Novartis AG Expects New Heart Failure Drug As "Multi-Blockbuster"
October 28, 2014
By Mark Terry, BioSpace.com Breaking News Staff
In a third quarter conference call yesterday, Joe Jimenez, CEO of Swiss-based Novartis , confirmed expectations that the company’s new cardiovascular drug, LCZ696, would earn between $2 and $5 billion annually, making it a blockbuster standout in an already-crowded cardiac field.
In August 2014, Novartis presented data at the European Society of Cardiology (ESC) Congress 2014 regarding LCZ696. The compound is a twice-a-day tablet for heart failure that “acts in a unique multimodal way to enhance the protective neurohormonal system of the heart (NP system) while simultaneously suppressing the harmful system (the RAAS).”
The PARADIGM-HF trial, of which LCZ696 was part, was halted early in March 2014 because of significant positive results. The Data Monitoring Committee (DMC) made a unanimous recommendation for early closure because patients receiving LCZ696 lived longer without hospitalization for heart failure than whose who received enalapril.
Milton Packer, professor and chair of the Department of Clinical Sciences at University of Texas Southwestern Medical Center, Texas, USA, and one of two principal investigators, said in a statement, “The results of PARADIGM-HF are truly impressive. We now have compelling evidence that supports LCZ696 as a new cornerstone in the management of chronic heart failure.”
Apparently some analysts agree, indicating that LCZ696 could bring in revenues of $8 to $10 billion annually. Jimenez responded in the conference call that he felt that evaluation was overly optimistic.
“Even though it’s early, the data would support this drug being a multi-blockbuster. I’ve seen estimates of somewhere between $2 and $5 billion, and I think if you look at the data … I believe it should fall in that ballpark,” he said. “I think some of the analyst projections of between $8 and $10 billion are probably too optimistic, but again we don’t know until we launch the brand and see the reaction.”
Novartis is planning to submit LCZ696 to the U.S. Food and Drug Administration (FDA) in December of this year and hopes for a decision by the end of 2015.
Overall, Novartis showed strong results for Q3 2014. Net sales grew 4 percent to $14.7 billion (U.S.) with operating income growth of 14 percent. In addition to the promise for LCZ696, the FDA recommended approval of AIN457 for psoriasis and Simbrinza has been approved in the EU for treatment for glaucoma.
“Novartis delivered a very strong third quarter,” said Jimenez in a statement. “We delivered solid sales growth with margin expansion. At the same time, we reached key innovation milestones, particularly with LCZ696 in heart failure and AIN457 in psoriasis, underlining the innovation power of the company.”