Diagnosis of Related Condition
Diagnostics are also helpful in identifying new patient populations that can benefit from available treatments. Niaspan, an
extended-release formulation of niacin launched by Kos Pharmaceuticals (now Abbott) in 1997, offers one example of how to
maneuver in this area.
Niaspan treats hypercholesterolemia, and is indicated as an adjunct to diet and statin medications. When taken in large doses,
the drug blocks the breakdown of fats in adipose tissue, specifically very low density lipoprotein (VLDL), the precursor of
LDL or "bad" cholesterol, and increases the level of high density lipoprotein (HDL) or "good" cholesterol in blood.
The traditional routine cholesterol panel (total cholesterol, HDL, and LDL) provides only a 40 percent predictive value for
coronary heart disease. But in 2003, several diagnostic companies launched a new test—an LDL subfractionization test—that
identifies more than 90 percent of patients at risk for heart disease. The tests identified at-risk patients with normal LDL
test results (that is, patients who would otherwise not be diagnosed) and identified a subset of patients who would benefit
from a combination of drugs to boost HDL levels using Niaspan instead of statins alone.
Although there were many drugs physicians could choose from, based on Kos' marketing effort, Niaspan achieved US sales of
approximately $225 million by 2003, growing at a 26 percent pace compared to 14 percent growth for statins, the standard of
care for patients with high cholesterol.
Earlier Treatment Migration
Prescription by trial-and-error, particularly when it comes to more serious conditions, is an unacceptable approach to treatment.
However, in multiple sclerosis, that was the standard of patient care for far too long.
The symptoms of MS mimic many other neurological disorders and may disappear and recur periodically. Physicians diagnose MS
mostly by ruling out other conditions, and then conducting tests of visual-evoked response and brainstem auditory-evoked response,
followed by a brain MRI to confirm diagnosis. As the degenerative nature of the disease takes its toll over time, second and
third line treatments are used until they are no longer efficacious.
An Austrian company, Sanochemia AG, saw a market opportunity to improve MS diagnosis and improve uptake of Viveo (tolperisone),
an immediate-release muscle relaxant used to treat painful muscle cramps and spasticity associated with neurological conditions.
Tolperisone is a third line treatment that was originally launched in Europe by Orion Pharmaceuticals at the end of 2007.
Viveo is a more potent form of tolperisone, which is available as a generic in Germany, and was launched at a 20 percent price
premium. Orion detailed the drug with a 130-person, neurology-focused sales force. In March 2008, Sanochemia launched MR-Lux,
an MRI contrast agent (gadopentate dimeglumine) used to diagnose MS and other CNS conditions.
With this diagnostic on the market, neurologists were able to make a definitive diagnosis of MS, which in turn meant that
patients migrated to Viveo more quickly. Since launch, Viveo has doubled initial expected sales and is projected to grow at
40 percent compared to 7 percent projected increase in sales of generic tolperisone. The ability of Viveo to leapfrog less
expensive generic tolperisone is due to its improved dosing, which leads to better patient compliance. The chronic and degenerative
nature of MS puts a premium on simplifying the therapeutic regimen for a patient.
Other diseases that follow this pattern present an opportunity for linking diagnostics with therapeutics. These examples vary
by therapeutic area, geography, and developer—but there are also striking similarities. First, the marketed drugs are not
targeted therapies that work against a specific biomarker or unique disease pathway. Rather, they are small-molecule drugs
whose mechanism of action is not unique. In each case, the drugs are reformulations of compounds with generic competitors
available. Second, the diagnostic was brought to market after the drug was launched, often by a third party with no special
knowledge of clinical results from drug development.
Because the biomarkers used for the bundled diagnostic are not exclusive to the drug developer, there is an opportunity for
late-to-market participants to effectively compete using this approach. In fact, the basic science that underpins the biomarkers
was either developed by academic research institutions and licensed by diagnostic developers, such as the case with Prometheus
and Berkeley Heart Lab, or had been on the market for some time, as was the case with Sanochemia Diagnostics.
Given that the diagnostic test only identifies the class of drugs that are effective for a group of patients, sales presence
does matter. The sales force must be able to answer questions about the diagnostic and clinical guidelines for disease treatment.
There cannot be a single-minded pursuit of sales of a particular drug, because the diagnostic will also highlight patient
subgroups that will not respond appropriately.