Generic Simvastatin No Heartache For Crestor Or Vytorin

Market share growth by generic simvastatin continues to come primarily at the expense of Pfizer's Lipitor as Schering-Plough and AstraZeneca report strong growth and maintained market share from their cholesterol-lowering products.

AstraZeneca's Crestor (rosuvastatin) and Schering/Merck's Zetia (ezetimibe) and Vytorin (ezetimibe/simvastatin) have managed to avoid the same degree of generic substitution since the introduction of generic pravastatin (Bristol-Myers Squibb's Pravachol ) and simvastatin (Merck's Zocor ) in 2006.

Earlier this year, Pfizer announced a three-pronged marketing approach to revitalizing Lipitor sales growth, but it does not appear to be working as the blockbuster continues to steadily lose share (¹ , p. 17).

As of June, Lipitor had lost 4.22 percentage points of market share in the U.S. statin market, adding to market share erosion of 8.5 points in 2006. So far this year, generic simvastatin has gained 5.27 points, while Vytorin gained 0.64 points and Crestor lost 0.06 points, according to ² AstraZeneca.

"The U.S. statin market grew by 10 percent in total prescriptions in the second quarter," AstraZeneca CEO David Brennan noted during a second quarter earnings call July 26. "However, the last six months have been challenging in terms of market share progress, with Crestor share holding steady at 8.6 percent."

However, AstraZeneca is optimistic that market share for Crestor will move up again. Brennan said, "After the initial burst of formulary-driven switches from Crestor to simvastatin at the beginning of the year, we're now seeing a gradual improvement in that trend. If that continues, our rate of new patient starts and switches to Crestor should ultimately come through in market share growth."

Schering is similarly positive about the prospect of continued growth for its ezetimibe franchise.

"We continue to grow Vytorin and Zetia market share even in the face of the new wave of generic statins. In fact, Vytorin and Zetia are the only major cholesterol-lowering brands that have gained market share in dose prescriptions since the end of '06," Schering CEO Fred Hassan said during a July 23 earnings call.

Schering "more than double[d] the growth of the entire cholesterol market," President-Global Pharmaceuticals Carrie Cox said.

Cox reported first-half prescription growth of 20 percent for Zetia and Vytorin in the U.S. and projected second half sales growth in the "high single-digits" for the products.

Global sales for Vytorin and Zetia increased 30 percent from last year's second quarter to $1.2 billion. Crestor sales in the second quarter were up 38 percent to $678 million, and U.S. sales grew 30 percent to $353 million.

Both Schering and AstraZeneca are conducting outcomes trials for their statin products to establish a unique clinical profile and defend against therapeutic interchange.

Schering currently has four outcomes trials for Vytorin in its pipeline. VP-Investor Relations Alex Kelly said the ENHANCE trial, for high risk hypercholesterolemia, is under data analysis; the SEAS trial for aortic stenosis is ongoing and expected to be complete in 2008 to 2009; the SHARP trial for renal disease is not fully enrolled and expects a 2009 completion; the IMPROVE-IT trial for acute coronary syndrome, "the real hard endpoint trial," should have results by 2011.

As part of the product's lifecycle plan, Crestor is in development for "potential combination products with fibrates and cholesterol absorption inhibitors, including our own AZD4121, which is now in clinical development," Brennan said. Outcomes trials for rosuvastatin are also progressing, and an application for an atherosclerosis indication has a November user fee action date, he added.

Schering's overall sales for the quarter increased by 13 percent to $3.2 billion, compared to the year-ago period. Second quarter sales for AstraZeneca grew 6 percent to $7.3 billion.

- Daniel Poppy ([email protected]) and Brian Marson ([email protected])