Fresenius alleges ‘blatant fraud’ at U.S. drugmaker Akorn

German healthcare group Fresenius (FREG.DE) alleged it uncovered “blatant fraud at the very top level” of U.S. generic drugmaker Akorn Inc (AKRX.O) after Fresenius agreed to acquire the company for $4.75 billion, according to a court filing made public late on Tuesday.

Fresenius abandoned the merger agreement last month, and Akorn has sued in Delaware Court of Chancery to try to hold Fresenius to the deal.

Shares of Akorn fell more than 8 percent in early trading Nasdaq on Wednesday to $13.57 per share. The stock has plummeted from more than $30 per share in February after Fresenius said it was investigating data integrity at Akorn, and warned it could end their merger agreement.

Fresenius officially abandoned the $34 per share deal for Akorn in April.

Akorn spokeswoman Jennifer Bowles said the company categorically disagreed with the allegations and intended to enforce the merger agreement.

The drugmaker will ask a Delaware judge at a hearing on Tuesday to fast-track its lawsuit and schedule a trial as soon as next month, according to court documents. Fresenius wants the trial to be held in January.

Akorn said in its lawsuit last month that Fresenius uncovered data integrity problems that are common in the generic drug industry and is seizing on them to try to back out of a deal it soured on for financial reasons.

Fresenius SE & Co KGaA65.16

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Fresenius alleged that an Akorn executive vice president for quality assurance, whose name was redacted from the court filing, knowingly directed the submission of fraudulent testing data to the U.S. Food and Drug Administration.

The fabricated data concerned Akorn’s application to market the antibiotic azithromycin, and Fresenius alleged the fraudulent scheme began in 2012.

Fresenius also alleged that “the same scheme has infected” at least five other Akorn products.

In the court filing, Fresenius said its investigation revealed “blatant fraud at the very top level of Akorn’s executive team, stunning evidence of blatant and pervasive data integrity violations.”

Akorn has said in court documents it investigated the possible submission of falsified data and fired an executive who was involved.

“Critically, azithromycin and the five other drug products in question either have never been marketed or are not currently being marketed and were never forecasted to form a material portion of Akorn’s future earnings,” the company said in one of the documents.

https://reut.rs/2HKepiH

InVivo releases complete 6-month results from cancelled trial

InVivo Therapeutics (NSDQ:NVIV) today released complete six-month results from the company’s Inspire study of its neuro-spinal scaffold, which it ended in January after halting enrollment last July.

Results were presented by Dr. Stuart Lee of Vidant Health at the 2018 AANS meeting yesterday, the Cambridge, Mass.-based company said. The presentation was the first to include complete six-month data from the cancelled Inspire study.

InVivo’s neuro-spinal scaffold is a novel, biodegradable device designed to be surgically implanted following acute spinal cord injuries to act as a physical substrate for nerve sprouting.

A total of 19 patients in the trial were implanted with the neurospinal scaffold, with three patients dying within two weeks of implantation. Data indicated that 44% of patients who reached the six-month primary endpoint visit in the trial had an ASIA Impairment Scale conversion at six months, which was the primary endpoint of the trial.

The objective performance criterion for the study was a 25% AIS conversion rate based on published conversion rates for thoracic spinal cord injury as reported in literature, which the trial met, InVivo reports.

InVivo also presented results from the Contempo study, which was intended to provide natural history benchmarks for the neuro-spinal scaffold. The trial analyzed neurological recovery data from 170 patients across three registries of patients with spinal cord injuries similar to those in the Inspire trial. Results from the Contempo study “validated the company’s previously established OPC with AIS conversion rates,” the company said.

“I was honored to present these clinical findings at the AANS Annual Scientific Meeting, and I believe the complete six-month Inspire findings encourage future clinical investigation of the Neuro-Spinal Scaffold,” Dr. Lee said in a press release.

In March, InVivo said it won FDA investigational device exemption for a new pivotal trial of its neuro-spinal scaffold. The new trial is slated to enroll 20 patients with acute spinal cord injuries to explore the use of the company’s neuro-spinal scaffold in hopes that results will enhance existing evidence.

https://bit.ly/2IaMuHS

Humana: Strong Medicare Advantage growth in 1Q

“We experienced strong Medicare Advantage enrollment growth and solid performance across all segments in the first quarter, with early positive indicators of medical utilization allowing us to raise guidance for the year,” said Brian A. Kane, CFO. “Together, these results reflect the effective execution of our strategy.”

https://bit.ly/2HOSenr

CVS EPS outlook above views

Sees FY18 adjusted EPS $6.87-$7.08, consensus $6.22  Sees FY18 net revenue growth 1.25%-3%, consensus $189.17B. Sees FY18 enterprise adjusted operating profit growth (1.5%)-1.5%. Sees FY18 tax rate approximately 27%. Guidance from slides presentation for Q1 earnings conference call.
https://bit.ly/2I7IHLu

CVS: Operating profit more weighted to 1H18

Says: $275M of investments made with a portion of the savings from tax reform is predominantly back-half weighted. Retail/LTC segment making better progress on certain pharmacy initiatives in front half, and was positively affected by strong flu season in Q1. LTC business experiencing some challenges, and its growth rate is lower than previously expected. While not different from prior expectations, Anthem implementation costs are back-half weighted.

https://bit.ly/2JLOmUQ

Gilead turnaround thesis unchanged: Jefferies

Jefferies analyst Michael Yee says that while Gilead Sciences last night didn’t report the best quarter, the turnaround thesis remains unchanged. The results won’t prove the thesis to bears, but Gilead’s turnaround is underway and should play out over the next four quarters, Yee tells investors in a post-earnings research note. The stock, trading at an 11-12 times price-to-earnings ratio, is “cheap” and the worst is mostly behind the company, Yee adds. He keeps a Buy rating on Gilead with a $95 price target.

https://bit.ly/2I9SvVg

Gilead target cut by Maxim

Gilead price target lowered to $89 from $94 at Maxim. Maxim analyst Jason McCarthy lowered his price target on Gilead to $89 after the company’s Q1 results missed consensus, driven by lower than expected HIV/HBV revenues. The analyst has also reduced his FY18 EPS view to $6.14 from $6.74 and revenue to $20.5B from $21.4B, adding that while CAR-T treatment is promising, it is still a long way away. McCarthy keeps his Buy rating on Gilead, noting the company’s “multiple” catalysts in 2018-2019 along with its $32B cash cushion that can expand the pipeline through M&A

https://bit.ly/2FAjEvl