1. Assuming Biocon receives approval for BioMAb, should it launch the drug immediately or conduct phase 3 trials before launch? Elaborate the various elements of your action plan.
Even if the Drug Controller General of India (DCGI) grants permission for BIOMAb in fall 2006, Biocon should still conduct phase 3 trials before launching. Both Biocon and Clinigene are new to the industry and strong reputations have yet to be developed. Therefore, Biocon must means make sure BIOMAb is a proven quality drug before it’s released. Biocon should enter the cancer pharmaceutical sector as soon as possible to begin building a name for itself in the cancer industry by selling other generic cancer drugs first. R&D costs may be significant, but not as much as creating drugs from scratch. This would generate revenue and start getting Biocon’s name familiar in the market. Also, by waiting to launch, Biocon would be postioned to defend BIOMAb better if and when Eribtux uses the lack of Biocon’s experience against them.
By waiting to launch, BIOMAb might not be the first new drug in the head and neck cancer market, however, Biocon will still be the first Indian company to produce a proprietary drug since Erbitux is an existing drug with a new use.
2. How big is the current and future market opportunity in BIOMAb?
The market in India consists of both public and private sectors, 20% public sector and 80% private. India comprises up 21% of the worlds’ cases of head and neck cancer and 27% of the deaths from head and neck cancer. 85% of head and neck cancer patients are due to excessive use of tobacco and alcohol and India has a high population use of tobacco and alcohol.
Venky Rao, senior manager of business strategy, expects that 95% of the patients using BIOMAb would be self-paying. The cost of the drug is a main determinant on the possible market for the drug as most citizens of India are likely unable to afford expensive health care, however the