Mon, Mar. 9, 7:52 AM
- Pozen (POZN) Q4 results: Revenues: $9.9M (+110.6%); R&D Expense: $0.9M (-60.9%); SG&A: $2.2M (-52.2%); Net Income: $7M (+418.2%); EPS: $0.21 (+400.0%).
- FY2014 results: Revenues: $32.4M (+214.6%); R&D Expense: $5.7M (-42.4%); SG&A: $10.1M (-41.3%); Net Income: $19.7M (+218.0%); EPS: $0.60 (+209.1%); Quick Assets: $40.6M (+23.8%).
- No guidance given.
Mon, Mar. 9, 7:33 AM
Sun, Mar. 8, 5:30 PM
Fri, Jan. 9, 5:35 PM
Dec. 29, 2014, 7:44 AM
- Pozen (NASDAQ:POZN) and Cilag GmbH International terminate their license agreement for the development and commercialization of MT 400 in Brazil, Colombia, Ecuador and Peru. Under the terms of he contract, the partnership will terminate on January 21. At any time within two years after January 21, at Pozen's request, the parties will negotiate a supply agreement whereby Cilag will supply MT 400 to Pozen or its licensees for a period equal to the shorter of two years or Pozen's establishment of an alternative supplier.
- Pozen will recognize ~$257.3K in licensing revenue in Q4 as a result of the termination.
Dec. 17, 2014, 12:46 PM
Dec. 17, 2014, 9:13 AM
Dec. 17, 2014, 8:28 AM
- Pozen (NASDAQ:POZN) receives another Complete Response Letter (CRL) from the FDA pertaining to its application for Yosprala 81.40 and 325/40 (aspirin/omeprazole delayed release tablets). Again, the problem is manufacturing deficiencies at a facility of an ingredient maker. This time, though, there was no on-site inspection. The agency reviewer issued the CRL based on the perceived failure of the supplier to address the issues cited in the first CRL.
- According to Pozen, its supplier, in response to the first CRL received in April, submitted a complete plan of action to correct all the deficiencies. Since then, it provided updates to the regulator on its progress on the plan. The FDA did not communicate or comment on the information other than to say it was under review. Pozen hired a consultant to review the documents and communications with the supplier in order to assess the completeness of its response. The consultant determined that the issues had been adequately addressed.
- The company will seek a meeting with the FDA review team as soon as feasible to clarify the steps necessary for the approval of the NDA.
- POZN is off 23% premarket on average volume.
- Previously: Pozen receives a Complete Response Letter (April 28, 2014)
Dec. 15, 2014, 12:36 PM
- Added to the Nasdaq Biotechnology Index, effective Dec. 22: AAVL, AERI, AKBA, ALDR, ALIM, AMPH, ANIP, ASPX, CARA, CGEN, CLDN, CNCE, ENTA, FLML, FMI, FOLD, FPRX, GWPH, HPTX, ICPT, INO, INSM, KITE, KPTI, MGNX, OPHT, PCYC, PETX, POZN, PTX, QLTI, RARE, RCPT, RDUS, RLYP, RTRX, RVNC, SAGE, TBPH, TTPH, VSAR, XLRN, ZFGN, ZSPH.
- Deleted: AMRN, AUXL, CRIS, EXPR, ICEL, ONTX, RIGL, ZGNX.
- Source: Press Release
Dec. 1, 2014, 9:13 AM
Dec. 1, 2014, 7:41 AM
- Sanofi (NYSE:SNY) (OTCQB:SNYNF) and Pozen (NASDAQ:POZN) "mutually agree" to terminate their commercialization agreement for PA8140 and PA32540 effective November 29, 2014. All rights to the products will revert back to Pozen at that time.
- No specific reason (s) are disclosed explaining the move although Pozen will host a webcast this morning at 8:30 am ET to discuss the issue.
- Henceforward, the two products will be referred to as Yosprala 81/40 (enteric-coated aspirin 81 mg/immediate release omeprazole 40 mg) and Yosprala 325/40 (enteric-coated aspirin 325 mg/immediate release omeprazole 40 mg).
- The PDUFA date is December 30, 2014 for the FDA's review of Pozen's NDA resubmission. The company received a Complete Response Letter (CRL) on April 28, 2014 related to deficiencies noted during an on-site inspection of an ingredient maker.
- Pozen President & CEO Dr. John Plachetka says, Our goal at Pozen continues to be to maximize shareholder return. Management and the BOD are taking this opportunity to evaluate all strategic options for Yosprala and Pozen. With respect to how well Yosprala may perform in the marketplace, we believe that the clinical profile of the drug, as described in the current FDA-proposed package insert, will meet or exceed the assumptions we made when we started our development and evaluated the commercial potential for this product."
- POZN shares are off 10% premarket on light volume.
- Previously: Pozen soars on Sanofi deal
- Previously: Pozen receives a Complete Response Letter
- Previously: Pozen resubmits NDA
- Previously: PDUFA date set for PA8140/PA32540
Nov. 6, 2014, 7:44 AM
Aug. 20, 2014, 9:03 AM
- Pernix Therapeutics Holdings (NASDAQ:PTX) finalizes its acquisition of the U.S. commercial rights to GlaxoSmithKline's (NYSE:GSK) Treximet (sumatriptan/naproxen sodium). Pernix has expanded its sales force to 100 to support the marketing of the product which it plans to launch next month.
- Under the terms of the deal, Pernix paid GSK an upfront payment of $250M, an additional payment of $17M upon the resolution of the recent supply constraint and royalty payments of 18% of sales (minimum: $4M/qtr). GSK assigned the product development and commercialization agreement (PDC Agreement) between GSK and Pozen (NASDAQ:POZN) to Pernix.
- Updated 2014 guidance: revenue: $110M - 120M; non-GAAP EBITDA: $22M - 24M.
- 2015 guidance: revenue: ~$230M; non-GAAP EBITDA: ~$95M.
Aug. 7, 2014, 12:02 PM
Aug. 7, 2014, 7:36 AM
Aug. 5, 2014, 7:57 AM
- Horizon Pharma (NASDAQ:HZNP) reports that Pozen (NASDAQ:POZN) has received notices of allowance from the USPTO for two patent applications that cover Vimovo (naproxen/esomeprazole magnesium) delayed release tablets. The patents are entitled "Pharmaceutical Compositions for the Coordinated Delivery of NSAIDs." The patents, when issued, should be in effect until 2022.
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