BioDelivery Sciences International Inc. is set to receive $30 million in an up-front payment from Swedish specialty pharma Meda AB under a licensing agreement for BEMA Fentanyl, a dissolvable opioid disc product.
Morrisville, N.C.-based BDSI has entered into an exclusive and perpetual license and related supply agreement with Meda for the U.S., Canadian and Mexican commercialization rights to the product.
BDSI plans to soon file a new drug application with FDA for BEMA Fentanyl to control breakthrough pain in cancer patients. The company anticipates approval of the product by late 2008, CEO Mark A. Sirgo told BioWorld Today.
Under the terms of the Meda deal, BDSI will receive an additional $30 million after BEMA Fentanyl has achieved FDA approval. The firm also is set to receive a "significant double-digit royalty" on net sales, the company stated.
The agreement also calls for Meda to pay BDSI a total of $30 million, in $10 million increments, when certain sales milestones are met.
Meda also has guaranteed minimum annual royalties, based on low sales, during the first seven years.
Sirgo said BDSI chose Meda, a Solna, Sweden-based company that specializes in respiratory and pain products, as its North American partner based on an ongoing pact formed in 2006 to commercialize BEMA Fentanyl in Europe, once the product is approved in those markets.
Meda's acquisition in July of Somerset, N.J.-based MedPoint, which gave the firm an immediate 400-person sales force in the U.S., was an attractive incentive for BDSI to expand its collaboration with the company to North America, Sirgo said, noting that Meda's European sales force is 1,100 strong.
A robust sales force in the U.S. and Europe, Sirgo said, will help BDSI further develop BEMA Fentanyl as a treatment for other noncancer breakthrough pain indications, such as osteoarthritis and lower-back pain.
Lower-back pain is the most commonly reported type of pain in Americans, according to the Centers for Disease Control and Prevention, and osteoarthritis is the most common type of joint disorder.
Under the agreement, Meda will take on the financial responsibility of the development, studies and marketing for the expanded pain indications, Sirgo noted. The partnership, which he called an "ideal" and "fair" situation for both companies, also sets the stage for BEMA Fentanyl to compete in a market for breakthrough cancer pain dominated by Cephalon's fentanyl products Actiq and Fentora.
Sirgo argued that BEMA Fentanyl, which is absorbed through the inner lining of the cheek, is superior to Actiq, a fentanyl lozenge on a stick, and Fentora, a fast-dissolving oral tablet.
While Cephalon's fentanyl products have been found to cause some oral irritations, such as mouth ulcers, BEMA Fentanyl, which has been studied in more than 300 patients, has not, he maintained.
The product, which Sirgo described as similar to dissolving breath strips, is more convenient for use in cancer patients than Cephalon's effervescent- and lollipop-style products, he contended. The bioavailability - the total amount absorbed from the delivery system - of BEMA Fentanyl, he asserted, also is superior to that of Actiq and Fentora.
In May, BDSI reported that study results showed that the absolute bioavailability of fentanyl from BEMA Fentanyl disc was more than 70 percent with 50 percent absorbed through the buccal mucosa.
BDSI, Sirgo said, is seeking to market BEMA Fentanyl in a broad range of dosage strengths: 200 mcg, 400 mcg, 600 mcg, 800 mcg and 1200 mcg. In addition to those strengths, Actiq is sold in a 1600-mcg strength. Fentora is marketed in dosage strengths of 100 mcg, 200 mcg, 300 mcg, 400 mcg, 600 mcg and 800 mcg.
Sirgo said BDSI plans to use the funds from the Meda deal to "take care of some bills" and to continue to build its infrastructure by adding new personnel to support development activities. The funds, he added, also will be used to more aggressively advance the firm's other products, BEMA Long Acting Analgesic, or BEMA LA, and Bioral Amphotericin B, an antifungal.
During a late afternoon investor call, Sirgo noted that once the firm pays off a $1.9 million loan to Clinical Development Capital, which it plans to do by March 2008 with funds from the Meda deal, the company will be debt-free.
Sirgo said BDSI and Meda have projected sales of BEMA Fentanyl to reach at least $200 million.
On news of the deal, BDSI's stock (NASDAQ:BDSI) rose earlier in the day, but fell to close at $3.94, losing 6 cents.