By Randall Osborne
To develop its drug for nausea and vomiting in cancer chemotherapy patients, RiboGene Inc. entered an option and licensing agreement with Roberts Pharmaceutical Corp., which also made a $10 million equity investment in RiboGene and could pay $10 million more if the drug is approved.
Roberts, of Eatontown, N.J., bought 1.4 million shares of convertible preferred stock at $7 per share in Hayward, Calif.-based RiboGene, and will conduct clinical trials of Emitasol, an intranasally administered formulation of metoclopramide.
Emitasol is intended for both the prevention and treatment of chemotherapy-induced emesis, particularly for delayed onset emesis, which is nausea and vomiting 24 to 72 hours after chemotherapy.
Roberts expects to submit a new drug application (NDA) for Emitasol to the FDA in the second half of next year. If the drug is approved, Roberts may exercise within 90 days an option for an exclusive license to market it, in exchange for a milestone payment of $10 million to RiboGene and royalties.
Of the funding for Phase III trials and the NDA submission, RiboGene will provide up to $7 million, with Roberts supplying the rest, if needed.
"That's a 'not to exceed' number," said Timothy Morris, chief financial officer of RiboGene. "Roberts is in the process of putting together a clinical plan."
RiboGene's research focuses on fighting bacteria, fungi and viruses with anti-infective compounds that inhibit pathogen-specific translation mechanisms.
Translation, which occurs in cytoplasm, is the process whereby amino acids are assembled into proteins according to sequences specified by messenger RNA. Translation is the second of two main steps in cellular protein production, the first being transcription at the genetic level.
Emitasol was part of RiboGene's acquisition of Hyline Laboratories in 1994. A Phase III trial was ongoing. "[RiboGene] put the product on hold until they could find a marketing partner," Morris said.
RiboGene raised $20 million in an initial public offering and private placement earlier this year. (See BioWorld Today, June 1, 1998, p. 1.)
The company's stock (AMEX:RBO) closed Tuesday at $6.562, up $0.187. *