There’s good news ahead for TV commercial junkies. Just as the supply of political ads suddenly runs dry this evening –- who won’t miss all that misinforming backbiting from all sides of the spectrum? -- a new generation of the “we-have-a-pill-for-that” ads that fuel news and current affairs programming appears to be more than a glimmer in Big Pharma’s eye.
“A new class of powerful cholesterol-reducing drugs is showing promising results, potentially offering a new option for people who do not respond to medication now on the market, according to studies presented at an American Heart Association conference of heart specialists here on Monday,” Andrew Pollack reports in the New York Times. “Although the final word on the effectiveness of the drugs is still a few years away, the results so far are so promising that pharmaceutical companies are racing to bring them to market.”
The Wall Street Journal’s Ron Winslow and Jennifer Corbett Dooren add: “The crescendo of activity comes just a year after Lipitor, the pharmaceutical industry's biggest-selling drug ever, came off patent, turning a multibillion-dollar-a-year cash cow for Pfizer into an under-$10-a-month generic medicine. It also follows an especially fallow period when industry struggled to develop cardiovascular drugs that could achieve meaningful benefits beyond those attained with statins.”
The new agents, which are being developed by Amgen, Pfizer and Sanofi and its partner Regeneron, are antibodies, not statins. They must be injected every two to four weeks and “are not likely to be widely used for ‘garden variety high cholesterol,’” according to Dr. Gordon Tomaselli, chief of cardiology at Johns Hopkins. Still, Pollack reports, a successful drug “could reach billions of dollars in annual sales.’
High “bad” cholesterol levels (LDL) are not a disease in themselves but they often lead to cardiovascular problems.
“Factors within your control — such as inactivity, obesity and an unhealthy diet — contribute to high LDL cholesterol and low HDL cholesterol,” according to the Mayo Clinic. “Factors beyond your control may play a role, too. For example, your genetic makeup may keep cells from removing LDL cholesterol from your blood efficiently or cause your liver to produce too much cholesterol.”
The Sanofi (Paris-based) and Regeneron (Tarrytown, N.Y.-based) drug appears to be leading the race to market, according to Pollack, with a Phase 3 trial involving 18,000 patients getting under way. It will take at least two years to complete. Amgen’s product is said to be in line for Phase 3 trials in 2013.
It “is focusing on the drug’s potential to help offset declining sales of its anemia drugs Aranesp and Epogen, which together will generate $4 billion in estimated sales this year and face increased competition by 2015,” Ryan Flinn reports in Bloomberg Businessweek. Thousand Oaks, Calif.-based Amgen is the largest biotechnology company in the world.
The road from consumer trials to marketing bonanza is pocked with many potholes, of course. For example, Basel, Switzerland-based Roche’s “abandoned heart drug dalcetrapib, designed to raise levels of good cholesterol, also boosted blood pressure and inflammation,” researchers told the AHA conference yesterday, reports Bloomberg Businessweek’s Michelle Fay Cortez.
“‘It was a surprise that the blood pressure effect was evident,’ since earlier studies didn’t find any increase,” Gregory Schwartz, chief of cardiology at the U.S. Department of Veterans Affairs Medical Center in Denver tells Cortez. “‘That’s why it’s so important to do large trials, to detect small but important safety effects.’”
Pfizer’s patent on Lipitor, which once spent as much as $272 million a year on marketing, ran out almost a year ago. Still, it spent more than $87 million promoting “its once-great cash cow” through the first half of the year before throwing in the towel as it faced competition from more products, the Wall Street Journal’s Jonathan D. Rockoff reported in May. “Pfizer sought to wring as much revenue from Lipitor as it could for as long as it could while generic competition [atorvastatin] was still in its infancy, with the help of heavy marketing, promotions and price rebates,’ Rockoff wrote, as befits a product that “at its peak generated $12.9 billion in annual sales.”
Also on the high-cholesterol front, Forbes contributor Larry Husten takes a look at two press releases issued at the AHA conference about other research: “Infusing ‘good’ cholesterol protein may lower risk of subsequent heart attack” and “Genetically engineered tomatoes decrease plaque build-up in mice.”
Coming someday to “Meet the Press” commercial breaks?: “A GMO Tomato a Day Keeps the Heart Doc Away.”