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GlobalData: Upcoming Novartis chronic heart failure drug expected to dominate market by 2022

By Mia Burns

Research and consulting firm GlobalData has released a new report, PharmaPoint: Chronic Heart Failure - Global Drug Forecast and Market Analysis to 2022 and forecasts global sales of Novartis’ combination drug LCZ-696 to reach a massive $1.86 billion by 2022.  GlobalData estimates that 15 to 20 percent of all chronic heart failure patients across the United States and Europe treated with the drug by the end of the forecast period. LCZ-696 is expected to enter the U.S. and EU markets in 2015 and 2016, and according to GlobalData, the drug will rapidly dominate the global chronic heart failure therapeutics sector and mark a drug development paradigm shift.

“The CHF market is primarily dominated by cheaply priced generics,” says Claire Herman, director of CVMD and Infectious Diseases, GlobalData. “Novartis’ novel combination drug LCZ-696 in 2015 will mark the first entrance of a novel branded CHF drug in the past five years, boosting the overall market size considerably during the forecast period, 2012-2022. The ACE inhibitor class of drugs is one of the main standards of care in a vast majority of CHF patients.  LCZ-696 is currently in a head-to -head, Phase III trial with an ACE inhibitor, enalapril. Interviewed key opinion leaders in the field of CHF suggest that if LCZ-696 is proven to be significantly superior to enalapril then it could potentially replace ACE inhibitors, ARBs and other key drugs in the CHF treatment paradigm.”

LCZ-696 is being evaluated in a trial for patients with heart failure with reduced ejection fraction, Herman told Med Ad News, but if clinical trial data continue to demonstrate the drug’s efficacy in patients with heart failure with preserved ejection fraction, and it gains approval for use in this population, it will be the first drug to show efficacy in this largely underserved patient population. “The bottom line is that any branded drug entering the CHF market that is able to gain uptake in a substantial segment of the treated population will easily dominate in terms of market value, simply because it is competing against very inexpensive generic drugs,” she said.

As the United States will be the first market to receive the new Novartis product, GlobalData expects the U.S. market to make up the bulk of LCZ-696’s sales during the next decade. Revenue for the first-in-class combination drug is anticipated to top $1.6 billion by 2022, making it the most valuable drug in the US chronic heart failure market, with a 55 percent share. “GlobalData predicts that within the forecast period, 2012-2022, LCZ-696 will be the first and only major branded drug to be launched in the CHF market,” says Herman. “We anticipate that LCZ-696 will enter the U.S. and EU markets in 2015 and 2016, respectively.  The potential of the other late-stage therapies is relatively uncertain.”

The chronic heart failure pipeline is sparse and only a handful of drugs are in the late stages of development, says Herman. “For that reason, any takeover of the market by branded products is unlikely to occur during the next ten years,” she says. “In addition, while there are pressing unmet needs in CHF – such as the need for drugs that are efficacious in patients with HF-PEF and in patients with renal impairment – many patients are well-served by the inexpensive standard-of-care drugs. In order for a true ‘takeover’ to happen in terms of gaining both the bulk of the revenues and the bulk of the patient share, any new market entrants would need to meet one or both of these needs.”

Herman notes that the early stage pipeline is more active with the aim to fulfil some of the unmet needs within the chronic heart failure market, but these products are expected to launch well after LCZ-696. “These include pharmacological therapies such as Bayer’s BAY 94-8862 and Cytokinetics/Amgen’s omecamtiv, as well as non-pharmacological therapies such as Celladon’s gene therapy, Mydicar, and Bioheart and Cardio3 BioSciences’ stem cell therapies,” Herman says.

In contrast, the current late stage chronic heart failure pipeline comprises of only three drugs: Novartis’s two drugs, LCZ-696 and Tekturna, and Zensun’s Neucardin, and not including non-pharmacological approaches such as stem cell and gene therapies. “Among the late stage pipeline agents, Tekturna is already marketed for treating hypertension,” Herman told Med Ad News. “Tekturna’s questionable safety profile in patients with diabetes and renal impairment is a huge setback to its uptake in the CHF market.  Zensun is small biotech company currently recruiting for a Phase III trial of Neucardin, a genetically-engineered recombinant peptide fragment of neuregulin-1, in China. Interim results from a Phase II study in the U.S. have shown encouraging results. Neucardin may provide a therapy option for many patients with early- to mid-stage CHF who deteriorate despite the use of standard therapies. Zensun is positioning Neucardin as an anti-HF drug that can lower the mortality rate and reduce re-hospitalizations in patients who are receiving standard therapy for CHF.”

The patent for Novartis’ hypertension drug Diovan expired in September 2012, leaving a gap that needs to be filled. “Novartis is a major player in the cardiovascular market and in CHF in particular,” Herman told Med Ad News. “In the wake of Diovan’s patent expiry in September 2012, and launch of generics in many major markets, we expect that the company will plan for a global launch for LCZ-696 in order to fill the void left by Diovan. Novartis will capitalize on its existing marketing and distribution channels for the launch of LCZ-696, and the drug’s entry into the CHF market will be further facilitated by its anticipated initial approval and launch for hypertension.  Diovan is prescribed in both hypertension and CHF patients. Total sales of Diovan were 5.7 billion in 2011 before its patent expired. Following the footsteps of Diovan, LCZ-696 is expected to be first approved for hypertension and then for CHF. GlobalData predicts that LCZ-696 will make close to 2 billion by 2022 in the chronic heart failure market alone.”

Posted: June 2013