A BBI

Medtronic (Minneapolis) reported early last month its receipt of the CE mark for its Endeavor Drug-Eluting Coronary Stent with Rapid Exchange Delivery System and said it planned to launch the drug-eluting stent (DES) system simultaneously in 40 countries, outside the U.S. The Endeavor system – which Medtronic bills as the first cobalt alloy platform on the DES market – features “best-in-class deliverability, excellent clinical results and a strong patient safety profile,” according to the company

Scott Ward, president of Medtronic Vascular (Santa Rosa, California), said, “We believe the Endeavor system offers a powerful combination of deliverability, efficacy and safety that is unmatched by any other commercially available stent.” Ward said Medtronic sales representatives and customer support staffs were fully trained, and that it had an ample supply of Endeavor systems to support the global rollout.

Dr. Jean Fajadet, MD, Clinique Pasteur Unite de Cardiologie Interventionnelle (Toulouse, France), a co-principal investigator of the ENDEAVOR II pivotal trial, said, “The results from the ENDEAVOR trials to date have been both comprehensive and positive. I have had experience with each of the drug-coated stents on the market, and I believe that physicians in the European Union and elsewhere around the world will find that Endeavor represents an excellent course of treatment for their patients.”

Medtronic reported strong clinical results in the ENDEAVOR II clinical trial, including a 47% reduction in Target Vessel Failure (TVF), the study’s primary endpoint, between the Endeavor arm and the control group. It also demonstrated a 62% reduction in target lesion revascularization (TLR). Safety data from the ENDEAVOR II study indicated a 50% reduction in the major adverse cardiac event (MACE) rate, compared to a conventional bare-metal stent, and just a 0.5% rate of stent thrombosis at 30 days — with no late thrombosis beyond 30 days and no late stent malapposition.

“The overall clinical results of the Endeavor stent are impressive, and I think Endeavor will be a valuable addition to the drug-eluting stent marketplace,” said William Wijns, MD, co-director of the Cardiovascular Center, OLV Ziekenhuis (Aalst, Belgium), and a co-principal investigator of the ENDEAVOR II trial. “Endeavor has proven to be highly deliverable and is effective in reducing clinical restenosis. It also offers an excellent safety profile, which is important to both physicians and patients.”

Medtronic said it would report results of the ENDEAVOR III trial at the Transcatheter Cardiovascular Therapeutics (TCT) meeting in Washington in October, and noted that a fourth trial, ENDEAVOR IV, also is under way. The four trials will provide data on more than 2,000 Endeavor patients and will complete the information needed for submission to the FDA, the company said.

The Endeavor DES system combines the Driver bare-metal stent with a Sirolimus-analogue drug, known as ABT-578, and a biocompatible polymer, called PC Technology, to treat coronary artery disease. ABT-578 is a compound licensed to Medtronic by Abbott Laboratories (Abbott Park, Illinois) and designed to inhibit the cellular process leading to restenosis.

Medtronic also licenses Abbott’s phosphorylcholine polymer coating technology (PC Technology), licensed under patents owned by Biocompatibles (Oxford, UK). PC Technology is designed to serve as the delivery matrix that controls the release of ABT-578 directly into the arterial wall.

Philips lighting upon acquisition of Lumenis

The Israeli press and capital markets were lit up with reports in early August that Royal Philips Electronics (Amsterdam, the Netherlands) is negotiating to acquire Lumenis (Yokneam, Israel), currently trading at a market cap of $60 million after losing more than 15% of its value since the beginning of the year. Lumenis, still considered the global leader in medical and cosmetic devices based on laser light technology, had $64.7 million in revenues in 1Q05, down from $65.7 million a year earlier. Its net loss grew to $5.8 million from $5 million in 1Q04.

The company has been trading on the Pink Sheets since it was delisted from the Nasdaq exchange in February 2004 when company auditors refused to sign financial reports. A full investigation and civil proceedings revealed that Lumenis, under previous management by Arie Genger, had inflated financial results for 2002 and 2003.

Genger had led a takeover, ousting company founder and serial entrepreneur Shimon Eckhouse, an industry pioneer who went on to co-found neighboring firm Syneron Medical (also Yokneam), already a major competitor in the rapidly expanding medical and aesthetics markets.

Avner Raz, Lumenis CEO for the past two years, has been battling to reclaim the wounded giant’s path of profitability and its share of the burgeoning growth in this sector that it played a key part of ushering into exponential growth as ESC Medical Systems in 1991. ESC acquired Laser Industries in 1998, with its well-known Sharplan brand name, a significant force in medical lasers since 1973.

