Updated to include BTG’s guilty plea entered Nov 7.
BTG (LON:BTG) said today that it agreed to pay the U.S. Justice Dept. $36 million (£28.4 million) to settle a probe into the marketing of the LC Bead embolization microspheres made by its Biocompatibles subsidiary.
The company plead guilty on Monday, November 7, to charges of improperly marketing its embolic LC Bead device.
Biocompatibles admitted to a misdemeanor charge of introducing a misbranded medical device into interstate commerce, according to court documents.
The company is slated to pay $8.75 million criminal fine and $2.25 million in criminal forfeiture onto of $25 million for civil claims under the federal False Claims Act.
In signed court papers, the company admitted to having market its LC Bead as a drug delivery device between 2006 and 2010, despite having told the FDA earlier that it would not market it as such.
The Justice Dept. launched the probe in July 2014, saying it would investigate the marketing practices for LC Bead from 2003 to 2011, covering a period before the January 2011 buyout of Biocompatibles by the British drug-delivery giant. The settlement does not include a corporate integrity agreement, BTG said.
“It is good to resolve this legacy issue. We understand our responsibilities to patients and healthcare providers and, in addition to our robust ethics and compliance program, we strive to have a corporate culture where we do the right thing, every time. This allows us to focus on what we do best: delivering innovative therapies to improve people’s lives,” CEO Louise Makin said in prepared remarks.
In a separate release, BTG said its preliminary half-year results are expected to top its revenue guidance of $645.6 million to $683.5 million (£510 million to £540 million) for the 6 months ended Sept. 30.
“Strong growth in interventional medicine revenues reflects continued good performances from interventional oncology, which included the 1st revenues from Galil Medical following its acquisition in June 2016, and from EKOS. Varithena revenue reflects the gradual increase in customers and reorder rates during the period, while PneumRx revenues are lower than last year, reflecting the current interim reimbursement environment in Germany,” BTG said in a press release. “Specialty pharmaceuticals has delivered a good performance across the portfolio. In licensing there were good performances from Zytiga and Lemtrada, while year-on-year growth was held back by the 1-off uplift of £8.5m ($10.8 million) in the prior period for Zytiga.”
“We have had a strong 1st half, delivering double-digit constant currency revenue growth as we have continued to grow the business. The acquisition of Galil Medical has strengthened and diversified our interventional oncology portfolio, which also saw the U.S. launch of our innovative visible bead LC Bead Lumi and approval in Canada of DC Bead Lumi. We anticipate further progress in the 2nd half of the year, including the E.U. approval of DC Bead Lumi, completing the U.S. [pre-market approval] submission for the PneumRx coil and the launch in Canada of Varithena,” Makin said.
BTG said it plans to release its full 1st-half results Nov. 15.
Material from Reuters was used in this report.