Astellas Buys Iveric Bio for $5.9 Billion to Bolster Ophthalmology Portfolio

By Mark Terry
May 2, 2023

Tokyo-based Astellas Pharma is buying Parsippany, NJ’s Iveric Bio for $5.9 billion. Iveric Bio focuses on ophthalmology diseases, which is one of Astellas’ five Focus Areas, Blindness & Regeneration.

As part of the deal, Astellas picks up Iveric Bio’s avacincaptad pegol (ACP), branded as Zimura, which is under review by the FDA for Geographic Atrophy (GA) secondary to Age-Related Macular Degeneration (AMD). The company has a target action date of August 19, 2023.

ACP is a complement C5 inhibitor, which the company says, “has significant potential to deliver value to a large and underserved patient base.” The drug hit its primary efficacy endpoint, reduction of the rate of GA progression, in two pivotal clinical trials. The FDA also granted it breakthrough therapy designation.

The acquisition also will offer Astellas a “foundation of ophthalmology-focused capabilities,” including a skilled commercial team, a broad network of ophthalmology experts, established relationships with medical institutions, and the infrastructure to support the combined ophthalmology business in the future.

“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 avacincaptad pegol, an important program for Geographic Atrophy secondary to Age-Related Macular Degeneration, and 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,” Naoki Okamura, president and CEO of Astellas, said in a statement.

This marks the fifth major overseas takeout by Astellas since 2019 as it works to bolster its pipeline as its main drivers lose patent protection, particularly its prostate cancer drug Xtandi.

In 2019, Astellas picked up U.S. biotech Xyphos Biosciences for $665 million and Audentes Therapeutics for approximately $3 billion. It acquired Nanna Therapeutics for $15 million in April 2020 followed by Iota Biosciences for $128 million in October 2020.

In a note to investors, Jefferies analysts said the Iveric deal “is mainly about a soon-to-be approved asset and seems less likely to generate impairment losses.”

There is a possibility of real competition in the GA market. Apellis Pharmaceuticals received FDA approval for Syfovre in February. Other companies developing therapeutics for the condition include AstraZeneca, Johnson & Johnson, Novartis and Roche. It appears that Iveric Bio is likely to be the first competitor to Syfovre if approved by August.

Geographic atrophy is a chronic progressive degeneration of the macula, part of late-stage age-related macular degeneration. It affects more than 8 million people globally, or about 20% of all people with AMD, according to the American Academy of Ophthalmology.

Astellas believes that ACP with fezolinetant and PADCEV will strengthen its portfolio to compensate for future Xtandi sales drops due to patent expiration in 2027. Iveric was in the process of ramping up its sales team for ACP, with 120 people, including 50 to 70 field sales representatives.

ACP is also in mid-stage clinical trials for autosomal recessive Stargardt disease. The company also has a preclinical asset, IC-500, an HtrA1 inhibitor, being developed for GA. Iveric’s AAV gene therapy pipeline, still in the research and preclinical stages, includes mini-CEP290 for Leber congenital amaurosis type 10, mini-ABCA4 for autosomal recessive Stargardt disease, and mini-USH2A for Usher syndrome type 2A.

In addition to Blindness & Regeneration, Astellas’ four other Primary Focus Areas include Genetic Regulation, Immuno-Oncology, Mitochondria, and Targeted Protein Degradation. The company indicates vision loss caused by diseases of the eye presents a market of more than 160 people globally, many of which have no effective treatments. Its own lead program for GA and Stargardt disease is ASP7317. ASP2020, a universal donor cell-derived program, is now in the company’s pipeline. In addition, its Prograf is a prominent drug in the transplantation field.

Its pipeline includes drugs for GA, glaucoma, retinitis pigmentosa, Dry AMD, optic neuropathy, corneal dystrophy and vascular disease.

“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 GA,” Pravin U. Dugel, president of Iveric Bio said in a statement.

Both companies declined to provide additional information related to the deal.