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.