The European Commission last month gave its approval to a proposed joint venture in the acute hospital care market involving Draegerwerk (Luebeck, Germany) and Siemens Medical Solutions (Erlangen, Germany). The joint venture, which will be named Draeger Medical AG & Co., will be headquartered in Luebeck and will have a global workforce of about 5,700. Draeger will hold 65% ownership and Siemens 35% of the joint venture, plans for which originally were revealed last fall.

The approval is subject to various conditions, including that Siemens sell the Life Support Systems unit, which produces anesthesia and ventilation devices, to a third party, and that the joint venture continues to supply open data interfaces to enable integration of its products and devices with those of third parties. Draeger contributes its entire Medical division and Siemens its Patient Care Systems (patient monitoring) unit, which in conjunction with Life Support Systems makes up the company's Electromedical Systems Division (Solna, Sweden).

Dr. Wolfgang Reim, CEO of the new firm, said the commission decision "has assured us that we will be able to get the joint venture under way as briskly as possible." He said the company is expanding its portfolio to include monitoring, which he described as "an integral component of our customers' clinical processes." Reim said the expanded portfolio "will put Draeger Medical in a better position for developing process-oriented solutions in acute hospital care. These system solutions will assist present and future customers in further lowering process costs while enhancing the quality of care."

Draeger and Siemens said their development goal is focused on the seamless integration of acute-care information within the hospital information technology (IT) network. In cooperation with Siemens and through the basic architecture of its software platforms syngo and Soarian, the joint venture company will develop, produce and market critical-care IT solutions for integration into more comprehensive healthcare solutions. In the medium term, by accelerating existing innovation initiatives for products and process solutions, the joint venture will have a sustained boost on sales, the companies said.

Draeger Medical is expected to generate sales of more than EUR 1.1 billion in 2004, its first full fiscal year. The parties are forecasting that the joint venture will deliver double-digit sales growth in the current fiscal year compared with the preceding year. Proceeds from the disposal of Life Support Systems, less transaction costs and taxes, will accrue to the joint venture.

The new company will have research and development and production facilities in Luebeck; Telford, Germany; Best, the Netherlands; Danvers, Massachusetts; and Shanghai, China. Sales and service subsidiaries are located in more than 40 countries and the company is represented by distributors in more than 190 countries.

The joint venture's sales organization will work closely together with that of Siemens, with emphasis on developing cross-departmental solutions for hospitals and in supporting key accounts. "The j-v solidifies Siemens' position as a solutions provider. Acute care will thus remain an integral part of our business," said Dr. Erich Reinhardt, CEO of Siemens Medical Solutions.

Draegerwerk's Medical Division is the company's largest unit, offering products, integrated systems and services throughout the entire patient care process in all care areas emergency care, operating room/anesthesia, critical care and home care. The company employs around 4,900 worldwide. It had fiscal 2002 sales of about EUR 848 million.

Siemens Medical Solutions is a provider of a broad range of healthcare products and services, from imaging systems for diagnosis and therapy, electromedicine and audiology to IT solutions designed to optimize workflows and improve efficiency in hospitals and physicians' offices. It employs around 31,000 worldwide and had sales of EUR 7.6 billion in fiscal 2002.

Roche completes deal for Disetronic

The acquisition of Disetronic (Burgdorf, Switzerland) by Roche Holding (Basel, Switzerland) was completed last month following approval by relevant antitrust authorities and the tender of just under 98% of Disetronic shares during Roche's public tender offer period. At an April 23 extraordinary general meeting, Disetronic's shareholders approved a number of proposals necessary to make the acquisition happen, and followed that meeting up by agreeing to Roche's exchange offer, which called for each Disetronic share to be exchanged for two non-voting Roche shares plus CHF 670 in cash.

Roche said it planned to begin integrating Disetronic's Infusion Systems division into its Roche Diabetes Care unit "as soon as possible." Roche Diagnostics, which it said is No. 1 in global diabetes monitoring, "now is in a position to offer comprehensive solutions for the integrated management of diabetes." Disetronic's headquarters facility in Burgdorf will become what Disetronic characterized as "an important center in the Roche Diabetes Care network." Roche Diabetes Care is one of Roche Diagnostics' five business areas. Its primary products are the Accu-Chek family of blood glucose meters and test strips. The business has major facilities in Mannheim, Germany; Indianapolis, Indiana; and Ponce, Puerto Rico.

