreaking innovations that improve global health through safe and effective vaccines. CPL Biologicals conducts end-to-end research, development and manufacturing based on these technologies in India. The current biologics and diagnostics portfolio of CPL Biologicals comes from original technologies developed at Cadila Pharmaceuticals. CPL Biologicals is currently developing new biologics and diagnostics products on its own. The company has a strong management team comprising deep expertise and experience in the areas of research, process development, medical affairs, manufacturing, commercialisation etc. and is governed by the Board of Directors with representation from both Novavax and Cadila Pharmaceuticals leadership.

According to Global Business Intelligence Research forecasts, India’s vaccine market is likely to grow to $871million by 2016. Which segments will drive growth and will we be able to touch the target?

The growth for the vaccine market in India will be driven by expansion of vaccination coverage for new borne, new approvals and inclusion of new vaccines like rota virus in national immunisation programme as well as emerging area of adult vaccination. Adult vaccination is a proven way of improving overall health and productivity of the society, however, it has not caught up in India due to lack of awareness and availability of options. CPL Biologicals is spearheading the campaign for adult vaccination in India with its seasonal influenza and swine flu vaccines.

The company is involved in developing vaccines based on ‘Virus Like Particles’ (VLP) and nano-particle based technology. Tell us more about these technologies and and how advanced are they in India?

Virus Like Particles (VLPs) are similar to a virus in structure but without the genetic material required for viral replication. Once injected into the body, VLPs trigger a specific and target immune response against the VLP, thereby generating a strong response and protection against the disease. Also, as VLPs and nano-particles do not contain viral nucleic acids, they present no threat of infection to a person being vaccinated, unlike other vaccines where there is a chance of disease being caused by the vaccine itself. Being proprietary and patented technologies, no body other than CPL Biologicals has the technologies or capabilities to develop vaccines using these technologies in India. Our swine flu (H1N1) and seasonal influenza vaccines are the first licensed vaccines in the world based on VLP technology.

How do we ensure that vaccines produced through VLP technology is safer and more effective than other available vaccines? Tell us about the other technologies available for developing vaccines and how effective are those?

As VLPs and nano-particles do not contain viral nucleic acids, they present no threat of infection to a person being vaccinated, unlike other vaccines which are developed based on the viruses which can replicate in human body thereby causing disease by the vaccine itself. Our recombinant VLP and nano-particle technology completely takes that risk away providing safer and more effective vaccine compared to other available vaccines. Unlike traditional vaccines the VLP technology does not use bovine serum or eggs in its manufacturing, thus no allergies related to egg products or risks of bovine diseases.

How many vaccines are in the pipeline and when are you planning to launch it in the Indian market?

We already have swine flu (H1N1) and seasonal influenza vaccines licensed in India. We will be applying for registration in multiple countries outside India for these vaccines in the coming year. Our three dose rabies vaccine in currently undergoing clinical phase III trials and will be licensed in 2018, followed by single dose Rabies and Varicella Zoster Virus (VZV) vaccines.

CPL Biologicals has developed and commercialised recombinant influenza vaccine and is currently focusing on developing innovative second generation vaccine for rabies. Can you elaborate about it in detail?

Our already licensed recombinant influenza vaccines for H1N1 (swine flu) and seasonal flu are world’s first VLP based influenza vaccines and offer significant advantages over the currently available conventional influenza vaccines. Our next vaccine, a 3 dose Rabies vaccine, with a three dose regimen (0-3-7 days) will be a significant improvement over currently available vaccines around the globe where one needs five doses over a period of 28 days (0-3-7-14-28). Our vaccine will significantly improve compliance towards full course of immunisation as the dropout rate for the current rabies vaccines is maximum for doses four and five (Day 14 and 28). Our eventual target is to reduce the number of doses for the rabies vaccine to a single dose. That will help us significantly improve coverage and compliance of the vaccine and save human lives across the world. Our vaccine will be world’s first recombinant nano-particle based rabies vaccine.

CPL Biologicals offers novel, affordable solutions for global healthcare via vaccines, biologics and diagnostics with integrated capabilities, please explain the need for these vaccines in the Indian market? In which new markets are you planning to launch these vaccines and why?

First of all, with our technologies, we can quickly respond to any potential pandemic in India in the future. Our cutting edge technology allows us to have a vaccine ready for human use against a new target within three to four months of identification of genome sequence of the virus while the vaccines based on conventional technologies may require more than eight to nine months for the same. Influenza vaccines are a very important intervention to improve health and productivity of both paediatric and adult populations, however, it has not caught up in India due to lack of awareness and availability of options. CPL Biologicals’ seasonal influenza and swine flu vaccines are an important steps in this direction. Our three dose and, eventually, single dose rabies vaccine will significantly improve coverage and compliance of the vaccine and save human lives in India and across the world.

Currently, no VZV vaccine is manufactured in India and all of them are imported as bulk or finished formulations. This results limited supply/shortage of the vaccine. Our VZV vaccine will be the first VZV vaccine to be completely developed and manufactured in India and will address the current shortage of this critical vaccine for Indian market. We will license our vaccines globally, starting with India first and will manufacturing these vaccines for the whole world in India. Given the superior technology, our vaccines will be either first-in-class or best-in-class across the globe.

Tell us about the company’s future plans.

The strategy is growth oriented, realistic and focused on biologicals. For vaccines, along with the vaccines based on VLP and nano – particle technology described above, we also have an innovative pancreatic cancer vaccine, completely developed in India, in phase I human clinical trial. This cancer vaccine is a platform technology and can be applied for other types of cancers as well. We will leverage our in-house innovative technology and R&D capabilities, augmented by strategic partnerships to take a leadership position in chosen biologics market segments. We will expand our presence in the biologics area with novel and biosimilar antibodies-based therapeutics in oncology. In diagnostics, we are developing novel immune-diagnostics for infectious and non-infectious diseases to provide complete solutions for global heath from prevention (vaccines) and diagnosis (diagnostics) to treatment (biologics).

The overall strategy is to continuously consolidate the market position by building a robust pipeline and enhance our product portfolio.

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