AbbVie Enters into Option Agreement with Aldeyra Therapeutics for License to Develop and Commercialize Reproxalap

Aldeyra Therapeutics announced that it has entered into an exclusive option agreement with AbbVie in which AbbVie has the option to acquire a co-exclusive license to develop, manufacture, and commercialize reproxalap in the US, and an exclusive license to develop, manufacture, and commercialize reproxalap outside the U.S. 

Under terms of the agreement, Aldeyra will receive a non-refundable option fee of $1 million and an upfront payment of $100 million less option fees if AbbVie chooses to exercise the option. Aldeyra would be eligible to receive up to $300 million in regulatory and commercial milestone payments, inclusive of a $100 million milestone payment upon FDA approval of reproxalap in dry eye disease. In the United States, Aldeyra and AbbVie would share profits and losses from the commercialization of reproxalap according to a split of 60% for AbbVie and 40% for Aldeyra; and for markets outside the U.S., Aldeyra would be eligible to receive tiered royalties on net sales of reproxalap.

Exercise of the option will also grant AbbVie the right of first negotiation for compounds that are owned or otherwise controlled by Aldeyra in the field of ophthalmology relating to treating conditions of the ocular surface. The right of first negotiation is in addition to a right to review data for any other compounds that are owned or otherwise controlled by Aldeyra in the fields of ophthalmology and immunology before such data is shared with any other third party.

The option agreement comes 2 weeks after the FDA identified "substantive review issues" in the Aldeyra's new drug application for reproxalap. In a US securities filing on October 16, Aldeyra cited minutes from a late-cycle review meeting in which the FDA is quoted as saying "[i]t does not appear that you have data to support the clinical relevance of the ocular signs to support your dry-eye indication." Aldeyra stated in the SEC document that the company’s ability to generate revenue depends on FDA approval and successful commercialization of reproxalap.