Upcoming events: April 15-21

Welcome to your weekly digest of approaching regulatory and clinical readouts.

All information is sourced to analyst notes and the EvaluatePharma Calendar of Events tool.

MAP Pharmaceuticals/Allergan: Levadex

A second chance at US approval looms on April 15 for Levadex, the inhaled acute migraine treatment from Map Pharmaceuticals and Allergan.

In March 2012 Map received a complete response letter owing to manufacturing and usability issues, and the firm's investors responded by causing the shares to drop by 4%. However, they were perhaps reassured that no new clinical trials were needed. This setback did not discourage its partner Allergan, which would have been co-promoting Levadex in the US and Canada. The cosmetic giant started 2013 by buying Map for nearly $1bn, equivalent to a 60% share price premium (Allergan hopes Map buyout does not bring more headaches, January 23, 2013).

JP Morgan analysts expect approval to be granted for Levadex, noting a clean safety profile, meaningful efficacy and a clear vote of confidence from Allergan. They forecast peak sales of $500m. However, there are questions as to where the inhaled therapy might fit into the highly crowded and genericised antimigraine market.

Canaccord analysts note that triptans are considered first-line therapy for acute migraines, with the market opportunity for Levadex focused on non-triptan users. Their model implies that Levadex will gain 2% penetration of the non-triptan population, equivalent to around 230,000 patients by year five after launch.

Allergan, however, already has a trick up its sleeve: Botox for chronic migraines. This could be co-promoted or possibly used in combination with Levadex, according to analysts at Cowen. Botox migraine sales are forecast to reach $1.1bn by 2018, according to EvaluatePharma consensus data.

When it closes, the Map deal will become Allergan's second-largest acquisition to date after the $3.2bn paid for Inamed back in 2006. Investors will be eagerly watching Monday’s decision to see whether Allergan’s latest buyout gamble pays off.

To contact the writer of this story email Joanne Fagg in London at joannef@epvantage.com or follow @JoEPVantage on Twitter

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