bioMérieux-Pierre Fabre acquires Organon Teknika
On April 23, Akzo Nobel’s Board of Management approved the bid by bioMérieux of Marcy l’Etoile, France to acquire Organon Teknika’s diagnostics business.
The bid, which was made three months ago, recently was approved by the groups representing personnel in both companies. The definitive agreement will occur when the final authorizations from the regulatory bodies in the different countries concerned are obtained.
This new group, ”bioMérieux-Pierre Fabre,” is expected to generate sales of 10.7 billion French francs (EUR 1.61 billion) with more than 50 percent from international markets of over 120 countries. It would employ some 11,500 people.
The company’s portfolio includes diagnostics, pharmaceuticals, immunotherapy and dermo-cosmetics. The new entity aims to conduct research and design into new products, primarily for cancer and infectious diseases.
Upon completion of the merger, the bioMerieux-Pierre Fabre group, owned equally by the two founding groups, would be run by a Supervisory Board chaired by Pierre Fabre and a Management Board chaired by Alain Merieux. Two CEOs, Jean-Luc Belingard and François Guinot, CGIP, a shareholder of the bioMérieux group, will be on the Supervisory Board. The new group is expected to consider a public stock listing in the future.
“We are delighted with this takeover which represents a highly significant addition to bioMérieux-Pierre Fabre’s diagnostic, particularly in the field of infectious disease. This agreement will broaden our world-wide presence and also give us access to advanced research and technology potential” said Alain Mérieux, chairman of the board of the bioMérieux – Pierre Fabre Group.
“This is a good deal for all,” said Paul Brons, member of Akzo Nobel’s Board of Management responsible for the Pharma Group.
“Organon Teknika’s diagnostics business has over the years established strong worldwide positions for several specialized innovative diagnostic product lines through its committed R&D efforts. However, it missed the critical mass in R&D and international marketing to be able to establish a leading overall position for itself in a strongly consolidating global diagnostics market. As part of bioMérieux – a renowned innovative player and the No. 8 diagnostics company in the world – it will enjoy all the benefits that critical mass brings. This puts the future of the business and that of its employees on a solid footing. For bioMérieux this is an attractive deal as they are acquiring a company that has a similar R&D driven approach and whose products offer a good fit with its own product lines.”
The bioMérieux – Pierre Fabre Group is organized into five sectors: bioMérieux; Pierre Fabre Médicament; Pierre Fabre Dermo-cosmétique; Transgene and Dolisos. The new entity will devote 1.7 billion French francs to research and development.
Organon Teknika’s diagnostic division employs 1,800 people throughout the world. Its main research and production centers are located in the Netherlands and Durham, N.C. Founded in 1972, the company ranks No. 2 worldwide in the blood culture sector, with a market share of 36 percent.
Nova critical care analyzer returns to Boston Marathon
For the second year in a row, the Nova Stat M7 Critical Care Analyzer provided a valuable diagnostic tool for physicians and runners requiring medical assistance at the 2001 Boston Marathon.
The Nova Stat M7 analyzer provided stat analysis on the blood of about 100 adversely affected runners who required IV therapy following the race. Tests included blood gases, electrolites and hematocrit.
Situated in a medical tent just across the finish line, the analyzer provided stat analysis on the blood of about 100 adversely affected runners who required IV therapy following the race. The biochemical information helped clinicians immediately confirm health issues that suggested the need for further medical treatment. The tests included blood gases, electrolytes, metabolites and hematocrit. Medical teams from other marathons are closely watching the results, which could promote further use of stat analyzers at other venues.
Over the past several years, many marathon runners have experienced serious medical problems immediately following their races. For example, two runners died from hyponatremia (low sodium) in a recent San Diego marathon. Results of an ongoing study based on these tests will be submitted for publication following comprehensive analysis by the medical professionals.
