Biological E joins hands with VaxInnate Corp to launch recombinant H1N1 swine flu vaccine in India

India’s Biological E Limited has entered into an agreement with USA’s VaxInnate Corporation to license its recombinant H1N1 pandemic swine flu vaccine.

VaxInnate is a privately-held biotechnology company based in USA and is focused on developing proprietary vaccines, including those for both pandemic and seasonal influenza.

Biological E plans to manufacture H1N1 pandemic swine flu vaccine under a technology licence from VaxInnate.

VaxInnate recombinant H1N1 vaccine is based on the novel Toll-Like Receptor (TLR) technology platform, which dramatically improves vaccine immunogenicity and efficacy.

Using the TLR technology, vaccines can be produced by simple, low-cost, highly-scalable recombinant DNA techniques, avoiding many of the challenges and pitfalls of egg-based or cell-culture influenza vaccine production, Biological E said in a press release.

“This revolutionary technology can significantly improve the cost-effectiveness, manufacturing capacity, and potency of influenza vaccines and Biological E looks forward to working closely with VaxInnate to rapidly develop and manufacture this innovative vaccine in India,” stated Dr. Vijay Kumar Datla, chairman and MD of Biological E Limited.

Biological E has a successful history of partnering with large multinational companies such as Intercell A.G. and Emergent Biosolutions and is a key provider of vaccines to the Ministry of Health (MOH), Government of India, in support of the National Immunization Programme (NIP).

Under the terms of the agreement, Biological E has gained rights to manufacture the vaccine for South Asian countries which are home to one-fifth of the world’s population, about 1.3 billion people.

Biological E would produce vaccine for India and other South Asian countries, including Bangladesh, Bhutan, the Maldives, Nepal, Pakistan and Sri Lanka.

The H1N1 pandemic swine flu vaccine is projected to enter clinical development in India in early 2010. And the vaccine could become available for emergency use in India by mid 2010.

TLR technology enables Biological E to produce more than 300 million vaccine doses every month and is a practical indigenous solution to meet the needs of India’s 1.2 billion population, making the country self sufficient in the event of an emergency, the release said.

Biological E., Ltd is a biopharmaceutical company based in Based in Hyderabad, India.

VaxInnate’s is the sole technology currently capable of rapidly producing such high volumes of vaccine. VaxInnate’s proprietary technology based on a combination of toll-like receptor-mediated (TLR) immune enhancement and recombinant bacterial production of vaccine antigen conveys significant speed and volume advantages, which is also applicable in case of mutation of the strain.

Hundreds of millions of vaccine doses can be produced in a time frame of weeks instead of months. Currently in preclinical development, the vaccine is expected to move into human testing in the United States in 2010.

Cadila Pharmaceuticals, another pharma major from Ahemedabad, is also developing an H1N1 Swine flu vaccine in callaboration with Novavax.

CPL Biologicals Pvt. Ltd, the newly formed joint venture between Cadila Pharmaceuticals in India, expects to start producing H1N1 swin flu vaccine in next four months, Novavax Inc announced in a press release.

A few of the Indian companies are currently in the process of launching made-in-India H1N1 swine flu vaccines at half the price of imported vaccines will hit the markets by March.

Currently, the imported H1N1 swine flu is priced around Rs 300-400. But H1N1 swine flu vaccines produced by Indian companies may have a price of only Rs 50-100, reports said.

Initially, the India made H1N1 swine flu vaccines were expected to be launched in India only by April this year. However, Indian companies have advanced their their schedule to launch the vaccine as early by March, reports said quoting V M Katoch, director-general, Indian Council of Medical Research (ICMR) and secretary to the Government of India, department of health research.

Drug Control General of India has given approval to Zydus Cadila of Ahmedabad to carry out human studies of its H1N1 vaccine in India.

Zydus Cadila was the first Indian company to file the clinical trial protocol with the DCGI pushing back other domestic rivals who are also in race to launch H1N1 swine flu vaccine in India.

Zydus Cadila would have the vaccine ready by March, so the government would not need to import batches, according to government sources.

Bharat Biotech, Panacea Biotech and Serum Institute of India are the three biotech companies assigned by the Indian government to develop H1N1 swine flu vacccine.

New Delhi-based Panacea’s  egg based H1N1 vaccine is currently going through pre-clinical testing in animals.

Bharat Biotech, Hyderabad, which is currently working on a cell-based vaccine, also expects its animal studies to start human studies by January.

Probably Bharat Biotech would start the human studies of its H1N1 vaccine as early as  January, 2010. The clinical studies are expected to be complted by March, 2010, subject to regulatory approval and  Bharat Bio would launch its own vaccine by April 2010, if everything goes as planned.

In December, India placed an order with the French drug maker Sanofi Pasteur for supplying 1.5 million doses of H1N1 swine flu vaccine.

Sanofi Pasteur’s 2009 H1N1 swine flu vaccine batches will be available in India in January.

India has reported 1010 deaths confirmed by lab due to H1N1 as on January 6, 2010, as per the data available with the Union Health Ministry,.

Maharashtra on top of the list with 282 lab confirmed death cases. After Maharashtra, the maximum number of people who have lost their lives due to this pandemic disease is in Rajasthan which has registered 152 cases till January 6, and is followed by its neighbour Gujarat with 134 lab confirmed death cases so far. Gujarat is closely followed by the southern state of Karnataka with 133 death cases.

Delhi reported 73 deaths, Andhra Pradesh 52 , Kerala 34, Punjab 35 and Haryana 33.

The states which were registered comparatively less number of deaths included Uttar Pradesh (16), Uttarakhand (13), Madhya Pradesh (11), Chandigarh (8), Tamil Nadu (7), Himachal Pradesh (7), Puducherry (6), Goa (5), Orissa (3) Chhattisgarh (2), Jammu & Kashmir (2), Mizoram (1) and Assam (1).

However, no deaths were registered in some states like Bihar, Jharkhand, West Bengal, Nagaland, Manipur, Meghalaya, Andaman & Nicobar and Daman & Diu.