Eli Lilly has suffered a setback on the clinical front as a late-stage study of its experimental brain cancer drug was halted.
Lilly stopped the Phase III trial, which was evaluating enzastaurin for the treatment of an aggressive and recurrent form of brain cancer, glioblastoma, after a recommendation from a data monitoring committee. The latter’s interim analysis of the study, called STEERING, suggested that enzastaurin would not meet the primary endpoint of improvement in progression, which was free survival over an existing chemotherapy in this particular study.
Lilly accepted the DMC recommendation and immediately contacted all STEERING study investigators to inform them of the decision and to provide them all available information to manage patients.
Richard Gaynor, vice president of cancer research at Lilly, admitted that "we are disappointed for patients suffering from recurrent glioblastoma," noting that it is "a rare and difficult-to-treat tumour," but "we remain confident and committed to the development of enzastaurin."
Enzastaurin is also in a Phase III trial (which is currently enrolling patients) as a maintenance therapy for the treatment of non-Hodgkin's lymphoma as well as being evaluated in several Phase II studies for more common tumour types including breast, colon, lung, ovarian and prostate cancers. These additional trials are unaffected by the monitoring committee’s recommendation.
Lilly rejects fresh Zyprexa claims
Meantime, Lilly’s spate with The New York Times and its accusations over the company’s strategy concerning the schizophrenia drug Zyprexa (olanzapine) rumbles on. The newspaper has criticising Lilly all week, using as its source a leaked document, and its most recent article said that results from Lilly's internal tests showed patients given Zyprexa were 3.5 times more likely to experience high blood sugar levels compared with those patients given a placebo. It is then claimed that this data differed from information sent to the US Food and Drug Administration. The article based the data on a February 2000 memo sent to the firm’s scientists.
However, for the third time this week, Lilly responded, saying that "again, we were disappointed that only a small fraction of our viewpoint was contained in the Times story."
"Taking selected data points out of context can be very misleading," the firm said, noting that the document referred to in the article involved a data set later found to have contained "errors involving which patients were included or excluded in the analysis." A corrected analysis showed that 3.1% of patients given Zyprexa developed high blood sugar compared with 2.5% in the placebo group, Lilly said, and this was sent to the FDA.
Basingstoke facility to close
Lilly also announced that it is to close its dry products manufacturing facility in Basingstoke UK which will result in a $85-$95 million restructuring charge. The firm said that it had looked to sell the site, where some 550 people work, but that did not prove to be a viable option. A variety of severance packages have been offered to staff, and manufacturing is expected to cease at the end of 2007.
Lilly said it was responding to a "more challenging" pharmaceuticals industry and overcapacity in its manufacturing network for medicines in tablet and capsule form. It is developing more "parenteral" products, which are usually introduced to the body through injections and require a different manufacturing technology.
The drugmaker's UK headquarters remain in Basingstoke and the company has a research facility in Surrey and a biotechnology manufacturing facility on Merseyside.