Ocugen Gives Roots Pharmaceutical Middle East Rights To OCU400 For Up To $255 Million In Sales Milestones
Ocugen would also collect a 22% royalty on net sales and manufacture the gene therapy under a separate supply agreement.
Ocugen granted Roots Pharmaceutical exclusive rights to its OCU400 gene therapy for retinitis pigmentosa in certain Middle East and North Africa countries, with sales milestones of up to $255.0 million and a 22% royalty on net sales, according to an 8-K. The agreement is dated October 13; the filing was accepted by EDGAR at 9:22 p.m. ET Wednesday.
What the 8-K says
Ocugen will receive an upfront license fee plus potential regulatory and development milestone payments of up to $4 million in the aggregate. Sales milestones can reach up to $255.0 million, and the royalty is 22% of net sales Roots generates in the territory.
The license is exclusive and non-sublicensable. Roots will have sole control over regulatory submissions in the territory and has agreed to use commercially reasonable efforts to develop, register and commercialize the product. Ocugen will own the global safety database.
Ocugen and Roots also signed a commercial supply agreement on October 13, under which Ocugen will manufacture and supply the therapy.
The license runs until the last of three events: 20 years after the first commercial sale in the territory, expiry of the last valid licensed patent claim, or expiry of market exclusivity, including regulatory exclusivity. It then ends automatically.
What it changes
Ocugen now has a regional commercial partner, and the payments are tied to milestones and sales rather than paid up front. The headline figures are ceilings: the $4 million and $255.0 million are described as "up to" amounts.
In the press release, Ocugen said it estimates retinitis pigmentosa prevalence in the region is 10 to 20 times higher than in the U.S. and EU. Chief Executive Shankar Musunuri said the deal is "another important step in our strategy to build strong regional partnerships."
Ocugen continues its Phase 3 liMeliGhT trial of OCU400, a late-stage trial, with topline data expected in the first quarter of 2027, followed by planned U.S. and European regulatory submissions.
Ocugen shares closed at $0.84 on Wednesday, down about 5% on the session.
Share-authorization vote pushed back
In the same 8-K, the board postponed the special stockholder meeting, previously adjourned to October 26, on a proposal to add 250,000,000 authorized common shares. The postponement gives stockholders more time to vote.
The meeting is now set for Tuesday, December 22, at 8:00 a.m. ET, held virtually, with a new record date of October 30.
The next dated event is the December 22 special meeting, where stockholders vote on the 250,000,000-share increase.
Sources
- 8-K Filing — Ocugen, Inc. (OCGN) — SEC EDGAR
- Exhibit tm2627592d1_ex99-1.htm — Ocugen, Inc. 8-K exhibit — SEC EDGAR
