Prostatectomy is a relatively common operation among older men, with an estimated 170,000 thousand performed each year in Western Europe alone. However a recent British analysis of results of the operation showed that in 20% to 30% of men, symptoms of bladder-flow obstruction were not relieved.

According to Clive Griffiths of the Freeman Hospital (Newcastle-upon-Tyne, UK), the leading cause of surgical failure is the presence of "low pressure, low flow" urine output resulting from poor contraction of the bladder muscle. This "hypocontractility" produces similar symptoms to bladder-flow obstruction and routine flowmetry tests do not differentiate between the two conditions. Pressure-flow cystometry can provide a diagnosis, using a urethral catheter, but is time-consuming and expensive and risks resulting in urinary tract infections in around 5% of cases, Griffiths said.

His team at the Freeman Hospital, together with Mediplus (High Wycombe, UK), has developed a solution in the form of an inflatable penile cuff similar to a blood pressure cuff, which can progressively obstruct the flow of urine during emptying of the bladder, causing only mild transient discomfort and differentiating the two conditions.

A recently completed clinical trial on 150 patients comparing the new non-invasive test with standard invasive cystometry has shown encouraging results, Griffiths said. An independent collaborative study is currently under way at the Bristol Urological Institute (Bristol, UK), led by Professor Paul Abrams, chairman of the International Continence Society.

Gyrus Medical (Cardiff, Wales) has developed a new device to remove tissue during transurethral resection of the prostate in cases of benign prostatic hyperplasia (BPH). The Plasma-Sect Large Loop forms a plasma corona, rapidly vaporizing excess tissue pressing against the urethra. The loop is used in conjunction with the PlasmaKinetic Tissue Management System (also made by Gyrus), which provides high levels of pulsed radiofrequency (RF) energy. A clinical study on 40 patients operated on an ambulatory basis showed that 34 were able to return home the same day and that all 40 felt the procedure helped to relieve their symptoms.

Instrumentarium completes divestments

Instrumentarium (Helsinki, Finland) is already a truly international organization, with 91% of sales outside Finland in the first nine months of this year, up 8% over last year at $770 million. The acquisition in July of Spacelabs Medical (Redmond, Washington) has proceeded apace, Instrumentarium said, and plans are under way for the disposal of areas outside Spacelabs' core businesses. The company said that around $50 million of synergies are forecast on an annual basis as of the second half of 2003. The Washington-based unit will become the center for all of Instrumentarium's critical care operations in the U.S.

North America now accounts for almost 50% of total sales, up from 44% last year. Diagnostic imaging equipment sales by Instrumentarium Imaging and Soredex were up 48% to $62 million, with mammography equipment showing the greatest increases, according to Juhani Lassila, company treasurer.

In the anesthesia and critical care sectors, the Spacelabs Medical acquisition produced greatest growth in patient monitoring sales, although anesthesia equipment sales also were up, particularly in the U.S. Investment in developing the Deio unit, which specializes in critical care information software systems, has negatively impacted operating profits by $7 million in the first nine months, Lassila said. Deio has launched version 5.1 of the deioClinisoft point-of-care module aimed at improving information communication in critical care episodes both electronically and by paper printout. The Renal Replacement Therapy (RRT) module has been updated so that the user can document different RRT regimes safely and accurately either through a device interface or manually.

Instrumentarium has sold its optical retail business in Finland, Sweden, Estonia and Russia for $124 million to Pearle Europe (Rotterdam, the Netherlands). This represents the company's final non-core divestment.

Bayer continues refocusing moves

The sale by Bayer (Leverkusen, Germany) of its household insecticides unit for $725 million to SC Johnson (Racine, Wisconsin) is the latest in a continuing series of divestments as part of Bayer's major restructuring in the wake of the withdrawal of Baycol/Lipobay, its lucrative cholesterol-lowering drug, last year.

Bayer also has announced the sale of its Rhein Chemie Rheinau unit, a specialist in industrial additives, to Advent International, a U.S. private equity group, for $210 million. Haarmaan & Reimer, the Bayer flavors and fragrances unit, was sold to EQT (Stockholm, Sweden) for $1.65 billion and PolymerLatex, a 50-50 joint venture with Degussa (Frankfurt, Germany), is up for sale and expected to raise another $200 million for Bayer.

