Zydus Cadila could be first Indian firm to launch H1N1 swine flu vaccine

Cadila Pharma, Serum Institute are also in race to launch H1N1 swine flu vaccine in next 4 months

Zydus Cadila of Ahmedabad could be the first pharmaceutical firm to launch H1N1 swine flu vaccine in India, even as several others including Cadila Pharma and Serum Institute of India are speeding up their plans to bring in the vaccine.

Zydus Cadila has already sought permission to conduct human studies of the H1N1 candidate vaccine with the Drug Controller General of India (DCGI), the approving authority for permitting to undertake clinical studies in the country.

Zydus Cadila is 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 is the first and the only Indian company to file for swine flu vaccine’s trial,”  Dr Surinder Singh, DCGI was quoted as saying.

GlaxoSmithKline (GSK), Novartis, Baxter International and Sanofi-Aventis are the multinational companies applied for test license to the DCGI for carrying out clinical trials in India for their version of swine flu vaccines.

Glaxo has a vaccine against H1N1 swine flu branded Pandemerix.

Filing for test licence to conduct clinical trials is normally long process. After Zydus Cadila, GlaxoSmthKline is “comparatively ahead”  in the filing process, DCGI said.

Zydus Cadila is working with BioCryst Pharmaceuticals on the potential H1N1 vaccine candidate, unconfirmed reports said.

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.

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.

The CPL Biologicals facility is expected to be be capable of producing over 60 million doses of flu vaccine annually at full capacity.

CPL Biologicals has already begun construction of a state-of-the-art 25,000 sq. ft manufacturing facility that will be used to produce pandemic and seasonal influenza vaccines.

CPL Biologicals will utilize Novavax’s virus-like particle (VLP) vaccine technology to produce commercial-scale quantities of VLP-based influenza vaccines using Novavax’s innovative disposable manufacturing solution.

CPL Biologicals facility will also be used to produce other novel vaccines being developed by CPL Biologicals, based on Novavax’s VLP vaccine technology.

CPL Biologicals facility is being 100% supported financially by Cadila Pharmaceuticals Ltd.

“We anticipate creating sufficient capacity for CPL Biologicals to sell influenza vaccines in India and at the same time become a potential supplier to Novavax for sale of vaccines in other markets where Novavax maintains complete commercial rights,” stated John Trizzino, Senior Vice President, International and Government Alliances for Novavax and Interim Chief Executive Officer of CPL Biologicals.

Meanwhile, Serum Institute of India has started preclinical animal studies for its indigenous H1N1 swineflu vaccines in India.
Pune, Maharashtra based Serum Institute has begun studies to test the toxicity and safety of its experimental vaccine currently being developed before attempting to study in humans, reports said quoting Serum officials.

Serum Institute plans administer around 500 doses of the H1N1 vaccine to animals over a period of 40 to 50 days.

Serum institute will submit the toxicity and immunogenicity data generated from the studies to the Drug Controller General of India (DCGI) for obtain permission permission to undertake first in man – Phase I – human clinical trials.

Serum Institute expects to complete animal trials by November end or December first week.

Serum Institute will begin human trials as soon as the company receives permission from DCGI.

Serum Institue is  developing two types of vaccine – one is injectable (inactivated) and other is intranasal route (live attenuated).

Serum plans to make H1N1 vaccine available to the Indian government by March 2010.