Lumenis was birthed in 2001 from the merger of ESC with Coherent Medical Group (Santa Clara, California), a company founded in 1966, which brought its engineering excellence and its lasers that were the “gold standards” for both medical and aesthetic applications. The firm has yet to overcome the travails of the past few years and return to profitability, due in large part to the costs associated with the Coherent acquisition for $228 million in cash and shares.

In order the finance that deal, the company opened a $240 million credit line from Bank Hapoalim. Lumenis and the bank restructured the debt in November 2003, with the revised plan deferring payment of principal until August 2006, when amortization will resume at the rate of $15 million annually. The bank also received more than 1 million shares and options in Lumenis, making it the firm’s largest shareholder.

Despite the company’s negative cash flow and only about $14 million in cash, Raz exudes confidence that Lumenis will recover its lead position in the sector, spurred on by customers, investors, 900 employees and suppliers. He refers to its installed base of more than 60,000 systems in 75 countries, with direct sales in 10 of these, more than 200 patents and several pending approval. Neither Philips nor Lumenis would make an official comment on the reports, but The BBI Newsletter was told by company insiders that “negotiations would probably continue for the next few weeks.”

Lab Tests Online to 3 more European countries

The American Association for Clinical Chemistry (AACC; Washington) and the European Diagnostic Manufacturers Association (EDMA; Brussels, Belgium) reported during the XIX International Congress of Clinical Chemistry with the International Federation of Clinical Chemistry and Laboratory Medicine (Milan, Italy) in Orlando in late July that the content of the U.S. web site Lab Tests Online would be translated to reflect the language and national healthcare policies of three European countries: Germany, Italy and Spain.

Lab Tests Online is a web site for consumers to research the variety of diagnostic lab tests available to them. Its purpose is to assist in understanding the purposes of the tests and how to interpret their results objectively in terms of their overall healthcare. It is already available in the UK. Susan Evans, a past president of the AACC who described herself as “an early advocate of Lab Tests Online, told BBI that, in particular, the translation of the site into Spanish represents “a huge opportunity to reach Spanish speakers around the world,” including the large population of Spanish speakers in the U.S., as well as those in Latin America.

The www.labtestsonline.org site was launched in July 2001 and served its 5 millionth visitor in the first half of 2003. The AACC said that Prevention magazine in its March 2004 issue called the online resource “one of the “smartest health sites on the web.” In June 2003, the site was launched in the UK as www.labtestsonline.org.uk.

The groups expect that by January 2006, information concerning the first set of 50 tests will be available in Spain, Italy and Germany, and that by 2006-2007 the current content of Lab Tests Online will be fully available in Spanish, Italian and German. Christine Tarrajat, director-general of EDMA, said it is “clear” that individuals in those European countries “need access to unbiased information.”

Fifteen multinational companies are corporate associate members of EDMA, and seven of those companies were involved in Lab Tests Online in the U.S.

Jean Francois de Lavison, the new president of EDMA and vice president of international affairs and public relations at bioMerieux (Marcy L’Etoile, France), said in a statement, “EDMA represents the interest of the European in vitro diagnostics industry to various stakeholders, namely: European governmental agencies, healthcare professionals who use or rely on IVD products, patient groups and the general public.” Lavison added: “I believe we all agree that a good portion – some say more than 50% of a patient’s notes – is generated through diagnostic testing. This is the information that a physician forms the basis of and confirms many of the decisions made in providing healthcare to consumers.”

The individual professional laboratory societies in the three new countries planning to have Lab Tests Online, at least initially, will be responsible for translation. National coordination committees and a European coordination committee have been established to adapt the U.S. web site content to “reflect national and cultural contexts,” Lavison said. “We are sure that we will raise the visibility of laboratory medicine” in those countries, said Mario Plebani, president of SIBoC, an Italian professional laboratory society.

The idea to add Europe to the now five-year-old U.S. project began in 2002 and led to early discussions among EDMA, several of its national association members, professional societies and AACC. Lavison told BBI that the efforts, thus far, to add Spain, Germany and Italy to the service are “a good start.” He summed up the effort’s key goal: “The objective is to do it, and to do it well.”

Bowel-cancer screening plan to start in UK

The UK’s National Health Service (NHS) will initiate a national bowel cancer screening program in England, beginning in April of next year. It is the first time such a program will operate in England and one of the first of its kind in Europe. Under the program, which will cost 37.5 million in its first two years of operation, men and women 60 to 69 years of age will be screened every two years. Home testing kits will be sent to around 2 million people in the target group each year. After conducting the tests in the home, the participants then will send the fecal occult blood (FOB) test kits back to a laboratory for analysis. People aged 70 and over will be provided with a FOB test kit on request.