While Roche takes over the Disetronic infusion systems business, the latter's Injection Systems Division has been acquired by Finox Beteiligungen, a company controlled by former Disetronic chairman Willy Michel. It will operate under the name Techpharma and remain headquartered in Burgdorf. With annual sales of about CHF 180 million, Techpharma will employ about 550.

Eucomed welcomes human tissue effort

Eucomed (Brussels, Belgium), the European medical technology industry association, last month said that it welcomes the European Commission's initiative to establish a European Union regulatory framework for human tissue products (HTPs). "Innovative medical therapies based on HTPs are among the most exciting and promising today," it said, and a harmonized regulatory framework "will greatly improve patient access to HTPs across the EU."

Eucomed in particular cited the use of human tissue products for treating burn injuries. While burn victims can be treated with replacement skin taken from another part of the body, there may not be enough skin available for coverage of large burn areas and those who are burned severely over a large area of the body often die within days of sustaining the injury. "Cultured epidermal autografts are the only form of permanent skin replacement available on a worldwide scale for patients with such life-threatening burns," according to Eucomed. "These epidermal grafts are grown from a patient's own skin cells and therefore are not rejected by the patient's immune system. Starting with a biopsy of healthy skin about the size of a postage stamp, it is possible to grow enough skin to cover a patient's entire body surface."

The agency also noted progress being made in the use of a patient's own bone cells to grow a bone substitute ex vivo, with use in treating bone defects. "This laboratory-made, tissue-engineered living bone equivalent, has similar mechanical, chemical and biological properties to normal human bone tissue," the organization said.

Eucomed said that the new regulation should include appropriate intellectual property provisions because of the high costs associated with this type of research. "The quid pro quo is an exclusive right of the patent owner to use the protected invention for a given period," it said. "However, in this case, where patents would essentially protect a process, this exclusive right is unlikely to be sufficient to encourage innovation, because process patents are difficult to enforce, and a regulatory data protection system would be recommendable."

UK firm in interbody fusion agreement

Biocomposites Ltd. (Stoke on Trent, UK) and Cortek (Dedham, Massachusetts), a developer of spinal implants for the treatment of degenerative disc disease, have completed an agreement focusing on next-generation interbody fusion devices for spinal surgery. The collaboration will see the companies continue an existing partnership on development of resorbable, osteoconductive implants designed for use in patients with degenerative disc disease. The devices will feature Biocomposites' Biosteon material and will be marketed by Cortek under the brand name Replace.

Stephen Bratt, managing director of Biocomposites, said that the spinal implant market to this point has not seen the development of an osteoconductive bioresorbable implant that provides the necessary strength and support required for a sufficient amount of time to allow fusion to occur. "The Replace implant has cleared this technical hurdle by combining Cortek's proprietary implant designs with [our] Biosteon composite," he said. Bratt said the Biosteon biomaterial contains a synthesized calcium phosphate, the mineral component of bone, which is distributed throughout the material and at its surface to facilitate cell attachment and bone bonding. He said Biosteon "already is proven through extensive testing and in devices used by surgeons in arthroscopic procedures."

Medicsight entering UK dental market

Medicsight (London), which is establishing a group of Lifesyne imaging centers in London, has signed an agreement with Image Diagnostic Technology (IDT; London) that will mark its entry into the UK dental market. IDT processes computerized tomography (CT) images of the jaw for dentists and dental surgeons to enable pre-operative planning for the placement of dental implants.

Lifesyne, which introduced the first General Electric 16-slice CT scanner to London earlier this year, is using that scanner to generate hundreds of sub-millimeter images of a referred patient's jaw in under 10 seconds. Within 24 hours, the computer image data is sent electronically to IDT for specialist processing, after which IDT sends the data to the dentist in a format compatible with his or her requirements.

With costs for implants ranging from 1,500 for a single implant to as high as 12,000 for a full jaw, Medicsight said "it is imperative that the dental professional [be] equipped with precise data before embarking on surgery." It said the processed Lifesyne scans provide detailed 2-D and 3-D images to enable a dental surgeon to select the best location for the dental implants and plan the details of surgery with "pinpoint accuracy" well before the operation.

