The original deal struck in September last year saw Sanofi gain exclusive US marketing rights to two enteric-coated aspirin formulations - PA8140 and PA32540 – developed by Pozen in return for an upfront fee, milestone payments and future sales royalties.
The tablets combine 40mg immediate-release omeprazole, a proton pump inhibitor, layered around an aspirin core coated in pH sensitive material and are designed to reduce the risk of ulcers and other gastro intestinal problems.
Neither firm gave reasons for terminating the agreement which, despite problems with an active pharmaceutical ingredient supplier in April, looked to be on track as recently as November 6.
Speaking during Pozen’s third quarter results presentation, CEO John Plachetka predicted that his firm would receive milestone payments from Sanofi in the first half of 2015 – see Seekingalpha transcript.
“There is a total of $20m in pre-commercialization milestone from Sanofi yet to be earned which will occur in the first half of 2015 assuming approval or launch of PA and our royalty on sales for PA in the United States will range from 12.5% to 22.5% of net sales.”
Termination
In a statement last night Plachetka said: “Our goal at Pozen continues to be to maximize shareholder return. Management and the Board of Directors are taking this opportunity to evaluate all strategic options for Yosprala [the proposed tradename] and Pozen,"
He added that: "With respect to how well Yosprala may perform in the marketplace, we believe that the clinical profile of the drug, as described in the current FDA-proposed package insert, will meet or exceed the assumptions we made when we started our development and evaluated the commercial potential for this product."
The PDUFA date for Pozen’s aspirin formulations is set for December 30. News of the Sanofi deal’s collapse was accompanied by a 10% drop in Pozen’s share price.