Daiichi Sankyo Enters Europe's Cholesterol Market
Nilemdo and Nustendi Approved
Executive Summary
The Japan-headquartered drugmaker says there is a need for affordable oral treatment options on top of currently available lipid-lowering therapies and the two drugs it licensed from Esperion can meet that need.
Having secured European approval for its cholesterol lowerer Nilemdo, Daiichi Sankyo Co. Ltd. now has the challenge of commercializing its first-in-class oral treatment in a crowded and competitively priced market.
The European Commission has approved both Nilemdo (bempedoic acid) and Nustendi (bempedoic acid/ezetimibe) for use in adults with primary hypercholesterolemia or mixed dyslipidemia in Europe. The green lights for the oral once-daily therapies are supported by a Phase III program in more than 4,000 patients which showed that Nilemdo provided up to 18% placebo corrected low-density lipoprotein cholesterol (LDL-C) lowering when used with moderate- and high-intensity statins.
The European rights to Nilemdo, which inhibits ATP citrate lyase (ACL), an enzyme involved in the production of cholesterol in the liver, and Nustendi were licensed by Daiichi Sankyo from Esperion Therapeutics Inc. at the beginning of 2019 for $150m upfront. Esperion, which stands to receive another $150m at the time of first commercial sale in Europe as well as up to $600m in other milestones and tiered royalties between 15% and 25%, got approval from the US Food and Drug Administration for the drugs in February this year where they are to be marketed as Nexletol and Nexlizet. (Also see "Asia Deal Watch: Boost For Esperion's Cholesterol Candidate As Daiichi Brought On Board" - Scrip, 8 Jan, 2019.) and (Also see "Esperion’s Nexletol Reaches The Cholesterol Market Priced To Sell" - Scrip, 21 Feb, 2020.)
Commenting on the European approvals, Kausik Ray of Imperial College London and a member of the Phase III steering committee for the drugs, said that Nilemdo "finally provides a preferred daily pill that easily fits into the routines of those struggling with high levels of bad cholesterol, which includes patients that are statin intolerant.” As for Nustendi, he added that "a single combination pill aids adherence, a critical factor to maintain long-term reductions in bad cholesterol.”
Despite the plethora of branded and generic cholesterol lowerers, the market still has considerable gaps. Up to 80% of patients do not reach recommended LDL-C goals despite receiving treatments such as statins, and are at increased risk of a heart attack or stroke.
"There is a clear need for additional, affordable, oral treatment options on top of currently available lipid-lowering therapies," Benoit Creveau, head of cardiovascular marketing at Daiichi Sankyo Europe, told Scrip. He noted that the company was currently in discussions with local health technology assessment bodies and claimed that Nilemdo and Nustendi "provide value for money at limited and predictable cost to payers for the management of high and very high cardiovascular risk patients who are not achieving appropriate LDL-C levels."
One of the impacts on the pharmaceutical industry of the COVID-19 pandemic has been on companies' strategies for marketing new products, with a prime example being Bristol-Myers Squibb Co.'s decision to postpone the launch of its recently-approved multiple sclerosis drug Zeposia (ozanimod). Creveau said that "all our launch activities are currently proceeding as planned and we aim to make Nilemdo and Nustendi available as soon as possible," although he acknowledged that "due to current circumstances, health authorities may give priority to vaccinations and therapies against COVID-19. (Also see "BMS Gets US Approval Of Ozanimod For Relapsing MS, But Launch Delayed" - Scrip, 26 Mar, 2020.)
When the time does come to launch, Daiichi Sankyo will not have to make major additions to its sales teams. Creveau said Nilemdo and Nustendi "are a perfect fit to the cardiovascular portfolio and we make full use of our current field force and the capabilities developed in the area, especially for our new oral anticoagulant (NOAC), the Factor Xa inhibitor Lixiana (edoxaban)." The Japan-headquartered firm has more than 1,000 professionals working on the commercialization of its cardiovascular medicines in Europe.
Creveau did not give any sales forecasts but the company will be hoping that Nilemdo and Nustendi make a better start than other recent entries to the cholesterol market. The injectable PCSK9 drugs launched for high cholesterol in 2015 – Amgen Inc.'s Repatha (evolocumab) and Regeneron Pharmaceuticals Inc./Sanofi's Praluent (alirocumab) – have failed to make any significant inroads into the space, despite significant price cuts.
Although reimbursement processes vary across the different markets in Europe, Daiichi Sankyo is expected to follow a pricing strategy similar to that employed by partner Esperion in the US where the wholesale acquisition cost of the drug is $10 per pill. However, Esperion claimed after approval stateside that patients could pay as little as $10 for a 90-day supply and CEO Tim Mayleben said in an interview with Scrip in January that "you have to make it convenient and easy and obviously inexpensive."