Arena Pharmaceuticals ($ARNA) has seen sales of its weight-loss drug Belviq improve since teaming up with marketing partner Eisai. But the two have hit a manufacturing stumbling block, having to voluntarily recall three lots of the drug because of labeling issues.
According to a recent FDA Enforcement Report, the duo recalled 121,680 bottles of Belviq because they may be missing a label or the label may not have the expiry date. It is a class III recall, the level of least concern, but still represents an interruption in their efforts.
Sales of Belviq started out slow but have picked up since Eisai signed on and the two started a television ad campaign and the Japanese company added 200 sales reps to help push the product. In its Q3 conference call, Arena execs said that prescriptions were running more than 5,000 a week in the last quarter, with sales of the drug hitting $16.8 million. Arena still reported a Q3 loss of $10.7 million, or $0.05 per share.
Labeling and packaging issues are particularly vexing for companies because they don't usually involve questions about the quality of drug but can disrupt supplies and add costs for recalling and replacing product. Last year, Mylan ($MYL) recalled 10 lots of the injectable "hypnotic drug" etomidate it was manufacturing for Pfizer ($PFE) because of labeling issues. The cartons for the product were missing lot numbers and expiry dates. In this case, the drug quality was potentially compromised because particulate from shipper labels were found in some vials. Novartis ($NVS) had to recall nearly 22,000 bottles of the attention deficit hyperactivity disorder drug Ritalin last spring because some packages contained the wrong insert.
- here's FDA Enforcement Report