BIOMAb was an anticancer drug that was undergoing research by Biocon owned by Dr Kiran Mazumdar-Shaw in 2006. However, Mazumdar-Shaw was impressed with the degree of successfulness showed by the drug that she found that a decision had to be made immediately. The Drug Controller General of India – DCGI (similar to the FDA) was likely to give a go-ahead for the drug. The drug had completed Phase 2 trials, but if the DCGI gave its approval then phase 3 trials would likely to get affected. Hence, experts from the company felt that even if the drug got its nod, phase 3 trials to determine safety and efficacy should continue.
This was to gather strong evidence for the drug. Besides, the company had not prepared a marketing strategy for the drug (the pricing, sales, marketing personnel, channels, etc) was not yet decided. Biocon was initially an enzyme manufacturing company, initiated in 1978, but slowly moved into other areas. It entered biopharmaceuticals in 1996. This was because the global enzyme market was about $ 2 billion and even a 10 to 15% share of the market would not be sufficient for the company to take on growth. The global biopharmaceutical market is more than $10 billion and is likely to grow to $80 billion by 2016.
The company had two problems when moving from one field to another: It had to move from technology required for enzyme manufacturing to proteins. The pharmaceutical market is highly regulated, and hence the company decided to launch generic versions of the drug to help understand the market. Biocon got approval to sell Levostatin in 2001 and sold the same through GenPharm. Within a few years, Biocon got a 15 to 20 % share of the statin market in the US. When Biocon wanted to enter the insulin market, it felt it had a few advantages over the others.
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Indians represented 1/5th of the world diabetic population and Biocon had fermentation capabilities such that it could manufacture huge amounts of the insulin. It was successful at these endeavors and soon took on proprietary drugs especially oral insulin. It crossed the $1 billion mark in 2004. Identification of major problems & Opportunities BIOMAb is an anticancer drug used to treat head and neck cancers. The company had accidentally taken up the drug in 2002, when Mazumdar-Shaw decided to visit CIMAB during her spare time. This organization had been working with several anticancer drugs.
It had developed monoclonal antibodies (Mabs) that could attack the cancer cells, block specific cell receptors and prevent further growth of the tumor. CIMAB had conducted extensive research on BIOMAb through phase 1 trials, and Mazumdar-Shaw realized that there was a tremendous opportunity. The company had an opportunity to take the drug further through research, market the drug, and further launch it. However, there were also several problems associated with the same. This was concerning a new technology for mammalian cells and a company making fermentation enzymes; it was really a grey area.
The company had no idea of the financial investments or the technology involved. Biocon had no experience in selling or marketing a proprietary anticancer drug. Besides, it did not have any idea of the patients, physicians, specialists, etc. Approval was required through the regulatory bodies and clinical trials were not extensively conducted in India. Experts estimated that more than $ 25 million were required through investments, which included 25% for costing, 15% R&D, 25% marketing, and the remaining as profits.
In 2005, the Indian government agreed to implement the TRIPS agreement, which saw major changes in the Indian patent laws. Many companies were not happy with the Indian patent laws, as their IP rights were not adequately protected. Biocon idea was to help a research institute take their products through various phases of clinical trials. It wanted to help the company commercialize their drugs and market the drug in various parts of the world including India. This was a unique model that demonstrated great opportunities worldwide.
Biocon was able to obtain a license from CancerVax in 2004 to market three cancer drugs developed by CIMAB in various parts of the world. It saw tremendous scope for BIOMAb in India, and decided to conduct trials for head and neck cancers, as the prevalence was high. At the time when BIOMAb was launched into India, about 95% of the cancer patients had to buy their own healthcare and only a small percentage actually could afford BIOMAb. However, a positive side was that the Indian economy was growing at 9% per year & the Indian population at 1.
4%, and hence more and more people could slowly afford the drug. About 10% of the cancer patients were actually the customers to receive the drug. Biocon was also receiving tremendous competition from Erbitux, which was originally an anticancer drug meant for colorectal cancers, but considering its huge potential, Merck decided to test it out for head and neck cancers. Merck had got the approval for using the drug in head and neck cancers from the DGCI in 2006. BIOMAb did had not have phase-3 data (unlike Erbitux).
However, BIOMAb had shown a 100% success rate and there were lesser side-effects such as skin rash associated with BIOMAb. The alternative marketing courses of action The alternative course of action selected by Biocon was interesting and noteworthy. Biocon strategy seemed to be very strong - to help research organization to go ahead with trials, ensure commercialization of the products, along with sharing of the IPR. As the drug went from phase 1 to phase 3, the number of subjects were increased.
Phase 4 trials included researching the drug after it was marketed to obtain data about the side-effects, efficacy and long-term use. Since, it was a new molecule, several experts in the field of cancer were skeptical about giving the drug to patients. However, Biocon tied up with premier cancer institutes in India such as Kidwai Institute of Oncology and used the drug for phase 2 trials. Clinigene aided in researching the drug. The drug was combined with other treatment modalities and it was found that when administered with radiotherapy-chemotherapy combination it could 100% get rid of the cancer.
However, BIOMAb had to compete with Erbitux which was internationally reputed. Biocon also considered whether BIOMAb could be utilized for treating colorectal cancers and hence directly compete with Erbitux. If BIOMAb was launched after phase-2 trials, then Erbitux may have been preferred as it had completed phase 3 trials. There was also the idea of launching BIOMAb with other generic drugs simultaneously which could help the users to use the generic version and get accomplished with the drug.
The company had problems deciding to price the drug. If it was set below the price of Erbitux, then it would lose its credibility and in case it was higher, it would not be affordable for the Indian public. Hence, it chose a two-tier pricing system for India so that certain people from the lower socioeconomic groups could even afford the drug and use it. There were two supply chains for BIOMAb, one through the traditional manufacturer-wholesaler-pharmacy and the other a doctor/hospital-pharmacy relationship.
Biocon provided much more services than merely drug supply to the patient, considering the fact that cancer was a fatal disorder and the patient and family needed support (such as web site information, consumer helpline, direct consumer advertising, education and awareness through sales representatives, etc). The medical representatives were spending a time educating the patients and their families about the drug. The company used its resources for various useful purposes.
- Gupta, S. and Narayan Das (2008). “Biocon: Launching a New Cancer Drug in India. ” Harvard Business School.
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