Separately, Bayer expects to finalize plans with Aventis (Strasbourg, Germany) to combine the company's blood plasma operations with those of Aventis Behring (Marburg, Germany) in a joint venture. "We are hopeful that we will conclude the talks (with Aventis) in the next few weeks," said Werner Wenning, Bayer CEO. Bayer will have a majority in and operational control of the joint venture.

Bayer has signed a letter of intent with Boehringer Ingelheim (BI; Ingelheim, Germany) for the co-marketing of BI's hypertension drug, telmisartan, in Germany, Switzerland and Scandinavia. The company says it plans to launch the angiotensin II receptor antagonist in January. The agreement will also cover a recently approved product combining telmisartan with a diuretic.

On the downside, Bayer still has to face the potential results of 3,500 suits for damages in the U.S. over the Baycol/Lipobay affair, according to Wenning. "We anticipate the start of the first legal case during the first quarter of 2003," he said, confirming that more than 100 cases had been settled out of court without giving any details as to the damages agreed. He also confirmed that Bayer had not yet made any provision in its accounts to reserve for potential payments.

Merger of medicines, devices agencies coming

The British government intends to merge the Medical Devices Agency (MDA) and the Medicines Control Agency (MCA) as of next April.

The reasons given for the merger have changed somewhat since 1998, when the merger was first proposed. Today, the emphasis is on convergence of technology and on improving the protection of public health. Improved governance also is high on the agenda, with the creation of a board with a chairman to whom the CEO of the merged agencies will report.

Michael Kreuzer, technical director of the Association of British Health-Care Industries (ABHI; London), expressed concern at the long-term implications of the merger. "ABHI has always accepted that a merger for mainly cost or administrative reasons is not something to be opposed. However, the longer-term picture remains more uncertain," he said. "Will we see the eventual creation of a 'super agency' similar to the FDA, possibly at European Union level?"

CJD and blood transfusions

Experiments by British Ministry of Health scientists have shown that in sheep at least, the transmission of bovine spongiform encephalitis (BSE, or "mad cow" disease) from one sheep to another as a result of transfusion of infected blood has been proven. As a result the ministry has decided to exclude from its register of blood donors anyone who has received a transfusion, no matter how long ago. Professor Robert Will of the University of Edinburgh's (Edinburgh, Scotland) TSE (transmissable spongiform encephalitis) surveillance unit said recently that its organization had identified 22 people who had already received blood donations from people who had subsequently developed Creutzfeldt-Jakob Disease (CJD). So far none of the transfusees had shown any CJD symptoms.

There have been 115 cases so far of CJD in Britain vs. only six in France. In view of the lower incidence of CJD in France, regulations imposed by the French blood transfusion service are slightly different with a ban on donors who have lived for one year or more in Britain during the period 1980 to 1996. In addition nanofiltration and deleucocytation of all plasma is intended to reduce the risk of infection of blood product derivatives, especially Factor VIII for hemophilia.

At the present time, there is neither prophylaxis nor cure for people who have been accidentally exposed to prions causing TSEs. Now there is hope arising from German researchers working in collaboration with Coley Pharmaceuticals (Langenfeldt, Germany) who have recently shown that CpG oligodeoxynucleotides (CpGs) may prolong prion incubation and extend life.

In experiments with mice exposed to a mouse variant of TSE, all the control mice died within 183 days, whereas those treated with CpG daily for four days survived 38% longer, while those treated for 20 days were still alive after 330 days. Although the mode of action is not yet clear, CpG prophylaxis could reassure those unwittingly exposed to prion-infected material. Coley Pharmaceuticals is currently testing CpGs as treatments for asthma, allergies and infectious diseases.

Arthritis and smoking

Women with rheumatoid arthritis (RA) who smoke tobacco and who lack the gene for the detoxifying enzyme glutathione S-transferase M1 (GSTM1) are more likely to have higher levels of serum rheumatoid factor (RF) and to have severe RA compared to women non-smokers.

This finding is the result of a study by Dr. D.L. Mattey and colleagues at the North Staffordshire Hospital (Stoke-on-Trent, UK), and seems to establish a link between smoking and RA in women. Mattey and his group analyzed the association of the three factors, smoking history, GSTM1 genotype and disease severity in 164 women who had had RA for at least five years. They found that patients with a current smoking history and without a functioning GSTM1 gene were five times more likely to be RF-positive than those who had never smoked.

