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POZEN Reports Second Quarter 2013 Results
NDA for PA8140/PA32540 Accepted for Review by
Recent Corporate Highlights
POZENannounced that the U.S. Food and Drug Administration( FDA) accepted for review, the New Drug Application (NDA) for PA8140/PA32540. Both products are coordinated-delivery tablets combining immediate-release omeprazole (40 mg), a proton pump inhibitor (PPI), layered around a pH-sensitive coating of an aspirin core. The FDAhas assigned a user fee goal date of January 24, 2014. POZENis seeking approval for the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers.
Results from POZEN’s Phase 1 study, PA10040-101, demonstrated that
PA10040, POZEN’s proprietary combination of aspirin (100 mg) and
omeprazole (40 mg), had comparable bioavailability, and is
bioequivalent to a
European Union(E.U.) reference listed enteric-coated (EC) aspirin (100 mg). The 100 mg dose of aspirin is most commonly used in Europeand in other ex-U.S. regions.
- Data from a post-hoc analysis of diabetic subpopulation results from two POZEN Phase 3 PA32540 (325 mg EC aspirin / 40 mg immediate-release omeprazole) studies were presented at the American Diabetes Association’s 73rd Scientific Session. Nearly 40% of patients in the Phase 3 studies had diabetes and were on aspirin (325 mg) for secondary prevention of cardiovascular (CV) events. In this subpopulation (n=400), PA32540 was associated with a significantly lower rate of endoscopic gastroduodenal ulcers as compared to taking aspirin alone (2.3% vs. 11.2%, p<0.001). A lower rate of treatment discontinuation was also observed in this subpopulation (1.4% vs. 5.9%, p=0.018).
July 26, 2013, the United States Court of Appeals for the Federal Circuitdenied a petition by Par Pharmaceuticals Inc.(Par) and Doctor Reddy’s Laboratories (DRL) for a rehearing en banc in connection with its September 2012decision holding that U.S. Patent 7,332,183 covering the Treximet formulation was valid, enforceable and infringed by their respective Abbreviated New Drug Application (ANDA) products.
- Partnership discussions for PA continue to progress. While there can be no assurances, the Company continues to expect to close a partnership deal in 2013.
Q2 2013 global net sales of VIMOVO by
AstraZeneca, as defined under our agreement, were $23.3 million, up 19% from Q1 2013 and 41% vs. Q2 2012. POZENearned a royalty of $1.7 millionin Q2 2013, a 30% increase over Q2 2012. As discussed in our Q1 Earnings Call, AstraZenecais discontinuing certain promotional activities in countries where they have not seen a positive effect, including the U.S. and most of the E.U.
Second Quarter Results
For the second quarter of 2013,
Operating expenses for the second quarter of 2013 totaled
The Company reported a net loss of
First Half Results
For the first half of 2012 and 2013,
Operating expenses for the first half of 2013 totaled
The Company reported a net loss of
2013 Strategic Focus
The Company’s areas of strategic focus for 2013 remain: securing a
commercial partnership(s) for its PA products, completing the PA
regulatory submission(s) in the U.S. and potentially one or more other
regions of the world, and controlling expenses. The Company is
estimating a net cash burn of less than
Second Quarter Results Webcast
The Company's common stock is traded under the symbol “POZN” on The
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 administered orally once a day and an indication will be 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.
VIMOVO® (naproxen / esomeprazole magnesium) is a fixed-dose combination of delayed-release enteric-coated naproxen, a non-steroidal anti-inflammatory drug (NSAID), and immediate-release esomeprazole, a stomach acid-reducing proton pump inhibitor (PPI), approved for the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers.VIMOVO is not recommended for use in children younger than 18 years of age. VIMOVO is not recommended for initial treatment of acute pain because the absorption of naproxen is delayed compared to absorption from other naproxen-containing products. Controlled studies do not extend beyond 6 months.VIMOVO should be used at the lowest dose and for the shortest amount of time as directed by your health care provider.
For Full Prescribing Information see www.vimovo.com.
Statements included in this press release that are not historical in
nature are “forward-looking statements” within the meaning of the “safe
harbor” provisions of the Private Securities Litigation Reform Act of
1995. You should be aware that our actual results could differ
materially from those contained in the forward-looking statements, which
are based on current market data and research (including third party and
Statements of Operations
Three Months Ended
Six Months Ended
|Selling, general and administrative||3,713,032||4,070,707||7,347,076||9,718,630|
|Research and development||1,941,346||2,874,068||5,525,286||6,978,514|
|Total operating expenses||5,654,378||6,944,775||12,872,362||16,697,144|
|Interest and other income, net||15,382||72,663||40,434||141,300|
|Loss before income tax benefit||(3,987,996||)||(5,104,112||)||(9,765,928||)||(13,498,844||)|
|Income tax expense||—||—||—||—|
Net loss attributable to common
Basic and diluted net loss per common share
Shares used in computing basic and diluted net loss
|June 30,||December 31,|
|Cash and cash equivalents||$||76,931,505||$||68,416,308|
|Prepaid expenses and other current assets||263,550||858,423|
|Total current assets||78,846,055||89,524,867|
|Equipment, net of accumulated depreciation||54,957||71,945|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Total current liabilities||3,089,047||5,519,450|
|Total stockholders’ equity||75,811,965||84,077,362|
|Total liabilities and stockholders’ equity||$||78,901,012||$||89,596,812|
Bill Hodges, 919-913-1030
Chief Financial Officer
Stephanie Bonestell, 919-913-1030
Manager, Investor Relations & Public Relations