- An experimental anemia treatment for kidney disease patients has met the primary endpoints of a Phase 3 study, according to a Thursday report from Astellas Pharma, one of its developers.
- A common side effect of chronic kidney disease is anemia, where patients lack adequate amounts of oxygen-carrying red blood cells. Astellas is aiming to treat this with roxadustat, a drug that works by inhibiting enzymes that regulate oxygen homeostasis in the body.
- Topline results from the late-stage ALPS study showed roxadustat beat out placebo in measurements of both hemoglobin response rate over 24 weeks and change in hemoglobin levels from baseline at weeks 28 to 52.
Astellas is perhaps best known for the prostate drug Xtandi (enzalutamide) that it developed with Medivation (later bought by big pharma Pfizer). For the quarter ending June 30, the Japanese drugmaker saw Xtandi sales rise 18.3% year over year to 81.2 billion yen ($743 million).
Also on the oncology front, almost 40% of the drugs in Astellas' pipeline were cancer treatments as of July 2018.
Despite that focus, Astellas has been on a tear to diversify. Last month it acquired Quethera, a U.K. biotech developing an ophthalmic gene therapy, in a deal potentially worth £85 million ($109 million). And in 2017, it agreed to pay up to $450 million for Mitobridge, which works on medicines for improving mitochondrial functions, and up to $820 million for Ogeda, which operates as a women's health drugmaker.
Urology and nephrology treatments have also captured Astellas' eye, and understandably so. The company identified its overactive bladder drugs Vesicare (solifenacin succinate) and Myrbetriq (mirabegron) — sold outside the U.S. as Betanis or Betmiga — as main products during its most recent quarterly report, saying they raked in nearly 60 billion yen ($550 million). Notably, the Mitobridge acquisition also handed Astellas the preclinical kidney disease asset MTB-2.
Astellas' pipeline had nine urology and nephrology drugs as of July, with roxadustat being one of the more advanced candidates. It's developing the drug alongside San Francisco biotech Fibrogen, and has two more Phase 3 studies planned that "will ultimately support filing and reimbursement in Europe," according to a Sept. 20 statement from Astellas.
The pharma said preliminary safety data from the ALPS trial were consistent with previous clinical investigations.