FTC pulls remaining case against AbbVie; New EU clinical trials system coming in 2022; Abingworth bets big on CymaBay
The Federal Trade Commission on Friday withdrew its remaining case against AbbVie after the Supreme Court declined to review a lower court’s ruling.
The punt by SCOTUS means that while the Illinois pharma company illegally blocked patients’ access to lower-cost alternatives to its testosterone drug AndroGel, the FTC will no longer be able to return about $500 million directly to AndroGel consumers.
“This case highlights the pressing need for legislation reinstating the FTC’s authority to seek equitable monetary relief for consumers in competition cases,” Holly Vedova, FTC’s acting director of the Bureau of Competition, said in a statement. “Congress should act quickly to restore Section 13(b) of the FTC act and the Commission’s ability to return to consumers money lost due to illegal anticompetitive behavior by pharmaceutical companies.” — Zachary Brennan
Europe’s new clinical trial system coming in 2022
The long-awaited European Clinical Trials Information System is set to go live on Jan. 31, 2022, the European Medicines Agency announced Monday.
The launch of the CTIS will mean sponsors no longer have to submit trial applications to separate national authorities and can instead send them to a single entry point for submission, authorization and safety reporting in the EU, Iceland, Liechtenstein and Norway.
“With CTIS, sponsors can apply for clinical trial authorisation in up to 30 EEA countries with a single application,” the EMA said, noting the upcoming transition period.
EU member states will work in CTIS after it goes live, but for one year, until Jan. 31, 2023, applicants can still choose whether to submit their application to start a clinical trial according to the current system, Ethe MA says. After that date, submission to the new system is mandatory, and by Jan. 31, 2025, all ongoing trials approved under the old system will need to migrate to the new one. — Zachary Brennan
Abingworth bets $100M on CymaBay’s upcoming Phase III
A year after the FDA lifted a clinical hold on CymaBay’s seladelpar and gave it a green light following safety fears, Abingworth is stepping up with a $100 million bet on a Phase III gamble.
Abingworth will hand over $75 million of that over the next six months to fund their late-stage effort on primary biliary cholangitis (PBC). And CymaBay will have an option on the fourth tranche.
In return, the biotech agreed to a six-year repayment plan, depending on potential approvals in the US and EU. And it will also pay out sales milestones.
Abingworth has a noted interest in risk-sharing deals, particularly on late-stage pivotal efforts.
“By thoughtfully risk-sharing development costs with Abingworth, who shares our belief in the potential of seladelpar to serve as an improved second-line treatment for patients with PBC, we have secured the additional funding needed for the Phase 3 program,” says CymaBay CEO Sujal Shah. — John Carroll
Irish Tax Appeals Commission upholds assessment of Shire’s break fee
Takeda’s attempts to appeal a tax assessment from a break fee Shire received from AbbVie back in 2014 have failed. But the company’s not giving up just yet.
AbbVie backed out of a proposed $55 billion purchase of Shire nearly seven years ago, citing rule changes by the US Treasury Department intended to curtail deals in which US companies would redomicile overseas to take advantage of lower corporate tax rates, according to a Reuters report. When it walked away, AbbVie paid the Irish company $1.64 billion. And in 2018, Shire received a tax assessment from the Irish Revenue Commissioners for €398 million ($472.7 million).
Takeda acquired Shire in 2019, and appealed the tax assessment in a hearing late last year. On Friday, the Irish Tax Appeals Commission decided to uphold the assessment.
“Takeda intends to challenge this outcome through all available legal means including appealing the decision to the Irish courts,” the company said in a statement. — Nicole DeFeudis
New data show promise for a six-week regimen of Biogen’s Tysabri
While Biogen’s multiple sclerosis drug Tysabri is currently approved to be administered every four weeks, one analysis showed that giving every six weeks could lower patients’ risk of developing progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection.
On Monday, the company unveiled new data showing that the six-week regimen is no less effective than the four-week one.
According to Biogen, patients who received Tysabri every four weeks saw a mean number of new or newly enlarging T2 hyperintense lesions at week 72 of 0.05, compared to 0.02 for the patients receiving the drug every six weeks. That figure isn’t clinically meaningful, the company said, adding that the p-value was 0.0755.
According to new data from a two-year study, Biogen’s multiple sclerosis drug Tysabri shows no meaningful difference in efficacy when given every six weeks as opposed to the currently every four.
“The numerical difference was driven by a high number of lesions occurring in two participants in the Q6W arm – one patient who developed lesions three months after treatment discontinuation and a second patient who developed asymptomatic progressive multifocal leukoencephalopathy (PML)…” Biogen said in a statement.
The proportion of patients who developed new or newly enlarging T2 lesions was 4.1% in the four-week arm, and 4.3% in the six-week arm.
A complete analysis of the data is ongoing and more detailed results will be shared in a future scientific forum, Biogen said. — Nicole DeFeudis