Orthopedic software packages

Rogan Medical Systems (Veenendaal, the Netherlands) has installed its orthopedic HyperOrtho software in a number of major hospitals in Europe. The system is based on the HyperView work station and consists of three modules to help planning of prosthetic implantations, report the radiological outcome of the implants and to measure the wear and tear on implants over time to determine when an implant needs to be replaced.

Philips Medical Systems (Best, the Netherlands) has developed with the University of Hull and the Hull Royal Infirmary (both of Hull, UK) a Computer-Assisted Orthopedic Surgical System (CAOSS) which is currently undergoing clinical trials. The system, which was approved for clinical use by the UK Medical Devices Agency in June 2000, has been used in the operating theater more than 20 times with encouraging results in terms of clinical efficacy the company said. Pilot clinical trials are scheduled to be completed by 3Q03.

The CAOSS, which consists of an intelligent image intensifier and an intelligent trajectory guide linked by a PC-based computer system, allows the surgeon to plan a surgical trajectory on the computer screen using information from two real-time X-ray images. Sophisticated registration and calibration techniques are used to remove the various distortions inherent in image intensifier X-ray images, allowing 3-D positioning of anatomical features to be obtained from a pair of images to an accuracy of 1 mm.

The final system design and protocol should enable a surgeon to position a surgical drill on a planned trajectory to an accuracy of 1 mm within 30 seconds.

GSK seen as possible PowderJect bidder

GlaxoSmithKline (GSK; London) has emerged as a second potential bidder for PowderJect Pharmaceuticals (Oxford, UK) as advisors to the company try to drum up bids to rival the informal offer of $705 million from Chiron (Emeryville, California). At the time of the offer, a 100% premium on the closing price, PowderJect had lost over half its stock market valuation as a result of allegations of political contributions in exchange for major vaccine contracts and of a forced recall of BCG vaccine against tuberculosis.

GSK already is a major world vaccine producer and holds a 5.4% stake in PowderJect as a result of a collaboration to develop DNA vaccines. GSK also used to own Evans Vaccines (Liverpool, UK), the business that is now the cash-generating heart of PowderJect.

PowderJect has recently started a Phase I clinical trial of its powder injection flu vaccine, PowderJect Fluvirin. The study will compare the needle-free powder injection vaccine with its currently marketed Fluvirin in liquid formulation and administered using a traditional needle and syringe. The powder injection system uses a single-use disposable device.

Stressgen, Roche in vaccine deal

Stressgen Biotechnologies (Victoria, British Columbia) has signed a co-development and marketing deal with Roche (Basel, Switzerland) for HspE7, its human papillomavirus (HPV) therapeutic vaccine candidate. The vaccine is in a Phase III trial for anal dysplasia and Phase II trials for several indications including recurrent respiratory papillomatosis, for which Stressgen already has U.S. orphan drug status. Stressgen will get $5 million as an equity investment and up to $200 million in fees and milestone payments as well as royalties. Roche gets worldwide marketing rights, but may co-promote in the U.S.

Lee Mizzen, chief scientific officer at Stressgen, forecast that HspE7 could become the first marketed therapeutic vaccine for HPV-related diseases by 2006. Competition is likely to be mainly from Xenova (Slough, UK) and Transgene (Strasbourg, France), both of whom have therapeutic vaccines for HPV-related diseases in Phase II studies.

Separately, Roche has reported that together with its U.S. partner, Trimeris (Durham, North Carolina), it has received fast-track status for their new AIDS therapy, Fuzeon (T20). Analysts estimate that Roche and Trimeris can expect peak sales of up to $700 million a year with the newly developed HIV fusion inhibitor.

European patent on stem cells amended

The so-called "Edinburgh patent," a controversial stem cell patent granted to the University of Edinburgh in 1999, has been amended by the Opposition Division of the European Patent Office (EPO; Munich, Germany) so that it covers adult human and animal stem cells only, but not embryonic stem (ES) cells. The ES-cell claims of the patent had been formally opposed by 14 groups, including the governments of Germany, Italy and the Netherlands.

The opposition successfully claimed that the Edinburgh patent was not suitable for creating ES cells and, additionally, that the European Patent Convention excludes the patenting of human embryos for industrial and commercial purposes. The decision does not rule out the possibility of future patents on human ES cells so long as the application does not mention embryos, but focuses on the resulting cell's physical properties such as pluripotency.