Cephalosporin drug injectable once a day - C&EN Global Enterprise

Nov 7, 2010 - ... in the U.S. Current injectable cephalosporins require three or four daily injections, so the once-a-day injection regimen of Monocid...
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Final standards for benzene emissions set Adhering to a court-mandated schedule, the Environmental Protection Agency has issued final standards aimed at reducing by 70% fugitive emissions of volatile organic compounds, primarily benzene—a listed hazardous air pollutant—from petroleum refineries and chemical manufacturing plants. The Natural Resources Defense Council, which was a party to the suit forcing EPA to issue the standards, charges that although the Clean Air Act prohibits EPA from watering down public health standards for reasons of cost, the agency has done just that by completely exempting many benzene sources from cleanup requirements. The regulations were published in the May 30 issue of the Federal Register. The final standards require monthly monitoring of valves and pumps to spot any leakages of volatile organics and require repair of equipment within 15 days if a leak is found. Special leak-prevention equipment must be installed on compressors, sampling connections, openended valves or lines, and accumulator vessels. According to EPA, the final standards covering some 229 sources in the U.S. will reduce emissions of

benzene—which has been linked to numerous blood disorders, including leukemia—from a total of about 8690 tons to about 2750 tons. The lifetime risk of suffering adverse health effects for the most-exposed individuals would be reduced from 15 chances in 10,000 to 4.5 in 10,000, according to EPA. And estimated cancer cases per year would be reduced from 0.45 to 0.14. Capital costs of complying with the standards are estimated at $5.5 million for all sources, with annual costs totaling about $400,000. EPA also has proposed standards for the 42 existing coke oven byproduct recovery plants that would require enclosure for most sources; wash-oil scrubbers for certain storage tanks; process changes for cooling towers; and the same controls for fugitive emissions as those set for chemical manufacturing plants and petroleum refineries. The agency is withdrawing proposed fugitive emission standards for maleic anhydride plants, ethylbenzene/styrène plants, and benzene storage vessels, because, it says, there would be no significant health benefit from controlling these sources, which account for only 3.3% of total benzene emissions from stationary sources. G

Monsanto wins appeal in U.K. herbicide case Monsanto, earlier this month, won another skirmish in its patent battle against Stauffer Chemical's Touchdown glyphosate-based herbicide. Touchdown competes with Monsanto's big money-maker Roundup, also glyphosate-based. An interlocutory injunction sought by Monsanto restraining Stauffer from sale in the U.K. of its Touchdown has been upheld by the U.K. Court of Appeal, according to Monsanto. Monsanto says the decision "means that Stauffer continues to be enjoined from conducting any importation, supply, offering, sale, or keeping of its glyphosate-based herbicide Touchdown in the U.K." Stauffer has obtained patents on the Touchdown herbicide throughout the European Economic Com-

munity and in the U.S., but Monsanto is fighting these patents. Stauffer began limited sale of Touchdown in the U.K. in August 1983. The interlocutory injunction is akin to a restraining order in the U.S., according to a Monsanto spokesman, preventing Stauffer from engaging in trade pending the outcome of a separate case filed in the U.K. by Monsanto on the merits of the Stauffer patent and whether it infringes on Monsanto's glyphosatebased herbicide patents. Stauffer says that a further appeal of the interlocutory injunction is under consideration. In a statement, Stauffer says it recognizes "that the appeal would be difficult since the review of an interim injunction is limited in scope and involves subjective considerations."

The statement also says, "We are anxious to proceed to the full trial [concerning patent infringement] where we are confident of a favorable decision." Stauffer says it is convinced that its patent does not infringe on those of Monsanto. No date has been set for the patent infringement case in the U.K. A similar patent infringement case is awaiting court action in the U.S. D

Cephalosporin drug injectable once a day A cephalosporin antibiotic that can be administered as a once-a-day injection has been introduced by Smith Kline & French Laboratories, Philadelphia, following final marketing approval from the Food & Drug Administration. Called Monocid, the drug will be used to treat hospitalized patients suffering from a variety of infections, including those of the respiratory and urinary tracts, bone, skin, and blood. It also will be used before many types of surgical procedures to prevent infections that may result from surgery, the company says. Cephalosporins are a major family of antibiotics, and Smith Kline & French is third in sales among the six major companies that market these products in the U.S. Current injectable cephalosporins require three or four daily injections, so the once-a-day injection regimen of Monocid may lead to substantial cost savings for hospitals and patients requiring the drug. One study commissioned by the drug company estimates savings of up to $27 per day per patient for the new drug, or annual savings of $277 million for all hospitals, assuming that 75% of current cephalosporin injections are replaced by Monocid. SmithKline Beckman, the parent company of Smith Kline & French Laboratories, is counting on current pressures to lower hospital costs to provide an immediate market for the new drug. President and chief executive officer Henry Wendt predicts annual sales of Monocid to exceed $100 million by mid-1986. D June 4, 1984 C&EN

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