Start-up Andaris develops agents for venture into ultrasound contrast

Quantison agents use microcapsule technology

A team of British biotechnology veterans at a U.K. start-up calledAndaris is developing ultrasound contrast technology designedto provide myocardial perfusion imaging for extended periods oftime.

Andaris, a Nottingham-based biopharmaceutical company, was formedin June 1994 following a management-led buyout of British pharmaceuticaldeveloper Delta Biotechnology's microencapsulation technology.When used for ultrasound contrast, this technology produces sphericalmicrobubbles that are detected by ultrasound scanners.

The company has two ultrasound agents in the product developmentpipeline. The farthest along is Quantison, an intravenous agentdesigned for myocardial perfusion and cardiac chamber analysis.It also may be suitable for peripheral vascular and general radiologyapplications, according to the company.

Quantison consists of an air-filled albumin microcapsule witha mean diameter of 3.2 microns. The agent comes in powder formand is easily reconstituted in water prior to injection, accordingto Paul Pay, commercial director. In addition to ease of use,Quantison offers 10 to 30 minutes of imaging, a selling pointfor the technique, Pay said.

"It comes back to one of the key advantages that ultrasoundfor cardiac imaging has over other modalities, which is real-timeimaging," Pay said. "The clinician can make his diagnosisright there and not have to send something away for developingand come back to it half a day or a day later."

Quantison is in phase II clinical trials in Europe, with phaseIII trials planned for late 1997. The company expects to filean investigational new drug (IND) application with the Food andDrug Administration early this month. U.S. phase II clinical trialscould then begin by mid-1997, Pay said. Ideally, Quantison couldbe ready for the U.S. and European markets by 1999, he said.

The company is also in discussions with a number of potentialdistribution partners for Quantison, either on a regional or worldwidebasis, Pay said.

"Andaris does not plan to be a sales and marketing organization,"Pay said. "We will partner with somebody who will completethe clinical and regulatory process and do the sales and marketing."

The company would be involved both in completing product developmentand in manufacturing of the agent, however. In addition to a 30,000-square-foothead office and R&D facility, Andaris also has a 10,000-square-footmanufacturing production unit that has been certified to complywith Good Manufacturing Practices rules. The company has 60 employees.

Another agent in the Andaris pipeline is Quantison Depot, a microcapsuleagent that bypasses the traditional route of intravenous administrationfor ultrasound contrast agents in favor of intra-arterial deliveryvia a catheter.

"Rather than delivering the agent through the blood pooland then having it cross over to the myocardium, you're actuallygetting delivery directly via the specific arterial group intothe myocardium itself," he said.

The agent resides in the myocardium for several hours, enablingdetailed analysis of perfusion, such as identifying the area andextent of infarction and monitoring the success of therapeuticand surgical interventions, Pay said.

Quantison Depot has a mean diameter of 9 microns. In animal studiesconducted at the University of Virginia, results obtained usingQuantison Depot correlated closely with those achieved with technetium-labelednuclear medicine procedures, Pay said.

Quantison Depot is undergoing late-stage preclinical studies,with the goal of entering European clinical trials during 1997,Pay said. Andaris is also seeking a development and marketingpartner for distribution of Quantison Depot.

In addition to its ultrasound contrast efforts, Andaris is usingits microcapsule drug delivery technology to develop a range oftherapeutic products in the blood protein, pulmonary, and parenteralfields. The company is also researching cellular transport ofdrugs.