February 4, 2016
By Alex Keown, BioSpace.com Breaking News Staff
THOUSAND OAKS, Calif. – Amgen took an unusual step for a pharmaceutical company this week, publishing the company’s failed attempts at replicating scientific findings in high-profile science journals, Nature reported this morning.
The California-based company said it wanted to publicize its own failings in “hopes the move will encourage others in industry and academia to describe their own replication attempts, and thus help the scientific community to get to the bottom of work that other labs are having trouble verifying,” Nature reported. The three reports were posted on the Preclinical Reproducibility and Robustness channel, hosted on F1000Research.com. The platform was designed for open and transparent publication of confirmatory and non-confirmatory studies in biomedical research, according to the site. The site will be open to all industry and academic scientists as a space for “researchers to start an open dialogue, thereby helping to improve the reproducibility of studies.”
The site sprung from discussions at the 2015 meeting of the U.S. National Academy of Sciences about improving scientific integrity. Amgen’s Sasha Kamb, research discovery leader, told Nature there have been multiple trials and failures to replicate studies conducted by Amgen. However, he said it takes “too much time and effort to publish these accounts through conventional peer-review procedures.”
Amgen is currently the only company to post its failures on the new site. The company shared its failures in replicating a 2012 report in Science that a cancer drug called bexarotene could reduce amyloid plaque and reverse signs of Alzheimer’s disease in mice subjects. That study had already had a number of questions raised about it and Amgen’s failure was another question mark for the findings, Science reported this morning.
Other studies Amgen said it failed to replicate included a 2010 report finding that blocking an enzyme called Usp14 helped cells degrade toxic proteins involved in Alzheimer’s and amyotrophic lateral sclerosis, Science reported. Additionally, Amgen highlighted failures with the protein Gpr21.
The Preclinical Reproducibility and Robustness channel is not the only site devoted to promoting transparency in replicating studies. The University of Virginia has a project aiming to replicate 50 high-impact cancer biology papers, Science said. There is also the Meta-Research Innovation Centre at Stanford, in California, which is also devoted to replication failures, the Economist reported.
While Amgen reported replication failures, the company is still surging forward with its own pipeline that includes nine biosimilar molecules. Amgen said it has the potential to launch five of the biosimilars between 2017 and 2019. The most advanced is ABP 501, a biosimilar for Humira. In Oct. 2015, Amgen announced positive Phase III results of ABP 501, a biosimilar to Humira (adalimumab) in patients with rheumatoid arthritis.
In addition to its growing biosimilar pipeline, analysts are predicting a strong year of revenue from its anti-cholesterol drug Repatha, a PSCK9 inhibitor. Additionally, there are other revenue sources for Amgen. Following its 2013 acquisition of Onyx Pharmaceuticals for $10.4 billion, Amgen has been in a stronger position with 10 products either ready for regulatory approval, or in mid- to-late stage clinical development. In December, the FDA also approved Blincyto, a drug designed to treat a rare form of acute lymphoblastic leukemia. Analysts predict Blincyto could generate about $400 million in annual sales.
