Amgen-UCB Drug Reduces Spinal Fractures, Fails on Non-Vertebral

  • Drug could generate billion-dollar sales, analyst predicts
  • If approved, romosozumab would compete with Lilly's Forteo

Amgen Inc. and UCB SA said their experimental drug for osteoporosis reduced the frequency of new spinal fractures, but didn’t help prevent non-vertebral fractures in post-menopausal women.

Patients taking romosozumab had 73 percent reduction in the relative risk of a spinal fracture than those on placebo after a year of monthly injections, the companies said in a statement. Both drug- and placebo-treated patients then switched onto Amgen’s bone drug Prolia for a year, and the benefit continued, with romosozumab patients seeing a 75 percent reduction in new spinal fracture risk at two years.

The final-stage trial of 7,180 post-menopausal women didn’t meet a secondary trial goal of reducing the frequency of non-vertebral fractures, according to the statement. The magnitude of the reduced fracture risk is “perhaps underwhelming,” Peter Welford, an analyst at Jefferies Group LLC, wrote in a note to clients. Doctors are most likely to focus on the drug’s impact on fractures of bones elsewhere, he said.

The drug was developed by a partnership of Amgen and Brussels-based UCB, with the companies splitting development costs and profits equally. UCB fell 3.7 percent to close at 74.01 euros in the Belgian capital, while Amgen’s shares fell 1.3 percent to $148.21 at 11:58 a.m. in New York.

Radius Health Inc., whose experimental drug abaloparatide has shown benefit in non-vertebral fractures, jumped 25 percent to $33.70.

UCB will lead commercialization of the drug in Europe, Australia and New Zealand, while Amgen will lead in the U.S., Canada, Mexico and Japan, according to spokeswoman Kristen Davis.

Growth Driver

The drug works by blocking a protein called sclerostin, which normally slows bone formation, in order to increase the amount of bone in the skeleton. While more than 75 million people worldwide suffer from osteoporosis, romosozumab would be used primarily by high-risk patients, according to Thousand Oaks, California-based Amgen. If approved, it would compete with Eli Lilly & Co.’s injection Forteo, which generated $1.35 billion in sales in 2015.

Romosozumab is expected to be more effective and safer than Forteo, according RBC Capital Markets analyst Michael Yee, who wrote in a Jan. 29 note to clients that Forteo carries a warning on its label for cancer risk, which isn’t expected for Amgen’s treatment. Yee estimates romosozumab could be a “$1 billion plus growth driver over time.”

Joint Pain

The most common adverse events in the treatment period from both drug- and placebo-treated patients were joint pain, inflammation of the nasal passages, and back pain, according to Amgen. Studies evaluating hearing loss and and worsening of arthritis in the knee showed no difference between treatment groups, the statement said.

While approval would be a positive development, romosozumab is “not a huge needle mover” for Amgen, according to Evercore ISI analyst Mark Schoenebaum, since the biotech company will split revenue with UCB.

Amgen has invested heavily in research and development, introducing six new drugs in 2015, including the cholesterol treatment Repatha and the cancer medicine Kyprolis. It will report results from a mid-stage trial for a migraine medication in the second half of the year.

The company is also developing biosimilars, drugs that mimic other biological treatments, creating one of the most ambitious pipelines in the industry. It plans to have as many as five biosimilars on the market by 2019.

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