BioDelivery says disc gives faster cancer-pain relief

Last Updated: 2007-05-14 16:03:13 -0400 (Reuters Health)

By Jennifer Robin Raj

BANGALORE (Reuters) - BioDelivery Sciences International Inc. said a disc it developed to deliver a pain reliever significantly reduced severe cancer-related pain faster than a previous review had shown.

The product, Bema Fentanyl, produced statistically significant reduction in cancer pain -- which breaks through medication -- within 15 minutes of applying the disc, the company said in a statement.

In April, it had said a late-stage study of the disc had reached its main goal of reducing the pain in 30 minutes.

It was the "same exact study" but the company has completed a more comprehensive review of the data now, Mark Sirgo, chief executive of the Morrisville, North Carolina-based company, said by phone.

"When we reported in April, we didn't have the results from an earlier timepoint and now we have it."

Bema Fentanyl is placed in the inner lining of the cheek. It dissolves over 15 to 20 minutes, delivering fentanyl, which has an analgesic potency of about 80 times that of morphine.

BioDelivery plans to apply for marketing approval for the product in the third quarter and expects annual peak sales of $250 million. It is also in discussion with several potential marketing partners.

The market for breakthrough cancer pain is about $700 million based on 2006 sales of in-line products, Megan Murphy, an analyst at Lazard Capital Markets, said.

PROMOTION-SENSITIVE MARKET

If approved, the disc will compete with market leader Cephalon Inc.'s lozenge Actiq and Fentora tablet, both fentanyl-based products. Actiq relives pain within 30 minutes and Fentora within 15 minutes, Murphy said.

"It is a very promotion-sensitive market -- you have got to spend a good bit of money to make money, investment in the product will likely need to be high," Murphy said.

The company now can use the Bema technology to deliver other compounds and treat other indications, Murphy said.

BioDelivery is currently also developing Bema LA for acute and chronic pain.

BioDelivery shares were up almost 5 percent at $4.89 in afternoon trade on the Nasdaq. They had hit a life high of $8.26 on April 25, when the company announced the phase-III data for Bema Fentanyl.