A judge in Brazil fined Eli Lilly and Co. and a unit of Italy's ACS Dobfar an estimated $450 million on May 9 for allegedly exposing workers at a Brazilian plant to toxic substances. According to Reuters, the ruling followed a 2008 lawsuit that accused Indianapolis-based Lilly of incinerating toxic waste from third parties, releasing heavy metals and gases that poisoned some of the 500 workers. Lilly made agricultural chemicals at the plant north of Sao Paulo from 1977 to 2003. Lilly will appeal the ruling, General Counsel Michael Harrington said in a statement. The alleged contaminants–benzene and heavy metals–were never used in manufacturing operations, Harrington said, and the court’s ruling is based on inaccurate scientific claims as well as mathematical errors.
Eli Lilly and Co. announced Monday that its once-a-day insulin injection did a better job in clinical trials controlling diabetic patients’ blood sugar than Lantus, the dominant diabetes medicine sold by France-based Sanofi. But Lilly’s basal insulin also raised safety concerns, according to Bloomberg News. The clinical studies showed increases in liver enzymes, a potential sign of toxicity, and lower rates of good, or HDL, cholesterol. Those issues could hamper Lilly’s sales efforts, said ISI Group LLC analyst Mark Schoenebaum. U.S. regulators may also require another trial before granting approval, he said. Lilly said it plans to file the drug for U.S. regulatory approval in the first quarter. “We are reasonably bearish on this molecule due to potential toxicity concerns,” Schoenebaum wrote in an email to Bloomberg. Annual sales of the drug may be $600 million by 2020 if it is approved, he said. Lantus generated $7.6 billion for Sanofi last year. Lilly’s drug “is the first basal insulin to demonstrate consistently superior HbA1c reduction versus insulin glargine in Phase III clinical trials,” Enrique Conterno, president of Lilly’s diabetes business, said in a statement. In three trials including 3,373 patients, Lilly’s insulin was superior to Lantus in controlling blood sugar. It was tested in patients who’d never used an insulin before, those switching over from another insulin, and in combination with a shorter-acting insulin meant to control blood sugar after meals.
Indiana University biologists will receive more than $6.2 million from the U.S. Army Research Office to study how bacteria evolve in response to their environments. The five-year grant will fund research in the labs of professors Michael Lynch, Patricia Foster, Jake McKinley and Jay Lennon. They will sequence entire genomes of the bacteria that replicate under changes in conditions. The researchers hope to pinpoint—and possibly predict—molecular mechanisms of evolutionary change.
The Indianapolis-based American Legion, the nation's largest veterans service group, called for the resignations of U.S. Veterans Affairs Secretary Eric Shinseki and two of his top aides amid an investigation into allegations of corruption and unnecessary deaths at the veterans' hospital in Phoenix. "The existing leadership has exhibited a pattern of bureaucratic incompetence and failed leadership that has been amplified in recent weeks," National Commander Daniel Dellinger said in a news conference at legion headquarters. According to the Associated Press, the Department of Veterans Affairs issued a statement rejecting the call for the resignations. The Phoenix hospital has been under fire over allegations that as many as 40 patients might have died because of delays in care and that the hospital kept a secret list of patients waiting for appointments, to hide the treatment delays. Shinseki announced May 8 that three officials there have been placed on leave. Dellinger also cited VA's acknowledgement that 23 have died as a result of delayed care in recent years and the findings of a VA Office of Medical Inspector investigation that clerks at the Fort Collins, Colo., clinic were instructed last year how to falsify appointment records.
Algaeon Inc. plans to use $2.75 million in new funding to begin commercial production of its algae-based nutritional supplements. The Indianapolis-based biotech company will move into an acre of greenhouse space owned by Heartland Growers at 2621 E. 186th St. in Westfield. The 18-employee firm plans to install more than 800 of its bioreactors that produce algae. The company in June will begin selling antioxidant supplement Astaxanthin. Its immune system booster Beta glucan will hit the market later this year. Algaeon markets Astaxanthin as a prevention for eye, heart and brain degeneration as well as an anti-inflammatory for joints. Beta glucan replaces antibiotics in animal feed. Last year, the company signed a “multi-year, multimillion-dollar” contract with Florida-based supplement manufacturer Valensa International to produce Astaxanthin. Three prior rounds of funding raised a total of $2 million for Algaeon.