IC 500 (IVERIC bio)

This includes Iveric’s lead candidate, which is due for an approval decision from the U.S. Food and Drug Administration (FDA) in August 2023. Astellas acquired Iveric via Berry Merger Sub, a subsidiary of Astellas U.S. Holding, for $40.00 per share. This is a premium of 64% over Iveric Bio’s unaffected closing share price at the end of March, which was $24.33. Going forward, Iveric Bio will be an indirectly wholly-owned subsidiary of Astellas and will add its ophthalmology expertise and infrastructure to Astellas’ own efforts. “The opportunity to create a world-class entity with the ophthalmology expertise and capabilities of Iveric Bio and the global reach and resources of Astellas is unique and has the potential to benefit patients worldwide suffering from blinding retinal diseases, including geographic atrophy (GA),” said Pravin U. Dugel, president of Iveric Bio, in a public release. Close to the market Iveric Bio’s lead candidate, avacincaptad pegol (ACP), is in development for the treatment of GA secondary to age-related macular degeneration (AMD). In this condition, cells in the retina degenerate and die with age, leading to visual impairment and eventually complete blindness. ACP is an oligonucleotide drug designed to block the cleavage of a protein in the complement immune system called C5. The dysregulation of C5 leads to harmful inflammation linked to the development of GA, so ACP has the potential to slow the development of the condition. In February 2023, Iveric applied for the U.S. FDA approval of ACP in GA based on promising results from two large clinical trials. A decision is expected by August 19, 2023. googletag.cmd.push(function () { googletag.display('text-ad1'); }); Other pipeline candidates In addition to its lead program, Iveric is developing ACP for the treatment of the rare genetic condition autosomal recessive Stargardt disease. The program is currently in a phase 2 trial ​ expected to finish next year. In the preclinical stage, Iveric also has a second treatment for GA, in addition to several gene therapy candidates for the rare conditions Stargardt disease, Leber congenital amaurosis type 10 and Usher syndrome type 2A. Astellas’ plan With the Iveric buyout, Astellas continues to prioritize investments in blindness and regeneration, one of its five primary focuses. The deal, with a potential commercialization on the horizon, is expected to help Astellas beef up its revenues as the patent expires on Astella’s prostate cancer treatmnent, Xtandi, later this decade. To bankroll the deal, Astellas amassed cash from bank loans and issuing of commercial paper. The acquisition is expected to close in late 2023. GA market to grow As the population of many countries gets older, the need for treatments for AMD and GA are increasing. The market size for GA was worth ​ $37.8 billion in 2023 ​ and could reach $126.41 billion by 2031. The market growth is also spurred by the emergence of new treatments for GA. In February 2023, the first-ever GA treatment was greenlit by the U.S. FDA: Apellis Pharma’s Syfovre. Assuming a positive decision by the regulator in August, ACP could become the second.

Astellas framed the deal to buy Iveric Bio as a way to further its focus on blindness and regeneration. The multibillion-dollar biotech buyouts keep on coming. Astellas Pharma is the latest drugmaker to get in on the act, agreeing to pay $5.9 billion to buy Iveric Bio and establish itself as a player in an emerging eye disease niche.  Iveric is less than three months away from learning whether the FDA will approve avacincaptad pegol, a complement C5 protein inhibitor that reduced the rate of geographic atrophy (GA) progression in a phase 3 clinical trial. Patients with GA, a cause of irreversible loss of vision in patients with age-related macular degeneration (AMD), lacked treatments until recently, but the market is heating up fast. Apellis Pharmaceuticals won the first FDA approval for a GA drug, Syfovre, in February, and companies including AstraZeneca, Johnson & Johnson, Novartis and Roche are in pursuit. Iveric, a biotech formerly known as Ophthotech, is poised to be the first commercial rival to Apellis, though. That fact has caught Astellas’ attention. Astellas has agreed to pay $40 per share in cash to buy Iveric. The fee represents a 22% premium over Iveric’s closing price at the end of last week. That may seem light in the wake of the triple-digit premiums that GSK and Sanofi have paid recently for Bellus Health and Provention Bio, respectively, but it follows a steady rise in Iveric’s share price. The premium over Iveric’s March 31 share price is 64%. The willingness of Astellas to pay $5.9 billion for Iveric reflects the Japanese drugmaker’s desire to hit its 2025 sales target and need to add new growth drivers to offset the anticipated loss of revenue when the prostate cancer drug Xtandi loses patent protection in 2027. Astellas also framed the deal as a way to further its focus on blindness and regeneration. Cell and gene therapies are part of the strategy, but that side of the pipeline has stuttered, with enrollment in a phase 1 trial of GA candidate ASP7317 stopping for two years and a glaucoma prospect acquired in the Quethera buyout yet to reach the clinic.  Buying Iveric will give Astellas a GA drug that could be approved by the time the deal closes in the third quarter and accelerate an expansion into ophthalmology by providing control of the commercial team and other infrastructure that the biotech has built up to support the launch. Earlier this year, Iveric said it was building a 120-person sales team that would include 50 to 70 field-based reps.  The deal completes an impressive recovery for Iveric, which was on the ropes in 2017. Back then, a run of three clinical trial failures for Fovista sunk the biotech’s stock and wiped out the optimism generated when Novartis paid $200 million for ex-U.S. rights to the AMD asset. Yet, Iveric recovered, changing its name from Ophthotech and embarking on a GA strategy that culminates today in the Astellas buyout.