With biopharma assets getting bid up so much nowadays, thanks to their resistance to future generic competition, any drugmaker with an approved biologic therapy should be on investors' watch lists. Yesterday, one such biotech, Alexion Pharmaceuticals
In March, Alexion received FDA marketing approval for Soliris, which is the only approved treatment for paroxysmal nocturnal hemoglobinuria, a very rare blood disorder that affects 8,000 to 10,000 people in North America and Europe. In June, the European Union regulatory authorities approved Soliris as well.
Alexion owns the worldwide rights to Soliris, but it may have to pay a small royalty to PDL BioPharma
Soliris is a monoclonal antibody. It's now Alexion's main clinical-stage pipeline candidate, after another biologic that it promoted with partner Procter & Gamble
Soliris sales should experience some serious growth in 2008. Alexion's priority for the year is to help doctors find and diagnose patients who might benefit from Soliris -- because finding them is half the battle with this ultra-rare disorder -- and then getting them on the drug. In Europe, Soliris is only on the market in the U.K. and Germany, but sales in France, Italy, and Spain are expected to commence in the middle of the year. Alexion is also awaiting a Soliris marketing decision in Australia and has a phase 3 study under way in Japan to help get approval there as well.
Alexion suffered a $14 million non-GAAP net loss in the third quarter last year and is pretty much a one-drug-wonder biopharma right now. With $126 million in cash and a $2.4 billion market capitalization, shares of Alexion are a little too expensive for my conservative tastes right now, but other companies, such as BioMarin Pharmaceuticals
BioMarin is an active pick of our Rule Breakers newsletter service.