Labopharm sees light at end of tunnel

Canadian group Labopharm may be on the verge of being rewarded for sheer perseverance in their pursuit of FDA approval for painkiller drug Tramadol OD, despite having its latest appeal turned down by the US regulator on Monday.

Whilst the FDA officially rejected the appeal, the company was thrown a lifeline with the suggestion by Dr John Jenkins, the FDA’s director for the Office of New Drugs, that the company submits a specific statistical analysis to prove the drug’s efficacy, which may then be sufficient for approval. Investors were certainly encouraged by the news, sending Labopharm’s shares up 32% since to C$1.75, admittedly from a relatively low base.

Forcing the issue

As previously highlighted by EP Vantage - Labopharm seeking reward for sheer perseverance, May 8, 2008 – the company has strained every sinew to try and achieve FDA approval without the need to conduct further costly and lengthy trials in order to address the FDA’s concerns over efficacy of Tramadol OD.

This strategy, which even included a request to meet with the FDA’s director at the Center for Drug Evaluation, Janet Woodcock, looks like it may pay off. Labopharm, who have already conducted the statistical analysis suggested by Dr Jenkins, expect to submit their response by the end of the week.

The company then states, perhaps somewhat hopefully, that the FDA will respond in a “timely basis”, which would have to be a minimum of three months, with a real prospect the company may have to wait considerably longer.

Touching distance

However, given the whole saga has lasted two and a half years since the drug’s original filing, the company is probably prepared to wait as long as it takes if the end result is an approval letter on their doormat.

Tramadol OD is by far the group’s most valuable product, with an NPV of $469m based on royalties from multiple marketing partners, including Purdue Pharma in the US if it ever gets approved, according to EvaluatePharma’s NPV Analyzer.

Compared to the group’s current enterprise value of $25m, FDA approval for Tramadol OD is clearly of massive importance to Labopharm, if it is to get anywhere close to realising these analysts’ expectations.

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