To those who believe we have everything we need in the lipid-lowering world, Ben Stakely, Kowa Pharmaceuticals America (KPA) CEO and president, has one thing to say: “I would argue with you.”

Stakely, whose company co-launched cholesterol reducer Livalo in the US this week with Eli Lilly, is not so much answering a rhetorical question as responding to those who have second-guessed the wisdom of bringing a new statin to a market where there are some pretty effective, and inexpensive, medicines already.

KPA’s parent company, Kowa Co. Ltd., developed Livalo to address a very specific niche of the cardiovascular category, then made the drug its flagship product and grew it to a 13.1% share of the Japanese market with $399 million in sales. What’s the commercial case for Livalo?
“Heart disease is still the number-one killer in the world,” the CEO said in an interview with MM&M. “Eighty million Americans have one or more types of cardiovascular disease. About 75 million of these have multiple conditions. They can’t always tolerate the statin, [and therefore] can’t all get to [cholesterol] goal.”

These CV patients with comorbidities are Livalo’s target market. Many of them don’t handle a lipid-lowering drug well. Dr. Craig Sponseller, VP of medical affairs for KPA, compared the problem to a road block, the road in this case being the cytochrome P450-mediated metabolic pathway. This system is involved in approximately 75% of all drug metabolism.

“Other drugs that want to go down that route can’t anymore because another drug is inhibiting the ability to do so,” Sponseller explained. That can create a “backup,” he said, increasing exposure to the body and resulting in hepatic and other side effects.

That may be why less than half of patients who qualify for any kind of lipid-modifying treatment are receiving it. “Patients don’t metabolize all these drugs in the same way,” said Sponseller. “That’s why we need other options to try and reduce the astounding number of people with heart disease.”

Livalo is metabolized through a different pathway. A small amount runs through the P450 route, but most passes through the gut or kidneys and is excreted. Its most common side effects include muscle and back pain and constipation. “We avoid the logjam of drugs, and therefore we have potentially fewer drug-drug interactions,” said Stakely. “That’s a pretty important piece of the Livalo story.”

It’s that story which the companies’ combined sales force of 750 reps—250 from KPA and 500 from Lilly—will begin telling PCPs and cardiologists this week. Stakely said the launch will focus mainly on professionals. His hope is that once the product gains some traction, he can sit down with Lilly to hash out a DTC component. One thing the KPA executives would not question—the leading lipid-lowering products provide some stiff competition.

Livalo has been tested against the two most commonly prescribed statins, Pfizer’s megablockbuster Lipitor and simvastatin (the generic name for Merck’s Zocor), and has been shown to provide a comparable (45%) reduction in LDL-C. KPA has priced Livalo 15% lower than AstraZeneca’s Crestor, the number-three US statin, and also has co-pay assistance in place. Out-of-pocket costs will not exceed $25. “We don’t want price to be an obstacle either,” Stakely said.

The attractiveness of Livalo’s other attributes for those on multiple medications is up to physicians to judge.