BioSpectrum India Magazine November issue BioSpectrum India Magazine | Page 17

www.biospectrumindia.com
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November 2017
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BioSpectrum
l COMPANY NEWS
Piramal Pharma announces
API facilities expansion
Piramal Pharma Solutions (PPS) which is a leading Contract
Development and Manufacturing Organisation (CDMO) and part of
Piramal Enterprises Ltd (PEL) has announced investments of $55
million across its sites in North America & Asia, to expand its API
manufacturing capabilities and capacities. A part of this investment
will go into new state-of-the-art, multi-purpose plants, with over 270kL
of total capacity, to support the current pipeline of approximately 80
late stage programs that PPS is currently assisting its partners with at
various global sites. PPS will also expand its potency footprint at its
plant in Riverview, Michigan, while augmenting early development
capabilities out of Ennore, India through additions of GMP kilo
labs and a pilot plant. It will also add early development capabilities
in both, drug substance and drug product, out of its Morpeth, UK
facility. Support functions such as Analytical capabilities, R&D
infrastructure, automation, and IT systems will also be expanded at
all API sites through this investment.
Typhoid vaccine by Bharat
Biotech shows efficacy
Bharat Biotech Ltd, a Hyderabad-based vaccine maker,
said its next-generation typhoid vaccine, Typbar-TCV, had
demonstrated its safety and efficacy in a high-risk human
challenge clinical study carried out at Oxford University.
The clinical studies showed 87 per cent effectiveness
as per the trial results published in Lancet. The Lancet
study demonstrated that immunization with Typbar-TCV
is safe, well tolerated and will have significant impact on
disease incidence in typhoid-endemic areas that introduce
the vaccine. This study was conducted in 112 adult
volunteers and used a controlled human infection model.
According the Lancet study, the vaccine is safe, 100
per cent immunogenic and
prevents 55 per cent of typhoid
infections in the challenge
trial and up to 87 per cent of
infections, when using real-life
definitions of typhoid fever.
Multi-drug-resistant
Salmonella typhi has become a
major public health problem,
as more people are prescribed
antibiotics for even common
fever in developing nations.
Typbar-TCV is currently licensed
in India, Nigeria and Nepal,
with registrations underway
in Malaysia, Turkey, Thailand,
Uganda, Kenya, Bangladesh,
Pakistan and Vietnam.
Hilleman Laboratories
receives grant for
cholera vaccine
Hilleman Laboratories, a joint-venture
partnership between MSD and Wellcome Trust,
received a 6 million krona Indo – Swedish grant
for the project ‘Improved, affordable single
strain whole cell B subunit oral cholera vaccine’.
The proposed project, carried out by
Hilleman Laboratories, is being jointly
funded by the Department of Biotechnology
(DBT), Government of India and Vinnova, the
Swedish Governmental Agency for Innovation
Systems. The project will fuel further Research
& Development of the Oral Cholera Vaccine
(OCV) with knowledge exchange and transfer
of scientists across India and Sweden.
The OCV developed by Hilleman Labs would
make mass vaccination a reality in Cholera
endemic zones due to ease of manufacturing
and low cost, which would improve vaccine
affordability and accessibility. The grant is
expected to incentivize advancement of clinical
R&D against diseases that disproportionately
affect poor countries.
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