FDA clears course for MAP

The race to the finish line for MAP Pharmaceuticals’ anti-migraine drug Levadex has stepped up a gear after the FDA removed a key regulatory hurdle.

MAP announced yesterday that the FDA will not ask for a second phase III efficacy study in its new drug application for Levadex, an inhaled formulation of the tried-and-tested injection treatment, dihydroergotamine mesylate, first launched way back in 1946. The decision, which sent the group's shares up by 33%, is likely to make MAP, with only one active product in the pipeline, a more attractive partner or acquisition target.

Long term safety

While it has been given a waiver for a second efficacy trial following the Freedom-301 study, which found that migraine patients taking Levadex were significantly more likely to experience pain relief and be free of phonophobia, photophobia and nausea than patients taking a placebo, it is not quite game over and the company still has to complete a long-term safety trial.

This open label extension study will assess the safety of the treatment in more than 300 of the 792 patients who took part in Freedom-301. MAP executives said they expect the safety study to end in 2010. What should encourage investors waiting on the side lines is that the drug has so far shown a very good side effect profile with no serious adverse events reported in the efficacy part of the study.

If the safety of the drug is confirmed the next question for partners is how well Levadex will muscle its way into the crowded migraine market. Indeed, according to consensus forecasts from EvaluatePharma Levadex will only be the ninth-biggest anti-migraine preparation in 2014, accounting for $96m of the forecast $2bn in sales for branded migraine medications in that year (Therapeutic focus - Lack of innovation in migraine market a headache, November 10, 2009).

This ranking includes the now-delayed Merck & Co oral therapy, telcagepant, that is expected to book $190m in sales in 2014 and rank fifth. This consensus has plunged from $872m since Merck ended a phase III trial of telcagepant in April 2009 due to evidence of elevated liver enzymes in a small number of patients, and the future of the drug is still uncertain.

Increased opportunity

Levadex is set to be the second biggest growth driver for migraine drugs over the next six years, behind telcagepant but just ahead of Glaxo's Treximet and Johnson & Johnson's Axert, suggesting there is an opportunity for Levadex to capture further sales with the expected removal of a potential major competitor in telcagepant.

This second piece of good news on Levadex, following surprising efficacy results for the drug in May, represents a turnaround for MAP. It was less than a year ago that the company’s paediatric asthma medication unit dose budesonide failed in phase III trials, causing its share price to tumble to a 52-week low of $1.57 (MAP gasping for breath after UDB failure, February 24, 2009).

Prior to today's news analysts were setting price targets ranging from $11 to $17 on Map stock, based on the drug’s expected approval. Shares in MAP were at $12.43 today, indicating that there is still a little way to go.

But with one less barrier in the way, MAP is able to chart its course a little more easily.

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