Vertex Urges CDC to Recommend Hep C Screening, To Nudge “Second Tsunami” of Patients
If Vertex Pharmaceuticals gets its way in talks with U.S. public health officials, most people over 50 could soon get blood tests to screen for hepatitis C infections at the doctor’s office. If the U.S. Centers for Disease Control and Prevention (CDC) agrees this is a good idea, it could prompt another 1 million patients who don’t realize they are infected to come out of the woodwork and start clamoring for Vertex’s new hepatitis C drug over the next few years.
The Cambridge, MA-based biotech company (NASDAQ: VRTX), which has operations in San Diego, has joined other drugmakers in supporting studies they hope will persuade the CDC to recommend routine screening for hepatitis C, Vertex CEO Matt Emmens said in a recent interview. The company is one of the sponsors of what’s called the Viral Hepatitis Action Coalition, a public-private partnership with the CDC, which is conducting studies known as BEST-C. These studies could determine how effective it is to screen patients for hepatitis C infection more widely.
These studies, which are expected to cost a total of $3.6 million, could be worth billions to Vertex if they show that screening random Baby Boomers is worthwhile.
An estimated 600,000 patients in the U.S. are expected to seek treatment that could include Vertex’s drug, or a rival offering from Merck, if the FDA clears the new drugs for sale as analysts expect in the middle of this year. The two new protease inhibitors are being hailed as major steps forward, as they have been shown to roughly double cure rates of hepatitis C, a viral infection that damages the liver over many years. Vertex’s drug, telaprevir, has shown it can push the cure rate up as high as about 75 percent, while cutting the treatment time in half to about six months. That means patients don’t have to endure such a long period of flu-like symptoms, which has traditionally discouraged many patients from getting treatment.
The new advance from Vertex, demonstrated in a trio of pivotal clinical trials, has created this huge wave of pent-up demand from patients and doctors. Knowing this, many analysts have projected the product will be pretty much an instant hit, topping $2 billion in U.S. sales after just a couple years. But then, some expect sales to taper off, as many of the most motivated patients get cured, and don’t need the drug anymore. Essentially, they see Vertex possibly becoming a victim of its own success.
That’s not how it will play out, says Emmens, a marketing veteran who spent much of his career at Merck. An estimated 3.2 million to 3.9 million people in the U.S. have chronic hepatitis C infections. That’s a lot more than the initial wave of patients, which is mostly composed of people who sought treatment before but relapsed. Besides those patients, many more candidates are Baby Boomers who don’t know they contracted the hepatitis C infection decades ago through unprotected sex, IV drug use, or blood transfusions from contaminated supplies. Many of these infections lie dormant for about 20 years or more, but are just now starting to emerge over the decade to come, Emmens says. Some patients won’t see symptoms at all, and as the AP pointed out in this solid feature last month, it’s hard to tell which infected patients are likely to get the worst symptoms. The unluckiest ones will end up suffering severe liver scarring (cirrhosis), liver cancer, liver transplants, and ultimately, premature death.
Connecting with that massive crowd of patients, who aren’t motivated to seek treatment today because they don’t see any really bad symptoms yet, is one of the big marketing challenges Vertex faces. The company is planning to spend some of its $1.3 billion cash hoard on a public awareness campaign designed to urge people to get tested to see if they have the virus, Emmens says. But even more important than the ad campaign, Vertex is hoping the CDC will recommend … Next Page »