Held in Boston in conjunction with the Patriot’s Day holiday commemorating the start of the Revolutionary War, the Boston Marathon is the world’s oldest annually contested marathon.
Point-of-care coordinator of the year is Virginia med tech
Lou Ann Wyer (left), a medical technologist at Sentara Healthcare in Norfolk, Va., has been named the 2001 winner of the Point-of-Care Testing (POCT) Coordinator of the Year award by the American Association for Clinical Chemistry’s (AACC) POCT Division.
The award, sponsored by LifeScan Inc., a Johnson & Johnson company, will be presented at the annual meeting of the AACC on July 31 in Chicago. It is conferred annually by the AACC’s POCT Division to recognize outstanding achievements in the POCT field by people who are primarily responsible for a given institution’s POCT program.
“Lou Ann has overseen the growth of the POCT program at a top healthcare facility through laboratory integration and systems expansions,” said Catherine J. Cox, MD, chair of the awards committee for the AACC’s POCT Division. “She has developed an exemplary program at Sentara.”
A clinical specialist for POCT and quality management since 1996, Wyer directs a team that coordinates more than 3,000 POCT operators at the 70-site Sentara Healthcare, which was recently ranked the top integrated healthcare network in the United States.
Wyer’s program manages all of Sentara’s POCT patient data, gathered from the healthcare network’s 185 glucose meters, 100 handheld blood gas and electrolyte instruments, 25 activated-clotting time (ACT) instruments, the rapid coagulation testing program and numerous POC tests. She also provides technical expertise for the institution’s POCT system processes, instrumentation, quality outcomes, accreditation issues and the development of new programs. Wyer also has written articles on POCT for several industry publications.
Nomination letters for this award from front-line nurses, healthcare system administrators and manufacturers praised Wyer’s professionalism and unfailing willingness to share her knowledge with others.
“Ms. Wyer represents the very best in POCT and quality management,” noted Karen McCormick, vice president of LifeScan’s Hospital Business Unit. “Her activity at the state, regional and national levels has brought significant advances to the POCT field.”
BD offers easy-to-use portfolio for microbiology products
BD Diagnostic Systems recently established a Product Optimization Program (POP) to offer customers an accurate, easy-to-use portfolio of microbiology products and expertise.
To improve service levels and ensure utilization of products appropriate for today’s SOPs, the company is phasing out redundant and sub-optimal catalog numbers. Contract customers will receive an amended contract indicating any changes relative to the Product Optimization Program.
Up-to-date information also will be maintained at www.bd.com/clinical. The Web site will include: a list of products which will be phased out as part of the program; reason for phasing out product; recommended product substitute; detailed technical information.
For Dehydrated Culture Media (DCM), the program follows the completion of the company’s integration of Difco Laboratories and the subsequent manufacturing transfer of Difco and BBL brands into a new facility in Sparks, Md. During the transfer, BD will maintain duplicate production and inventory of similar Difco and BBL formulations. Once the DCM production transfer is completed, BD will begin the POP. It will examine and select the optimum formulation for customers, packaged in the Difco packaging material.
For prepared media, reagents and other products, BD will phase out certain portfolio items. In many cases, these products have been replaced over the years by other products. Many of the recommended product substitutes are Formulary products.
Bayer rounds out its infectious disease diagnostics menu
Bayer Corp. of Tarrytown, N.Y., has acquired certain development, manufacturing and sales rights to immunodiagnostic products for the detection of Hepatitis C (HCV) and HIV antibodies from Ortho-Clinical Diagnostics, Chiron Corp., Roche Diagnostics and Dade Behring.
Bayer is developing Hepatitis B and Hepatitis A assays for its immunoassay platform, the Advia Centaur. Expanding its infectious disease menu, will help it compete more effectively in the $1 billion Hepatitis and HIV diagnostics market.
Bayer obtained licenses to HCV and HIV-I and HIV-II testing technology from Ortho and Chiron. It obtained licenses from Roche and Dade Behring related to the development, manufacture and marketing of immunoassays for HIV Group O.
