Company must work on getting reimbursement for productThe Food and Drug Administration this month dispelled any notion that it might be dragging its feet on the approval of ultrasound contrast agents when it gave the go-ahead on Nov. 3 to Bracco
Company must work on getting reimbursement for product
The Food and Drug Administration this month dispelled any notion that it might be dragging its feet on the approval of ultrasound contrast agents when it gave the go-ahead on Nov. 3 to Bracco Diagnostics for its SonoRx imaging agent. Bracco, an Italian company with U.S. headquarters in Princeton, NJ, plans to market the product as an orally administered gastrointestinal agent that promises to improve scans of the upper abdomen.
SonoRx is approved as a means to enhance delineation of upper abdominal anatomy in conjunction with ultrasound imaging, specifically by reducing shadowing on ultrasound scans due to gas in the upper abdomen. The FDA has agreed that clinical trials demonstrated the ability of SonoRx to consistently absorb and disperse gas, creating a uniform sonic window, which produces statistically significant improvement in ultrasound images versus baseline images.
The U.S. will be the first country in the world to gain access to this agent. Regulatory submissions outside the U.S are expected in the near future, according to Dr. Norman LaFrance, Bracco vice president of medical and regulatory affairs.
SonoRx was designed and clinically developed by ImaRx Pharmaceutical, a drug developer with interests in a wide range of technologies, from delivery systems to therapeutic agents to cosmetics, sun screens, and gene therapy. The Tucson company in 1993 sold SonoRx marketing rights to Bracco (SCAN 3/10/93), which filed a new drug application on the product in the third quarter of 1996. One or more contract manufacturers will make the agent for Bracco, which will market the product in the U.S. utilizing more than 100 sales representatives dedicated to imaging products.
We will have a major presence with SonoRx at the (Radiological Society of North America) meeting, and we will be shipping the product by the end of the year, which gives us six to eight weeks to get it out on the market, said Don Evans, Bracco vice president of sales and marketing.
The companys ultimate financial success with SonoRx will depend on several factors, including clinical acceptance and price. About four million upper abdominal sonograms are done each year in the U.S. Many of these are expected to benefit from the use of the agent.
As with any new drug, however, an early challenge to its use will be lack of reimbursement. The inability to collect insurance payments doomed another oral gastrointestinal agent, Imagent GI, which was introduced for MRI studies in 1994 by Alliance Pharmaceutical of San Diego. Alliance stopped selling Imagent GI after it produced revenues of less than $200,000 in the year after its launch.
Bracco, however, hopes to gain national reimbursement for its agent sometime next year.
We are breaking new ground with SonoRx in that it is the first available oral ultrasound agent, Evans said. With any new class of drug there is a process to go through with HCFA (Health Care Financing Administration, which administers Medicare) in order to gain reimbursement. So we are working with them to establish reimbursement for SonoRx, but that will take place in 1999.
Softening the impact of the reimbursement challenge is the price per dose of SonoRx, which is expected to range from $25 to $30. Even without compensation, SonoRx might be popular if its use can eliminate the need for additional testing.
In at least some of the cases, the use of SonoRx will result in the ultrasound exam answering the clinical question without the need to refer to CT or MR, LaFrance said.
The ImaRx agent sailed through FDA review, according to LaFrance. The relative ease of passage was accomplished largely because of a detailed and carefully compiled clinical database with results obtained on more than 400 patients.
There were some questions and (the FDA) came out with approval once their questions were answered, LaFrance said.
The ease with which SonoRx was approved is particularly significant in that Bracco and ImaRx were among the companies that filed a lawsuit last year that forced the FDA to defend its review process regarding EchoGen, a cardiac ultrasound contrast agent developed by Molecular Biosystems of San Diego. The plaintiffs, which included Sonus Pharmaceuticals of Bothell, WA, alleged that the FDA had in place two different and contradictory regulatory pathsone being followed by Molecular Biosystems in which microbubbles were considered to be devices; the other addressing ultrasound contrast agents as drugs. Ultimately, the FDA changed its policy and now routes all ultrasound contrast agents through the drug review process.
LaFrance believes that the process that led to this revision was not adversarial, and the relatively easy approval of SonoRx is proof that there are no hard feelings at the agency toward any of the plaintiffs.
The lawsuit was not personal. It was a policy issue, LaFrance said. I dont get any sense that anyone at FDA saw it as personal or interpreted it that way.
SonoRx is the first step toward Braccos long-term plans to develop a product line of ultrasound contrast media. LaFrance hopes to build on the relationships established at the FDA in the review of the companys next NDA, for the agent BR-1. Similarly, Evans hopes the oral agent will acquaint the sales force with this new type of technology and develop customer relationships that might open channels for the eventual sale of BR-1.
We as a company are very committed to building a presence establishing Bracco as a dominant force in ultrasound contrast agents, with SonoRx being our entry into that market, Evans said. Obviously this agent serves to increase the awareness of Bracco as an ultrasound contrast company and will set the stage for future products.