Pharma

FDA’s REMS program puts BDSI at a disadvantage in cancer drug market

Commercializing a new drug in the face of strict U.S. Food and Drug Administration guidelines is tough. It’s even tougher when direct competitors don’t have those same limits. That’s the situation facing Raleigh, North Carolina-based BioDelivery Sciences International (NASDAQ:BDSI). A cancer patient seeking relief from breakthrough cancer pain would be able to fill a prescription […]

Commercializing a new drug in the face of strict U.S. Food and Drug Administration guidelines is tough. It’s even tougher when direct competitors don’t have those same limits.

That’s the situation facing Raleigh, North Carolina-based BioDelivery Sciences International (NASDAQ:BDSI). A cancer patient seeking relief from breakthrough cancer pain would be able to fill a prescription for a number of products at a retail pharmacy. But right now, that selection does not include BDSI’s Onsolis.

BDSI has been working with the FDA on changes to get its lead product on the same footing as its competitors. While BDSI had hoped to finish those changes in the second quarter, now it looks like it will be a little bit longer. Vice president of marketing Al Medwar said that the changes should be finished “sometime this summer.”

Onsolis is a thin piece of film that when placed on the inside of the cheek quickly delivers the powerful painkilling drug fentanyl as it dissolves. The product is prescribed to cancer patients experiencing breakthrough pain. The FDA’s 2009 approval of Onsolis came with a risk mitigation plan as a condition of approval. “Risk Evaluation and Mitigation Strategies,” or REMS for short, are guidelines set for drugs with known risks. Fentanyl is an opioid narcotic that could be the target of substance abuse. But Medwar said the main reasons for the REMS requirement on Onsolis is the risk to patients who are not opioid tolerant and could suffer respiratory depression on the drug. The REMS also offers guidelines on storage of the product so that it’s not accessible to kids. The guidelines are intended to make sure that doctors, and in turn their patients, are aware of the risks. Those guidelines also restrict Onsolis’ availability from retail pharmacies.

Patients who are prescribed Onsolis can only get it through a specialty pharmacy that fills prescriptions by mail. According to the REMS, doctors must sign a registry acknowledging that they’ve read the material on Onsolis’ risks. Patients must also sign a registry. Doctors have told BDSI that the restrictions are burdensome to physicians and patients. Under the proposed REMS amendments, the registry will still be required, but patients will be able to get Onsolis from their local pharmacy. Right now, Onsolis’ competitors face none of those requirements. Medwar said that the marketing challenges posed by the REMS were not initially foreseen by BDSI. But he adds that as a small company trying to commercialize its first product, BDSI had every incentive to file its REMS plan quickly so it could get to market. Large companies with already approved and marketed products don’t have an incentive to move quickly so that they can face more regulation.

BDSI estimates that the overall U.S. market for transmucosal fentanyl products for breakthrough pain, including generics, totaled $375 million in 2009. The chief competitor to BDSI in this space is Cephalon (NASDAQ:CEPH), which has two comparable products. Cephalon’s Actiq and Fentora combined to generate more than $223 million in 2010 sales. BDSI says Onsolis offers some advantages, including ease of use. But Onsolis generated just over $3.4 million in 2010 revenue. In its annual report, the company attributes the low revenue total to the “highly restrictive” REMS program.

“The lack of approved REMS programs for our direct competitors has resulted in an unlevel playing field, which has created an unfavorable selling environment for Onsolis,” the company said.

Larry Smith, a former Wall Street analyst, wrote in a Seeking Alpha blog post that the REMS restrictions put Onsolis at a disadvantage compared to older competitors that don’t yet have a REMS program in place. The competition, Smith wrote, has been delaying their REMS programs for some time. He expects that Onsolis and others will compete on the same level playing field, REMS and all, by the third quarter of 2011.

Medwar said that BDSI and its marketing partner Meda have been working with the FDA on the remaining components of a modified REMS program. Amendments to REMS programs take about six months, but Medwar said that the FDA is under no obligation to follow a particular time line.

“There’s not very much left of it, but it’s hard to predict when the FDA will turn things around,” Medwar said.

So BDSI waits. And so, too, do cancer patients who for now have one less choice for breakthrough cancer pain relief available at their pharmacies.