BioWorld International Correspondent

LONDON - SynGenix Ltd. acquired Dallas Burston Ltd. in an all-share deal that gives SynGenix access to sublingual drug delivery technology, a product for breakthrough pain in clinical trials and two other compounds that are ready to enter clinical development.

Both companies are privately held, and SynGenix CEO Tom Saylor told BioWorld International, "We haven't given any financial details. Given the volatility of the market, we wouldn't like to put a value on it."

SynGenix, of Cambridge, UK, was formed around a technology called axonal transport for delivering drugs to the central nervous system, but Saylor said the acquisition of Dallas Burston, based in Northampton, UK, will enable it to build a stronger pipeline. "We now have products we can see through to marketing licenses within a short period of time."

Saylor said the sublingual route of delivery is under-exploited, with existing products relying on simple aerosols that were developed for pulmonary delivery. "We are able to apply some clever technology to the route, modifying the whole aerosol system and formulation to create some significant advantages for this mode of delivery.

"The theme that pervades everything we do is to squeeze more out of products in terms of therapeutic effect and bioavailability."

The product in Phase I, SGX 2001, is a sublingual formulation of the anesthetic fentanyl for the treatment of breakthrough pain in cancer. Such episodes can be extremely severe and happen without warning, and the sublingual route provides rapid onset of effect. This product is expected to progress to Phase III by the end of 2003. Another product, SGX 2010, a sublingual formulation of a serotonin agonist for treating emesis, also illustrates the value of the sublingual route, offering fast onset of effect and preventing the drug being discharged through vomiting. That product is ready to enter Phase I and is expected to reach Phase III in early 2004.

"There are a dozen or so other molecules in various stages of [sublingual] formulation," Saylor said. However, he added, "We don't want to be a generics company. With the acquisition of Dallas Burston we have a nice balance of clinical-stage products with a clear pathway through the clinic, and our earlier-stage axonal transport programs."

Saylor is now putting the final touches to the business plan in preparation for a third funding round in which he hopes to raise £15 million to £20 million. The company raised £5 million (US$8.1 million) in its second-round funding in September 2001.

The company also has a polymer delivery technology, Controlled Kinetics (CK), which arose from the axonal transport program. Unlike existing technologies CK does not encapsulate drugs in a polymer matrix, but instead acts as a scaffold to which the active drug is covalently bound. The company said this allows for finely controlled release and greater flexibility with regard to physical characteristics of drugs such as solubility. SynGenix has optimized one compound, SGX0355, for the long-lasting relief of neuropathic pain by linking the CK technology to a derivative of a known sodium channel blocker. In preclinical studies SGX0355 was effective for one week following a single dose.

Axonal transport is the process by which nerve cells maintain their sensory nerve endings, or axons. SynGenix uses this natural transport mechanism to "hitch a ride" to the nervous system, including the brain, via a route that bypasses the immune system. The company has a collaboration with GlaxoSmithKline plc, of London, entered in August 2000 around axonal transport. "It is all preclinical, but we have got confirmation of significant benefits. We hope to convert the collaboration in the not too distant future," said Saylor.