To: richardred who wrote (979 ) 1/10/2006 12:48:03 AM From: richardred Read Replies (2) | Respond to of 7243 Mergers, Safety Top Medical Device Focus Monday January 9, 3:52 pm ET By Wallace Witkowski, AP Business Writer Medical Device Industry Mergers, Safety Awareness to Continue As Themes in 2006 NEW YORK (AP) -- Industry analysts predict the medical device sector will continue to place emphasis on more rigorous safety standards and mergers designed to jump-start growth in 2006. Piper Jaffray medical device analyst Thom Gunderson said safety came to the fore in 2005 because of an event outside the immediate sector: the withdrawal of Merck & Co.'s top-selling arthritis drug Vioxx and the resulting liability trials. With Vioxx, Gunderson said, nobody questioned whether the drug worked, but the risks came to outweigh the benefits and forced the company to pull the drug off the market. "For devices, we generally talk about safety and efficacy, and Wall Street just assumes safety but looks at efficacy," Gunderson said in an interview. "What happened in 2005 was that the safety issues were raised up and re-examined." Gunderson said Johnson & Johnson elevated the safety discussion within the industry in March in a clinical trial presentation that compared its Cypher drug-coated stent to Boston Scientific Corp.'s Taxus Express2 stent. Stents are tiny wire mesh tubes that are expanded inside plaque-congested arteries to act as scaffolding. Drug coatings help prevent the artery from reclogging by keeping tissue from growing through the mesh. "What Johnson & Johnson did was imply with some data that their stent was safer, with fewer adverse events," Gunderson said. "That worked and got them 10 points of market share." Boston Scientific held about two-thirds of the U.S. drug-coated stent market at the beginning of 2005, a stake that has dwindled recently to about 55 percent. AG Edwards analyst Jan Wald agreed that safety was one of the main industry themes in 2005 at the demand of investors and patients alike after well-publicized device recalls, such as Guidant Corp.'s recall of thousands of implantable defibrillators and pacemakers over the summer. CIBC World Markets analyst John Calcagnini remarked that companies going forward will likely have to start disclosing lower failure rates of devices. "It's good in that it will probably raise the bar for quality control," Calcagnini said. The issue of safety clashed with the year's other dominant trend, device company mergers, particularly in the case of J&J's bid to acquire Guidant. Just over a year ago, J&J had offered about $25.4 billion for Guidant but managed to lower its bid to $21.5 billion after the summer recalls had caused J&J to reconsider the deal. Then, Boston Scientific made a surprise $25 billion bid the company in December. On Sunday, Boston Scientific made a formal offer of $72 per share, compared with J&J's $64 per share offer. Piper's Gunderson called 2005 a "banner year" for medical device mergers and acquisitions, comparing the recent flurry of activity to a five-year harvest cycle, where new technologies mature and make the whole company desirable enough to acquire. One recent merger drama involved Allergan Inc., the maker of wrinkle treatment Botox, and its successful bid for Inamed Corp., which is awaiting Food and Drug Administration approval for silicone-gel filled breast implants. Allergan offered $3.2 billion for Inamed, trumping a $2.8 billion offer from Medicis Pharmaceutical Corp., to get a larger stake in the cosmetic surgery products market. CIBC's Calcagnini said growth in most core device markets like drug-coated stents, defibrillators and orthopedics are slowing down, and that large cap companies need to find growth engines. That is why Johnson & Johnson and Boston Scientific aren't just battling it out for domination in the drug-coated stent market: they also need Guidant to fill out a heart device portfolio that lacks cardiac rhythm management devices. Calcagnini rates the whole medical device sector as "Sector Perform," claiming most large capitalization companies are trading in line with their historical price-earnings ratios, or about a 35 percent to 40 percent premium to the S&P 500. New safety strategies and mergers will play heavily in the growing neurostimulation device market, AG Edwards' Wald predicted. The analyst cited the recent acquisition of Advanced Neuromodulation Systems Inc. by St. Jude Medical Inc. as the heart device maker's play to take advantage of a field with "tremendous upside." Advanced Neuromodulation makes pacemaker-like devices that treat chronic pain. Another company, Cyberonics Inc., gained FDA approval in 2005 to use a stimulation device to treat drug-resistant depression. Wald said that neurostimulation clinical trials have traditionally required far less data than trials for stents and other devices. But the analyst said that may change with Medtronic Inc.'s hiring of Richard Kuntz in September to head their neurostim business. Wald said that Medtronic plans to have Kuntz "up the ante" in the neurostim market by generating larger amounts of clinical trial data to support marketing efforts over the next year.biz.yahoo.com