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GlaxoSmithKline PLC (GSK.L)

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Latest Key Developments (Source: Significant Developments)

Australian Competition & Consumer Commission Says GSK And Novartis Misled Consumers
Thursday, 16 May 2019 10:12pm EDT 

May 17 (Reuters) - Australian Competition & Consumer Commission (ACCC)::GSK AND NOVARTIS MISLED CONSUMERS WITH VOLTAREN OSTEO GEL CLAIMS.FEDERAL COURT FOUND GLAXOSMITHKLINE HEALTHCARE AUSTRALIA AND NOVARTIS CONSUMER HEALTH AUSTRALASIA BREACHED AUSTRALIAN CONSUMER LAW.AN ACCC PROBE FOUND THAT DESPITE HAVING SAME ACTIVE INGREDIENTS, OSTEO GEL WAS OFTEN SOLD AT A SIGNIFICANTLY HIGHER RETAIL PRICE THAN EMULGEL.HEARING WILL BE HELD AT A LATER DATE TO DETERMINE PENALTIES SOUGHT BY THE ACCC.  Full Article

Vectura Wins U.S. GSK Patent Litigation, Awarded $89.7 Mln In Damages By Trial Jury
Saturday, 4 May 2019 09:54am EDT 

May 4 (Reuters) - Vectura Group Plc ::VECTURA WINS US GSK PATENT LITIGATION AND AWARDED $89.7MILLION IN DAMAGES BY TRIAL JURY.VECTURA GROUP- CLAIM OF VECTURA'S U.S. PATENT 8303991 WAS FOUND VALID AND INFRINGED BY U.S. SALES OF THREE OF GLAXOSMITHKLINE'S ELLIPTA PRODUCTS.JURY AWARDED VECTURA $89.7 MLN IN DAMAGES FOR PERIOD FROM AUGUST 2016 THROUGH DECEMBER 2018.VECTURA EXPECTS TO SEEK APPLICATION OF 3% ROYALTY TO SALES OF INFRINGING PRODUCTS THROUGH END OF PATENT TERM IN MID-2021.JURY ALSO FOUND THAT GSK'S INFRINGEMENT WAS WILLFUL.WILLFULNESS FINDING GIVES VECTURA RIGHT TO SEEK ENHANCED DAMAGES; GSK HAS OPTION TO APPEAL DECISION.  Full Article

Fulcrum Therapeutics Acquires Global Rights To Losmapimod From GlaxoSmithKline
Tuesday, 23 Apr 2019 07:00am EDT 

April 23 (Reuters) - Fulcrum Therapeutics Inc::FULCRUM THERAPEUTICS ACQUIRES GLOBAL RIGHTS TO LOSMAPIMOD, A POTENTIAL DISEASE-MODIFYING THERAPY FOR FACIOSCAPULOHUMERAL MUSCULAR DYSTROPHY.FULCRUM THERAPEUTICS - AS PAYMENT FOR LICENSE, GSK GOT CO'S PREFERRED STOCK REPRESENTING HIGH SINGLE-DIGIT OWNERSHIP PERCENT OF CO.FULCRUM THERAPEUTICS - PLANS TO LAUNCH A PHASE 2B CLINICAL TRIAL IN FSHD IN MID-2019.FULCRUM THERAPEUTICS - GSK WILL BE ELIGIBLE TO RECEIVE FUTURE MILESTONE PAYMENTS AND ROYALTIES AS PER DEAL.  Full Article

GlaxoSmithKline Announces Further Positive Data From Dreamm-1
Thursday, 21 Mar 2019 12:00pm EDT 

March 21 (Reuters) - GlaxoSmithKline PLC ::GSK ANNOUNCES FURTHER POSITIVE DATA FROM DREAMM-1.ANNOUNCES FURTHER POSITIVE DATA FROM DREAMM-1 STUDY OF ANTI-BCMA ANTIBODY-DRUG CONJUGATE IN PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA.MEDIAN PROGRESSION-FREE SURVIVAL EXTENDS TO TWELVE MONTHS.THESE NEW DATA CONFIRM THAT 60% OF PATIENTS RECEIVING GSK2857916 ACHIEVED AN OVERALL RESPONSE RATE (ORR).  Full Article

New Zealand Commerce Commission Says Received Clearance Application From Glaxosmithkline Seeking Clearance To Buy Consumer Healthcare Business Of Pfizer
Friday, 8 Mar 2019 02:36am EST 

March 8 (Reuters) - :NEW ZEALAND COMMERCE COMMISSION - RECEIVED CLEARANCE APPLICATION FROM GLAXOSMITHKLINE SEEKING CLEARANCE TO BUY CONSUMER HEALTHCARE BUSINESS OF PFIZER.  Full Article

GSK Continues To Expect HIV Portfolio To Be 'Meaningful' Growth Driver
Wednesday, 6 Feb 2019 10:07am EST 

