BioSpectrum India Magazine November issue BioSpectrum India Magazine - Page 17

www.biospectrumindia.com | November 2017 | 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. 17