Despite a thriving generic,
formulation and bulk drug industry, India has lagged in developing
skills to support discovery-oriented innovative research. However, the
Indian drug discovery research is catching up slowly and steadily. In
this special series BioSpectrum profiles inimitable contribution of Dr
Jitendra N Verma and this emerging area of liposomal drugs
After upholding the Trade Related Aspects of
Rights (TRIPS), committing to recognize product patents, Indian
companies, in the last decade, have invested in innovation-led drug
discovery and produced a reasonable talent pool in biological sciences.
This month, in CSO Series, BioSpectrum brings you the achievements of
Dr Jitendra N Verma, a senior scientist and managing director of
Lifecare Innovations based in Gurgaon.
Experience and expertise
With a masters degree in science from Allahabad University and PhD from
PGIMER, Chandigarh, Dr Verma has 32-year of academic and industrial
research experience. He specializes in infectious diseases, NDDS and
vaccine development with an expertise in a variety of disciplines,
including protein and lipid isolation and characterization, human
hybridoma development, drug targeting, liposome technology, vaccine
delivery, molecular biology and immunochemistry.
His areas of research have been application of liposome technology for
development of pharmaceuticals, vaccines and diagnostics, development
of nano-drugs, bio-chemistry and metabolism of lipids.
Besides the scientific background, Dr Verma’s management background
includes implementing successful research, development and marketing
strategies, including commercialization.
Known as a person with straightforward approach, he has numerous
achievements to his credit. Distinct achievements include the
development of first liposomal product of India which is a syphilis
test. He is also the founder of the first company, which focuses on
controlled release drug formulations, in India.
Lifecare Innovations has launched Fungisome, which is said to be the
most effective anti-fungal drug in the world. The company has also
launched two other new liposomal drugs. Now Dr Verma is developing a
sustained release oral nano-drug against tuberculosis. He has several
patents, four national awards, a state award and a research
foundation’s Scientist of the Year award in his kitty.
Leading liposomal revolution
Dr Verma was engaged in medical research at University of Pennsylvania,
Northwestern University, Georgetown University and Walter Reed Army
Institute of Research in the US. Known for his expertise in life
sciences and biotechnology, Dr Verma was acclaimed for promotion of
R&D and later, commercializing their outcome by industry-academia
interactions and public-private partnerships. He has pioneered
development of NDDS-based liposomal and nano-drugs. As a world leader
in liposome technology application for drugs, diagnostics and vaccines,
he developed and commercialized India’s first liposomal product and
world’s only liposomal diagnostic-liposome agglutination test for
He has contributed to Asia’s first anti-fungal drug Fungisome — a
liposomal amphotericin B. Working on malaria vaccine, Dr Verma was the
first to report that liposomal vaccines elicit cellular immune response
necessary for protective immunity. He is presently involved in
developing liposomal and nano-drugs for the treatment of tuberculosis,
cancer, leishmaniasis and fungal infections. By applying science and
technology in everyday life, Dr Verma has been keenly involved in
translational research resulting in a number of publications, reviews
and patents to his credit.
In May 2009, a jury comprising officials from British High Commission,
International Business Wales (IBW) and Ernst & Young selected
Lifecare Innovations as the winner for Technium 2009 – a global
business contest based on emerging technologies and innovations. The
Technium Challenge, established in 2003, is a business planning
competition, which identifies and supports innovative businesses with
high growth potential to invest in Wales, UK.
Lifecare Innovations’ business plan on Fungisome emerged as the winner
owing to its merits in treating systemic, invasive or topical
infections. This anti-fungal drug is said to be the only drug and
Lifecare Innovations the only pharmaceutical company among the six
country winners of Technium Challenge 2009, which included a company
each from the US, Canada, South Africa, Australia, New Zealand and
Exploring new possibilities
Under the leadership of Dr Verma, two new liposome technology-based
formulation for the treatment of psoriasis, viz Lipotar and Lipotar-S,
are scheduled for launch. Also, the Drug Controller General of India
(DCGI) has approved the company’s two novel nano-drug formulations for
Lifecare Innovations is also working on a project for the development
of effective anti-malarial treatment options. For the project, it has
partnered with International Center for Genetic Engineering and
Biotechnology (ICGEB) New Delhi; Birla Institute of Planning and
Technology (BITS), Pilani; and University Health Network (UHN), Canada.
This research project would facilitate licensing and commercialization
of the discoveries.
Also, the company’s R&D, product development, process development,
scale-up, pilot plant and production center at Biotech Park, Lucknow,
is expected to become operational by the end of 2010.
As an extension to its R&D center, the company has set up Lifecare
Innovations Laboratory for Translational Research in Nanomedicines at
Biotech Center, University of Delhi. The laboratory has attracted
attention of researchers on novel drug delivery systems.
The current interests of Dr Verma include the application of
nanotechnology and liposome technology for the development of
pharmaceuticals and vaccines. Talking about the nanotechnology research
in India, he says “There is a need for the allocation of funds
separately for nanobiotechnology and specifically for the product
development and clinical trials. Only then we can see some visible
progress in this field.”
Lifecare innovations has also partnered with PGI Chandigarh, Punjab
University and IIT on the development of nanoliposomal drugs. Dr Verma
feels that more partnerships between the academia and industry in this
particular sector will help in bringing the products to the market.
“The research going on in the academic and research institutes have not
reached to the manufacturing stage and tends to get lost only due to
lack of coordination between the public and private sector.” concludes
Eradicating leishmaniasis and kala-azar
Leishmaniasis is caused by macrophage resident intracellular protozoan
parasites Leishmania donovani, Leishmania infantum and Leishmania
chagasi. Parasite transmission occurs through the bite of infected
female phlebotomine sandfly. One-third of the new cases of
leishmaniasis are visceral leishmaniasis (VL) and 90 percent of the VL
cases are prevalent in Bangladesh, Brazil, India, Nepal and Sudan.
India alone accounts for one-fourth of the total worldwide incidents.
Strategic suitability of lipid formulations of Amphotericin B for the
treatment of visceral leishmaniasis emanates from several factors viz.
leishmania resides in the macrophages, liposomes are rapidly taken up
by the macrophages, Amphotericin B is an effective anti-leishmanial
drug, and Amphotericin B can be formulated as liposomal preparation.
All of these facilitate targeted delivery of Liposomal Amphotericin B
to the desired site for anti-parasitic action and thus reduces the
Additionally, liposomes offer an amplification effect, through
concentrated encapsulation of numerous molecules in each liposomes
particle which are delivered at the desired site of action. Liposomal
Amphotericin B has been used extensively throughout the world as the
best option for treatment of VL even in cases resistant to standard
drugs. Fungisome has shown to have proven advantage over
conventional drug regimen in the treatment of visceral leishmaniasis in
Tissue distribution of Fungisome has been studied in experimental
animals infected with Leishmania donovani. At the maximum tolerated
doses of conventional treatments and Fungisome, higher levels of
Amphotericin B were achieved in liver and spleen in the mice treated
with Fungisome. In comparison, conventional Amphotericin B was found to
be less effective at the tolerated doses.
Similarly, kala-azar is a major public health problem in certain parts
of India. Standard treatment involves use of antimonials and sodium
stibogluconate. Considerable resistance to the standard drugs has
pushed the need to look for alternative drugs. Amphotericin B has been
found clinically effective even in resistant cases of kala-azar. Use of
Amphotericin B, however, is restricted due to its well-known toxicities.
in New Delhi