BioWorld International Correspondent

LONDON - Arakis Ltd. embarked on its third funding round to raise £25 million (US$45.5 million) or more, and acquired privately held Sirus Pharmaceuticals Ltd. in an all-share deal.

The Sirus acquisition gives it access to AD 923, an opioid analgesic in Phase II, and an associated sublingual drug delivery platform.

Arakis CEO Ken Cunningham told BioWorld International, "We bought Sirus to acquire AD 923 and have not publicly disclosed the value of the deal." He added that the market has been "quite receptive" to the fund raising, which on current plans will take Arakis through the end of 2006.

The money would allow Arakis to pursue an aggressive timetable for the further development of AD 923, with Phase III trials due to start in March 2005. The company is eyeing marketing approval in 2007.

AD 923, a formulation of fentanyl, is being developed for the treatment of breakthrough pain in cancer. Such episodes can be severe and happen without warning, and the sublingual route provides a rapid onset of effect.

"Sublingual delivery is definitely the optimal route for cancer breakthrough pain because the sublingual mucosa is highly absorptive, leading to a rapid uptake and rapid plasma levels," Cunningham said. Arakis has a second product in a pain indication that will use the sublingual delivery technology.

Existing products for sublingual delivery typically use aerosols intended for pulmonary administration. Sirus developed aerosol systems and formulations that maximize the potential of the delivery route.

Sirus, based in Cambridge, UK, was formed around axonal transport technology for delivering drugs to the nervous system, and moved into sublingual technology when it acquired Dallas Burston Ltd. in 2002. Cunningham said Arakis was not interested in axonal transport and that, along with a polymer delivery technology called Controlled Kinetics, was disposed of prior to the acquisition of Sirus. Arakis is retaining Sirus' formulation facility and some of its staff.

The sublingual technology fits well with Arakis' main focus on performance-enhanced medicines in which it finds new clinical uses for known drugs, or known drug templates, and then optimizes them through chemical modification, such as selecting the optimal isomer or changing the pharmacokinetic or pharmacodynamic properties. The company specializes in inflammatory diseases and adjunctive therapy in oncology.

Arakis' lead in-house product is AD 237, a once-daily bronchodilator for chronic obstructive pulmonary disease. The product, in a Phase IIa trial in COPD, is currently approved for a different nonrespiratory indication. "We are making good progress on the Phase IIa study, where we have absolutely great data showing significant improvements over placebo," Cunningham said.

Arakis, based in Saffron Walden, was formed in March 2000 by former Chiroscience plc executives. It raised £4 million in its first round in August 2000, and £16 million in the second in April 2002.