Exelixis (EXEL) announced that Daiichi Sankyo (“Daiichi Sankyo”) reported positive top-line results from a phase 3 pivotal trial of esaxerenone for essential hypertension in Japan. The product is the fruit of the collaboration agreement signed by both firms back in 2006.
More than ten years ago, in March 2006, Daiichi Sankyo and Exelixis signed a research collaboration agreement to discover, develop and commercialize treatments that target the mineralocorticoid receptor (MR). The outcome of the research collaboration was a product the firms called Esaxerenone, which is an oral selective blocker of the MR. The drug was subsequently developed by Daiichi Sankyo.
Why targeting the nuclear hormone receptor?
Because this receptor is implicated in cardiovascular and metabolic diseases. That’s why Esaxerenone has the potential to treat essential hypertension and congestive heart failure.
Under the terms of the agreement:
Daiichi Sankyo has exclusive global development, manufacturing, and commercialization rights for the compounds.
Exelixis is eligible for substantial clinical development, regulatory, and commercialization milestones, as well as double-digit royalties on sales
For Essential Hypertension
THE TRIAL ESAX-HTN
The trial ESAX-HTN is a randomized, double-blind, three-arm parallel group comparison study evaluating the efficacy and safety of esaxerenone versus eplerenone in patients with essential hypertension in Japan.
The primary endpoint: Sitting systolic blood pressure (SBP)/diastolic blood pressure (DBP) change from baseline after 12 weeks of treatment.
The secondary endpoint: Is mean 24-hour SBP/DBP change from baseline after 12 weeks of treatment.
The trial achieved its primary endpoint and Daiichi Sankyo announced its intention to submit a Japanese regulatory application for esaxerenone as an essential hypertension indication in the first quarter of 2018. Daiichi Sankyo plans to disclose the detailed study results at future scientific meetings.
For Type 2 Diabetes
THE TRIAL ESAX-DN
Daiichi Sankyo also announced the initiation of the ESAX-DN trial in patients with type-2 diabetes with microalbuminuria who are taking an angiotensin II receptor blocker or an angiotensin-converting enzyme (ACE) inhibitor in Japan.
The primary endpoint is the rate of remission to normo-albuminuria after 52 weeks of treatment.
The secondary endpoints are the change rate in urinary albumin creatinine ratio (UACR) and estimated glomerular filtration rate (eGFR).
There are an around 43 million patients with hypertension in Japan, which accounts for 60% of men and 45% of women over the age of 30 in the general Japanese population.
Only 30% of men and 40% of women with hypertension treated with antihypertensive medication achieve the goal of systolic and diastolic blood pressure lower than 140/90mm Hg.
Essential hypertension is the most common form of hypertension affecting 90% of hypertensive people. It is the outcome of genetic and factors lifestyle habits.
Secondary hypertension is associated with underlying disease factors.
Diabetic Nephropathy is one of the most significant long-term complications in terms of morbidity and mortality for individual patients with diabetes. In Japan, approximately 10 million people, or 12.1% of the population, are estimated to have diabetes. Diabetic nephropathy is the leading cause of dialysis (43.7%, 2015) in Japan.
Recent studies have shown beneficial effects of adding MR blockers to the usual treatments given to patients with type-2 diabetes with nephropathy. As a non-steroidal, selective mineralocorticoid blocker esaxerenone has the potential to treat hypertension, diabetic nephropathy and congestive heart failure, in addition to providing protection from end-organ damage due to vascular complications.
When it comes to signing collaborative agreements with large drug companies, Exelixis’ management has always acted in favor of its shareholders. Exelixis is one of rare biotech firms that own their first two approved products. The revenues from the products’ sales end up in Exelixis’ coffers.
The agreement with Daiichi Sankyo over the mineralocorticoid blocker saxerenone for essential hypertension and other applications is fair for both companies. The upfront payments and milestone payments Exelixis has received and the royalties on the sales of the product, which the firm will continue to receive as long as the product is selling will help finance the marketing of Exelixis’ approved products, in addition to financing more clinical trials of combinations treatments with Exelixis products plus immunotherapy drugs or other drugs.
That’s why we like EXEL.
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