Feb 6 (Reuters) - GlaxoSmithKline PLC ::GSK SAYS CONTINUES TO EXPECT HIV PORTFOLIO WILL BE A MEANINGFUL GROWTH DRIVER, INCLUDING IN 2019 - CONF CALL.GSK SAYS WITH GENERIC ADVAIR, EXPECT PARTICULAR VOLATILITY ACROSS Q1, Q2 AS MARKET ADJUSTS INVENTORY IN RESPONSE TO SUPPLY AVAILABLE - CONF CALL.GSK - EXPECT PHARMACEUTICAL BUSINESS OVERALL TO SEE A SLIGHT SALES DECLINE IN 2019 BEFORE RETURNING TO GROWTH IN 2020.GSK SAYS FROM Q1 2019, WILL REPORT OLDER RESPIRATORY PRODUCTS, INCLUDING ADVAIR SERETIDE WITHIN ESTABLISHED PHARMACEUTICALS.GSK SAYS FY CONSUMER SALES GREW 2 PERCENT DESPITE DRAG OF ABOUT 1 PERCENT POINT FROM IMPACT OF DIVESTMENT OF NONSTRATEGIC BRANDS, Q4'S IMPACT TO GST IN INDIA.GSK SAYS 2019 CASH FLOWS WILL SEE A "STEP DOWN" AS ADVAIR GENERIC FLOWS THROUGH AND CO PAYS OUT DEBT PAYMENTS ON PRE GENERIC SALES OF ADVAIR.GSK SAYS "REMAIN COMFORTABLE THAT THE BALANCE SHEET CAN SUPPORT OUR FUTURE INVESTMENT REQUIREMENTS".  Full Article

GlaxoSmithKline Posts Qtrly Adjusted EPS 31.2 Pence
Wednesday, 6 Feb 2019 07:01am EST 

Feb 6 (Reuters) - GlaxoSmithKline PLC ::FINAL RESULTS.FY ADJUSTED EPS ROSE 7 PERCENT TO 119.4 PENCE.EXPECT FY 2019 ADJUSTED EPS TO DECLINE -5 PCT TO -9 PCT CER REFLECTING RECENT APPROVAL OF A GENERIC COMPETITOR TO ADVAIR IN US.EXPECT 80P DIVIDEND FOR 2019.QTRLY TURNOVER 8,197 MILLION STG VERSUS 7,639 MILLION STG REPORTED A YEAR EARLIER.QTRLY TOTAL EPS 24.7 PENCE.FY GUIDANCE REFLECTS EXPECTED IMPACT OF TESARO DEAL, ASSUMES CONSUMER HEALTHCARE NUTRITION DISPOSAL & CONSUMER JV WITH PFIZER CLOSE.FY SHINGRIX SALES 784 MILLION POUNDS, +>100 PCT AER, +>100 PCT CER.QTRLY PHARMACEUTICALS TURNOVER 4,810 MILLION POUNDS VERSUS 4,540 MILLION POUNDS REPORTED A YEAR EARLIER.FOCUSED ON COMPLETING TRANSACTIONS TO DIVEST CONSUMER HEALTHCARE NUTRITION BUSINESS TO UNILEVER.23 PENCE DIVIDEND DECLARED FOR QUARTER; 80P FOR FULL YEAR 2018.QTRLY VACCINES TURNOVER 1,479 MILLION POUNDS VERSUS 1,208 MILLION POUNDS REPORTED A YEAR EARLIER.QTRLY CONSUMER HEALTHCARE TURNOVER 1,908 MILLION POUNDS VERSUS 1,891 MILLION POUNDS REPORTED A YEAR EARLIER."WE ARE MAKING GOOD PROGRESS AGAINST OUR PRIORITY TO REBUILD OUR PHARMACEUTICALS PIPELINE, PARTICULARLY IN ONCOLOGY".IF EXCHANGE RATES HOLD AT 31 JAN RATES FOR REST OF 2019, ESTIMATED POSITIVE IMPACT ON 2019 STERLING TURNOVER GROWTH TO BE LESS THAN 1 PCT.IF EXCHANGE GAINS/LOSSES WERE RECOGNISED AT SAME LEVEL AS 2018, ESTIMATED POSITIVE IMPACT ON 2019 STERLING ADJUSTED EPS GROWTH WOULD BE AROUND 1 PCT.  Full Article

GSK And Merck Announce Global Alliance For M7824
Tuesday, 5 Feb 2019 06:58am EST 

Feb 5 (Reuters) - GlaxoSmithKline PLC ::GSK AND MERCK ANNOUNCE GLOBAL ALLIANCE FOR M7824.MERCK KGAA, DARMSTADT, GERMANY WILL RECEIVE AN UPFRONT PAYMENT OF EUR 300 MILLION (£260 MILLION).PROPOSED DEAL FOR TOTAL POTENTIAL DEAL VALUE OF UP TO EUR 3.7 BILLION (£3.2 BILLION).EIGHT HIGH PRIORITY IMMUNO-ONCOLOGY CLINICAL DEVELOPMENT STUDIES ONGOING OR EXPECTED TO COMMENCE IN 2019.  Full Article

Mylan Announces FDA Approval Of Wixela Inhub, The First Generic Of ADVAIR DISKUS
Thursday, 31 Jan 2019 02:59pm EST 

Jan 31 (Reuters) - Mylan NV ::MYLAN ANNOUNCES FDA APPROVAL OF WIXELA™ INHUB™ (FLUTICASONE PROPIONATE AND SALMETEROL INHALATION POWDER, USP), FIRST GENERIC OF ADVAIR DISKUS® (FLUTICASONE PROPIONATE AND SALMETEROL INHALATION POWDER).MYLAN NV - WIXELA INHUB, THE FIRST GENERIC OF ADVAIR DISKUS, WILL LAUNCH IN H2 OF FEBRUARY.  Full Article

Exagen Extended Agreement With GSK
Wednesday, 2 Jan 2019 11:46am EST 

Jan 2 (Reuters) - EXAGEN::EXAGEN - EXTENDED ITS AGREEMENT WITH GSK.EXAGEN - DETAILS OF AGREEMENT ARE CONFIDENTIAL.  Full Article

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Germany's Stada buys six of GSK's consumer brands, eyes further deals

FRANKFURT Private equity-backed generic drugmaker Stada said on Friday it would buy six consumer healthcare products from British drugmaker GlaxoSmithKline to bolster its presence in Europe.