Lupin Ltd, the leader in anti-TB (tuberculosis) drugs, has drawn up ambitious plan to file for four abbreviated new drug applications (ANDAs) and at least two investigational new drug applications (INDAs) with the Food and Drug Administration of the US in the current financial year.
ANDAs are made to conduct trials on generic variants of drugs going off patent in the near future.
The four ANDAs that Lupin plans to file would be in the novel drug delivery system (NDDS) category.
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While the two INDAs would be in the area of new chemical entities (NCEs), The R&D effort is part of company's strategy to remain competitive post-2005 when India would brace up worldwide patent standards.
In the anti-migraine segment, which falls under NCE, Lupin has completed 80 per cent of the pre-clinical trials procedure.
It will begin clinical trials and file for an INDA in 2001-2. Phase I and II trials are expected to be completed by 2001-2.
Lupin is also trying to cement its numero uno position in anti-TB drug segment where it is the leader with 45 per cent of the national market share.
Its R&D initiative is now focused on creating a new anti-TB compound by using herbal mixture to enhance the efficacy of the drug.
It is also working on areas like asthma and psoriasis. While clinical trials for asthma drug has been carried out on animals and a systematic study would follow, for psoriasis, Lupin is expected to file an INDA in 18 months.
The company's strategy would be to take a molecule up to INDA stage and then enter into an alliance for co-developing the molecules.
The partner will bear the development costs while Lupin is will receive royalty and rights to sell the product in Asian countries.
The upfront fees expected could range between $8-12 million in addition to the $15-$20 for clinical development.
In the drug delivery system front, Lupin has already invested heavily in NDDS to make its existing drug more attractive to the end-user. The new drug delivery mechanisms, being developed by Lupin, is aimed at to support the NCEs in the pipeline of Lupin.
The company plans to develop NDDS on a rate-dependent-not dose-dependent-strategy. Its objective is to emerge as a preferred outsourcing partner for innovators. The company is expected to use the R&D facility in Pune to spearhead NDDS and NCE experiments. This endeavour will be a costly endeavour for Lupin, which merged its two entities, Lupin Laboratories and Lupin Chemicals earlier this year. The combined turnover in 2000-1 stood at Rs 902.84 crore.