Expects FDA Decision Regarding New PDUFA Date by Mid-July
CHAPEL HILL, NC, USA I July 1, 2014 I POZEN Inc. (NASDAQ: POZN),a pharmaceutical company committed to transforming medicine that transforms lives, announced today that it has resubmitted the New Drug Application (NDA) for PA8140/PA32540 to the U.S. Food and Drug Administration (FDA). In accordance with the regulations, FDA is expected to notify POZEN within 14 days of receipt of the NDA whether or not the submission will be accepted, and if accepted, what the new PDUFA date will be. The FDA will determine whether a two month or six month review is necessary. Issues raised during an audit of the manufacturing facility producing an active ingredient used in the manufacture of the products were the only deficiencies noted in the Complete Response Letter (CRL) POZEN received on April 25, 2014. Final agreement on the draft product labeling is also pending.
“Our API supplier has been working to respond to the observations contained in the FDA inspector’s report. We recently completed our own onsite audit, and we understand that the supplier has now submitted a supplement to its May 9, 2014 initial response to the FDA,” said John Plachetka, chairman, president and CEO. “Based upon the available information, we believe there are actions in place that address the deficiencies noted by FDA.”
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. 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.
The Company’s common stock is traded under the symbol “POZN” on The NASDAQ Global Market. For more detailed company information, including copies of this and other press releases, please visit www.pozen.com.
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 PA8140, containing 81 mg of aspirin, and PA32540, containing 325 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 PA 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.
SOURCE: Pozen
Post Views: 26
Expects FDA Decision Regarding New PDUFA Date by Mid-July
CHAPEL HILL, NC, USA I July 1, 2014 I POZEN Inc. (NASDAQ: POZN),a pharmaceutical company committed to transforming medicine that transforms lives, announced today that it has resubmitted the New Drug Application (NDA) for PA8140/PA32540 to the U.S. Food and Drug Administration (FDA). In accordance with the regulations, FDA is expected to notify POZEN within 14 days of receipt of the NDA whether or not the submission will be accepted, and if accepted, what the new PDUFA date will be. The FDA will determine whether a two month or six month review is necessary. Issues raised during an audit of the manufacturing facility producing an active ingredient used in the manufacture of the products were the only deficiencies noted in the Complete Response Letter (CRL) POZEN received on April 25, 2014. Final agreement on the draft product labeling is also pending.
“Our API supplier has been working to respond to the observations contained in the FDA inspector’s report. We recently completed our own onsite audit, and we understand that the supplier has now submitted a supplement to its May 9, 2014 initial response to the FDA,” said John Plachetka, chairman, president and CEO. “Based upon the available information, we believe there are actions in place that address the deficiencies noted by FDA.”
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. 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.
The Company’s common stock is traded under the symbol “POZN” on The NASDAQ Global Market. For more detailed company information, including copies of this and other press releases, please visit www.pozen.com.
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 PA8140, containing 81 mg of aspirin, and PA32540, containing 325 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 PA 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.
SOURCE: Pozen
Post Views: 26
