Amersham R&D head extols virtues of life cycle management

Bottom line growth feeds on new clinical applications

Amersham Health is at the top of its game. Revenues are up. So is market share. The reasons are three-fold: a strong patented portfolio, active life cycle management, and aggressive R&D of new products. Of the three, life cycle management has been the star performer.

The concept behind life cycle management is to squeeze as much utility as possible from existing products. This utility comes from clinical tests that demonstrate new applications, leading to data that support FDA applications for on-label uses. The SPECT agent Myoview is an example. The value of this cardiac imaging agent expanded late last year when the FDA approved its use with pharmacologic stress agents for patients who are unable to physically exercise. This extension could boost already skyrocketing sales of the product, which last year rose 27% to £110 million ($158 million).

"You have to demonstrate new and valuable uses for your products," said Dr. William R. Clarke, executive vice president of R&D at Amersham Health. "Physicians will use products off-label, but it's better to show in clinical trials, and then get the FDA and professional community to agree, that these new indications are valuable and safe."

Myoview is one of several Amersham radiopharmaceuticals that generated revenues of £241 million ($346.1 million) in the fiscal year ending Dec. 31, up 17% from the year earlier. The success of Amersham radiopharmaceuticals is part of the positive financial picture for this multinational company headquartered in Buckinghamshire county, in the U.K.

Aging populations in developed countries drove demand for medical imaging products last year, according to Amersham management, helping to boost company revenues by 13% to £1.603 billion ($2.3 billion). Amersham also edged its global share of the market for imaging agents from 35% to 37%.

Product extension has helped support this growth, and some of that extension has come from advances in the underlying imaging equipment. The sale of x-ray contrast agents is booming on the heels of growing interest in multislice CT, Clarke said.

Last year Amersham's x-ray agents accounted for the lion's share of the company's imaging agent revenues, £324 million ($465.3 million), 14% better than the year before. Amersham's most popular product is one of its oldest. Omnipaque, which was commercially introduced to the U.S. in the mid-1980s, generated £222 million ($318.8 million), up 10%. It was one of the first low-osmolar nonionic contrast agents to be developed. Today Amersham makes "many tons" of this agent, according to Clarke. Quantities being made and sold continue to increase.

"The pharma industry is used to a square-wave falloff in sales when a product goes off patent," he said. "This hasn't happened to Omnipaque because of our ability to make large quantities of this product and because of the competencies in the organization to move it."

Omnipaque's lasting appeal comes from its exceptional safety record and relatively low cost, compared with the company's third-generation x-ray contrast agent Visipaque, which itself achieved a 28% revenue growth last year to £80 million ($114.9 million).

Sales of Amersham's MR contrast agents rose 19%, accounting for some £86 million ($123.5 million) in revenues. Omniscan generated most of that on increasing demand for MR procedures. The extension of this modality into angiography is another factor behind Amersham's success. Fast scanning techniques, coil development, and innovations such as Philips MobiTrak, which supports peripheral runoff studies, have bolstered the use of MR angiography. Amersham has benefited from the successful development of new scanning equipment just as the future for MR contrast agents looks even brighter because of this equipment's shortcomings.

"There was a hope several years ago that MR angiography could be done without contrast agents," Clarke said. "But what we are seeing is that you get better information, faster and more reliably, with contrast media. I think you will see more clinical trials done with MR agents to demonstrate their utility in MR angiography."

Amersham originally planned to launch a dedicated vascular product, Clariscan, to fill the expected demand for vascular products, but it has opted instead to extend the life cycle of Omniscan. The company is now engaged in several clinical trials designed to extend the on-label uses of this product to vascular applications, including coronary angiography. This decision sounded the death knell for Clariscan, whose development has been stopped, according to Clarke, even though the company had invested tens of millions of dollars in its development.

"You don't get emotionally involved with products," he said.