Genentech Neuleze BLA Plans Nullified By Negative Trial Results
Executive Summary
Genentech has abandoned its plans to file a BLA for the nerve growth factor product Neuleze after a Phase III study of the agent in diabetic neuropathy "did not meet its objectives," Genentech said.
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Genentech has abandoned its plans to file a BLA for the nerve growth factor product Neuleze after a Phase III study of the agent in diabetic neuropathy "did not meet its objectives," Genentech said. Genentech had planned a fast-track filing for Neuleze during the second quarter followed by launch of the product before the end of the year. The product was the centerpiece of the company's January meeting with securities analysts, which included a presentation by an outside clinical investigator about some of the anecdotal evidence of efficacy of NGF ("The Pink Sheet" Feb. 8, p. 16). "Based on the promising results of the Phase II study, we are disappointed in the preliminary findings of this trial," Genentech said. "We are thoroughly analyzing the data to better understand the results and are reviewing future plans for rhNGF research." One problem with the Phase II results was that injection site tenderness associated with Neuleze had the effect of unblinding the study. Genentech told analysts in January that it had resolved the problem via a new placebo formulation. Genentech recently suffered another setback in a high-profile research program when Phase II data for its angiogenic vascular endothelial growth factor agent failed to show efficacy in coronary artery disease. Genentech announced the negative Neuleze developments April 8, a day after it disclosed that it may pay $50 mil. in criminal fines and restitution under a potential settlement with the Justice Department to resolve the government's investigation into promotions of the human growth hormone Protropin (somatrem for injection) from 1985 to 1994. Under the settlement, Genentech would admit to criminal violation of the FD&C Act. Finalization of the settlement is expected "very soon," Genentech said. Genentech is a little over two months away from the June 30 deadline for the Roche buy-out option. Genentech shares have recently been trading well above the Roche buy-out price, suggesting that investors have decided Roche will not exercise its option. The effect of the two announcements may be to drive Genentech shares below the buy-out price and re-open speculation about Roche's decision. |