“This transaction is a critical part of our growth strategy in the laboratory testing segment of the in-vitro diagnostics marketplace,” said Rolf Classon, president of Bayer Diagnostics. “The infectious disease market is the fastest growing segment of the diagnostics industry.”
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Diagnostic Deals |
 COLA, a national healthcare accreditation organization, has promoted Gerard Weiss from its Operations Division Manager to Chief Operating Officer. Weiss will be responsible for day-to-day operations, assuring operational compliance with corporate policy, the development and implementation of strategic initiatives, management of business consultants, Board of Directors and committee meeting arrangements and varied employment-related activities. He will also be representing the organization to the public, government agencies and other organizations.
J. Stephen Kroger, MD, MACP, Chief Executive Officer of COLA, was awarded a Mastership by the Board of Regents of the American College of Physicians — American Society of Internal Medicine. Dr. Kroger is one of the original founders of COLA and a lifetime advocate of education, quality laboratory testing and overall excellence in patient care. Thoratec Corp., recently named Lawrence Cohen, who has more than 25 years of healthcare diagnostics industry experience, president of its International Technidyne division. Headquartered in Edison, N.J., ITC is a leading manufacturer of blood coagulation testing equipment, related disposables and single-use skin incision devices. Prior to joining ITC, Cohen was CEO of HemoSense, a developer of point-of-care coagulation monitoring systems. The Diagnostic Systems Group of Olympus America has appointed Therese Francoeur Giacomo as Product Manager for its AU2700 and AU640 automated chemistry-immuno systems. Giacomo has worked in business development and product management for companies including Roche Diagnostics, Syva and Abbott Laboratories. Meridian Bioscience of Cincinnati has hired Susan Rolih as its vice president of regulatory affairs and quality systems. Most recently, Rolih was corporate vice president of regulatory affairs and quality assurance at Immucor in Norcross, Ga. Bartels Diagnostics of Issaquah, Wash., recently was acquired by Trinity Biotech. All Bartels manufacturing was transferred to Trinity’s existing operations in California, New York and Ireland. Third Wave Technologies recently announced that Kaiser Permanente Regional Laboratory Service of Los Angeles has begun using its proprietary Invader operating system for routine clinical applications. Kaiser Permanente Regional Laboratory Service is a part of Kaiser Permanente, a prepaid, group practice HMO serving more than 5.9 million members throughout California. A manufacturer of in vitro diagnostic devices in San Antonio, Texas is the district SBA Small Business Exporter of the Year. Rodney Martin, district director of the San Antonio Office of the U.S. Small Business Administration announced that William Pippin, president of Stanbio Laboratory is the winner of the 38th annual entrepreneurial award. The company was founded in 1958, and Pippin acquired the company in 1995 with an SBA-guaranteed loan. DiaSys Corp. recently reported the results of its operations for the three- and nine-month periods ended March 31, 2001. Total revenue for the three-month period ended March 31 was $432,126, an increase of 84 percent over the $234,236 recorded for the same period in 2000. Total revenue for the nine-month period ended March 31, 2001 was $1,391,169, an increase of 83 percent over $762,215 for the same period of the prior year. St. Louis-based AmeriNet Inc. has renewed its agreement with Specialty Laboratories of Santa Monica for clinical laboratory services. Physicians at AmeriNet’s member facilities can continue to access Specialty’s array of esoteric assays in more than 15 specialty areas. AmeriNet also has signed a three-year membership agreement with Shriners Hospitals for Children to represent the non-profit/charitable healthcare organization in negotiations with healthcare vendors and suppliers. Shriners Hospitals for Children operates a network of 22 pediatric specialty hospitals throughout North America that provide expert, no-cost orthopedic, spinal cord injury and burn care to children under age 18. American Bio Medica Corp., of Kinderhook, NY, has signed an agreement to provide Rapid Drug Screen assays to Northwest Drug Testing, a division of NWT Inc., and a leader in drugs of abuse and adulterant testing. Rapid Drug Screen will be offered to NDT customers to complement the Salt Lake City-based laboratory’s extensive array of drugs of abuse testing services. With Rapid Drug