A new player with a familiar face is making waves in the not-yet-emergedultrasound contrast market. Salutar founder and Omniscan inventorDr. Stephen C. Quay formed Sonus Pharmaceuticals in 1991 withthe intention of duplicating his MRI contrast success in
A new player with a familiar face is making waves in the not-yet-emergedultrasound contrast market. Salutar founder and Omniscan inventorDr. Stephen C. Quay formed Sonus Pharmaceuticals in 1991 withthe intention of duplicating his MRI contrast success in ultrasound.
Quay founded Salutar in 1984 to develop MRI contrast agentsand invented Omniscan while at the company. He left Salutar in1990 after it was purchased by Hafslund Nycomed of Norway (SCAN4/12/89). Omniscan, which is marketed by Sterling Winthrop, receivedFood and Drug Administration approval in January (SCAN 1/27/93).
Sonus recently completed a round of venture capital financingthat brought $3 million to the Costa Mesa, CA-based company. Theproceeds will be used to build an office and laboratory and tobegin research and development in ultrasound contrast.
The company has also been filling out its executive line-up.Dilip Worah, who worked with Quay at Salutar, has been named vicepresident of research and development. Worah oversaw pharmacologyand toxicology studies for Omniscan.
Appointed vice president of regulatory affairs this month wasCharles H. Davis, who held a similar position for 13 years withAlpha Therapeutic, a division of the Japanese pharmaceutical companyGreen Cross. Davis will handle interactions with the FDA and willcoordinate regulatory filings of Sonus' products.
Sonus plans to develop intravascular ultrasound agents basedon a proprietary phase-shift colloid compound Quay developed afterleaving Salutar. The compound is a form of liquid emulsion thatbecomes gaseous at body temperature. When the agent is injected,it is transformed into gaseous microbubbles that become echogenicby scattering the ultrasound signal to create a contrast effect.
Echocardiography and perfusion studies will be the major applicationsof the agent, according to Quay, although the company also intendsto develop radiologic and gynecologic applications.
"We have looked at myocardial tissue, perfusion in the(heart) muscle itself. We have looked at perfusion in the liverand in the kidney," Quay said. "Those are the organswe've studied most extensively."
Such a product would be a competitor to Molecular Biosystem'sAlbunex, a cardiac blood-flow agent under Food and Drug Administrationreview (SCAN 12/2/92). If approved, Albunex would be the firstcommercially available ultrasound contrast product.
A recently released Hambrecht & Quist report on Albunexprojected total U.S. annual sales of the agent to reach $232 millionin 1998.
Perfusion studies of other organs, such as the breast and prostate,are also possible with Sonus' compound, which is in preclinicaltoxicity and efficacy studies. The agent could also be used forcentral nervous system studies with some of the new transcranialprobes on the market, according to Quay.
Sonus researchers have made an interesting discovery in theirwork with coatings for the compound, Quay said.
"If we put something specific on their surface, we seemto be getting targeting, for example of tumors or infections,"he said.
Quay declined to elaborate on the targeting effect, but saidit could make ultrasound contrast studies easier because the agentswould home in on the area to be examined.
The large installed base of ultrasound scanners translatesinto a potentially huge contrast agent market. The clinical utilityof ultrasound is also increasing as many physicians begin usingit in place of more expensive modalities. Ultrasound contrastcould be the missing link that would allow physicians to obtainthe same level of diagnostic information from sonography as fromMRI or CT.
"There are 11 ultrasound scanners to each MRI scanner,"Quay said. "If you can provide an agent that will give aphysician a definitive diagnosis short of requiring an MRI, you'reprobably going to get that patient."
Quay compares the current state of ultrasound contrast developmentwith the infancy of MRI contrast. The potential of ultrasoundcontrast agents can only grow as both contrast and scanner technologymature.
"In the first human studies at Salutar with an MRI contrastagent for renal imaging, it took 17 minutes to take one pictureof the kidney," Quay said. "The drug was being clearedin 10 or 15 seconds. Our pictures weren't great, but we saw thetechnology was going to change and we persisted in it. I thinkthere's a similar evolution going on in ultrasound. It is theimaging modality that will show the greatest effect of contrastagents over the next five years."
Stewart Carrell, chairman and CEO of Diasonics, has replacedRoderick Young as CEO of the focal surgery business unit. EdwardC. Driscoll was named president of the business. Young resignedto pursue other business interests.
Initial clinical trials on 100 patients have been completedusing the Sonablate focal surgery system for treatment of benignprostatic hyperplasia. Further trials are planned in the U.S.and Europe. Diasonics has signed Takai Hospital Supply as a distributorof Sonablate in Japan.
Two InstaScan sites were installed last month at Yale Universityand Michigan State University, raising the equipment's total installedbase to five. InstaScan functions as an upgrade to GE's 1.5-teslaSigna MRI systems.