Cadila to apply for clinical trials for swine flu vaccine

New Delhi: With an aim to launch vaccine for
Influenza H1N1 A Virus (swine flu) in India, Cadila
Pharmaceutical will seek the government`s nod in two days for
initiating clinical trials in this regard.

Cadila Pharmaceutical Ltd (CPL) had set up a joint
venture `CPL Biologicals Pvt Ltd` with the US-based vaccine
maker Novavax for manufacturing and developing a host of
vaccines, including for swine flu, in India.

"The joint venture is going to file the application with
the Drug Controller General of India (DCGI) in the next two
days for phase-I clinical trials for swine flu vaccine," CPL
Chairman and Managing Director I A Modi told PTI.

Modi expressed confidence that Cadila would be the first
Indian pharma company to launch the swine flu vaccine in India
by December.

"If we get the permission of DCGI soon, then with the
advanced technology available from our partner, (we) would be
able to launch it in India by December this year," Modi said.

With its existing facility, Cipla can produce up to one
million doses of the vaccine per month, which can be scaled
up to two million doses, Modi said.

"Novavax has already received permission for clinical
trials from the US Federal Drug Administration and if we get
it soon, we can simultaneously start the trials," he added.

The government has already indicated that swine flu
related applications it would clear on a fast track basis and
the company is hopeful of getting instant approval for it,
Modi added.

He said to protect from swine flu pandemic, two dosages
of the vaccine are required over two weeks.

The JV has already started building a facility with an
estimated investment of Rs 100 crore. In the joint venture
Cadila has 80 per cent stake and the remaining 20 per cent is
held by Novavax.

Besides this, Cadila Pharma also holds 5.75 per cent
stake in Novavax Inc US and has a position on the board of
directors of the US-based company.

Bureau Report