The screening program will be phased in gradually over a three-year period, giving the NHS time to prepare and allocate resources. It is anticipated that around 25% of England will be covered by the end of 2006-2007. Another 25% will begin in 2007-2008, with the final 50% beginning in 2008-2009. Five program hubs, including testing laboratories, will be set up for analyzing the kits. Strategic Health Authorities will bid to provide the first wave of local screening centes. The NHS Cancer Screening Program will begin the procurement exercises for the five program hubs and the first year’s supply of testing kits later in the summer.

Julietta Patnick, director of NHS Cancer Screening Program, said, “Early detection is crucial to lowering the number of deaths from bowel cancer and a screening program will play a vital role in achieving this.” Bowel cancer is the second-largest cause of cancer deaths in the UK, with around 30,000 new cases each year. In 2003, more than 16,000 people died from the disease.

In unveiling the plans for the program, Health Minister Rosie Winterton said, “The NHS has already made significant progress in reducing deaths from bowel cancer, with mortality rates falling by 17% over the last 10 years. The roll-out of the national screening program will help save even more lives.” She added: “Because of the nature of the disease, people can feel uncomfortable talking about it, let alone coping with the symp-toms. That is why the privacy ... that the home testing kits afford will help us better tackle the disease.”

Winterton noted that although bowel cancer affects more than one in 20 people in their lifetime, “of those who get the disease 90% survive if it is caught early.” Hilary Whittaker, chief executive of the national charity Beating Bowel Cancer, said, “Bowel cancer is a huge disease in this country, killing almost 50 people every day, and we believe that the screening program will be a positive step in reducing the number of deaths from this cancer, as well as raising awareness of bowel cancer amongst the general public.”

Retractable gets contract for 400M syringes

Retractable Technologies (Little Elm, Texas) said it has signed a “landmark” contract aimed at eliminating the spread of HIV/AIDS and other blood-borne diseases via contaminated needles in China. The licensing agreement with a government-designated medical device maker will result in production of about 400 million VanishPoint safety syringes annually for Chinese healthcare providers. Under the terms of the agreement, Baiyin Tonsun Medical Device Co. Ltd. (BTMD) was designated by the China Center for Disease Control and Prevention to license and manufacture Retractable’s automated retraction devices for use in China.

In commenting on the new contract, Retractable President and CEO Thomas Shaw also ripped the group purchase organization (GPO) system in the U.S. and hailed the ability of smaller device firms to compete on a free-market basis in China. He said: “Ironically, this licensing agreement demonstrates that free market competition in the medical device industry is alive and well in China, but moribund in the U.S. We hope that Congress will soon introduce GPO reform legislation so that we can compete at home on the basis of quality, safety and cost-effectiveness, just as we now are able to do in China.” Retractable and many other small medical device makers have been “blocked for years by giant hospital GPOs and their big supplier partners from selling their innovative products in most U. S. hospitals,” Shaw said.

Baiyin Tonsun will pay Retractable a royalty of 2-1/2 cents to 3-1/2 cents per unit, based on syringe size. In the first year of the contract, the Chinese firm expects to produce about 40 million units, followed by about 400 million units each year thereafter. The initial term of this agreement is three years, effective Aug. 4. To manufacture the devices, BTMD has started building a new production facility in Baiyin City, Gansu Province.

Prior to the contract award, the China CDC conducted an evaluation of available safety needle devices worldwide. Dr. Huo Zhuoping, associate director of the agency, said, “We are strongly committed to protecting our people, especially the patients and healthcare workers, from infectious disease, including HIV/AIDS and hepatitis C, transmitted through needle reuse and accidental needlestick injuries. We believe that Retractable’s VanishPoint devices can help us accomplish this goal.”

MedMira in China j-v for tests

In other China market news, MedMira (Halifax, Nova Scotia), a provider of rapid flow-through diagnostic products, said it has entered into a strategic partnership with Tianhe Pharmaceutical Co. Ltd. (Guilin, China), which it described as “one of the most successful pharmaceutical companies in China.” The companies have formed a joint venture that MedMira said would open new markets in China and other Asian markets for its current and future rapid diagnostic products in China, including over-the- counter sales.

MedMira said the joint venture will include some production of tests in China, while the majority of research and development and manufacturing will remain in Nova Scotia at the company’s global headquarters. The work done in China, it said, will allow “faster approval of new products in China and speedier entrance into other Asian markets.”

“The rapid growth of China’s economy and [its] recent entry into the World Trade Organization make this region the biggest future market for high-quality in vitro diagnostics (IVD) products,” said Tianhe Chairman and CEO Guifa Tan.

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