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2014 POZEN News Archive

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12/17/14POZEN’s YOSPRALA™ Receives Complete Response Letter from The FDA
CHAPEL HILL, N.C.--(BUSINESS WIRE)--Dec. 17, 2014-- POZEN Inc. (NASDAQ: POZN), a pharmaceutical company committed to transforming medicine that transforms lives, announced today that their investigational drug candidates YOSPRALA™ 81/40 and 325/40 (aspirin / omeprazole delayed release tablets) have received a second 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 fi... 
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12/01/14POZEN Inc. and Sanofi US Mutually Agree to Terminate U.S. Partnership for PA8140/PA32540
FDA Provides Preliminary Approval for Tradename ‘YOSPRALA’ Pending Approval of the PA8140/PA32540 NDA CHAPEL HILL, N.C.--(BUSINESS WIRE)--Dec. 1, 2014-- POZEN Inc. (NASDAQ: POZN), a pharmaceutical company committed to transforming medicine that transforms lives, today announced that it and Sanofi US have mutually agreed to terminate their agreement for commercialization of the investigational products, PA8140 and PA32540 effective November 29,... 
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11/06/14POZEN Reports Third Quarter 2014 Results
Reports Net Income of $6.8 million, Including VIMOVO Royalty of $5.5 million CHAPEL HILL, N.C.--(BUSINESS WIRE)--Nov. 6, 2014-- POZEN Inc. (NASDAQ: POZN), a pharmaceutical company committed to transforming medicine that transforms lives, today announced results for the third quarter ended September 30, 2014. Corporate Highlights POZEN reported net income of $6.8 million for the third quarter, including $2.8 m... 
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10/30/14POZEN Announces November 6th Webcast of Third Quarter 2014 Results
CHAPEL HILL, N.C.--(BUSINESS WIRE)--Oct. 30, 2014-- POZEN Inc. (NASDAQ: POZN), a pharmaceutical company committed to transforming medicine that transforms lives, announced today that it plans to release third quarter 2014 results on November 6, 2014, before the market opens. The announcement will be followed by a live webcast at 11:00 a.m. (ET) with a discussion by POZEN management of the earnings and business results. The webcast can be a... 
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10/23/14POZEN Announces Receipt of Three Patents from the United States Patent and Trademark Office
CHAPEL HILL, N.C.--(BUSINESS WIRE)--Oct. 23, 2014-- POZEN Inc. (NASDAQ: POZN), a pharmaceutical company committed to transforming medicine that transforms lives, today announced that it has received three patents from the United States Patent and Trademark Office (USPTO), entitled “Pharmaceutical Compositions for the Coordinated Delivery of NSAIDs” that cover the U.S. approved product VIMOVO® (naproxen / esomeprazole magnesium) delayed-release tab... 
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08/20/14POZEN Announces U.S. Rights For TREXIMET® Have Been Acquired by Pernix Therapeutics
POZEN Receives Pernix Warrants and ROW Rights to Treximet CHAPEL HILL, N.C.--(BUSINESS WIRE)--Aug. 20, 2014-- POZEN Inc. (NASDAQ: POZN), a pharmaceutical company committed to transforming medicine that transforms lives, today announced that the acquisition of all of GlaxoSmithKline’s (GSK) rights to Treximet® (sumatriptan / naproxen sodium) have been acquired by Pernix Therapeutics Holdings, Inc. (Pernix). The previously announced transaction ... 
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08/07/14POZEN Reports Second Quarter 2014 Results
Record Quarterly VIMOVO® Sales Generate >$5.4 Million Royalty CHAPEL HILL, N.C.--(BUSINESS WIRE)--Aug. 7, 2014-- POZEN Inc. (NASDAQ: POZN), a pharmaceutical company committed to transforming medicine that transforms lives, today announced results for the second quarter and first half ended June 30, 2014. Corporate Highlights POZEN reported net income of $3.0 million for the second quarter and, base... 
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07/24/14POZEN Announces August 7th Webcast of Second Quarter 2014 Results
CHAPEL HILL, N.C.--(BUSINESS WIRE)--Jul. 24, 2014-- POZEN Inc. (NASDAQ: POZN), a pharmaceutical company committed to transforming medicine that transforms lives, announced today that it plans to release second quarter 2014 results on August 7, 2014, before the market opens. The announcement will be followed by a live webcast at 11:00 a.m. (ET) with a discussion by POZEN management of the earnings and business results. The webcast can be ac... 
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07/16/14POZEN Announces FDA Acceptance of Refiling of New Drug Application for PA8140/PA32540 Tablets
CHAPEL HILL, N.C.--(BUSINESS WIRE)--Jul. 16, 2014-- POZEN Inc. (NASDAQ: POZN), a pharmaceutical company committed to transforming medicine that transforms lives, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review, the resubmission of the New Drug Application (NDA) for PA8140/PA32540. The FDA also indicated the NDA would be treated as a Class 2 resubmission; therefore, the new user fee goal date is December 30,... 
