The Hindu Business Line : Nicholas’ drug trial plan on expected lines

With Nicholas Piramal’s lead oncology drug P-276 — for blood and head-neck cancers — expected to commence US trials in the first quarter of 2008, the molecule appears to be progressing in-line with earlier announced objectives.

P-276, an injectable, targets a category size having revenues of $2.7 billion. Nicholas Piramal’s molecule is competing with Seliciclib from Cyclacel Pharmaceuticals, SNS-032 of Sunesis Pharmaceuticals and PD-0332991 from Pfizer, all which are undergoing trials.

Potential Rewards

Nicholas Piramal, which will be transferring its innovative R&D research assets to a new demerged company, also has an orally active derivative of P-276. Named as P-1446, this drug molecule is also expected to go to Phase-I trials in the first quarter of 2008.

Nicholas Piramal has indicated that it wants to continue development of their compounds and seeks to bring at least one compound to the market on its own.

By choosing not to out-license compounds at an earlier stage, the potential rewards become higher but so does the risk. The creation of a new R&D company, whose shares will be listed on BSE and NSE, may cushion against such risk.

Clinical Trials

It is unclear at this stage whether Nicholas Piramal will out-license P-276. The new R&D company will have cash of Rs 95 crore on demerger, which might not last for very long given the expensive nature of clinical trials.

External equity funding or placement of shares will be the other options that may be considered.

With Phase I studies (on smaller number of patients) of P-276 completed in Canada and India, receipt of regulatory approvals for Phase II (on larger number of patients) was expected. The USFDA has granted approval for Phase II clinical trials in the USA.

A second study for P-276 is expected to begin in India for specific types of cancers in the first quarter of 2008 also.

Once the initial safety of the study drug has been confirmed in Phase I trials, Phase II trials are performed on larger groups and are designed to measure how well the drug works, as well as to maintain Phase I safety assessments in a larger patient-group.

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