AstraZeneca and Ardelyx have announced a worldwide exclusive licensing agreement for Ardelyx’s NHE3 inhibitor program, including the Phase II-ready lead compound RDX5791, for treating end-stage renal disease and chronic kidney disease. Under the agreement, AstraZeneca will pay $35 million up front, with development milestones of $237.5 million and milestones related to launch and commercialization, as well as tiered, double-digit royalties. AstraZeneca will assume the subsequent development costs and Ardelyx will conduct clinical trials in Phase II. As part of the transaction, Ardelyx has secured an option to copromote the product in the US, subject to agreed limitations. Read More

Mayne Pharma has agreed to acquire the CDMO Metrics for an upfront payment of $105 million, plus further payments of up to $15 million based on fiscal year (FY) 2013 performance. The deal is subject to regulatory approval and customary closing conditions. Read More

Sanofi and Bristol-Myers Squibb (BMS) have restructured their long-term alliance following the loss of exclusivity of Plavix (clopidogrel bisulfate) and Avapro (irbesartan)/Avalide (hydrochlorothiazide; irbesartan) in several major markets. Under the revised agreement, which will go into effect Jan. 1, 2013, BMS will return to Sanofi its rights to Plavix and Avapro/Avalide in all markets worldwide with the exception of Plavix in the US and Puerto Rico, giving Sanofi sole control and freedom to operate commercially. In exchange, BMS will receive royalty payments on Sanofi’s sales of branded and unbranded Plavix worldwide, excluding the US and Puerto Rico, and on sales of branded and unbranded Avapro/Avalide worldwide, in each case through 2018, and will receive a terminal payment of $200 million from Sanofi in December 2018. Plavix rights in the US and Puerto Rico will continue unchanged under the existing agreement through December 2019. Read More

A roundup of additional company and people news from pharmaceutical and biopharmaceutical companies, their suppliers, and contract-service providers. Read More