Amgen's Repatha Decision Not Unexpected But Caveats Are Key, Say Analysts
June 11, 2015
By Riley McDermid, BioSpace.com Breaking News Sr. Editor
Analysts are weighing in Thursday on the U.S. Food and Drug Administration (FDA)'s decision yesterday to approve Amgen 's cholesterol lowering drug Repatha, saying investors should take a close look at how the panel made its decision if they want clues about future products and their prospects.
Geoffrey Porges, an analyst with Sanford Bernstein, said the FDA appeared to follow the roadmap it used earlier this week when approving Regeneron Pharmaceuticals, Inc. ’s similar drug Praulent.
“Yesterday the FDA's advisory committee reviewed the application for Amgen's PCSK9 cholesterol lowering antibody Repatha (evolocumab). The discussion and question responses generally followed the outline from the prior day's Praluent meeting.
Porges said the criticism Amgen faced from the panel has also put Wall Street on notice that safety data needs to be flawless before approval is sought.
“Amgen did sustain some criticism from the agency and its advisor about the conduct and duration of their Phase III trials, allegedly lacking sufficient safety data beyond the 12 week endpoint used in most of the company's trials,” he wrote in a note to investors.
“FDA staff and advisers still appear to be enamored with REGN's 2-dose step up offering, and criticized Amgen for their failure to develop and study a lower dose. We expect both stocks to be volatile at least until their late summer launches.”
Other analysts seemed to echo that assessment, saying that while the approval was no surprise, the details in the FDA’s decision were worth noting. Joshua Schimmer, an analyst with Piper Jaffray, said that the committee appeared to be interested in the miniutae of how both drugs are administered and labeled.
“The panel discussion focused on many of the same points as yesterday's, but raised the issue of dose titration, a feature which Repatha does not offer. In this regard, the panelists seemed more focused on the clinical management of ultra-low LDL levels in general in the absence of CVOT rather than specific LDL titrating, which they believed could be addressed through proper labeling (i.e., modification of existing background therapy, discontinuing Repatha, etc.),” Schimmer wrote in a note to investors.
“This indicates to us that there is little barrier to approvability and potentially little meaningful differentiation with Praluent on this point. In addition, while the issue of only 12 week efficacy trials for the majority of the Phase 3 program was called out, we don't see this precluding approval.”
Mark Schoenebaum, a biotech analyst for ISI Evercore, said in a note to investors late Wednesday that how the panel voted is a good indicator for what other companies debuting similar drugs might be able to expect.
“Of the 4 panelists who voted ‘no’ on approval today, three also voted ‘no’ yesterday. The fourth "no" vote was from Dr. Thomas (an endocrinologist who voted ‘yes’ yesterday) [and] he cited AMGN's 12-week blinded trials (vs 24 weeks for REGN) and one 52-week blinded trial as too short to adequately assess safety, a concern echoed by a at least one other panelist (yet Dr. Thomas acknowledged that the outcomes study should address his concerns),” noted Schoenebaum. “However, in his comments Dr. Thomas also noted that he felt the drug should still be used in HeFH.”
As for dosing, Schoenebaum said the panel remained concerned, although it had several caveats that could provide solid guidance going forward.
“The panel appeared mixed as to whether AMGN's lack of titratable dosing presented a concern, given still unproven safety at low LDL levels (thus far there seem to be no major concerns) and the possibility that physicians unable to reduce the evolocumab dose might reduce the statin dose,” he wrote.
“However, the panel acknowledged that this issue could be addressed in the label and that drugs like Zetia can provide a suitable substitute for PCSK9s if LDL levels are too low.”
More broadly Wall Street appeared pleased that Amgen had weathered the panel, saying it was well-positioned following Repatha’s approval and had several major events still on the horizon that could potentially affect its earnings and market position.
“Overall we continue to see AMGN as relatively well positioned with a much larger CVOT trial (FOURIER) set to read out potentially one year ahead of Praluent,” said Schimmer.
“During the panel, AMGN noted that they believe that FOURIER is generally based on highly conservative assumptions and likely overpowered. Data is expected no later than 2017, but may come as early as late 2016 (or sooner if stopped by the DSMB sooner),” he wrote.
“Assuming the initial Repatha label is narrow, we can envision a best case scenario for AMGN in which premium pricing is easier to procure at launch with a focused patient population followed by a subsequent explosive label expansion after CVOT data and additional safety experience have been garnered.”
When Will Pfizer's Breakup Happen?
Speculation that the revamping of Pfizer Inc. ’s internal business structure could happen as soon as this year has biotech wondering just when this Big Pharma company could see changes.
Last week an analyst with J.P. Morgan said he thinks there will be a much faster timeline than most of Wall Street had predicted for Pfizer’s stated mission to refocus its efforts on new medicines.
Pfizer initially announced in 2012 that it would be shedding units that were non-essential to that goal. It then promptly sold its nutrition silo to Nestle for $11.85 billion, which was rapidly accompanied by a public spin-off of its animal health business for $2.2 billion.
“While a Pfizer break-up would likely be a 2017 event, we see potential catalysts in 2015-2016," said Chris Schott, an analyst at J.P. Morgan. "Three years of audited financial statements (2014-2016) are required before any part of Pfizer can be spun off, and we also see 2017 as an attractive time for action as investors see Pfizer’s innovative pipeline clearly contributing to growth and the established business having transitioned to a more stable profile."
BioSpace wants to know what you think: Will Pfizer be a changed company by the end of 2015?