Astellas and Iveric Bio entered into a definitive agreement to acquire the company

Astellas and IvericBio have entered into a definitive agreement to acquire IvericBio, with both companies committed to building a world-class ophthalmic business.

Main program AvacincaptadPegol (ACP), a potential therapy for macular geographic atrophy, has a PDUFA target date of August 19, 2023.

The acquisition will advance Astellas' primary focus area of blindness and regenerative therapeutics.

The cash purchase price is $40 per share, giving a total equity value of about $5.9 billion.

Tokyo and PARSIpani, N.J., April 30, 2023 -- Astellas Pharma Group and IvericBio announced that on April 29, 2023 (Japan time), the parties have entered into a definitive agreement under which, Astellas acquired all of the outstanding shares of IvericBio through BerryMergerSub, a wholly owned subsidiary of Astellas Holding,Inc., for $40.00 per share in cash for a total equity value of approximately $5.9 billion (the "Acquisition Transaction"). IvericBio will become an indirect wholly owned subsidiary of Astellas through the acquisition. The Acquisition transaction calculates IvericBio's total equity value assuming that there are approximately 148.2 million shares of IvericBio common stock outstanding on a fully diluted basis. The acquisition price represents a 64% premium over IvericBio's unaffected closing stock price of $24.33 on March 31, 2023; This represents a 75% premium over IvericBio's 30-trading day volume-weighted average price through March 31, 2023. The boards of directors of both companies unanimously approved the deal.

Strategic objectives of the acquisition

Astellas has a vision of "being at the forefront of the changing healthcare industry, translating scientific advances into value for patients". Through this development strategy of focus area research, Astellas is working to find unique combinations of biology and therapeutics/technologies from multiple perspectives to create innovative medicines for diseases with unmet medical need. Astellas has identified five primary focus areas, including blindness and regeneration, to prioritize resources, and this transaction is a key step in building Astellas' portfolio in this important area.

IvericBio focuses on the development of new treatments in the field of ophthalmology. IvericBio announced in February 2023 that the U.S. Food and Drug Administration (FDA) accepted a new drug application for ACP for the treatment of macular geographic atrophy secondary to age-related macular degeneration. This New drug application has been prioritized for review with a Prescription Drug User Fee Act (" PDUFA ") target date of August 19, 2023.

ACP is a complement C5 protein inhibitor that is used to treat macular geographic atrophy secondary to age-related macular degeneration, a disease of which the number of patients is large and treatment options are lacking. This investigational agent has great potential to deliver value to this population. ACP met the primary efficacy end point of statistically significant reduction in the rate of progression of macular geographic atrophy in both pivotal clinical trials (the GATHER trial) and was granted breakthrough therapy designation by the FDA for this indication.1

1. The FDA breakthrough-therapy designation is designed to expedite the development and review of new drugs for the treatment of serious or life-threatening diseases. Criteria for break-through designation require preliminary clinical evidence that a drug is likely to provide a significant improvement over existing therapies in at least one clinically relevant end point. The FDA reviews all data submitted to support approval of the breakthrough-therapy designation to determine whether the drug is safe and effective for its intended use before it is approved for marketing.

In addition, IvericBio has a multifaceted business team, an extensive network of external ophthalmology experts, established partnerships with multiple medical institutions, and the infrastructure and experience to drive our combined ophthalmology business forward. By acquiring IvericBio, we will strengthen the foundation of the field of ophthalmology. In addition, the capabilities acquired will enable Astellas to accelerate preclinical and clinical development and commercialization activities to advance the goals of our primary focus area of blindness and regenerative Therapeutics."

The financial impact of the acquisition

Astellas' consolidated financial forecast for the fiscal year ending March 31, 2024 was published on April 27, 2023, and the impact of the completion of the acquisition on Astellas' financial results is not reflected in this consolidated financial forecast. Astellas is still reviewing the impact and will promptly announce any publicly reported events.

Astellas' primary focus on blindness and regenerative therapy

Premier Focus's mission is to discover, develop, and deliver next-generation therapies to restore vision to patients with retinal diseases. Astellas is passionate about research and development, by optimally combining internal and external capabilities to increase productivity and creativity and bring innovative treatments to patients as quickly as possible.

Regarding macular geographic atrophy secondary to age-related macular degeneration

Age-related macular degeneration (AMD) is the leading cause of moderate and severe central vision loss in the elderly. The macula is a small area in the central part of the retina that is responsible for central vision. As AMD progresses, the loss of retinal cells and underlying blood vessels in the macula leads to significant thinning and/or atrophy of retinal tissue. Macular geographic atrophy secondary to AMD leads to irreversible vision loss in patients, and there is currently a highly unmet medical need. It is estimated that approximately 1.6 million people in the United States have macular geographic atrophy in at least one eye.

About AvacincaptadPegol (ACP)

Avacincaptadpegol (ACP) is an investigational drug currently under evaluation for safety and efficacy by the US Food and Drug Administration (FDA). ACP is a novel complement C5 protein inhibitor. Overactivity of the complement system and C5 protein plays a key role in the development and growth of scar formation and vision loss associated with macular geographic atrophy secondary to age-related macular degeneration. By targeting the C5 protein, ACP is expected to reduce the activity of the complement system that leads to retinal cell degeneration and may slow the progression of macular geographic atrophy.

About the GATHER clinical trial

ACP met its primary endpoint in the completed GATHER1 clinical trial and the ongoing GATHER2 clinical trial, both randomized, double-blind, sham-handled controlled, multicenter phase III clinical trials. These two clinical trials evaluated the safety and efficacy of 2 mg of ACP administered monthly in the vitreous of patients with macular geographic atrophy secondary to age-related macular degeneration. During the first 12 months of the two clinical trials, patients were randomized to 2 mg of ACP or sham treatment per month. A total of 286 subjects participated in the GATHER1 trial and 448 in the GATHER2 trial. In both pivotal studies, the primary efficacy end point was based on the area of geographic macular atrophy measured with fundus autofluorescence at baseline, 6 months, and 12 months. Based on the observed data, the mean growth rate (slope) of the area of macular geographic atrophy from baseline to month 12 was 35% in GATHER1 and 18% in GATHER2. When the GATHER1 and GATHER2 trials were pooled, the most frequently reported adverse events during treatment for the 2 mg recommended dose were related to the injection procedure. "In patients treated with AvacincaptadPegol2 mg, the most frequently reported adverse effects (≥5% and greater than sham treatment) were conjunctival hemorrhage (13%), elevated intraocular pressure (9%), and CNV (7%)." There were no serious events of intraocular inflammation, vasculitis, or endophthalmitis after 18 months of GATHER1 treatment and 12 months of GATHER2 treatment.