Judge threatens to delay or even spike $70m CVS-Aetna merger

CVS health, AetnaA federal judge last week reportedly threatened to derail the already-closed $70 billion buyout of health insurer Aetna (NYSE:AET) by CVS Health (NYSE:CVS), saying he felt “kept in the dark, kind of like a mushroom.”

At a normally routine hearing last week prior to approving the deal, Judge Richard Leon, of the U.S. District Court for the District of Columbia, said he might put off a decision until the summer or even spike the deal altogether, Reuters reported.

“I was reviewing your motion, which, of course is not opposed. And I kind of got this uneasy feeling that I was being kept in the dark, kind of like a mushroom,” Leon said, noting that the American Medical Association, among others, had objected to the deal. “I’m very concerned, very concerned that you all are proceeding on a rubber-stamp approach to this.”

The companies closed the buyoutannounced in December 2017, on Nov. 28. It calls for Aetna stockholders to receive $145 in cash and 0.8378 CVS shares for each AET share, for a total value of $212 per share or roughly $70 billion. Woonsocket, R.I.-based CVS is financing the deal with cash on hand and debt, including a $40 billion senior notes offering and a two-tranche term loan of $5 billion. But in order to seal the deal, Aetna had to agree to deal its 2.2-million-member Medicare Part D drug plan to WellCare Health Plans (NYSE:WCG). That deal is slated to close within the next few business days, pending Leon’s approval.

“It’s commonplace for acquisitions to close before this final step in the process is complete, and our focus remains on delivering on the combined company’s potential,” CVS said in prepared remarks to the wire service.

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ACC ’18 Roundup: Abbott releases long-term HeartMate 3 data

Abbott (NYSE:ABT) touted two-year data yesterday from its trial designed to compare the company’s HeartMate 3 left ventricular assist device to its HeartMate 2 device in patients with advanced heart failure.

Data from the study were published in The New England Journal of Medicine and presented at the American College of Cardiology’s 67th Annual Scientific Session.

More than 1,000 patients participated in the study. Researchers assessed the trial’s participants for a short-term endpoint of six months and long-term endpoint of two years.

The two-year cohort met its primary endpoint, achieving 77.9% event-free survival – topping the 56.4% rate seen in patients treated with the HeartMate II LVAD.

Patients treated with the HeartMate 3 device had a survival rate of 82.8% after two years, compared to 76.2% for the HeartMate II group. Abbott also reported that low pump thrombosis rates remained low at 1.2% for the HeartMate 3 group, with no reoperations or pump replacements needed at two years.

Finally, the stroke rate in the HeartMate 2 group was 19% compared to just 10% for the patients treated with HeartMate 3.

“The long-term data for the pivotal Momentum 3 trial demonstrate overall survival of 83% at 2-years and marked improvement in clinical outcomes for our patients suffering with advanced heart failure,” Dr. Mandeep Mehra, medical director of Brigham and Women’s Hospital Heart and Vascular Center, said in prepared remarks. “We have seen greater pump durability—mostly driven by an absence of confirmed pump thrombosis—as well as a significantly lowered stroke rate without an increase in other adverse events.”

“As the leader in LVAD therapy, our goal is to provide patients with life-changing health technology that minimizes risk and offers them an enhanced quality of life. Data from the Momentum 3 study show Abbott’s significant progress in LVAD innovation and how it’s improving patient health outcomes,” Dr. John O’Connell, medical director for Abbott’s mechanical circulatory support business, added.

Abbott’s HeartMate 3 LVAD has CE Mark clearance in the E.U. and is approved by the FDA in the U.S. for short-term use. The company plans to use data from its Momentum 3 trial to support an regulatory bid for a long-term indication for HeartMate 3 in the U.S.

NEXT: Philips touts NEJM study on iFR v. FFR

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