Daiichi Sankyo, Inc. and Forest Laboratories, Inc. announced that they have signed a Letter of Intent to enter into a definitive co-promotion agreement in the United States for Azor.
Azor is a fixed-dose combination of two antihypertensives, the calcium channel blocker amlodipine besylate and the angiotensin receptor blocker olmesartan medoxomil.
Daiichi Sankyo filed a New Drug Application (NDA) in November 2006 for the fixed-dose combination of the two antihypertensives. This investigational agent is currently under regulatory review in the United States by the Food and Drug Administration, including trade name review, with a decision anticipated by late September.
"The signing of the Letter of Intent with Forest to co-promote Azor provides us with important additional resources to support this product as we continue to increase the size of our own sales force," said Joseph P. Pieroni, president and CEO, Daiichi Sankyo. "The additional resources allow us to realize the full potential of Azor. Our existing arrangement with Forest on Benicar (olmesartan medoxomil) and Benicar HCT (olmesartan medoxomil-hydrochlorothiazide) is nearing the end of its active co-promotion term. This relationship has been a very successful one for both companies, and we are pleased to begin a new arrangement with our valued partner."
Under the terms of the Letter of Intent, Forest will pay Daiichi Sankyo an upfront payment of $20 million. Forest will enter into a co-promotion arrangement in the US, providing an agreed minimum number of product details, and will receive an annual co-promotion payment based upon US product net sales. Daiichi Sankyo will record product sales and bear all marketing and development expenses for the product during the term of the agreement. The amount of Forest's payment will be determined by annual sales levels of Azor, with Forest eligible to receive higher levels of payment based upon the product achieving undisclosed pre-specified sales targets in the US.
The term of the agreement is six years. Forest and Daiichi Sankyo will co-promote the product during the first three years of promotion followed by a three-year period of residual payments to Forest from Daiichi Sankyo during which Forest will no longer co-promote the product. Additional financial terms were not disclosed.
Howard Solomon, chairman and chief executive of Forest, commented: "We are pleased to build upon a successful partnership with Daiichi Sankyo that began with our initial co-promotion agreement for Benicar in 2001. During the ensuing years we have fostered a strong relationship and believe that the agreement for Azor wills only further the strength and the success of the partnership."
Hypertension, also known as high blood pressure, affects approximately 72 million people in the United States and approximately one billion worldwide. It is often difficult to control, and of those diagnosed with high blood pressure, 64.9 percent do not have the condition under control. The number of people with high blood pressure is expected to reach about 1.6 billion worldwide by 2025.
Daiichi Sankyo, Inc., headquartered in Parsippany, New Jersey, is the US subsidiary of Daiichi Sankyo Co., Ltd., Japan's second largest pharmaceutical company and a global leader in pharmaceutical innovation since 1899.