Botox, Dysport Competitor Xeomin Expected To Hit U.S. In Late September

Xeomin, a new wrinkle-relaxing injectable developed by German pharmaceutical company Merz, was recently FDA-approved and is expected to hit doctors’ offices in the U.S. by late September 2010.

Like Dysport and Botox, Xeomin is a botulinum type A neurotoxin designed to temporarily paralyze muscles that cause facial expressions and neuromuscular conditions, such as cervical dystonia and blepharospasm.

However, unlike Botox and Dysport, Xeomin is not yet approved for cosmetic use in the U.S., although it has been used for both therapeutic and cosmetic purposes in Europe since 2008.

It is anticipated that Xeomin will be used off-label for reduction of expression lines between the eyebrows and on the forehead, especially if the product’s price point is lower than the standard cost of Botox and Dysport, putting the new injectable in the running to claim a share of the aesthetic medicine market.

A lower Xeomin price point is unlikely, however, if the April 2009 launch of Dysport, Botox’s first-ever U.S. competitor, offers any indication of market behavior. It was assumed when Dysport was released that the competition between the two products would drive wrinkle-relaxing injection prices down, but this has not yet occurred.

Physicians anticipate that because the Xeomin is free of complexing proteins, it may have an edge over Botox and Dysport in treating neuromuscular conditions, since the higher doses necessary can be given without resulting in antibody formation.

This slight possible advantage will extend only to therapeutic uses of Xeomin, as the doses needed for cosmetic injection will be so small by comparison that the lack of complexing proteins will be irrelevant.

Some physicians believe that Xeomin might be at a disadvantage when used for cosmetic purposes, given the product’s tendency to migrate or spread beyond the injection site, which may result in unwanted muscle relaxation that causes facial features to droop temporarily if extreme care is not used in administering the injections.

Xeomin will be distributed in 50- and 100-unit vials and will not require refrigeration prior to reconstitution, as Dysport and Botox do. The effects of Xeomin purportedly resemble the effects of Botox, and the per-unit ratio of the two products is about equal, however, the each product is composed of different botulinum type A toxin formulation.