Hyderabad, Oct. 18

Bharat Biotech on Monday announced the launch of an indigenously developed cell culture H1N1 swine flu vaccine under the brand name ‘HNVAC’.

In a press release, the Hyderabad-based company claimed that the vaccine is the only developing world flu vaccine to be manufactured in cell culture, a highly sterile and controlled manufacturing process, instead of eggs.

The vaccine was tested extensively in phase I, II and III clinical trials for flu vaccines in India and has proved that it is safe and well tolerated.

Making the announcement, Bharat Biotech’s Chairman and Managing Director, Dr Krishna Ella, said: “The vaccine will help prevent the spread of H1N1 pandemic influenza, which can spread rapidly with a high rate of disease and death”.

Bharat Biotech will offer the vaccine with the best USFDA recommended cell culture technology for Indian consumers.

“The key benefit of our cell culture vaccine is its potential to scale up and produce large quantities quickly as required.

It also has a much more sterile and faster production cycle, without the external dependence on eggs and thus enabling quicker response times in the event of a pandemic,” Dr Ella added.

Drug Controllers Nod

Bharat Biotech received the approval from the Drugs Controller-General of India earlier this month to launch the vaccine.

HNVAC was developed with approved strains from WHO and CDC Atlanta.

This single dose vaccine has been developed by Bharat Biotech’s scientists at the Genome Valley facility in Hyderabad. The vaccine will be made available in the private market and through government procurement agencies.

It will be competitively priced as Bharat Biotech is committed to ensuring pricing does not become a barrier for consumers to access its vaccines, he said.

Dr BG Rhee, President of Green Cross Corporation said, “The year 2010 will be a very critical one for the life science industry in Korea. The Korean government has initiated a special programme for biosimilar development and has also set up a fund to support this programme. Several biopharmaceutical companies are preparing clinical trials and some companies are already in a clinical trial for biosimilar or biobetter projects. For biosimilar/biobetter projects, Green Cross will initiate a Phase II trial for pegylated G-CSF and a Phase I trial for Fc-EPO. Another area the Korean government will be focusing on is vaccine development”.

Mr Jung-Jin Seo, CEO & Chairman of Celltrion, a leading contract manufacturing company, said that ‘biosimilars’ and ‘growth of emerging markets’ are the buzzwords in the Asian bio-pharmaceutical industry for 2010. He put forward two points. Firstly, the transition from chemical drugs to biologicals has already become an irreversible trend in the global pharmaceutical industry. In particular, the patent expiration of blockbuster biologicals and the global attempt to reduce healthcare cost draw attention to biosimilars. Under these circumstances, Asian countries including Korea, which has no patent issues and possess advanced R & D capability, are anticipated to take the initiative in the biosimilars market with their products in 2010. Secondly, one should pay keen attention to the importance and growth potentials of emerging markets such as Korea and China. Novartis, for instance, recently announced its US$1 billion investment to expand its R & D operation in China. The slow growth in developed markets such as the US and Europe has initiated the global pharmaceutical giants, such as GlaxoSmithKline and sanofi-aventis, to expand their business to emerging markets due to constant increase in demand for growth of the healthcare industry. Therefore, emerging markets, including the Asian countries, will become increasingly important and have growth potential in the bio-pharmaceutical industry in 2010.

“The prospect for the Korean bio-industry is promising due to strong government support, large business groups such as Samsung and LG‘ involvements and biomedical funds to upgrade the Korean bio-industry. As in Korea, many APAC (Asia-Pacific) countries are striving to develop the bio-industry as their key industry and we believe that there will be plenty of room for complementary co-operations between APAC countries in 2010. KoreaBIO will be open to discussions for such co-operations”, concluded Dr Jeong-Sun Seo, President of KoreaBIO.

The Australian Government Agencies will provide full financial funding for the facility, which is part of the Queensland 10-year Biotechnology Strategic Plan. DSM will provide no capital but will provide technological expertise to design and set up the facilities and will employ its technologies during its operation.

“This offering will be an important continuation and expansion of the services we currently provide out of our facility in Groningen, The Netherlands,” says Karen King, president of DSM Biologics. “Clients will have the added advantage of being able to choose between standard technology processes or Royal DSM’s proprietary XD® and DSP optimization technologies.

“The services offered at the site will support all mammalian cell lines and process technologies including standard CHO-based systems and the PER.C6® cell-line technology, to which DSM has co-exclusive licensing rights for proteins and mAbs, together with the Dutch biotech company Crucell,” she continues.

The new biologics manufacturing facility is anticipated to be commissioned and operational in 2013. BioPharmaceuticals Australia is responsible for the overall initiative on behalf of the Queensland Government and has selected DSM Biologics to operate the facility.

The biotechnology industry in Australia is rapidly growing with over 400 companies currently engaged in development activities and an estimated A$60 million ($55.47 million) in annual CMO activity fees being exported out of the country due to the lack of a local CMO, according to DSM.

Under the twenty-year renewable agreement, Novartis said it will provide the “know-how” of vaccine manufacturing, while Arabio will begin distributing and licensing vaccines including Menveo, Quinvaxem and Agrippal, eventually progressing to packaging of vaccines, and ultimately to formulation and filling.

Novartis said the vaccines will be used to help prevent meningitis, seasonal influenza, whooping cough, diphtheria, tetanus, haemophilus influenza and hepatitis B.

Andrin Oswald, division head of Novartis vaccines and diagnostics, told Outsourcing-Pharma,”The partnership with Arabio shows our commitment to the Middle East,”

His sentiment was reinforced by a Novarits spokesperson, who said the Swiss-Saudi partnership will address “a significant unmet need [for meningitis vaccines] in countries with large Muslim populations participating in the Hajj and Umrah pilgrimages.”