By Mary Welch

Eli Lilly and Co., after temporarily delaying Phase III trials of LY334370, pulled the plug on the migraine development collaboration it had with Synaptic Pharmaceutical Corp.

Lilly, of Indianapolis, discontinued commercial development as a result of its recent review of data from an ongoing confirmatory animal toxicology study started late last year. The company refused to provide any additional information about the data. Prior to Lilly¿s hesitation, Phase III trials were slated to start this month.

¿We were totally surprised. We didn¿t see it coming,¿ said Robert Spence, chief financial officer for Paramus, N.J.-based Synaptic. ¿In hindsight, we probably should have been more skeptical, but we had no reason to believe anything else other than what Lilly told us a few weeks ago, that they just needed to supply additional information to the FDA.¿

In the short term, Lilly¿s decision will have ¿virtually no effect on the company other than what it¿s doing to our stock,¿ he said. Lilly was in charge of all future development, so there will be no effect in terms of lost income or jobs.

Synaptic¿s stock (NASDAQ:SNAP) Friday fell 44 percent, closing at $6.50, down $5.817. The stock had fallen from $15.5 to $11.875 when Lilly announced the delay on March 4.

¿In the long term, because it was our lead program and would have been the first program that would have generated revenues, the day when the company would become profitable has been pushed off to a greater time in the future,¿ Spence said.

The compound, an agonist of the 5-Hydroxytryptamine (5-HT1F) ¿ or serotonin ¿ receptor, is part of a collaboration with Lilly that began in 1991 and was expanded in 1996. Serotonin is a neurotransmitter that has been implicated in a variety of central nervous system disorders, such as depression, anxiety, migraine headaches, sexual dysfunctions, gastrointestinal movement and sleep disorders. Synaptic discovered and patented the human 5-HT1F receptor.

Earlier this month, Lilly told Synaptic it wanted to gather more information on safety and tolerability of the compound as a result of some discussions Lilly had with the FDA. ¿That¿s all Lilly has disclosed to us,¿ Kathleen Mullinix, Synaptic¿s president and CEO, told BioWorld Today at the time. (See BioWorld Today, March 5, 1999, p. 1.)

Spence said Lilly still has not told it much else, even after the cancellation.

¿They (Lilly) have given us limited information,¿ he said. ¿We really don¿t know anything that we didn¿t put out in the press release, which states that it was as a result of a recent review of data from a confirmatory animal toxicology study.¿

Companies Plan To Continue Collaboration

Blair Austin, a spokesman for Lilly, agreed. ¿We received new results from an ongoing animal toxicity study that caused us to review the results and led to the decision to cancel the program. We do not believe there are any safety concerns for [clinical trial] subjects.¿

The oral compound fared well in three Phase II trials ¿ two in the U.S. and one in Europe ¿ that showed the drug¿s efficacy without cardiovascular side effects associated with migraine products already on the market.

The two companies will still work on developing other selective serotonin 1F-receptor agonists. ¿We believe the platform is promising,¿ Austin said. ¿There were just safety and tolerability issues related to this specific compound.¿

Spence confirmed the collaboration would continue but, he said, ¿I don¿t know what Lilly¿s priorities are in terms of developing any of their programs.¿

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