A Medical Device Daily
Boston Scientific (Natick, Massachusetts) reported late Wednesday that it has won antitrust clearance from the FTC for its $27 billion combination with Guidant (Indianapolis). While the agreement is subject to final review and approval by the FTC, the company said its execution resolves all outstanding antitrust issues with the FTC staff relating to the proposed transaction.
The company also reported that it will voluntarily withdraw and re-file its notification under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 in connection with the Guidant acquisition.
It said the re-filing is a procedural step taken to ensure that the FTC commissioners have adequate time to review the executed consent decree.
As reported earlier this week in Medical Device Daily, European regulators pushed back the deadline they set for completing their review of the deal until April 18 (MDD, April 3, 2006).
The European review period was originally set to expire on April 13, but an Easter holiday has extended that expiration date through April 17.
Guidant shareholders stand to gain from this disclosure, as they will receive an additional $0.0132 in cash per Guidant share for each day beginning on April 1 through the closing date of the merger – translating to roughly $4.5 million a day.
Both companies' shareholders recently approved the merger, which Boston Scientific said it now expects to close around the middle of the month, shortly after receiving final FTC and European Commission antitrust approvals.
To satisfy concerns that the combined company could command too great a share of the market for cardiovascular stents, Boston Scientific agreed before the regulatory reviews to sell a piece of Guidant's business, including its drug-coated stents, to a third company. Abbott Laboratories (Abbott Park, Illinois) will pay $4.1 billion in cash, provide a $900 million loan to Boston Scientific and acquire $1.4 billion in Boston Scientific stock.
Also on Wednesday, Guidant reported its 1Q06 earnings falling 6% from last year to $894 million, and it expects to record more than $120 million in charges for the quarter. The company has suffered slumping sales because of product recalls and news that the company withheld information about the faulty devices. But the $894 million figure was still ahead of analysts' forecasts of about $880.25 million.
Preliminary, unaudited U.S. and worldwide implantable defibrillator sales for the quarter were about $308 million and $419 million, respectively, representing declines of 16% and 12 %, compared to 1Q05, and growth of 13% each compared to 4Q05.
Larry Beigelsen, med-tech analyst with Prudential Financial (New York), said he believes that the 13% sequential quarterly increase in implantable cardioverter defibrillator revenues suggests that Guidant's market share in that sector has increased to 28% from 26%, though he noted this could change, based on as yet unreported quarterly earnings by the largest ICD maker, Medtronic (Minneapolis).
Perceptronix opens Vancouver laboratory
Perceptronix Medical (Vancouver, British Columbia) reported the opening of its first Quantitative Cytology Laboratory in Vancouver.
The Perceptronix Quantitative Cytology Laboratory offers advanced quantitative clinical laboratory services to assist clinicians in the diagnosis and prognosis of cancer. The lab utilizes the Perceptronix ClearCyte Quantitative Cytology System and Clear2C Quantitative DNA Staining Kit to measure gross genomic aberrations. Both devices received Health Canada Class II medical device approval earlier this year.
ClearCyte is an automated microscopy imaging system used to measure DNA properties in cell samples of tissues. Combined with expert interactive review of cells, ClearCyte test results may provide clinicians with valuable information related to the clinical diagnosis and prognosis of cancer.