From Phenotype to Genotype: Amersham Health Paves the Way - Pharmaceutical Executive


From Phenotype to Genotype: Amersham Health Paves the Way

Pharmaceutical Executive

Nevertheless, AH's products are not the only things that make its story compelling. Equally important is how it leveraged the years spent as a quiet industry insider to make the partnerships that will move the needle on genomics.

"The company's vision has changed. We now believe, perhaps more than we did five years ago, that the 21st century is all about diagnostics," says Padfield. He supports that vision by pointing to elements of the changing healthcare landscape that will drive growth of AH's products:

Aging population. Padfield notes that in ten years, 20 percent of the population of Western Europe, the United States, and Japan will be over the age of 65. Those numbers are poised to overwhelm current systems, with more people needing care and fewer people paying for it. Keeping patients out of the hospital represents the greatest cost-saving measure, while simultaneously improving patient outcomes. Padfield believes that improved diagnostic testing can do its part by allowing physicians to intervene in illnesses earlier, keeping patients healthier longer and reducing hospitalizations.

Background on John Padfield
He also believes that, through increased use of the internet for healthcare education, people will insist on early intervention to protect their quality of life. He predicts that US baby boomers will be the first to form a new class of patients, the "symptomless ill," because they will be prepared to pay for better lives. The onus will be on pharma companies to discover and develop the products that keep them healthy.

"Patients will become AH's customers much more than they are now," explains Padfield. "I can't use the word 'inconceivable' regarding Viagra (sildenafil), but 20 years ago, who would have imagined that we would be dealing with such sensitive issues? In 20 years, the world will be different again and it's our job to hold the crystal ball, see what the trends will be, and design products to meet those needs. We're all going to die at some point. The death rate is still one per person. It's only a question of when and how and whether we can improve patients' quality of life in the process."

Even with prevention, the graying of the population will drive product sales. According to the US Census Bureau, those age 45 and older require three to four times as many internal examinations as younger people. Currently, 35 million of "visually enhanced" procedures are done each year; by 2006 that number is predicted to increase to 50 million.

Down the Pike
Technology advancements. Hardware companies have invested in replacing traditional CT scanners with high throughput multi-slice CT scanners that take "salami slice" pictures of the body in three or four seconds, replacing slower machines that take only a single picture at a time. That trend is expected to continue, enabling hospitals to meet increased demand for scanning. The annual growth rate for multi-slice machines is predicted to be 48 percent during the next five years, according to AH. That demand should propel growth of CT visualization agents, such as Omnipaque, Visipaque, and new products in development. (See "Down the Pike.")

But because the machines run very fast, contrast products will be needed in greater quantity for most procedures to ensure the best possible image, as evidenced by an October 2001 study published in the American Journal of Roentgenology. A hospital upgraded to a multi-slice machine in one room after running single-slice CT machines in two rooms for one year. When compared with the control group, the number of scans conducted on the multi-slice machine increased by 50 percent, and the use of contrast products increased 70 percent.

New medical devices. Stenting, the procedure by which a thin, stainless steel mesh tube is inserted into a clogged artery, is possible because of arterial

visualization agents such as Visipaque. Currently, physicians conduct about 100,000 such procedures each year, but the compelling decrease in patient trauma, rate of restenosis-or reclogging-of the arteries, and faster recovery associated with interventional cardiology compared with surgery have analysts predicting that the number will more than triple to 350,000 by 2005.

From Modality to Disease Jean-Michel Cosséry, Pharm D, PhD, MBA, executive vice-president, product strategy, joined AH in November 2001 and helped shift the company's approcach from an imaging modality to a disease-focused one. That move helped integrate its R&D and marketing departments, which now more closely mirror traditional pharma companies' therapeutic franchise models.

"When R&D scientists work with Cosséry's product strategy and marketing people, they understand the disease, the unmet diagnostic needs, where therapy monitoring is going, and the product needs," says William Clarke."That gives them clear marching orders. That doesn't sound revolutionary to some of my Big Pharma colleagues-but it really is revolutionary in the diagnostics business."

The approach offers more flexibility in diagnosis, taking into account patients' medical histories as well as physicians' differing approaches, which often varies by region. It also fits AH's raison d'etre, which is to enable physicians to perform the least invasive procedure possible.

"If a patient comes in with chest pain, the physician can use a radiopharmaceutical like Myoview to assess myocardial perfusion [blood flow] and/or an ultrasound product like Optison to see the functioning and border delineation of the heart wall," says Padfield. "If there is a problem in the heart wall, the physician may conduct a cardiac catheterization, inject the patient with the x-ray diagnostic Visipaque, and see whether the narrowing of a particular blood vessel is causing the lack of blood flow to the heart. Then, if the physician decides to do an angioplasty and put a stent in, they can do so using Visipaque to guide the process. In that way, AH provides products from the least invasive to the most invasive for physicians for every stage of heart disease."

That principle-doing the most for patients by doing the least to them-is also the basis of the company's line of brachytherapies: OncoSeed (iodine-125), TheraSeed (palladium-103), EchoSeed (iodine-125), and a method of implanting the therapeutic "seeds" more precisely, Rapid Strand (a rigid, absorbable, permanent implant device). The seeds, each about the size of an uncooked grain of rice, are implanted into tumors using a minimally invasive outpatient procedure. The seeds give off localized doses of radiation without harming healthy tissue, compelling physicians to use it for a wide variety of cancers.

The procedure offers substantial benefits over other cancer treatments, such as radical prostatectomies and external beam radiation for prostate cancer. Implantation takes about an hour, with three days' home rest, compared with a one- to four-hour radical prostatectomy, three-day hospital stay, and three to eight weeks of recovery time. Seed implant therapy is also a one-time treatment, compared with external beam radiation that is administered five days a week for four to six weeks. A decrease in side effects such as erectile dysfunction and incontinence, and reduced hospital costs are other implantation benefits.

Media coverage of former New York mayor Rudolph Giuliani's fight against prostate cancer and his subsequent participation in PROstate Health, a public relations initiative aiming to raise prostate cancer awareness, highlighted use of TheraSeed, which AH co-markets with Theragenics. Although the publicity helped get the word out about the product, TheraSeed's success brought increased pricing pressure from the resulting entry of multiple competitors into that market, according to Credit Suisse First Boston.

Its analysts also believe that the small number of seeds used per procedure contributes to the weakness of the brachytherapy market. Yet, the company is optimistic that the European market, among others, holds substantial growth opportunities for seed implant therapy because it is not well known or widely available there. As awareness grows, analysts also expect demand to grow. That even includes Japan, which currently has no approved seed products. Although the Japanese population suffers less from prostate cancer than other populations, the incidence is on the increase and seed products are expected to soon be available in that market.


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