Cephalon to acquire rights to spasm drug

US-based pharmaceutical company Cephalon will pay USD 100m to acquire North American rights to privately held ECR Pharmaceutical's FDA-approved muscle-spasm drug Amrix (cyclobenzaprine extended-release).

In February 2007, the FDA approved two dosage strengths of the drug for short-term use, accompanied by rest and physical therapy, to treat muscle spasms associated with acute musculoskeletal conditions.

Amrix is not commercially available in the US as yet, but Cephalon says it will begin selling it by Q4 2007.

Cephalon has six marketed products in the US, including the insomnia treatment Provigil (modafinil) and the fentanyl-containing pain blockers Actiq and Fentora.

In a Q2 FY07 announcement to investors and an SEC filing, Cephalon said it had established a USD 56m reserve as an estimate of the minimum liability to resolve investigations by the US Attorney's Office in Philadelphia and the Connecticut attorney general.

In September 2004, the US attorney in Philadelphia subpoenaed documents about Cephalon's sales and marketing of Actiq and Provigil and the epilepsy drug Gabitril.

The Connecticut attorney general began a probe after information about off-label use and problems with illegal use of Actiq after the 2003 death of a US woman who overdosed after buying the drug from a dealer.

Actiq, which is delivered orally through a flavoured lolly, is approved for breakthrough cancer pain only, but doctors often prescribe it off-label to treat other types of pain, such as back pain and migraine headaches.

The US Attorney's and Connecticut Attorney General's Offices has yet to discuss the status of the investigations.

Natixis Bleichroeder analysts have said that Cephalon will settle the Justice Department investigation into off-label promotion for between USD 100m to USD 200m.