Musculoskeletal News Roundup 16-Apr-09
BY LAUREN UZDIENSKI, APRIL 16, 2009
Earnings
JNJ reported 1Q:09 sales of $15.0 billion, missing estimates by $0.4 billion and representing a 7% decline over 1Q:08, which the company attributed mostly to unfavorable exchange rates. Net income was $3.5 billion, or $1.26 per diluted share, beating estimates by $0.04. DePuy reported sales of $1.3 billion, up 7% over the year-ago period. Among segments, hip sales grew 9%, knees increased 3% and spine was up 13%. All growth rates are constant currency.
Regulatory
Intrinsic Therapeutics, Inc. received a CE mark for its Barricaid anular prosthesis for use in discectomies. The company says the product reconstructs the anulus with a partial disc prosthesis and is anchored to the vertebral body for stability.
Product Introduction and Update
DePuy Spine, Inc. introduced two new products in its EXPEDIUM line of spinal implants, the EXPEDIUM Favored Angle Screw and the EXPEDIUM Cobalt-Chromium Alloy Rod. The company says the screw "angulates laterally or medially for easier rod capturing" and the rod produces better imaging and less artifact on scans.
Legal
Following the unsealing of a qui tam lawsuit against manufacturers of bone growth stimulation devices, Orthofix, Smith & Nephew and DJO announced that they all received subpoenas from the DOJ regarding potential violations of the False Claims Act. Documents are being requested from 1995 to 2009.
A third former Stryker employee has pleaded guilty to a felony charge of misbranding a medical device in an ongoing investigation into off-label promotion of OP-1. The former territory manager for Stryker Biotech accepted a plea agreement that spared him jail time, and under the terms of the deal, he agreed to cooperate with the government in its continuing investigation of Stryker Biotech.
Distribution
Orthofix signed a five-year agreement with the MBA Group to expand the distribution of the Company's spine implant and biologic devices in the United Kingdom. The deal is effective May 1. MBA Group is also the company's exclusive distributor in Spain and Portugal.
U.S. Spine announced that it was expanding distribution of their facet fixation system through Europe, Asia, Africa and the Middle East. The company manages its North American and South American sales and distribution through its U.S. headquarters in Boca Raton, Florida.
Operations
Smith & Nephew will close a 30-employee facility in San Antonio by the end of 2009. The site houses operations for OsteoBiologics, which Smith & Nephew acquired in 2006. Late last year, Smith and Nephew announced plans to relocate all of its biologics research to a Durham, N.C. facility.
