BioDelivery Sciences International‘s (NASDAQ:BDSI) treatment for breakthrough cancer pain is now slated to launch in Canada this quarter – more than a year after the company had initially planned its Canada launch.
Raleigh, North Carolina-based BDSI received Health Canada approval for Onsolis in May 2010, which put the product on a track for a Canada launch last August or September. It is the first product approved in Canada for managing breakthrough cancer pain.
But problems at the site of the contract manufacturer have delayed Onsolis’ Canada launch three times. BDSI now says enough Onsolis has been produced to avoid shortages in the United States and supply sufficient product for a Canada launch.
A Canada launch will be crucial to BDSI. U.S. sales have been lackluster to date – just $3.4 million in 2010 – which the company attributes in part to Food and Drug Administration regulatory restrictions. The agency’s “Risk Evaluation and Mitigation Strategies” plan, often referred to as REMS, is required of some drugs that have known risks. Besides being an opiod narcotic, the drug poses a risk of respiratory depression in patients who are not opioid tolerant.
REMS limits Onsolis’ sale in retail pharmacies and also require doctors and patients to sign a registry for the drug. BDSI won’t face the same restrictions in Canada.
“The achievement of this important milestone provides an opportunity for growth of Onsolis outside of the U.S. market, particularly where commercial efforts will not be impacted by a REMS requirement,” CEO Mark Sirgo said in a prepared statement.
Onsolis is based on BDSI’s BEMA technology, which quickly delivers a drug via a thin piece of film placed on the inside of a patient’s cheek. Onsolis carries the powerful painkiller Fentanyl. The product is intended for breakthrough pain in cancer patients who don’t respond to other pain treatments. Onsolis is being marketed by Sweden-based Meda, which has commercialization rights for Onsolis worldwide except Taiwan.
Onsolis production shut down last summer due to problems that prompted an FDA warning for a plant operated by contract manufacturer Aveva. No Onsolis product was involved in the facilty’s problems but manufacturing of the product was shut down. Aveva resumed operations last November, prompting the company to set a first quarter Onsolis launch. Additional problems pushed the launch into the second quarter. Now BDSI plans to launch in the third quarter.
Besides Canada and the United States, Onsolis has received approval in the European Union. The product will be marketed in Canada by Meda Valeant Pharma, a joint venture between Meda and Canada-based pharmaceutical company Valeant Canada Limited. Sirgo said Osnolis will complement Valeant’s portfolio of oncology and pain products.