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07/01/14POZEN Resubmits PA8140/PA32540 NDA
Expects FDA Decision Regarding New PDUFA Date by Mid-July CHAPEL HILL, N.C.--(BUSINESS WIRE)--Jul. 1, 2014-- 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 rece... 
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05/14/14POZEN Announces U.S. Rights for Treximet® to Be Acquired by Pernix Therapeutics
POZEN to Receive Pernix Warrants and ROW Rights to Treximet CHAPEL HILL, N.C.--(BUSINESS WIRE)--May 14, 2014-- POZEN Inc. (NASDAQ: POZN), a pharmaceutical company committed to transforming medicine that transforms lives, today announced that GlaxoSmithKline (GSK) will divest all of its rights to Treximet® (sumatriptan / naproxen sodium) to Pernix Therapeutics Holdings, Inc. (Pernix). As part of the Divestiture, GSK will assign the Product Deve... 
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05/08/14POZEN Reports First Quarter 2014 Results
Net Income Increases to $2.9 Million on Rise in VIMOVO U.S. Royalty CHAPEL HILL, N.C.--(BUSINESS WIRE)--May 8, 2014-- POZEN Inc. (NASDAQ: POZN), a pharmaceutical company committed to transforming medicine that transforms lives, today announced results for the first quarter ended March 31, 2014. Corporate Highlights POZEN reported net income of $2.9 million for the first quarter and expects to be profitable for the y... 
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05/01/14POZEN Announces May 8th Webcast of First Quarter 2014 Results
CHAPEL HILL, N.C.--(BUSINESS WIRE)--May 1, 2014-- POZEN Inc. (NASDAQ: POZN), a pharmaceutical company committed to transforming medicine that transforms lives, announced today that it plans to release first quarter 2014 results on May 8, 2014, before the market opens. The announcement will be followed by a live webcast at 11:00 a.m. (ET) with a discussion by POZEN management of the earnings and business results. The webcast can be accessed... 
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04/25/14POZEN’S PA8140/PA32540 Receives a Complete Response Letter From FDA Citing Issues at a Facility of a Third Party Supplier of an Active Ingredient
CHAPEL HILL, N.C.--(BUSINESS WIRE)--Apr. 25, 2014-- 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 tha... 
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04/02/14Pozen Submits Final Study Report for PA8140/PA32540 Phase 1 Study on Schedule
CHAPEL HILL, N.C.--(BUSINESS WIRE)--Apr. 2, 2014-- POZEN Inc. (NASDAQ: POZN), a pharmaceutical company committed to transforming medicine that transforms lives, announced today that they have submitted the final study report for the Phase 1 study comparing the pharmacokinetic profile of the omeprazole component of PA8140 tablets to that of PA32540 tablets as agreed with the U.S. Food and Drug Administration. About POZEN POZE... 
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03/05/14POZEN Reports Fourth Quarter & Year End 2013 Results
Company Confirms Strategic Goals of Maximizing Shareholder Value, Expense Control and Returning Excess Cash to Shareholders CHAPEL HILL, N.C.--(BUSINESS WIRE)--Mar. 5, 2014-- POZEN Inc. (NASDAQ: POZN), a pharmaceutical company committed to transforming medicine that transforms lives, today announced results for the fourth quarter and year ended December 31, 2013. 2013 and Recent Corporate Highlights In ... 
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03/04/14POZEN to Present at the Roth Capital Partners 26th Annual Growth Stock Conference
CHAPEL HILL, N.C.--(BUSINESS WIRE)--Mar. 4, 2014-- POZEN Inc. (NASDAQ: POZN), a pharmaceutical company committed to transforming medicine that transforms lives, announced today that John R. Plachetka, Pharm.D., the Company’s Chairman, President and Chief Executive Officer, will present at the ROTH Capital Partners 26th Annual Conference on Monday, March 10, 2014 at 12:00 p.m. (PT) at The Ritz Carlton in Dana Point, California. The presentation will be we... 
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02/26/14POZEN Announces March 5th Webcast of Fourth Quarter and Year End 2013 Results
CHAPEL HILL, N.C.--(BUSINESS WIRE)--Feb. 26, 2014-- POZEN Inc. (NASDAQ: POZN), a pharmaceutical company committed to transforming medicine that transforms lives, announced today that it plans to release fourth quarter and year end 2013 results on March 5, 2014, before the market opens. The announcement will be followed by a live webcast at 11:00 a.m. (ET) with a discussion by POZEN management of the earnings and business results. The webca... 
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01/02/14POZEN Announces Appointment of Dennis McNamara to Senior Vice President and Chief Business Officer
CHAPEL HILL, N.C.--(BUSINESS WIRE)--Jan. 2, 2014-- POZEN Inc. (NASDAQ: POZN), a pharmaceutical company committed to transforming medicine that transforms lives, today announced the promotion of Dennis McNamara to Senior Vice President and Chief Business Officer. Mr. McNamara is responsible for leading corporate development, alliance management and intellectual property efforts at POZEN. Prior to this appointment, Mr. McNamara held the position of ... 
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