After reporting 'favourable' results for H1N1 vaccine testing in Mexico, US-based $ 350 million NASDAQ listed biotech firm Novavax is hopeful of producing a similar feat in India, where it has a joint venture with Cadila Pharmaceuticals called CPL Biologicals. Using the innovative virus like particle (VLP) technology CPL Biologicals is confident to produce about 10 million doses within a short span of time for the Indian market. In an interview with Sohini Das and Maulik Pathak, Novavax President & CEO and director of CPL Biologicals, Rahul Singhvi says that time is running out fast and it'll be redundant to roll out the vaccine after three-four months. Excerpts:
How much progress have you made so far in your swine flu vaccine venture? We have learnt that you have got some interesting results in Mexico.
We already have results from stage A trials that shows that the product is well tolerated and is producing the desired immunity levels. We are ready to roll out the product and our facilities in the US are ready and the one in India should be ready by February next year. We have applied for all the requisite permissions and are awaiting nod from the drug control department to carry on clinical trials for swine flu vaccine.
Yes, the Mexican government came forward pro-actively and allowed clinical trials to test Novavax' 'virus like particle' (VLP) technology. We started registration trials there on October 19 on 1000 people in stage A and another 3000 in stage B. The results of the stage A trials have already come on December 2.
Will this move help your plans for India through CPL Biologicals? How soon can you launch the product in India?
We plan to launch the product in Mexico first sometime during the first quarter of next fiscal. As for India we need to have the requisite permission to hold clinical trials in the country, which is awaited. Novavax can transfer the technology to CPL Biologicals for mass production of the vaccine here. As for the clinical trials, initial material could be provided from the US.
India wants indegenious technology so it does not have to be dependent on other countries for the cure. We are ready with the Rs 100 crore facility in Dholka near Ahmedabad that can roll out 10 million doses of the vaccine in the first phase during February-March 2010, and the capacity can be later ramped up to 250 million doses.
Our US facility in Rockville near Washington DC that has a capacity to roll out 30 million doses in six months is also ready while we haved tied up with Xcellerex for contract manufacturing for Mexico. Under any circumstance, the vaccine has to come into the market within the next three to four months after which it could be too late.
The US government hasn’t given you permission for clinical trials so far. Any specific reasons?
The VLP technology has not yet been tested for flu and does not have the US Food and Drug Administration (FDA) approval. The same technology has been tested and is applied in case of Human papillomavirus (HPV) infection that is a necessary factor in the development of nearly all cases of cervical cancer.
Currently, the embryonic technology is used for developing vaccines. Some countries are taking a conservative approach towards testing the new technology.
Novavax is yet to roll out any of its products commercially. How much have you invested in R&D? What kind of returns are you expecting in near future?
We have already invested around $ 100 million developing the VLP based vaccine for flu, both seasonal and pandemic.
Another tens of crore would be required to conduct clinical trials here in India. Once, a single product ‘clicks’, our investments would be recovered within no time.
As for the market size, already the US has placed orders for 256 million doses and around 90 million has been supplied so far. In India the potential market size is roughly 10 billion people.
Considering even five per cent use the vaccine, its a huge figure. Similar is true for the other countries especially with the vaccine coming in for $10 per dose.
How fast can you develop the vaccine using virus like particles technology as compared to egg-based technology? Don't you have an advantage as you were already working on the flu vaccine when swine flu came in?
Using the VLP technology, vaccines for swine flu were developed at half the time compared to the conventional egg-based technology. Also, the technology enables quicker mass production.
We did have the capability in place as we had already used the technology for developing seasonal flu vaccines.
So, in case of diseases like swine flu in which the virus attacks come in waves, VLP technology is more suited to manufacture updated variants of the vaccine that is equipped to take on the mutated virus.
What will be your next step in case you do not get permission to conduct clinical trials in India?
CPL Biologicals will continue to work on vaccines of seasonal flu. Besides, we are also bullish on developing vaccines for dengue and can start working on a project on malaria. We are also keen to work on cancer vaccines.
The Indian unit is designed on our US model which uses disposable manufacturing that uses single use equipment and makes products in batches. The same facility is useful for manufacturing a range of products.
