Event – NicOx limbering up for final data hurdle

Analysis

NicOx reported positive results from the third and final pivotal trial of its painkiller naproxcinod today, paving the way for a more important pooled analysis of the data which will be announced in the next couple of weeks, and hopefully a licensing deal.

All three trials have been positive, meaning there is a very good chance that the pooled analysis will show what the company has been striving to prove, that naproxcinod is just as effective as NSAID naproxen, but without raising blood pressure. The pooled data is important because it will give a better picture of exactly how differentiated the drug is, and how likely it is that regulators will allow the studies to be displayed on the label and promoted, which is essential if the drug is to have a chance of serious commercial success.

The aim of the naproxcinod project was to develop a safer NSAID, and emulate the success of Pfizer’s Celebrex, which has been largely based on studies pointing to fewer gastro-intestinal side effects than other NSAIDs. The drug generated sales of $2.2bn last year and is forecast to peak at $3bn by 2013, according to consensus data from EvaluatePharma.

Like Celebrex, naproxcinod is being trialled in osteoarthritis pain, and as a large proportion of the target population for this drug will be elderly and more likely to have high blood pressure, the rationale for NicOx’s strategy is clear.

Clinically relevant

However, while some analysts believe this means the drug has blockbuster potential, others are less convinced. The main fear is that the difference between the two drugs will not so significant that regulators allow the data to be displayed on the prescribing label.

Even if the company establishes with statistical significance that the drug does not increase blood pressure, regulators have to be convinced that translates into a benefit for patients. That question, whether the data is viewed as clinically relevant, will not be answered until regulators announce their final decisions, probably some time in 2010.

In the meantime, it looks likely that the data will be strong enough for NicOx to file for approval in the middle of next year. Actual data from the third trial was not released today, but the headline results showed that the drug met all three efficacy co-primary endpoints and showed similar blood pressure profile to placebo.

Still facing hurdles

The results will also probably be good enough to sign a licensing deal over, although partners are likely to want to wait to see the pooled data first, as NicOx’s finance director told EP Vantage in September. (EP Vantage Interview - NicOx waiting for final data as partners wait in the wings, September 17, 2008)

The identity of the final partner and terms involved will be a good indication of how big pharma views the drug's chances of being the next Celebrex. The company has enough cash to last until the middle of next year, so is not desperate for a deal, but clearly the stronger the pooled data is the better.

NicOx shares have enjoyed an impressive rally since mid October when they touched a two-and-a-half year low, and the stock jumped 18% today to a six-month high of €11.04. Investors' confidence is clearly growing that the company will achieve clinical success and a licensing deal. But whether it manages to jump the highest hurdle, that of regulatory approval and a differentiated label, remains to be seen.

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