More Bad News For Pozen: Another Delay To Market For Yosprala
This article was originally published in The Pink Sheet Daily
Executive Summary
The company received a second “complete response” letter from FDA for Yosprala, its fixed-dose combination of aspirin and omeprazole, due to issues with the undisclosed third-party supplier.
Aralez Pharmaceuticals Inc. expects a delay of up to eight months for its fixed-dose combination pill Yosprala to reach the market after receiving a second “complete response” letter from FDA, the firm announced Dec. 17.
The second action letter, like the first, cited manufacturing deficiencies by Pozen’s undisclosed third-party active ingredient supplier. The CRL came just ahead of the NDA’s Dec. 30 PDUFA date.
There are no clinical issues with the components, which are available over-the-counter and generically, enteric-coated aspirin and the proton pump inhibitor omeprazole (AstraZeneca PLC’s Prilosec plus generics). It is being developed for reducing gastric toxicities associated with the daily use of aspirin to prevent cardiac events. The drug is under review in two dosage forms.
The second “complete response” letter includes “an identical comment to that contained in the first,” CEO John Plachetka said during a same-day conference call. Specifically, FDA cited manufacturing deficiencies with the third-party supplier that need to be resolved before the application can be approved.
Nonetheless, Plachetka insisted the issues have been addressed and that FDA has not re-inspected the facility or responded to the manufacturer’s response.
“It appears that six months was not enough time for the compliance division to get this reviewed,” he said. “However, as of today, Pozen and the manufacturer believe that these deficiencies have been adequately addressed.”
Pozen plans to immediately request a Type A meeting with FDA to discuss the action letter, hopefully including both the review team and representatives from the compliance division, he added. A Type A meeting is generally granted within 30 days.
“From there, it is very simple on our part since it requires no new substantive information from us,” Plachetka added. Once the facility is determined to have fixed the deficiencies, he said FDA could grant either a two-month or six-month review of the NDA, pushing back approval possibly to August if a six-month review is granted.
Switching manufacturers at this stage would be a “substantial time investment,” he said when questioned by investors about that possibility. “The solution here that we believe is achievable is to get the compliance division to evaluate the progress made in this facility and to give us any feedback whatsoever as to what else needs to be done.”
Seeking A New Partner Too
The disappointing news is piling on for Pozen, coming just weeks after the company lost its big pharma partner for Yosprala, Sanofi (Also see "Pozen Says Yosprala On Track For Approval Despite Losing Sanofi As Partner" - Pink Sheet, 1 Dec, 2014.). Pozen said at the time that there had been no new communication from FDA that would have prompted Sanofi to pull out of the deal. The big pharma said it decided to end the commercialization collaboration, weeks after firing CEO Christopher Viehbacher, after reassessing the strategic fit following delayed approval of the product.
When it signed the deal with Sanofi, Pozen had anticipated FDA approval of the two dosage forms in January 2014. But FDA requested Pozen run a Phase I pharmacokinetic study before completing the NDA review. Eventually, FDA issued the initial “complete response” letter in April 2014 due to the manufacturing concerns. Pozen resubmitted the NDA July 1.
The latest delay may make it more challenging for Pozen to sign a new commercial partner, as management has said it is looking to do.
But Plachetka said the silver lining in the delay is that the company had already estimated it would take a new partner months to be in a position to launch Yosprala.
“We have estimated that the earliest launch date any new company can meet is the second quarter of 2015 and likely the third quarter,” he told investors. “We will not be wasting nearly as much and maybe any of our three-year product exclusivity.”
Sanofi first partnered with Pozen on the drug in September 2013, agreeing to pay $15 million up front in exchange to market the drug in the U.S. and another $20 million in pre-sale milestones [See Deal].