BioWorld International Correspondent

LONDON - Vernalis Group plc has extended its license agreement with Eli Lilly and Co. for VML 670, a 5-HT1A receptor agonist, to develop the compound as a treatment for sexual dysfunction. The original license, signed in October 1998, was to develop VML 670 for the treatment of delayed emesis in patients receiving cancer chemotherapy.

John Hutchison, Vernalis' vice president for development, told BioWorld International, "This will be an add-on to the existing license under the same terms." Vernalis, based in Winnersh, Berkshire, will carry out and fund development to proof of principle, at which point Lilly will have first refusal on licensing it back in return for milestone and royalty payments.

VML 670 is in a Phase Ib study in anti-emesis, looking at the effects in volunteers exposed to motion sickness, with results expected before the end of 2001.

The new indication will focus on patients taking selective serotonin reuptake inhibitors (SSRIs) for depression who experience sexual difficulties. A recent report indicated that 30 percent to 40 percent of patients on SSRIs suffer from sexual problems, including decreased libido, erectile failure and anorgasmia. There is no approved treatment. Vernalis noted that SSRIs are the most commonly prescribed type of antidepressant, with annual sales of US$8 billion.

In preclinical trials VML 670 has been shown to enhance sexual behavior. Vernalis said that some partial agonists of the 5-HT1A receptor have been used off-label to treat antidepressant-induced sexual dysfunction, so there is both preclinical and clinical data to support VML 670 in this indication. It is believed that the 5-HT1A receptor becomes partially inactivated in the presence of SSRI drugs.

With the existing Phase I safety data in hand, Hutchison said it will be necessary to conduct only a small trial to ensure there is no interaction between VML 670 and SSRIs. "We hope to be in a proof-of-concept trial in patients by the end of the year.

"This is still an early stage program, but it is in the central nervous system area, where we are concentrating. It is a step in the right direction, because the company needs to grow its portfolio," Hutchison said.