LONDON - Chiroscience Group plc last week said it had submitted its first new drug application (NDA) to the FDA. The company also disclosed financial results for the year ended Feb. 28 showing losses up - to £23.5 million from £19.3 million - on revenues of £26.2 million, more than double the £11.5 million in 1997.

Expenditures on research and development increased from £18.8 million to £36.4 million.

During the year, Cambridge-based Chiroscience entered partnerships with Schering-Plough Corp., of Madison, N.J., for asthma and Bristol-Myers Squibb Co., of New York, for cancer. Much of the increase in revenues is derived from up-front payments of £10.2 million, compared with £2.3 million in 1997, on the signing of these deals. The rest is from ChiroTech, the third-party services arm, where revenues increased to £16 million from £9.2 million in 1997.

The company has £40 million in cash, and a burn rate of £2 million per month.

CEO John Padfield cautioned that, while ChiroTech is growing steadily, “the timing of access and milestone payments is driven by the development progress in any one program, and as such revenues are unlikely to arise steadily over accounting years.“

There has been a setback in the asthma program, with Schering-Plough deciding not to take forward Chiroscience's lead compound, D4418. This is an orally active compound that inhibits the phosphodiesterase type IV (PDE 4) enzyme, which is involved in the body's inflammatory response. Padfield said in Phase I trials D4418 overcame the major drawback of other PDE 4 inhibitors by not inducing emesis (vomiting).

“However, for a PDE 4 inhibitor to maximize its market opportunity, its efficacy profile needs to be broader,“ he said. “It is thus Schering-Plough's intention to nominate later in 1998 a more potent follow-on compound.“

Chirocaine Launch Expected By Year's End

Chiroscience dropped another compound, D5410, a matrix metalloproteinase (MMP) inhibitor it was developing for inflammatory bowel disease. “Research has confirmed the effect of MMPs in inflammatory bowel disease, albeit a systemic rather than a topical effect, as first expected,“ Padfield said. “D5410 will therefore not be progressed further.“

The NDA is for Chirocaine, a single-isomer version of the established anesthetic bupivacaine that reflects the chiral chemistry expertise around which the company was founded. In clinical studies, Chirocaine was as potent as bupivacaine, but had a superior safety profile. Padfield called the NDA submission “a very significant event for Chiroscience.“ The first launch of the drug is expected before the end of 1998.

The drug has been licensed to Zeneca Group plc on an exclusive worldwide basis, excluding Japan. Under the deal, Chiroscience is responsible for gaining approvals in the U.S. and Europe. It is seeking very broad approval in local, epidural and spinal anesthesia, alone or in combination with other anesthetics. The company filed for regulatory approval in Europe in December 1997.

Submitting the NDA for Chirocaine underlines the importance of its chemistry skills to the company. The chiral chemistry arm, ChiroTech, showed a profit of £7.1 million for the year ended in February, up from £1.2 million. The company currently is “reviewing opportunities to maximize the return to shareholders from the ChiroTech business,“ and expects to give its verdict later this year, Padfield said.

One possibility is that ChiroTech, established in March as a stand-alone subsidiary, could be sold. *

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