Amgen ditches PhIII study plans for bone-healing drug as regulatory bar rises

As Amgen pursues a new strategy of picking pipeline winners, the biotech giant ($AMGN) and partner UCB have scuttled plans for late-stage development of their experimental antibody to speed up healing of bone fractures. Yet the companies are moving along with Phase III studies of AMG 785 for treating post-menopausal osteoporosis, which Bloomberg noted as a juicer market for the drug.

Brussels-based UCB revealed that the decision to abandon the fracture-healing studies was based on evaluation of Phase II data and a higher regulatory bar on drugs for this use. Yet there were no red flags about the safety of 785, or romosozumab, and the ongoing osteoporosis program is expected to yield results by the end of 2015. The antibody--which blocks sclerostin to help osteoblasts rebuild bone--could generate $99 million in sales for osteoporosis by 2017, UBS Securities analyst Matthew Rodden wrote, as cited by Bloomberg.

Amgen clearly has bigger market opportunities on its R&D agenda, which the Thousand Oaks, CA-based biotech rolled out to Wall Street types last week, touting its multibillion-dollar prospects with biosimilars based on blockbuster protein drugs. While the company highlighted the osteoporosis program for romosozumab among 8 novel drugs with late-stage data coming out over the next several years, it has more at stake with its massive late-stage effort for AMG 145, a potential blockbuster cholesterol drug that targets the PCSK9 protein involved in LDL synthesis.

Meantime, the biotech giant is pursuing a multi-pronged biosimilars strategy that advocates pushing up standards for the copycat versions of biologics, potentially limiting its competition, while working closely with generics specialist Actavis on biosimilars development. In several years, Amgen hopes to launch biosimilar versions of the TNF drugs Humira from AbbVie ($ABBV) and Remicade from Johnson & Johnson ($JNJ), as well as the hit anti-cancer biologics Herceptin and Avastin from Roche ($RHHBY) and Rituxan from Roche and Biogen Idec ($BIIB). The roster also includes a knockoff of Erbitux, Eli Lilly ($LLY) and Bristol-Myers Squibb's ($BMY) cancer drug, as Forbes reported last week.

Amgen aims bring in $2 billion in annual sales from the biosimilars, with launches expected to happen in 2017, Bloomberg reported.

Like the push into biosimilars, Amgen appears to have nixed the bone-fracture indication from development plans for AMG 785 for pure business reasons as the company seeks out its best prospects to succeed in development. Amgen R&D boss Sean Harper also aims to apply human genetics to the research process to support his "pick the winners" strategy.

- here's the UCB release
- check out Bloomberg's article    

Suggested Articles

Solid Bio fixed the manufacturing issue that led to a partial clinical hold on its DMD trial, but a full hold remains.

Commissioner Scott Gottlieb has laid out the reasons why he thinks the FDA needs a double-digit budget bump.

GW's cannabis-based epilepsy drug scored a favorable review from FDA staff ahead of an expert panel meeting.