Alimera Sciences announced that it secured the rights to pursue posterior uveitis, a secondary indication for Iluvien, in the European Union (EU), the Middle East and Africa.
Alimera secured the rights by signing a Second Amended and Restated Collaboration Agreement (the New Collaboration Agreement) with pSivida, US, a subsidiary of pSivida Corporation. The New Collaboration Agreement amends and restates the previous agreement entered into between the parties. Under the previous agreement, Alimera held the worldwide license from pSivida to sell Iluvien for the treatment of all ocular diseases other than uveitis. The New Collaboration Agreement allows Alimera to pursue the indication for posterior uveitis for Iluvien in the EU, the Middle East and Africa. Iluvien is currently approved in the United States and 17 EU countries and is currently marketed for diabetic macular edema (DME) in the U.S., the United Kingdom, Germany, Portugal, Spain, Italy, Austria, Ireland and several countries in the Middle East.
Under the terms of the New Collaboration Agreement, pSivida will withdraw its centralized application in the EU for posterior uveitis, and Alimera will be responsible for filing an application for a new indication for Iluvien for the treatment of posterior uveitis in the 17 countries in the EU where Iluvien is currently approved for the treatment of DME.
“We are excited to be able to move forward with securing rights to a possible second indication for Iluvien in the EU, Middle East and Africa,” Dan Myers, CEO of Alimera, said in a company news release. “pSivida has met its primary end point at 6 months in two phase 3 clinical trials for posterior uveitis, which we anticipate will support the approval of Iluvien for the treatment of posterior uveitis in these regions. Retina specialists in Europe and the Middle East regularly ask us about the availability of Iluvien for this debilitating disease, so we believe an expanded label will result in greater physician uptake in the future.”
The New Collaboration Agreement converts Alimera’s current obligation to share 20% of its net profits from Iluvien on a country-by-country basis with pSivida to a royalty payable by Alimera to pSivida on global net revenues. Alimera will begin paying a 2% royalty on net revenues and other related consideration to pSivida beginning in the third quarter of 2017. This royalty amount will increase to 6% upon the earliest of January 1, 2019, the receipt by Alimera of the first marketing approval for Iluvien for the treatment of posterior uveitis, or 1 year from Alimera’s filing of a marketing authorization application in the EU for posterior uveitis. Alimera will pay an additional 2% royalty on global net revenues and other related consideration in excess of $75 million in any year.
The New Collaboration Agreement does not require an upfront cash payment by Alimera. In connection with the New Collaboration Agreement, Alimera has agreed to forgive approximately $10 million of pSivida’s share of previous losses associated with the commercialization of Iluvien, which were to be utilized to offset profit sharing payments under the previous agreement. Following the signing of the New Collaboration Agreement, Alimera retains the right to recover an additional $15 million of pSivida’s share of the previous losses as a partial offset to future royalty payments following approval.
Alimera will forgive an additional $5 million of pSivida’s outstanding share of previous losses upon the approval of Iluvien for posterior uveitis in any EU country or January 1, 2020, whichever occurs first, unless certain conditions under the New Collaboration Agreement are not met. If the amounts recoverable by Alimera are less than $5 million at that time, Alimera will pay pSivida the difference in cash.