pSivida (NSDQ:PSDV) said today that it restructured a deal with Alimera Sciences (NSDQ:ALIM) to grant Alimera rights to the Durasert three-year treatment for posterior segment uveitis in Europe, the Middle East and Africa.
Alimera, which holds an exclusive license to pSivida’s intravitreal implant, Iluvien, plans to apply for a secondary indication for Iluvien for posterior segment uveitis.
According to the agreement, Alimera has the rights to Durasert in Europe, the Middle East and Africa under the Iluvien trademark in exchange for tiered, sales-based royalty payments. pSivida also plans to pull its EU marketing approval application and orphan drug designation for posterior segment uveitis. Alimera is responsible for filing a variation to Iluvien as a treatment for posterior segment uveitis in the countries where it is already approved for the treatment of diabetic macular edema, the companies reported.
“Today’s announcement fulfills a core pSivida objective to out-license Durasert EMEA rights as a means to optimize product value,” pSivida president & CEO Nancy Lurker said in prepared remarks. “We believe the EMEA out-license to Alimera, a company that is familiar with the complexity of the EU reimbursement environment and is currently marketing to target specialty physicians, could accelerate commercialization uptake and revenue realization for pSivida. The EMEA revenue opportunity for Durasert is estimated to be $30 to $50 million, and in the US it is estimated to be $80 to $120 million. We remain on track to file an NDA with the FDA by the end of this year. In parallel, the restructured global collaboration agreement benefits our shareholders as we immediately begin to recognize royalty income from sales of Iluvien as well as increase its long-term revenue opportunity.”
pSivida’s Durasert is an injectable, sustained-release drug delivery system that can last for up to 3 years. Administered in an office setting using a needle as small as 25-guage, the micro-insert is 3.5 millimeters in length with a diameter of 0.37 millimeters, according to the company.
