Clearside Biomedical (NSDQ:CLSD) said yesterday that it entered into a license agreement with Bausch Health Ireland (NYSE:BHC) worth up to $76 million for the Xipere device for the treatment of macular edema associated with uveitis.
The agreement grants Bausch an exclusive license to develop, manufacture, distribute, promote, market and commercialize the suprachoroidal injection device.
Bausch agreed to pay $5 million upfront, plus additional payments worth up to $15 million after achieving specified pre-launch development and regulatory milestones. And there’s another $56 million on the line in other milestone payments pegged to regulatory approvals for additional indications and sales goals, according to a regulatory filing.
Clearside is also entitled to receive tiered royalties at increasing percentages during the applicable royalty term after reaching the $30 million cumulative sales mark, according to the filing.
Under the agreement, Alpharetta, Ga.-based Clearside is responsible for all of Xipere’s development expenses until the company’s new drug application is approved by the FDA. It is also responsible for clinical and development expenses put toward the FDA’s requests in a complete response letter. If the FDA approves Xipere, Bausch holds responsibility for all expenses after the approval.
Last week, the FDA sent its CRL, saying it found no efficacy issues with Xipere and will not ask for further clinical efficacy studies. Clearside said it expects to address the recommendations in the CRL in a manner that would allow the company to resubmit its NDA in the first quarter of 2020.
Clearside also agreed not to develop or commercialize Xipere alone or with another device in the licensed field in the U.S. or Canada. Bausch has the right to terminate the agreement and have its $5 million upfront payment refunded if the FDA has not approved the Xipere NDA by February 28, 2021.
Shares of CLSD were up 8.9% at 86¢ per share while shares of BHC were down -0.2% at $22.53 per share in early-morning trading today.