Drug testing and road accidents In France, it is very difficult to calculate the preva-lence of driving under the influence of illicit or of ther-apeutic drugs because few studies have been pub-lished. Dr. Mura of the Centre Hospitalier Universi-taire (Poitiers, France) presented at a recent meeting of the French Society of Analytical Toxicology (SFTA) the best estimates currently available. He said that over the past two years the number of drivers in acci-dents who have tested positive for cannabis has dou-bled and is now running at 5.6% of all road accidents. Another 3.7% are positive for opiates and 1% to 2% for cocaine and for amphetamines. This implies that in about 10% of all accidents the driver causing the acci-dent has tested positive for a drug of abuse. Yves Gallard of Toxlab (Paris) said that the SFTA recommends a two-step testing approach - first, urine screening by immunoanalysis and subsequently, quantification in blood samples using gas chromatog-raphy coupled to mass spectrometry (GC/MS) or liq-uid chromatography/mass detector technology. He warned, however, that while immunoanalysis of urine samples was rapid and effective for cannabis and cocaine, it was not specific or sensitive enough for opiates or for newer "designer drugs." Paul Kintz of the Institut de Medecine Legale (forensic medicine) at Strasbourg, France, reviewed cur-rent testing procedures to confirm continued abstinence from drugs for drivers whose license has been sus-pended. In Germany and in Italy, for example, such dri-vers must produce evidence of abstinence from drugs and submit to a review to evaluate the risk of recidi-vism. He recommended the use of GC/MS testing on hair samples. The drugtaking diary of the patient can be established by segmenting the hair into 1 cm lengths (each represents one month) prior to testing. He said that hair treatments such as bleaching or permanents reduce drug concentrations by 40% to 70%, but enough remains to produce satisfactory test results. ERCP and biliary pancreatitis Rolf Nitsche and Ulrich Folsch at the University Clinic (Kiel, Germany) recently published results of a prospective, randomized multicenter trial (238 patients in 22 German centers) that aimed to establish whether ERCP (endoscopic retrograde cholangio-pancreaticography) should be performed urgently. Their study concluded that patients with biliary pan-creatitis, but without complications like obstructive jaundice or biliary sepsis, do not benefit from early ERCP, i.e., within 72 hours after the beginning of pain. They propose that urgent ERCP should only be performed in cases of obstructive jaundice, biliary sep-sis or persisting biliary cramps. The problem, accord-ing to Nitsche, is that a valid diagnosis of pancreatitis in a couple of hours is nearly impossible. The longer one waits, the more precise the prognosis will be. On the other hand, some gastroenterologists emphasize the need of urgent ERCP as soon as possible, especially in severe predicted cases. There are here two conflicting desires - if one wishes to perform ERCP as soon as possible, it is not possible to wait for a precise diagnosis; on the other hand, if one needs to stratify therapy according to prognosis, time is required. European deals and mergers Alliance Unichem (London) the international drug distributor group, will increase its holding in Safa Galencia, the second-largest Spanish distributor, from 36% to 96%, at a price of $ 37.6 million. Safa holds an 11% share of the Spanish drug-distribution market. Last year's profits of $4 million were on revenues of $120 million. Alliance Unichem's Italian subsidiary, Allianza Salute, plans to take control of its rival, Uni-forma Distribuzione, for an undisclosed sum. Cortecs (Isleworth, England) has spun out an independently funded biopharmaceutical company which will develop novel products for the prevention and treatment of allergies and autoimmune diseases through the process of tolerization. Cortecs will retain 75% of the new company, Oratol. Galen Holdings (Craigavan, Northern Ireland) is talking merger with Ferring Pharmaceuticals (Paris). A merger - or more likely a reverse takeover - would triple the size of Galen, which unveiled interim prof-its of $12 million, up 31% over last year. The deal is driven by growth opportunities, rather than cost cut-ting, since it will give Galen's hormone replacement therapy (HRT) products market access without the need to negotiate licensing deals. Galen's first HRT applications for an intravaginal ring are likely to be filed in Europe later this year. SmithKline Beecham (Brentford, England) has sold its Bencard Allergy (Worthing, England) sub-sidiary to a management team. The group, led by SKB's former U.K. corporate development director, Tony Berry, has formed a new company, Allergy Therapeutics, with a $34 million loan and credit facil-ity from BHF Bank. Bencard Allergy develops and produces desensi-tizing vaccines. The technique of allergy desensitiza-tion is practiced more widely in certain countries like Germany and Canada, Bencard's key markets, than in others, but its use is growing steadily. The world aller-gy market - including asthma, hay fever and skin irri-tation - is estimated at about $12 billion per year. Smith & Nephew (S&N; London) has acquired Exu-Dry Wound Care Products (New York) for an undisclosed sum. The Exu-Dry line of absorbent top-ical dressings will be marketed as a package with Smith & Nephew's Dermagraft TransCyte artificial skin product. They will also be used in the US clini-cal trials for S & N's other artificial skin graft prod-uct, Dermagraft.
