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Already on a roll in oncology, Astellas hunts for big wins in other areas

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“2023 for Astellas is a very important year,” said Mark Reisenauer, the company’s U.S. president.

If all goes right, the multinational Japanese pharma — most known for its oncology and urology drugs — could add two first-in-class therapies to its growing list of commercialized medicines and expand indication areas for two of its existing cancer drugs over the next 12 months.

Professional headshot of Mark Reisenauer

Mark Reisenauer, U.S. president, Astellas

Permission granted by Astellas


On the oncology side of its business, Reisenauer said the company has a long history of chasing “difficult to treat cancers.” Along those lines, Astellas is hoping to launch zolbetuximab by the end of 2023 to treat locally advanced as well as metastatic gastric cancer — an indication with a five-year survival rate of only 6% that is currently treated with surgery and chemotherapy.

The drug, acquired through Astellas’ 2016 buyout of the German-based Ganymed, is on the cutting edge of cancer research. The monoclonal antibody zeroes in on the Claudin18.2 protein, a molecular target first discovered by BioNTech founders Özlem Türeci and her husband Uğur Şahi who were on the hunt for new methods of treating solid tumors. Its cousin, Claudin6, has also drawn interest from several biotech and pharma companies, including BioNTech — who circled back to the approach after selling Ganymed to Astellas — as a potential solid tumor target for CAR-T therapies.

In results published Thursday from Astellas’ Spotlight trial, which tested the drug in combination with the chemotherapy regimen mFOLFOX6, zolbetuximab was found to substantially reduce the risk of death and disease progression.

“Much like what we did in oncology 10 or 15 years ago, where we really committed to that therapeutic area … we’re taking a similar strategic and holistic approach to building out those (gene and cell) capabilities.”

Mark Reisenauer

President, Astellas

But Astellas is also looking to expand its footprint past oncology in 2023 into women’s health and other indications, Reisenauer said. In February, the FDA is slated to review Astellas’ novel non-hormonal treatment to reduce the frequency and severity of vasomotor symptoms (VMS), characterized by severe hot flashes and night sweats, in menopausal women.

VMS has historically been treated with a hormone therapy linked to increased risk of endometrial cancer, blood clots and heart attacks, so the market for alternatives is heating up, and is expected to grow from its current value of $16.71 billion to over $27 billion by 2030. Bayer is also in the midst of a phase 3 trial for a similar candidate to Astellas’ drug, and has pegged the drug as a potential blockbuster.

These potential milestones follow what was a tumultuous 2022 for Astellas, marked by myriad setbacks particularly in its fledgling gene and cell therapy business — which saw two therapies put on FDA clinical holds and the discontinuation of several programs for Duchenne muscular dystrophy, together leading to $700 million in impairment losses for the company.

On Friday the FDA lifted one of those holds for the company’s phase 1/2 candidate in late-onset Pompe disease. Astellas’ said in a statement that it is “working on completing the clinical and regulatory activities necessary to resume dosing” in that trial. Prior to that FDA decision, Reisenauer also told PharmaVoice that Astellas’ expects to continue “looking for ways to augment” that business in 2023.

“We believe (2023) is going to be an inflection point in our growth,” Reisenauer said. “We’re not a large pharmaceutical company, we’re a mid-sized pharma company. And to have two first-in-class launches in the same year, I think is significant. Not only is it an accomplishment, but I think it’s a testament to the innovation and the R&D work that we’re doing.”

With major changes afoot, Reisenauer gave PharmaVoice a peek at why he’s preparing for a “very busy year” ahead.  

This interview has been edited for brevity and style.

PHARMAVOICE: How is your candidate for VMS, fezolinetant, different from other non-hormonal treatments on the market?

MARK REISENAUER: It’s a new mechanism. The KNDy neuron is a neuron that’s responsible for regulating body temperature. So fezolinetant blocks neurokinin B (NKB), binding on the KNDY neuron to moderate neuronal activity in the thermoregulatory center of the brain. We’re the first-in-class and there are others coming as well. But this is a very novel approach.

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