Screen, NDT can offer on-site drug testing resources that feature ease of sample collection and testing with quick turnaround of results. In addition, American Bio Medica Corp. announced that it and its distributor partner, Comprehensive Toxicology Services won a key State of New York contract to provide drug-testing resources statewide. The awarded contract is for “Lot II” of the state’s comprehensive substance abuse testing program, which covers “testing devices with laboratory confirmation and proficiency testing provided and including administrative services.” Under the agreement, Comprehensive Toxicology Resources will serve as contractor, managing and delivering these drug-testing services. ABMC will effectively be the sole provider of on-site drug testing products. Roche Diagnostics of Indianapolis and Premier have extended their immunodiagnostics agreement to cover Roche’s Elecsys instrumentation, reagents and services. Roche’s Modular Systems E170 for integrated immunodiagnostics and chemistry testing, also will be made available to Premier members later this year. The E170 was recently launched in the United States. Global Med Technologies of Denver has signed an agreement with Oklahoma Blood Institute in Oklahoma City, Okla., to license Wyndgate Technologies’ SafeTrace Tx hospital transfusion service management information system. Wyndgate is a division of Global Med, an information technology company that provides software products and services to healthcare. OBI is a statewide, not-for-profit blood center providing blood to patients in more than 70 hospitals in over 40 Oklahoma counties. Sigma-Aldrich Corp. announced an agreement with Proteome Systems under which Sigma-Aldrich would manufacture and/or exclusively distribute certain products developed in collaboration with Proteome Systems. The recently introduced ProteoPrep line of sample preparation kits is the first in a number of product groups that will be launched as a result of this agreement. The ProteoPrep line consists of three kits and two stand-alone reagents that are optimized for use in proteomic research, but also work well for standard research applications. The kits include new and innovative detergent formulations that improve solubility and allow for higher protein loads, study of membrane proteins and greater visibility of low abundance proteins in 2D gels. Genzyme General, a division of Genzyme Corp. of Cambridge, Mass., and privately-held Wyntek Diagnostics of San Diego announced an agreement under which Genzyme will acquire Wyntek for $65 million in cash. The transaction closed during the second quarter. The acquisition is designed to expand Genzyme’s position in the point-of-care market. Wyntek’s portfolio of rapid tests complement Genzyme’s existing offerings and will substantially enlarge Genzyme’s presence in the markets for infectious disease and pregnancy testing products. Wyntek generated $17.5 million from sales of rapid test products in 2000, and it expects sales this year to reach $25 million. Serologicals Corp. of Norcross, Ga., earned a ranking in the top-ten performing publicly traded companies in Georgia. The company, which is a worldwide provider of biological products to life science companies, ranked at No. 10 within the “Best of Business” list which profiles Georgia’s 100 top-performing companies as determined by five factors: revenue, revenue growth, return on equity, change in profit margin and total return. The figures were compiled and processed by PricewaterhouseCoopers. Serologicals provides antibody-based products that are used as active ingredients in therapeutic products for the treatment and management of diseases such as Rh incompatibility in newborns, rabies and hepatitis and in diagnostic products such as blood typing reagents and diagnostic test kits. Bayer Corp. of Tarrytown, N.Y., and Matsushita Electric Industrial Co. Ltd. of Osaka, Japan, best know for its Panasonic brand, have entered a long-term, strategic business relationship to jointly develop, manufacture and market diagnostic products. Through its Business Group Diagnostics, Bayer would acquire rights for the sale and marketing of newly developed products and services for a broad range of applications for the diagnostics market. Matsushita will be primarily responsible for developing and marketing the new products and services. Combining Bayer’s knowledge of the diagnostic customer and marketplace with Matsushita Electric’s technological expertise will enable both companies to develop products that meet the needs of the worldwide in vitro diagnostics market, which is estimated to reach $25 billion by 2005. |
Automated test for congestive heart failure under development by Bayer and Shionogi & Co.