Pfizer finishes spin-offs with Howmedica sale Undeterred from its previously announced strate-gy of focusing on pharmaceuticals - and only phar-maceuticals - Pfizer (New York) has unveiled a major deal in each of the last three months, most recently agreeing to sell its orthopedic unit, Howmedica (Rutherford, New Jersey), to Stryker (Kalamazoo, Michigan). Overall, Pfizer has announced or completed the sale of four former units in its medical technology group this year. The first came with the January sale of Valleylab (Boulder, Colorado) to U.S. Surgical (USS; Norwalk, Connecticut). Next, in mid-June, the company said it had agreed to sell its Schneider Worldwide unit to Boston Scientific (Natick, Massa-chusetts) for $2.1 billion in cash. That deal will bolster Boston Scientific's cardiovascular pipeline, the key assets involved being Schneider's patents covering "rapid exchange" catheters and angioplasty balloons, acquisitions that will put Boston Scientific in direct competition with Johnson & Johnson (J&J; New Brunswick, New Jersey) in this area. (The waiting period under the Hart-Scott-Rodino Act allowing that purchase expired July 31, with a third-quarter closing expected.) That purchase agreement was followed by Pfiz-er's July announcement that it will sell its American Medical Systems unit (AMS; Hopkins, Minnesota), a maker of urological devices, to the global investment firm E.M. Warburg, Pincus & Co. (New York). The $130 million to be paid for AMS is small change com-pared to the Schneider divestiture and the second blockbuster spin-off announced in mid-August - the sale of Howmedica for $1.9 billion. As with the Schneider divestiture, this spin-off creates another strong competitor for J&J, this time in the orthopedic arena. By buying Howmedica, Stryker will end up going head-to-head with J&J, which in early August moved to bolster its own offerings in the orthopedic sector through the purchase of DePuy (Warsaw, Indiana) from Roche (Basel, Switzerland). If the J&J/DePuy and Stryker/Howmedica deals are approved, the two new giants in a generally frag-mented market will divide up from 40% to 45% of the orthopedic devices and supplies market worldwide. A struggle for the No. 1 position is expected to ensue. For Stryker, the acquisition appears a bit out of character, since the company will have to take on about $1.6 billion in debt to consummate the pur-chase, and it will go through a period of approxi-mately 18 months during which its profits are expect-ed to dip below its historical annual growth rate of around 20%. Stryker President and CEO John Brown maintained, however, that the company couldn't con-tinue to produce that 20% rate of profit increase with-out the purchase. Consolidation of hospitals and the development of large purchasing groups had pro-duced significant leverage to negotiate lower prices, and Brown said the company had to counter that strategy by producing its own economies of scale. He said the merger would create a "larger, more efficient operation" and also establish the necessary broad platform for the launch of new products. American Medical Systems and Howmedica are the final medical technology units to be divested by Pfizer, thus giving the company total focus on what it now considers its core drug-making interests. Circon takeover saga nearing end? Reports out of California indicate that an end may be in sight in the two-year attempt by U.S. Surgical Corp. (USSC; Norwalk, Connecticut) at the hostile takeover of Circon (Santa Barbara, California). The Los Angeles Times reported that Circon "has begun shopping itself to prospective buyers because of declining sales, intense competition and an upcoming shareholders meeting that could give . . . U.S. Surgi-cal control of its board." Until now, Circon has been saying it is not for sale. USSC made its initial, unso-licited bid for Circon on Aug. 2, 1996, offering $18 a share. The offer has changed several times in reflec-tion of Circon's financial performance, and now is pegged at $16.50 a share, or about $220 million over-all, with the tender offer extended to mid-September. Having previously won two seats on Circon's seven-member board, U.S. Surgical may be eyeing the two seats that will be up for grabs at the Santa Bar-bara company's next annual meeting, which must be held before Nov. 24. "I can't imagine that Circon would prevail at the next meeting," an unnamed source told