Ranbaxy files IND for asthma molecule, silent on JV - Views on News from Equitymaster

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  • Mar 30, 2000 - Ranbaxy files IND for asthma molecule, silent on JV

Ranbaxy files IND for asthma molecule, silent on JV

Mar 30, 2000

Ranbaxy Laboratories has filed an Investigational New Drug application of its new asthma molecule RBx–4638 and plans to conduct clinical trials within the country. Ranbaxy is among the top Indian pharmaceutical companies ranks second in terms of domestic sales. It has interests in anti–infectives, respiratory and cardiovascular. It possesses 12 brands among the top 250 brands in the country and in terms of its therapeutic dosage offerings covers around 77% of the market.

The pharma research is initiated with the conceptualization, experimentation and early discovery of screening over 100,000 compounds. These are screened down to 1,000 by the pre–clinical stage. The next stage involves the three phases of clinical trials where the new drug is tested on animal and human volunteers. The compounds get screened down to 2 or 5 by the end of clinical trials and around 1 or 2 by the time they get through the regulatory review.

It is in the process of clinical trials that India offers a real cost advantage. However, the results of the trials conducted in India are not accepted by regulatory authorities worldwide. Many countries require a part of the trials to be conducted again in their respective countries before they allow the drug to be sold.

Besides this molecule, Ranbaxy had also announced a recently held analysts meet that there are two other molecules RBx 4467 (anti–fungal) and RBx 5736 which have also completed pre–clinical trials. The management was however not willing to disclose the plans as to whether they would sell out these molecules or develop them further.

It is the developmental phase, which includes regulatory review/approval apart from the clinical trials where the pharmaceutical companies incur the highest expenditure and face the highest risk. Besides, marketing a drug costs almost three times the amount spent on its development.

News reports a few days ago indicated that the company was to assign the molecule to a joint venture with a foreign partner. This would mitigate the risks for Ranbaxy. The present story is however silent on the transfer of ownership of the molecule, if at all.

Click here for a story on the skewed pharma valuations

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