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Executive Summary

The development of Upjohn's neuroprotective lazaroid compounds could be expedited through the final clinical states by FDA's Treatment IND procedures, Upjohn Senior VP Mark Novitch told financial analysts at a recent meeting in New York. Although noting that the company's first lazaroid compound (U74006-F) has not yet entered clinicals, Novitch speculated on the potential for the product in the later stages of clinical development. He pointed out that if the product turns out to show breakthrough potential in the treatment of central nervous system damage, Upjohn might consider using the Treatment IND procedures to foreshorten the period of extended clinical trials. "If compelling clinical results are evident at the end of Phase II," Novitch told the analysts on Dec. 10, "then Phase III requirements could be shortened under FDA's new 'Treatment IND' regulations making fast-track approval a distinct possibility." Upjohn's reference to the Treatment IND procedures in connection with lazaroid research is significant as one of the first statements by a major pharmaceutical firm on the possible effect of the new rules on a highly visible development project. The Treatment IND procedures have generally been viewed as providing a development path for smaller firms unable to afford major Phase III trials. The neuroprotective research category is a hot area of development with other major companies (including Merck with MK-801) studying different types of compounds. If one major company were to try to seek extended patient usage of a compound prior to final approval, others would be pressed to follows. Upjohn's comments on lazaroids are also noteworthy because Novitch is a former top FDA official with several stints as acting FDA commissioner. His interpretation of the potential for the Treatment IND procedures is instructive as a former insider's views of the significance of the new rules, Novitch reported that because of a reformulation the lazaroids have been delayed by about six months from entering the clinic. While still at an early research stage, the lazaroids are being given a lot of attention and publicity by Upjohn. The company included its discussion of the compounds among mid-term development projects scheduled for NDA filings within the 1989-1990 period. "We anticipated beginning Phase I human safety studies on the first of the compounds in July" 1987, Novitch commented. After filing the IND, he reported, "we made some modifications in the formula which required additional pathology and toxicology studies." The Phase I trials should begin early in 1988 with Phase II coming toward mid-year, Novitch said. The senior Upjohn exec explained to the analysts that its lazaroid compounds are being studied to prevent the rippling effect of secondary cell damage from trauma. "Within a few hours after the initial injury [spinal cord damage], secondary injury radiates progressively from the primary injury site and also destroys surrounding cells," Novitch said. The lazaroids may prevent that secondary damage.

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