Astellas Pharma Inc. (TSE: 4503) and IVERIC Bio, Inc. (NASDAQ: ISEE) have announced a definitive agreement on May 1st under which Astellas has agreed to acquire 100% of the outstanding shares of Iveric Bio., for US$40.00 per share in cash for a total equity value of approximately US$5.9 billion. When completed, Iveric Bio will become an indirectly wholly-owned subsidiary of Astellas. According to the companies, the purchase price represents a premium of 64% to Iveric Bio’s closing share price of US$24.33 on March 31, 2023. The acquisition may underpin a potential approval for avacincaptad pegol (ACP, “Zimura”), a pending treatment for geographic atrophy, previously announced as a Breakthrough Therapy Designation from the FDA, late in November 2022. The novel investigational complement C5 inhibitor will be applied for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). According to Astellas, ACP is the first and only investigational therapy to receive Breakthrough Therapy designation status for this indication, which was granted based on the 12-month pre-specified primary endpoint data in the GATHER1 and GATHER2 pivotal clinical trials.
FDA Breakthrough Therapy designation was aimed to accelerate the development and regulatory review of potential new medicines intended to treat a serious condition and address a significant unmet medical need. The new medicine needed to show preliminary clinical evidence that the drug may demonstrate substantial improvement in effectiveness or safety over available therapies on a clinically significant endpoint. The decision by the FDA was based on the 12-month primary efficacy endpoint data from the GATHER1 and GATHER2 pivotal studies, which evaluated the safety and efficacy of ACP in patients with GA located inside and/or outside of the clinical fovea. Following a special protocol assessment (SPA) agreement for GATHER2, the FDA required the mean rate of growth in GA area from baseline to month 12. The results showed a significant treatment difference of 35% (P=0.0050; GATHER1) and 18% (P=0.0039, GATHER2) compared to sham using observed (non-transformed) data; and 28% (P=0.0063; GATHER1) and 14% (P=0.0064; GATHER2) using square root transformation. In both GATHER1 and GATHER2 there were no events of serious intraocular inflammation, vasculitis, or endophthalmitis.
Following the announcement, Naoki Okamura, President and CEO of Astellas stated that, “we are pleased to reach an agreement with Iveric Bio, a company with exceptional expertise in the R&D of innovative therapeutics in the ophthalmology field”. Iveric Bio has promising programs including “capabilities across the entire value chain in the ophthalmology field. We believe that this acquisition will enable us to deliver greater value to patients with ocular diseases at high risk of blindness.” In addition, Glenn P. Sblendorio, Chief Executive Officer of Iveric Bio., commented that “this transaction with Astellas, a highly respected pharmaceutical company, demonstrates the significant value that we have built for our stockholders and recognizes the tremendous work by our dedicated team at Iveric Bio.