the Los Angeles newspaper. A majority of Circon shareholders at last year's meeting voted in favor of a non-binding resolution to sell the company. Complicating the situation is the acquisition of U.S. Surgical by Tyco International (Exeter, New Hampshire), announced in May. Tyco, widely known as favoring only friendly acquisitions, has not indicat-ed if it wants to buy Circon, a maker of surgical prod-ucts for urology and gynecology. Advanced Tissue continues Dermagraft trials Attempting to bounce back from an FDA decision that its Dermagraft product is non-approvable, Advanced Tissue Sciences (ATS; La Jolla, California) said it will carry out new trials it hopes will lead to eventual product marketing approval. ATS said it plans to complete another clinical trial for Derma-graft, its bioengineered skin implant for diabetic foot ulcers. Dermagraft is a metabolically active material derived from discarded foreskin tissue. In June, the FDA set aside an advisory panel's recommendation and turned down the company's premarket approval application, saying a retrospective analysis of a clini-cal trial was not enough to support it. (See BBI News, June 18, 1998) Enrollment for the new trial will begin soon, said Jack Strube, director of finance for ATS. "It's taken us this long to work out the protocol with the FDA," he said. "The plan is finally in place." He said an inter-im analysis will be done after 180 patients are enrolled. If that analysis proves encouraging, ATS could submit another PMA within about a year of the trial's start. The delay sets Dermagraft's launch back about two years. "We'd be looking at a potential launch in early 2000," Strube said. "We had originally hoped to launch in the second quarter of 1998." ATS also is preparing an investigational device exemption appli-cation for Dermagraft, which would let physicians use it on a patient-by-patient basis prior to formal FDA approval. ATS also has expanded its joint venture with Smith & Nephew plc (London) to include marketing Dermagraft-TC for burns in the U.S., beginning in October. The original deal, signed in 1996 and valued at $70 million, allowed Smith & Nephew to market the product for all wound care applications outside the U.S. and for all wound applications except burns in the U.S. Under the expanded joint venture with ATS, Smith & Nephew will market and sell Derma-graft- TC in the U.S. for full and partial-thickness burns. Dermagraft-TC is designed to act as an artifi-cial epidermis layer, the "TC" standing for "transi-tional covering." The product will be renamed Trans-Cyte to differentiate it from Dermagraft and to indi-cate its ability to allow migration of keratinocytes (the primary cells in the upper layer of skin) in partial-thickness wounds. Voxel reorganization fails, buyer sought Following a judgment of nearly $2 million against it earlier this year and the failure to develop a work-able reorganization plan, Voxel (Laguna Hills, Cali-fornia) has halted operations and terminated its 20- person work force. It is seeking seek a purchaser for all of its assets. The company has been developing a system for combining multiple MRI or computed tomography scans of the body to create holographic images that could be used in medical diagnosis and treatment (see BBI News, April 2, 1998). That development was ham-pered in 1997 by $6 million in losses and then, earlier this year, the company was hit with a judgment requiring it to pay $1.9 million to General Scanning (Watertown, Massachusetts), a company Voxel had contracted with to produce the system. General Scan-ning argued that it had developed a workable proto-type and charged that Voxel had refused payment for engineering services. General Scanning attempted to obtain rights to Voxel's technology, but the company rejected that proposal and then failed to develop a plan to pay the judgment. Subsequently, the company sought pro-tection in bankruptcy proceedings, but creditors - among them General Scanning - refused to accept the plan of reorganization. Subsequently, a bank-ruptcy court judge in Santa Ana, California, ruled that the company would have to liquidate its assets, with a trustee appointed to oversee the process. According to an attorney representing the company, the trustee will attempt to hire a limited staff of engi-neers and continue company operations while seek-ing a buyer.
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