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LEAD STORIES
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Onerous Provisions Stricken from House Draft of MDUFMA II
Ubl |
Earlier this month, as the House Committee on Energy and Commerce’s subcommittee on health was finalizing its work on a bill reauthorizing the Medical Device User Fee and Modernization Act (MDUFMA II), a discussion draft of the legislation emerged that drew sharp criticism from the medtech industry. The area of greatest concern was a provision that would have placed limits on federal preemption defenses in liability cases involving medical devices, including devices that have gone through FDA’s rigorous premarket approval (PMA) process.
Steven Ubl, president and CEO of industry association AdvaMed (Washington, DC), provided the subcommittee with written testimony, in which he stated, “Device-specific reviews, such as a PMA, entail a comprehensive review of safety and effectiveness by FDA’s expert scientists, physicians, and other analysts.” In a subsequent news release, Ubl added, “Elevating individualized state actions and decisions through tort lawsuits over FDA’s expert science-based determinations of safety and effectiveness would undercut the agency’s authority and create a disincentive for companies’ research and development efforts.”
Efforts to remove what the industry considered to be onerous provisions proved to be largely successful. The bill that emerged from the House on the final day of markups was much more in line with the Senate bill, with which the device industry is generally pleased. [More]
Biomet Recommends Shareholder Approval of Sweetened Takeover Bid
Noblitt |
Less than two weeks before shareholders of Biomet Inc. were set to vote on a $10.9 billion buyout bid from a consortium of private equity firms, Institutional Shareholder Services (ISS; Rockville, MD), a provider of corporate governance and proxy voting services, recommended that shareholders reject the offer. As reason for its recommendation, ISS said the offer’s premium did not reflect the improvement in Biomet’s market position since the proposed acquisition was first announced in December.
Shortly after ISS released its recommendation, Biomet announced that the private equity consortium had increased its offer to $46 a share, a 4.5% increase over the original proposal. Biomet chairman Niles L. Noblitt said the board had unanimously accepted the revised bid and recommended that shareholders endorse the deal. [More]
Judge Rejects Boston Scientific’s Federal Preemption Defense
Frank |
Earlier this month, a federal district court in Minneapolis ruled that product liability claims against Boston Scientific Corp. (Natick, MA) regarding implantable cardioverter-defibrillators (ICDs) can proceed to trial. The claims are part of the estimated 1660 lawsuits that Boston Scientific inherited as part of its $27 billion acquisition of Guidant last year.
Boston Scientific’s motion to have the cases dismissed on the basis of federal preemption was denied by Judge Donovan Frank. In doing so, Frank stated, “The court is mindful of Guidant’s arguments that allowing these claims to go forward will open the floodgates and unfairly stifle medical invention. The court does not see such a harsh result. The FDA regulatory system and a state tort system can and should work together.” [More]
Analysts: More Divestitures on Boston Scientific’s Horizon
Ro |
On June 11, Aspect Medical Systems Inc. (Norwood, MA) announced that its strategic alliance with Boston Scientific Corp. (Natick, MA) for the development of brain-monitoring technology was ending after a two-year period. Boston Scientific is the largest holder of Aspect Medical stock, owning approximately 27% of the company’s shares.
Not entirely surprised by the move, many industry analysts expect Boston Scientific to place a number of assets on the block in upcoming months as the company seeks to divest certain noncore assets. “Boston Scientific’s decision to end the alliance [with Aspect] will net the company in excess of $110 million—considering both the $90 million of the Aspect Medical stock it can sell and the $15 million never expended on the initiative,” says medtech analyst Isaac Ro, vice president for medical devices at Leerink Swan & Co. Inc. (Boston). “The company will likely use these funds to shore up assets and reduce its debt.” [More]
Medical Marketing Association Presents Industry Awards, Announces Merger
Johnson |
At the beginning of June, the Medical Marketing Association (MMA) named Bridget Johnson, director of marketing and clinical communications in the renal division of Baxter Healthcare Corp. (Deerfield, IL), as the winner of its annual Delta award. The award was announced during the presentation ceremony of MMA’s International Awards of Excellence (In-Awe), held in conjunction with the association’s annual conference in San Francisco.
In addition to announcing its annual medical marketing award winners, MMA had big news of its own to announce at this year’s conference. Effective January 1, 2008, MMA plans to join forces with two other healthcare marketing organizations—the Healthcare Marketing and Communications Council and the Midwest Healthcare Marketing Association—to form a single national entity. The new group will be called the Healthcare Communication and Marketing Association (HCMA). [More]
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| IN THIS ISSUE |
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Onerous Provisions Stricken from House Draft of MDUFMA II
Biomet Recommends Shareholder Approval of Sweetened Takeover Bid
Judge Rejects Boston Scientific’s Federal Preemption Defense
Analysts: More Divestitures on Boston Scientific’s Horizon
Medical Marketing Association Presents Industry Awards, Announces Merger
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Earlier this week, Roche (Basel, Switzerland) made an unsolicited tender offer to acquire Ventana Medical Systems Inc. (Tucson, AZ) for an estimated $3 billion. Roche reports that it decided to make its hostile bid after Ventana’s chairman and board refused its multiple efforts to enter transaction discussions. Ventana reports that it will review Roche’s offer and make a recommendation to shareholders in the coming days.
Less than three weeks after announcing its agreement to acquire all outstanding common stock of Biosite (San Diego), Inverness Medical Innovations Inc. (Waltham, MA) reported that it plans to acquire Cholestech Corp. (Hayward, CA) in a stock-for-stock merger valued at about $326.3 million. Cholestech is a provider of diagnostic tools for risk assessment and monitoring of heart disease and inflammatory disorders.
Abbott (Abbott Park, IL) has completed its premarket approval application to FDA seeking U.S. market approval for its Xience V everolimus-eluting coronary stent system to treat coronary artery disease. Abbott expects to launch Xience V in the United States in the first half of 2008.
Orthopedic and biologic implant manufacturer Regeneration Technologies Inc. (Alachua, FL) has signed an agreement to provide spinal allograft implants for Stryker Corp. (Kalamazoo, MI). Under the agreement, Regeneration Technologies will process cervical spinal grafts from designs developed by Stryker.
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CALENDAR
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July 9–11: World Congress on Bioengineering, Bangkok.
July 11: Regulatory Update: Emerging Markets: Asia, Webcast.
July 15–19: AACC Annual Meeting and Clinical Lab Expo, San Diego.
July 16: Accelerating Technological Change: Value and Health Reform, Washington, DC.
July 17–18: Clinical Trials Design, Web seminar.
July 17–18: Intellectual Property for Technology and Business Development, Pasadena, CA.
July 29–30: Senior RA Institute II: Post-Launch Challenges of Growth, Philadelphia.
July 30–31: Integrated Strategic Planning, Pasadena, CA.
August 13–14: Preparing for and Surviving an FDA Inspection, New Brunswick, NJ.
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