CHAPEL HILL, NC, USA I April 25, 2014 I POZEN Inc. (NASDAQ: POZN),a pharmaceutical company committed to transforming medicine that transforms lives, announced today that their drug candidates PA8140/PA32540 (aspirin and omeprazole) delayed release tablets have received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA). A CRL is issued by the FDA when the review of the file is completed and questions remain that preclude the approval of the new drug application (NDA) in its current form.
In the CRL, the FDA noted that, during an inspection of the manufacturing facility of an active ingredient supplier that concluded this week, inspection deficiencies were found. Satisfactory resolution of deficiencies noted by the field investigator is required before the NDA may be approved. POZEN believes that these manufacturing facility items can be addressed and will be working with the manufacturer to respond to the FDA as soon as possible. There were no clinical or safety deficiencies noted with respect to either PA8140 or PA32540 and no other deficiencies were noted in the CRL. Final agreement on the draft product labeling is also pending.
“Although we were hopeful for a first cycle approval, we believe that the issues raised during the inspection can be remedied to the satisfaction of the FDA. The timing of the inspection of this facility was unfortunate as the final inspection report was only issued today. Because it occurred so close to our PDUFA date, there was no opportunity to address the issues raised,” said John R. Plachetka, Chairman, President and Chief Executive Officer. “We don’t want to speculate on the timing of the resubmission of the NDA, or the timeline for eventual FDA action on that resubmission until we have had a chance to talk again with all the concerned parties, including the FDA. We will move as quickly as we can to resolve any outstanding issues. We hope to be able to provide more information about timing during our earnings call on May 8th.”
About PA
POZEN has created a portfolio of investigational integrated aspirin therapies – the PA product platform. The products in the PA portfolio are being developed with the goal of significantly reducing GI ulcers and other GI complications compared to taking enteric-coated or plain aspirin alone.
The first candidates are PA32540, containing 325 mg of aspirin, and PA8140, containing 81 mg of aspirin. Both products are a coordinated-delivery tablet combining immediate-release omeprazole (40 mg), a proton pump inhibitor, layered around a pH-sensitive coating of an aspirin core. This novel, patented product is intended for oral administration once a day and an indication is being sought for use for the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers.
Proposed PA8140/PA32540 Indications and Usage (Pending FDA Review and Approval)
PA8140/PA32540 Tablets contain 81 mg or 325 mg delayed release aspirin and 40 mg immediate-release omeprazole and are indicated for patients who require aspirin (1) to reduce the combined risk of death and nonfatal stroke in patients who have had ischemic stroke or transient ischemia of the brain due to fibrin platelet emboli, (2) to reduce the combined risk of death and nonfatal MI in patients with a previous MI or unstable angina pectoris, (3) to reduce the combined risk of MI and sudden death in patients with chronic stable angina pectoris, (4) in patients who have undergone revascularization procedures (CABG, PTCA) when there is a pre-existing condition for which aspirin is already indicated, and to decrease the risk of developing gastric ulcers in patients at risk for developing aspirin-associated gastric ulcers.
Controlled studies with PA8140/PA32540 Tablets do not extend beyond 6 months.
About POZEN
POZEN Inc. is a small pharmaceutical company that specializes in developing novel therapeutics for unmet medical needs and licensing those products to other pharmaceutical companies for commercialization. By utilizing a unique in-source model and focusing on integrated therapies, POZEN has successfully developed and obtained FDA approval of two self-invented products in two years. Funded by these milestones/royalty streams, POZEN has created a portfolio of cost-effective, evidence-based integrated aspirin therapies designed to enable the full power of aspirin by reducing its GI damage.
POZEN is currently seeking strategic partners to help maximize the opportunities for its portfolio assets.
SOURCE: POZEN
Post Views: 37
CHAPEL HILL, NC, USA I April 25, 2014 I POZEN Inc. (NASDAQ: POZN),a pharmaceutical company committed to transforming medicine that transforms lives, announced today that their drug candidates PA8140/PA32540 (aspirin and omeprazole) delayed release tablets have received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA). A CRL is issued by the FDA when the review of the file is completed and questions remain that preclude the approval of the new drug application (NDA) in its current form.
In the CRL, the FDA noted that, during an inspection of the manufacturing facility of an active ingredient supplier that concluded this week, inspection deficiencies were found. Satisfactory resolution of deficiencies noted by the field investigator is required before the NDA may be approved. POZEN believes that these manufacturing facility items can be addressed and will be working with the manufacturer to respond to the FDA as soon as possible. There were no clinical or safety deficiencies noted with respect to either PA8140 or PA32540 and no other deficiencies were noted in the CRL. Final agreement on the draft product labeling is also pending.
“Although we were hopeful for a first cycle approval, we believe that the issues raised during the inspection can be remedied to the satisfaction of the FDA. The timing of the inspection of this facility was unfortunate as the final inspection report was only issued today. Because it occurred so close to our PDUFA date, there was no opportunity to address the issues raised,” said John R. Plachetka, Chairman, President and Chief Executive Officer. “We don’t want to speculate on the timing of the resubmission of the NDA, or the timeline for eventual FDA action on that resubmission until we have had a chance to talk again with all the concerned parties, including the FDA. We will move as quickly as we can to resolve any outstanding issues. We hope to be able to provide more information about timing during our earnings call on May 8th.”
About PA
POZEN has created a portfolio of investigational integrated aspirin therapies – the PA product platform. The products in the PA portfolio are being developed with the goal of significantly reducing GI ulcers and other GI complications compared to taking enteric-coated or plain aspirin alone.
The first candidates are PA32540, containing 325 mg of aspirin, and PA8140, containing 81 mg of aspirin. Both products are a coordinated-delivery tablet combining immediate-release omeprazole (40 mg), a proton pump inhibitor, layered around a pH-sensitive coating of an aspirin core. This novel, patented product is intended for oral administration once a day and an indication is being sought for use for the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers.
Proposed PA8140/PA32540 Indications and Usage (Pending FDA Review and Approval)
PA8140/PA32540 Tablets contain 81 mg or 325 mg delayed release aspirin and 40 mg immediate-release omeprazole and are indicated for patients who require aspirin (1) to reduce the combined risk of death and nonfatal stroke in patients who have had ischemic stroke or transient ischemia of the brain due to fibrin platelet emboli, (2) to reduce the combined risk of death and nonfatal MI in patients with a previous MI or unstable angina pectoris, (3) to reduce the combined risk of MI and sudden death in patients with chronic stable angina pectoris, (4) in patients who have undergone revascularization procedures (CABG, PTCA) when there is a pre-existing condition for which aspirin is already indicated, and to decrease the risk of developing gastric ulcers in patients at risk for developing aspirin-associated gastric ulcers.
Controlled studies with PA8140/PA32540 Tablets do not extend beyond 6 months.
About POZEN
POZEN Inc. is a small pharmaceutical company that specializes in developing novel therapeutics for unmet medical needs and licensing those products to other pharmaceutical companies for commercialization. By utilizing a unique in-source model and focusing on integrated therapies, POZEN has successfully developed and obtained FDA approval of two self-invented products in two years. Funded by these milestones/royalty streams, POZEN has created a portfolio of cost-effective, evidence-based integrated aspirin therapies designed to enable the full power of aspirin by reducing its GI damage.
POZEN is currently seeking strategic partners to help maximize the opportunities for its portfolio assets.
SOURCE: POZEN
Post Views: 37
