Earlier this year, when Astellas announced that Naoki Okamura was taking over as CEO, the Japanese company said that 2023 was the right time for it to “go on the aggressive to further stimulate growth.”
It took Okamura less than a month into his tenure—which began April 1—to act on the company’s game plan. On April 29, he struck the largest acquisition in Astellas’ history, a $5.9 billion buyout of Iveric Bio.
With the New Jersey-based biotech two months away from an FDA decision on its geographic atrophy (GA) eye disease candidate Zimura, Astellas hopes to become a major player in a new arena.
“We had been closely watching the lead program for Iveric for a very long time, probably seven, eight years,” Okamura said in an interview with Fierce Pharma. “Because the modality of that project is very new to us, we were kind of hesitant to do any partnerships with them.”
But after seeing compelling clinical data and assessing the lone competitor in the market—Apellis’ Syfovre, which in February became the first drug approved in the indication—Okamura said that C5 agent Zimura has become “significantly de-risked.”
With GA striking patients in an advanced stage of macular degeneration, a lucrative market awaits. Evaluate Pharma has pegged Syfovre’s sales potential in 2028 at $2.6 billion.
Okamura knows transformative deals. In 2009, he was Astellas’ director of licensing and alliances when the company partnered with Medivation to develop and commercialize a prostate cancer drug, which came to be known as Xtandi upon its approval three years later.
Including regulatory and commercial milestones, Astellas paid a mere $765 million for a drug that generated $5.9 billion in worldwide sales last year, with $4.7 billion of that rung up by Astellas. The rest went to Pfizer, which paid $14 billion to buy out Medivation in 2016.
With Xtandi accounting for 44% of Astellas’ revenue last year and the cancer drug losing its exclusivity in 2027, the company must now find replacements. In the shorter term, Astellas also must compensate for generic competition to scanning agent Lexiscan, which is expected to begin this year. Enter Zimura.
“It’s a near-term opportunity for us,” said Okamura, who added that Iveric brings more than its attractive asset.
“Iveric Bio has established an excellent team focused on the back of eye, the retina,” Okamura said. “They have a great network of academia, a great network with healthcare professionals and we believe they can enhance our programs with their capabilities.”
Despite the increased sales of Xtandi over its decade on the market, Astella’s revenues have remained relatively flat. Every year since 2010, the company’s annual sales have toggled between $10.5 billion and $12.3 billion. Meanwhile, over the same period, revenue for Japanese rival Takeda has nearly doubled to $30 billion, although that company did buy Shire to catapult into the ranks of the top 10 drugmakers worldwide.
There have been several recent stumbles for Astellas. The company has taken a $340 million impairment loss on FibroGen-partnered anemia drug Evrenzo (roxadustat), which failed to meet sales expectations.
It also has grounded a hearing loss candidate after it flunked a phase 2b trial and terminated a deal with gene therapy specialist Adaptimmune.
“It’s not downsize for downsize sake,” Okamura said. “If the science tells us that this is not going to be successful, we have to close the project.”
Some of the moves have been made as Astellas has undergone an organizational transformation—switching from geographic-based management to a functional arrangement.
In addition to the Adaptimmune deal, a $3 billion buyout of gene therapy startup Audentes in 2019 has been a disaster. An X-linked Myotubular Myopathy trial was put on hold after the death of four patients.
Despite the woes, Astellas remains “fully committed” to advancing its program, Okamura said.
“Gene therapy is still in the very, very embryonic stage in terms of technology,” Okamura said. “We have to overcome a lot of challenges to make the technology platform mature.”
Okamura added that the North Carolina-based manufacturing facilities brought in through the Audentes acquisition have attracted much interest from gene therapy startups looking to collaborate.
Okamura has been with Astellas and its forerunner company for 37 years, with most of his time in corporate strategy and business development. He became chief strategy officer in 2018, following the path of his predecessor, Kenji Yasukawa, who now takes over as chairman of the board.
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