Bayer has agreed to licensing terms with Shionogi & Co. Ltd., for the development, manufacture and distribution of an automated test for B-type Natriuretic peptide (BNP), as an aid in the diagnosis and management of congestive heart failure. Bayer Diagnostics will develop this test for use on its Advia Centaur and ACS:180 immunoassay systems. Automation of this test on these systems will improve the availability of BNP to laboratories and their customers.
Shionogi’s radioimmunoassay kit (Shionoria BNP) is used in the United States and Canada on a research-use-only basis. Shionogi has marketed Shionoria BNP in Japan since 1994 and in Europe since 1997 as a diagnostic blood test for use by medical and laboratory investigators. In the past six years, more than 100 publications in leading cardiology journals have used the Shionoria BNP kit to define use of BNP as an aid in the diagnosis and management of patients with CHF.
BNP is a 32-amino acid hormone secreted into the bloodstream by the heart in response to CHF. The initial clinical diagnosis of CHF is problematic. Symptoms such as fatigue, pulmonary and peripheral edema and hepatic and visceral congestion can easily be associated with other pathologies such as respiratory disease and the secondary effects of obesity. For the primary care physician, making the initial diagnosis of CHF is difficult, requiring the use of expensive ultrasound and radiographic procedures. A simple biochemical test, especially one that is plasma based, could have value in the initial rule out of CHF, and thus confirm the need for further cardiac assessment.
A subset of cardiovascular disease, CHF ranks 3rd in prevalence as a discrete diagnosis behind hypertension and coronary heart disease, including both myocardial infarction (MI) and angina. Approximately, 75 percent of CHF patients have underlying hypertension as a symptom and upwards of 20 percent of MI patients will evolve to a diagnosis of CHF within six years of the MI.
According to American Heart Association statistics, approximately 4.6 million Americans suffer from CHF with 550,000 new cases being diagnosed each year. CHF is the single most frequent cause of hospitalization in people over 65 years and has been associated with both direct and indirect costs to the U.S. healthcare system of $21 billion per year and annual nursing home and hospitalization cost of $15 billion per year.
Free workshops and lectures offer ASCLS-approved CEUs
Beckman Coulter has scheduled a series of free lectures and workshops for laboratory administrators and managers in North America. The 2001 Symposia provide healthcare professionals with an opportunity to discover new techniques for addressing critical issues facing clinical laboratories. Leading scientists and medical professionals will explore methods of converting data to information, examine the impact of automation, provide topical updates and share their visions of the future. Attendees will hear about innovative approaches to enhancing quality, efficiency and productivity in the laboratory.
Symposia dates and cities are as follows: Charlotte, N.C. on August 8; San Antonio, Texas on August 15; Chicago on August 22; Boston on September 12; western Canada on October 3; Memphis on October 10; Montreal on October 24; and San Francisco on November 7. Last year, the Symposia toured 12 cities throughout North America and were attended by more than 1,300 healthcare professionals. Advance registration (required) and a schedule can be found at www.beckmancoulter.com/beckman/clindiag/promotions/2001calenda.asp. Healthcare professionals also may register by calling 800-526-3821 ext. 8847 or 714-993-884 or e-mail at [email protected].
Beckman Coulter is an approved provider of continuing education in the clinical laboratory sciences by the American Society for Clinical Laboratory Science (ASCLS) Professional Acknowledgment for Continuing Education (PACE) program. The PACE program includes educational courses for clinical laboratory professionals. Beckman Coulter 2001 Symposia attendees will earn one contact hour of PACE credit for each hour of lecture.
