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BY LAUREN UZDIENSKI, JUNE 29, 2009

We reported back in April that teriparatide, a recombinant form of parathyroid hormone marketed by Eli Lilly as Forteo, may help bones to heal following a fracture. Now a new study published in JBJS reports on an additional application for teriparatide: preventing new vertebral fractures in osteoporotic patients.

The analysis was conducted from previously-published data from about 1,200 patients in the Fracture Prevention Trial. These patients were able to walk, had undergone menopause at least five years previously and had at least one moderate or two mild atraumatic vertebral fractures at baseline.

At approximately two years, teriparatide was shown to “significantly reduce” the occurrence of new vertebral fractures in the study population. New, new adjacent and new nonadjacent vertebral fractures were reduced by 72%, 75% and 70%, respectively, when compared to placebo.

Raloxifene, a selective estrogen receptor modulator used to prevent osteoporosis, was found to have similar benefits. New, new adjacent and new nonadjacent vertebral fractures were reduced by 54%, 54% and 53%, respectively, when compared to placebo. The raloxifene data was pulled from about 2,500 patients in the Multiple Outcomes of Raloxifene Evaluation (MORE) trial. Raloxifene is marketed as Evista by Eli Lilly, who also provided funding for the study.

BY JOHN MCCORMICK, JUNE 25, 2009

This morning cardio giant, Boston Scientific, Inc. announced that former Zimmer Chief Executive Ray Elliott will become their new President and Chief Executive Officer.

Ray Elliott is famous in our industry for having led Zimmer 10 years first as President and then as Chairman, President and CEO. Through growth and acquisition, Elliott led Zimmer from $1 billion to $4 billion in revenues thereby creating $15 billion in incremental shareholder value. Nevertheless, Zimmer was challenged by a continuing Department of Justice investigation and oversight and lack of product innovation after Elliott’s departure.

Analysts and the stock market reacted favorably to the news. Depite the sudden nature of the announcement, Elliott’s experience (i) at Zimmer and (ii) as a former member of the Boston Scientific board combined with the formal handling of the transition process should ameliorate any negative perceptions.

Outgoing Boston Scientific CEO, Jim Tobin, announced his intention to retire after being at the helm for 10 years. The CEO transition will become effective July 13.

ScienceDaily (June 15, 2009) — In many sensory neuronopathies, painful conditions affecting sensory nerves outside the brain and spinal cord, the affected nerves are in a region known as the DRG. These conditions are difficult to treat. However, researchers have now developed an approach to target therapeutic genes to DRG nerves, and used it to reduce sensory nerve dysfunction in a mouse model of Sandhoff disease, an inherited condition in which many nerves, including those in the DRG, are affected.

Medical conditions that affect sensory nerves outside the brain and spinal cord are known as sensory neuronopathies. These conditions, which are extremely painful, include shingles and can be caused by anticancer drugs such as cisplatin. In many sensory neuronopathies, the nerves that are dysfunctional are those in a region of the body known as the dorsal root ganglion (DRG), and these conditions are particularly difficult to treat. However, Lawrence Chan and colleagues, at Baylor College of Medicine, Houston, have developed an approach to target therapeutic genes to nerves in the DRG, and used it to reduce sensory nerve dysfunction in a mouse model of Sandhoff disease, an inherited condition in which many nerves, including those in the DRG, are affected.

The authors developed a system to generate helper-dependent adenoviruses that targeted only DRG nerves. These were used to deliver genes to DRG nerves in mice and found to be dramatically more efficient at gene delivery than nontargeted helper-dependent adenoviruses. In mice lacking the Hexb gene, which are consider a mouse model of Sandhoff disease, administration of DRG-targeted helper-dependent adenoviruses carrying the Hexb gene restored Hexb expression in DRG nerves and eliminated sensory nerve dysfunction. The authors hope this approach could be developed for treating different forms of DRG sensory neuronopathies.

1. Terashima et al. DRG-targeted helper-dependent adenoviruses mediate selective gene delivery for therapeutic rescue of sensory neuronopathies in mice. Journal of Clinical Investigation, 2009; DOI: 10.1172/JCI39038

BY EDITOR, JUNE 19, 2009

Alphatec Holdings, Inc., the parent company of Alphatec Spine, Inc., a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spine disorders, with a focus on treating conditions related to the aging spine, today announced that, as of June 1,2009, over 115 patients in eight European countries have been treated with the OsseoFix Spinal Fracture Reduction System, the Company’s innovative product for the treatment of vertebral compression fractures. The first European training session was held at the University of Vienna in mid-December 2008. The first shipments of OsseoFix products into Europe occurred at the end of December 2008.

“We are pleased with the significant surgeon adoption of OsseoFix across Europe. Surgeons who are using the OsseoFix system benefit from the potential to improve patient outcomes by providing an enhanced ability for vertebral height maintenance while using less cement as a result of the permanent titanium implant. As this product represents our initial launch into the aging spine market, we are particularly pleased with the manner in which the adoption of OsseoFix appears to be accelerating. Over 60 patients were treated in May alone,” said Dirk Kuyper, Alphatec Spine’s President and Chief Executive Officer. Mr. Kuyper added, “Our next training lab, which will be held in July in Vienna, is oversubscribed, with 50 surgeons and over 70 total participants already enrolled in what will be our third training session.”

The OsseoFix system is not yet approved for sale in the United States and is currently under 510(K) review with the U.S. Food and Drug Administration.