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News Breaks
May 12, 2014
07:54 EDTGSK, LCILannett announces multi-services agreement with Sunshine Lake
Lannett Company (LCI) announced that it has entered into distribution and contract manufacturing services agreements with Sunshine Lake LLC, the U.S. subsidiary of the HEC Pharm Group of Shenzhen, Guangdong Province, China. Under terms of the distribution agreement, Lannett will be the exclusive distributor in the U.S. for Sunshine Lake’s Zidovudine generic pharmaceutical product in finished dosage form. Zidovudine Tablets 300 mg was launched by Lannett last week. According to IMS, full year 2013 total sales of Zidovudine Tablets 300 mg, the generic equivalent of Retrovir, a registered trademark of GlaxoSmithKline (GSK), at Average Wholesale Price were approximately $4.5M. The intention of the parties is to add additional products from time to time, and may include a number of ANDAs currently pending at FDA, as well as future filings.
News For LCI;GSK From The Last 14 Days
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February 9, 2016
08:40 EDTGSKVBI Vaccines announces research collaboration with GlaxoSmithKline
VBI Vaccines (VBIV) has entered into a research collaboration with GlaxoSmithKline Biologicals SA (GSK) to evaluate VBI's LPV Platform. VBI's LPV Platform is a proprietary formulation and process that enables the development of vaccines and biologics with improved stability and preserved potency. Under the terms of the research collaboration, GSK has the option to negotiate an exclusive license to VBI's LPV Platform for use in a defined field. Further terms of the collaboration were not disclosed.
February 8, 2016
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 4, 2016
10:00 EDTLCIOn The Fly: Analyst Upgrade Summary
Today's noteworthy upgrades include: ADTRAN (ADTN) upgraded to Market Perform from Underperform at Cowen... Alpha & Omega (AOSL) upgraded to Outperform from Market Perform at Northland... Ambarella (AMBA) upgraded to Buy from Neutral at Dougherty... ArcBest (ARCB) upgraded on valuation at Stifel... Arlington Asset Investment (AI) upgraded to Buy from Neutral at Ladenburg... Atwood Oceanics (ATW) upgraded to Accumulate from Hold at KLR Group... Buffalo Wild Wings (BWLD) upgraded to Outperform from Market Perform at Raymond James... C.H. Robinson (CHRW) upgraded to Outperform from Market Perform at Raymond James... CDK Global (CDK) upgraded to Outperform from Market Perform at Barrington... Cadence Design (CDNS) upgraded on valuation, guidance at DA Davidson... China Unicom (CHU) upgraded to Buy from Hold at HSBC... Cloud Peak (CLD) upgraded to Market Perform from Underperform at FBR Capital... Cree (CREE) upgraded to Outperform from Market Perform at Northland... CrossAmerica (CAPL) upgraded to Outperform from Neutral at Baird... Hub Group (HUBG) upgraded on results at Stifel... Kennametal (KMT) upgraded to Neutral from Underperform at Longbow... Lannett (LCI) upgraded to Buy from Hold at Craig-Hallum... Lowe's (LOW) upgraded to Conviction Buy from Buy at Goldman... Mattel (MAT) upgraded to Buy from Sell at Argus... New Oriental Education (EDU) upgraded to Buy from Neutral at Mizuho... Olin Corp. (OLN) upgraded to Buy from Neutral at Monness Crespi... RONA (RONAF) upgraded to Equal Weight from Underweight at Barclays... Red Hat (RHT) upgraded to Outperform from Market Perform at Cowen... Wayfair (W) upgraded to Buy from Neutral at Goldman... Whirlpool (WHR) upgraded to Buy from Neutral at Goldman... Yahoo (YHOO) upgraded to Buy from Neutral at Citi... Zumiez (ZUMZ) upgraded to Buy from Hold at Brean Capital... adidas (ADDYY) upgraded to Buy from Neutral at Goldman.
07:56 EDTLCILannett price target lowered to $28 from $46 at Canaccord
Canaccord lowered its price target on Lannett to $28 from $46 following Q2 results. The firm is lowering its estimates to reflect company guidance. Canaccord maintained its Buy rating on Lannett shares.
07:51 EDTLCILannett upgraded to Buy from Hold at Craig-Hallum
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07:23 EDTGSKGSK will not be pressured into early consumer unit spinoff, Reuters says
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February 3, 2016
16:27 EDTLCILannett sees FY16 revenue $585M-$595M, consensus $591.26M
16:27 EDTLCILannett reports Q2 EPS 95c, consensus 94c
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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
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
16:21 EDTLCILannett announces cost savings actions, to reduce workforce by 20% over 3 years
Lannett announced a number of restructuring actions to streamline operations, improve efficiencies and significantly reduce costs. The initiatives are part of the company's efforts to integrate the recently completed acquisition of Kremers Urban Pharmaceuticals, or KU. Actions have already begun and include the closing of KU's corporate offices in Princeton, New Jersey, an immediate workforce reduction of approximately 10% and a total staff reduction of approximately 20% over the next three years. The Plan is expected to result in approximately $40M of cost reductions during the 12 months following the close of the acquisition, including $27M in FY16, and is currently estimated to generate annualized synergies of approximately $50M by the end of FY18 and achieve an ultimate run rate of approximately $65M by the end of FY20. The company currently estimates that it will incur aggregate costs to implement the Plan of approximately $20M to $22M. The costs associated with the Plan, the majority of which are expected to be incurred between fiscal years 2016 and 2018, will primarily consist of a reduction in headcount through reorganization and integration, including severance and termination benefits for employees, expected to be approximately $11M to $13M, other costs primarily relating to the rationalization, consolidation and relocation of certain portions of our research and product development, manufacturing and distribution centers, as well as other facilities, expected to be approximately $8M and contract termination costs expected to be approximately $1M.
January 26, 2016
19:26 EDTLCIOn The Fly: After Hours Movers
UP AFTER EARNINGS: CA Technologies (CA), up 4.8%... Ethan Allen (ETH), up 10.6%... Hawaiian Holdings (HA), up 5.7%... Capital One (COF), up 1.1%. ALSO HIGHER: Fate Therapeutics (FATE), up 25% after announcing that the FDA has cleared the company's investigational new drug application for ProTmune... Raptor Pharmaceutical (RPTP), up 6.6% after being upgraded to Buy from Neutral at Citi. DOWN AFTER EARNINGS: U.S. Steel (X), down 9%... AT&T (T), down 1.9%... Apple (AAPL), down 2.6%... VMware (VMW), down 4.7%... TSYS (TSS), down 7.4% after reporting quarterly results and announcing the acquisition of TransFirst for $2.3B in cash. ALSO LOWER: Lannett (LCI), down 9% after giving second quarter and fiscal 2016 guidance... Baxalta (BXLT), down 2% after filing to sell $1.45B of common stock for holders.
16:26 EDTLCILannett sees FY16 revenue $585M-$595M consensus $609.29M
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16:24 EDTLCILannett sees Q2 adj. EPS 93-95c, consensus 98c
Sees Q2 revenue $127M, consensus $141.62M.

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