Lifesyne will have three centers in London area locations by the end of the year. The first, in Hammersmith, opened in March; a second opens in Victoria in early summer, followed shortly thereafter by the opening of a center in the city itself. Additional centers are planned for future opening elsewhere in the UK.

Collaboration on mammography systems

Development of a new generation of computer-aided detection (CAD) systems for mammography is the focus of an agreement between Mirada Solutions (Oxford, UK) and R2 Technology (Sunnyvale, California) reported by the companies last month. The agreement involves the integration of Mirada's Standard Mammogram Form (SMF) technology with R2's OmniCAD platform.

Christian Behrenbruch, PhD, Mirada Solutions' CEO, said that the SMF representation "is intrinsic to the tissue characteristics of the breast," and thus is "the optimal starting point to develop robust CAD applications that enhance the clinician's understanding of the mammogram image." He cited R2's "proven leadership in the area of CAD and tremendous expertise in developing and commercializing products for the breast care market," adding that Mirada expects that the integration of the two firms' capabilities "will result in significant benefits to women's healthcare."

The Standard Mammogram Form is a standardized representation of a mammogram computed from the image intensities either film or digital and imaging parameters of the system used to acquire the image. Behrenbruch said that the SMF technology "enables the optimization of mammograms acquired on different systems at different times for analysis, quantification and display."

Mirada Solutions has a diverse portfolio of products ranging from image fusion and functional analysis to quantification and standardization of images, addressing the image analysis needs of both molecular and functional imaging.

Artus, Abbott in agreement on SARS test

Artus GmbH (Hamburg, Germany), developer of the first commercial test to detect a form of the coronavirus suspected of causing severe acute respiratory syndrome (SARS), has signed Abbott Laboratories (Abbott Park, Illinois) to handle worldwide marketing and distribution of the test. Under the agreement, Artus will manufacture the test and Abbott will market and distribute it initially for use on the Roche (Basel, Switzerland) LightCycler thermal cycler system in the U.S., Canada, Germany, the UK and Austria, supplementing existing distribution agreements that Artus already has in place. As part of the agreement, Abbott also will assist Artus in submitting the test to the FDA as quickly as possible.

The test is based on the highly sensitive polymerase chain reaction (PCR) technology, which directly detects the virus in patient samples and produces results in two hours. The companies said that within several weeks, the test also would be available on the Applied Biosystems (Foster City, California) ABI Prism 7000 Sequence Detection System.

Developed by Artus in collaboration with the Bernhard-Nocht-Institute for Tropical Medicine (BNI; also Hamburg), the test was introduced by Artus in April to countries in Asia and Europe. It has been provided to laboratories under the direction of the World Health Organization (WHO; Geneva, Switzerland) and other major clinical sites conducting studies on the SARS virus. Abbott and Artus said initial results of different sample types (sputum, swabs, stool and tissue) from those WHO test sites are promising.

Michael Tillmann, managing director of Artus, said that because of the company's long-time experience with coronaviruses, "we were able to develop the SARS test very quickly."

Abbott said that it would market and distribute the test through its molecular diagnostics alliance with Celera Diagnostics (Alameda, California), which like Applied Biosystems is an Applera Corp. (Norwalk, Connecticut) company.

Artus was established as a spin-off of the Bernhard-Nocht-Institute in 1998. It is one of the first companies worldwide to offer a broad range of real-time PCR kits for pathogen detection, applying PCR in the fields of human diagnostics, veterinary medicine and biotechnology.

Italian regulators fine glucose-test providers

Italian newspapers reported last month that the country's competition authority, the Autorita Garante della Concorrenza e del Mercato, had fined five pharmaceutical companies a total of EUR 30.5 million for what was described as price-fixing on blood glucose tests.

The agency imposed a EUR 9 million fine on Roche Diagnostics SpA, a unit of Roche Holding (Basel, Switzerland); EUR 7.5 million on Ortho Clinical Diagnostic SpA, owned by Ortho-Clinical Diagnostics (Raritan, New Jersey), a unit of Johnson & Johnson (New Brunswick, New Jersey); EUR 6 million on Bayer SpA, a unit of Bayer AG (Leverkusen, Germany), and Italy's Menarini SpA; and EUR 2 million on Abbott SpA, a unit of Abbott Laboratories.

The decision and fines can be appealed. The Italian regulators said the five companies "orchestrated" marketing strategies in order to block competition and also offered identical prices to pharmacies and to the national health service.