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News Breaks
May 14, 2014
07:32 EDTPOZN, GSK, PTXPernix Therapeutics to acquire TREXIMET tablets for migrain from GlaxoSmithKline
Pernix Therapeutics Holdings (PTX) announced that it has signed an agreement with GlaxoSmithKline (GSK) to acquire the U.S rights to Treximet for the acute treatment of migraine attacks with or without aura in adults. Pernix’s team of approximately 90 specialty sales professionals will support the sales and marketing of Treximet. The transaction: Adds immediate revenues and earnings, FY13 Treximet net sales $78.7M; Leverages Pernix’s existing sales presence and experience across psychiatry and neurology customers; Expected to nearly double Pernix revenues and provide EBITDA margins in excess of 30% on a FY14 pro forma basis; Pernix estimates pro forma FY15 total company revenues will exceed $230M with an EBITDA margin of over 40%. Pernix will make an upfront payment to GSK of $250M for the U.S rights to Treximet. GSK will assign to Pernix the Product Development and Commercialization Agreement between GSK and POZEN (POZN). POZEN and Pernix will amend the PDC Agreement to facilitate further development of Treximet. Pernix expects to begin sales of Treximet immediately following the closing of the transaction with its approximately 90 sales professionals to specific targets in the Neurology, Psychiatry and the Primary Care audiences. Pernix also plans to seek an extension of the exclusivity of Treximet with the first ever pediatric indication for any sumatriptan treatment, expected to file by the end of 2014, as well as additional life-cycle opportunities that are currently being explored. Pernix will pay GSK additional consideration of $17M upon receipt of updated FDA Written Request for pediatric exclusivity.
News For PTX;GSK;POZN From The Last 14 Days
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February 8, 2016
14:58 EDTPTXPernix Therapeutics exploring strategic alternatives, Reuters says
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14:54 EDTPTXPernix Therapeutics exploring strategic alternatives, Reuters reports
08:10 EDTGSKOncoMed: FDA says PINNACLE trial should continue under supervision
Following notification of the ALPINE DSMB's findings, OncoMed (OMED) initiated interactions with tarextumab clinical investigators, partner GlaxoSmithKline (GSK), the FDA and the PINNACLE trial's DSMB chairperson to assess potential impact of these results on the overall development program, including the ongoing Phase 2 PINNACLE trial in small-cell lung cancer patients. PINNACLE trial investigators received an addendum to the informed consent form that included a description of the interim analysis from ALPINE. The FDA and the PINNACLE DSMB were provided unblinded data from both Phase 2 trials, a description of OncoMed's exploratory analysis of the ALPINE results and related trial materials for review. The independent analyses of the FDA and PINNACLE DSMB indicated that the PINNACLE trial could continue under the supervision of the PINNACLE DSMB monitoring for safety and efficacy and that appropriate safeguards are in place. OncoMed is conducting the PINNACLE Phase 1b/2 clinical trial of tarextumab for the treatment of small cell lung cancer. The randomized Phase 2 trial is comparing progression-free survival outcomes for patients treated with tarextumab administered at 15 mg/kg every three weeks in combination with etoposide and cisplatin or carboplatin versus patients who receive placebo plus chemotherapy. Additionally, PFS will be assessed using a predictive biomarker for high tumor Notch3 expression. Secondary endpoints for the Phase 2 study include overall survival, overall response rate, pharmacokinetics, safety and other biomarkers. The PINNACLE study is being conducted at about 40 sites in the U.S. and is expected to enroll approximately 130 patients. Results from the Phase 2 PINNACLE trial are anticipated in 2017.
07:03 EDTGSKBiogen joins Centre for Therapeutic Target Validation
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06:28 EDTGSKPharma trade group rolls out ad campaign aimed at lawmakers, WSJ says
The pharmaceutical industry is launching a new ad campaign with the intention of improving its reputation with lawmakers in an effort to lobby against drug price restrictions, the Wall Street Journal reports. The industry's biggest trade group the Pharmaceutical Research and Manufacturers of America, or PhRMA, says it plans to spend several million dollars this year, and 10% more than it spent last year, on digital, radio, and print advertisements that highlight the sector's role in developing new drugs and advancing medical science, the report says. Publicly traded companies in the space include AstraZeneca (AZN), Bristol-Myers (BMY), Eli Lilly (LLY), GlaxoSmithKline (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Pfizer (PFE), Roche (RHHBY) and Sanofi (SNY). Reference Link
February 5, 2016
13:20 EDTPOZNPOZEN, Tribute complete combination to create Aralez Pharmaceuticals
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February 4, 2016
07:23 EDTGSKGSK will not be pressured into early consumer unit spinoff, Reuters says
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February 3, 2016
07:23 EDTGSKGlaxoSmithKline confirms 2015 ordinary dividend of 80p, special dividend of 20p
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07:23 EDTGSKGlaxoSmithKline sees double digits CER FY16 core EPS percentage growth
If FX rates held at January average levels estimated impact of +5% on 2016 Sterling core EPS growth.
07:21 EDTGSKGlaxoSmithKline reports Q4 EPS (7.3p) vs. 21.5p last year
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February 2, 2016
09:39 EDTPTXPernix Therapeutics management to meet with Needham
Meeting to be held in New York on February 4 hosted by Needham.
09:04 EDTPOZNPOZEN's stockholders approved merger with Tribute Pharma Canada
POZEN announced that its stockholders approved the Agreement and Plan of Merger and Arrangement with Tribute Pharmaceuticals Canada and the carrying out of the transactions contained therein. Upon closing of the transaction, the POZEN and Tribute businesses will operate as subsidiaries of Aralez Pharmaceuticals, a company domiciled in Canada. The Merger Agreement was also adopted by the Tribute shareholders on February 1. The proposed transaction remains subject to certain conditions and approvals, including approval of the Ontario Superior Court of Justice, listing of Aralez shares and customary closing conditions, and is expected to occur promptly following satisfaction of all conditions. Aralez will be listed on the NASDAQ stock exchange under the ticker symbol "ARLZ" and is expected to begin trading on or about February 8 and will be listed on the Toronto Stock Exchange under the ticker symbol "ARZ" and is expected to begin trading on on or about February 10, assuming closing on February 5.
08:17 EDTGSKAdaptimmune, GSK expand strategic immunotherapy collaboration
Adaptimmune Therapeutics (ADAP) and GlaxoSmithKline (GSK) announced that the companies have expanded the terms of their strategic collaboration agreement to accelerate Adaptimmune's lead clinical cancer program, an affinity enhanced T-cell immunotherapy targeting NY-ESO-1, toward pivotal trials in synovial sarcoma. Adaptimmune and GSK announced a strategic collaboration and licensing agreement in June 2014 for up to five programs, including the lead NY-ESO TCR program. GSK has an option on the NY-ESO-1 program through clinical proof of concept and, on exercise, will assume full responsibility for the program.
07:42 EDTGSKPressure mounts on big pharma names to shrink, sharpen focus, FT says
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06:32 EDTGSKGSK, J&J back Index Ventures' $1B biotech business spinoff, Reuters says
GlaxoSmithKline (GSK) and Johnson & Johnson (JNJ) will back a new spinoff from Index Ventures, which is spinning off its biotech portfolio into a new $1B entity, Reuters reports. The New Medicxi Ventures business will be helmed by the existing life sciences team from Index and will include all the current biotech portfolio firms, the report says. Medicxi raises $229M for a new fund in Europe with GSK and J&J each putting in 25%, Reuters reports. Reference Link
February 1, 2016
14:49 EDTPOZNPOZEN to host special shareholder meeting
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