Strategists start planning extended applicationsBracco's next-generation contrast medium for general-purpose MR is about to enter the U.S. The Italian company has been discussing with the FDA how to label the product, called
Strategists start planning extended applications
Bracco's next-generation contrast medium for general-purpose MR is about to enter the U.S. The Italian company has been discussing with the FDA how to label the product, called MultiHance, in order to get it approved since receiving an approvable letter from the agency in September, a process that typically takes six months or so.
Even before the agent is on the U.S. market, the company is planning how to extend its commercial appeal. Studies in a variety of clinical areas are under way with the goal of building out beyond the central nervous system indications that are likely to be approved later this year by the FDA.
MultiHance is already marketed in Europe, Korea, and Hong Kong for CNS and liver applications. The approvable letter from the FDA, however, mentions only brain and spine applications. If the FDA initially approves MultiHance only for CNS applications, as it did for the product's predecessor, ProHance, the two Bracco agents would compete with each other, as well as with CNS agents from Schering and Amersham. But Bracco has a plan to keep both its new and old agents on the market.
ProHance will be positioned in niche applications where it is particularly strong. MultiHance, also known by its molecular name gadobenate dimeglumine, might then be aggressively marketed as a CNS agent, with sales reps in the U.S. talking up the new product's superior ability to enhance lesions.
The company will also continue research aimed at expanding applications other than the CNS. Clinical studies have already produced encouraging results for the use of MultiHance to detect focal liver lesions in patients with known or suspected primary liver cancer, such as hepatocellular carcinoma, or metastatic disease. Other studies are under way to assess its use in vascular and breast imaging.
Peripheral MR angiography is a major focus. The company believes that MultiHance and other such extracellular agents have an edge over dedicated blood pool agents when doing this type of study, partly because they are already on the market and in routine clinical use for MRA.
"We believe blood pool agents will be very useful for imaging the coronaries but not for normal peripheral MRA," said Valtero Canepa, Bracco's worldwide marketing director.
Agents optimized for CNS imaging rapidly leak from the bloodstream, but recent developments in high-speed MR have mitigated this drawback, at least for peripheral MRA. Radiologists routinely use them for MR angiography, even though this application is not included in product labeling approved by the FDA. Physicians have the right to prescribe such off-label uses. Drug makers, however, cannot promote their products for such applications.
"For the next three or four years, our main focus will be to enlarge the field of applications and consolidate the indications for gadobenate dimeglumine," Canepa said, being careful to use the molecular rather than the trade name of the agent. "We believe the agent will have a very long life."
The clinical extension of products into ever more applications is the cornerstone of life-cycle management, a strategy widely applied today by pharmaceutical houses. Drug manufacturers try to get as much revenue as possible from existing agents because of the time needed to bring a new product to market.
Ten years may pass from the start of preclinical studies until product launch, Canepa said. In this time, a lot of things can go wrong. Some promising candidates fail to be proven safe and effective. And some that make it through the process fail commercially.
"There is always the risk, when you are developing a new agent, that the rules for approval will change or something will change the market," Canepa said.
Because of the uncertainties and the cost of long-term product developments, the addition of more clinical applications to the labels of existing products has become a paramount consideration. While this product evolution involves less risk, it does not come cheap.
"We are still spending millions of dollars every year," Canepa said. "Sometimes you do it for indications that are not so big, such as breast imaging, but you do this because it is the way to improve global imaging-and the acceptability of your agents."