BioDelivery Sciences (Nasdaq: BDSI) won U.S. Food and Drug Administration approval for its powerful painkilling product Onsolis.
A patch that delivers an opiate pain killer, Onsolis is designed to dissolve in a patient’s cheek. It is intended to treat so-called “breakthrough,” or sever pain in cancer patients.
Onsolis utilizes proprietary technology at called BEMA, or bioerodible muco adhesive. It is BioDelivery’s first product.
BioDelivery expects to begin sale of Onsolis in the fourth quarter through commercialization efforts of Meda Pharmaceuticals, BioDelivery’s partner. Meda is the U.S. subsidiary of Meda AB.
FDA approval triggered a $12 million milestone payment to BioDelivery by Meda. The Raleigh firm had received a $3 million advance from Meda in January. Another $15 million payment is due since BioDelivery has also manufactured enough stock for product launch, the company said.
BioDelivery also will receive “double-digit” royalties on sales and could earn another $30 million in milestone payments if sales targets are met.
“All of us at BDSI, along with our partner Meda, are very pleased to provide healthcare practitioners and their patients suffering from breakthrough cancer pain with a new treatment option for this serious and debilitating condition,” said BioDelivery Chief Executive Officer Mark Sirgo in a statement.
Sirgo also said the FDA approval is validation for its technology as well as the company’s ability to test and advance products.
“We now look forward to replicating our performance and regulatory achievements as we progress our pipeline,” he said.