GLAXO

** Shares of GlaxoSmithKline Pharmaceuticals GLAX.NS jump 12.4% to 2,266 rupees

** Drugmaker reports 35% Y/Y jump in third-quarter adjusted profit, rev up 18% Y/Y

** GLAX's profit growth driven by strong demand for its respiratory drugs and antibiotic Augmentin, while demand for its vaccines also boosted earnings

** Analysts' avg rating on GLAX at "buy"; median PT is 2,675.50 rupees - data compiled by LSEG

** Stock gained 19% in 2024

(Reporting by Kashish Tandon in Bengaluru)

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Feb 14 (Reuters) - GlaxoSmithKline Pharmaceuticals Ltd GLAX.NS:

• GLAXOSMITHKLINE PHARMA Q3 CONSOL PROFIT 2.3 BILLION RUPEES

• GLAXOSMITHKLINE PHARMA Q3 CONSOL REVENUE FROM OPERATIONS 9.49 BILLION RUPEES

• GLAXOSMITHKLINE PHARMACEUTICALS - RE-APPOINTMENT OF JUBY CHANDY AS CHIEF FINANCIAL OFFICER

Source text: ID:nBSE1JhsBH

Further company coverage: GLAX.NS

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Feb 5 (Reuters) - GlaxoSmithKline Pharmaceuticals Ltd GLAX.NS:

• GLAXOSMITHKLINE PHARMACEUTICALS - GOT TAX DEMAND ORDER OF 4.8 MILLION RUPEES

Source text: ID:nBSE836t2c

Further company coverage: GLAX.NS

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** Shares of GlaxoSmithKline Pharma GLAX.NS rise 2% to 2,682 rupees

** The pharma co posted a 15% uptick in Q2 consol profit before tax to 3.44 bln rupees (~$41 mln)

** Rev for ops grew 5.6%, driven by strong demand for its generic drugs and vaccines

** Stock up 41% so far this year

($1 = 84.0770 Indian rupees)

(Reporting by Ashna Teresa Britto in Bengaluru)

(([email protected] ; ( +91 8078332441))

Oct 29 (Reuters) - GlaxoSmithKline Pharmaceuticals Ltd GLAX.NS:

• SEPT-QUARTER PROFIT 2.53 BILLION RUPEES

• SEPT-QUARTER REVENUE FROM OPERATIONS 10.11 BILLION RUPEES

• NUMBERS ARE IN CONSOLIDATED BASIS

• DIVIDEND 12 RUPEES PER SHARE

Source text: ID:nBSE4pH2MH

Further company coverage: GLAX.NS

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Adds details and background in paragraphs 3-7, responses from Moderna and GSK in paragraph 3

By Blake Brittain

Oct 15 (Reuters) - British drugmaker GlaxoSmithKline GLAX.NS sued Moderna MRNA.O in U.S. federal court in Delaware on Tuesday, accusing its American rival of violating GSK's patent rights in messenger RNA (mRNA) technology with its blockbuster COVID-19 vaccine Spikevax.

According to the two lawsuits, Moderna's lipid nanoparticles for transporting fragile mRNA into the human body infringe several GSK patents covering similar innovations. GSK filed a related lawsuit against Pfizer PFE.N and BioNTech 22UAy.DE in the same court in April over their COVID-19 vaccine. The new litigation seeks unspecified monetary damages.

A Moderna spokesperson said the company was aware of the new litigation and would defend itself against the claims. A GSK spokesperson said the drugmaker is "willing to license these patents on commercially reasonable terms and to ensure continued patient access."

The lawsuits add to a web of U.S. court cases involving Pfizer, BioNTech and Moderna over patent royalties for technology used in their vaccines, including one brought by Moderna against Pfizer in 2022.

Moderna earned $6.7 billion in revenue from Spikevax last year. Pfizer made $11.2 billion from sales of its and BioNTech's vaccine Comirnaty. Sales of both vaccines declined significantly last year from 2022.

GSK said in the new litigation that its patents cover mRNA technology pioneered in 2008 that provides "the foundation for Moderna's mRNA vaccine portfolio." GSK said it bought the rights to the inventions when it acquired part of Novartis' NOVN.S vaccine business in 2015.

(Reporting by Blake Brittain
Editing by David Bario and Will Dunham)

(([email protected];))

Sept 3 (Reuters) - GlaxoSmithKline Pharmaceuticals Ltd GLAX.NS:

• GETS INCOME TAX REFUND ORDER FOR 2.22 BILLION RUPEES

Source text for Eikon: ID:nNSE6ckYJW

Further company coverage: GLAX.NS

(Reporting by VijayDattaram Malkar)

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Aug 30 (Reuters) - GlaxoSmithKline Pharmaceuticals Ltd GLAX.NS:

• GLAXOSMITHKLINE PHARMACEUTICALS - GETS TAX ORDER OF 21 MILLION RUPEES, INTEREST 15 MILLION RUPEES

Further company coverage: GLAX.NS

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Aug 26 (Reuters) - GlaxoSmithKline Pharmaceuticals Ltd GLAX.NS:

• GLAXOSMITHKLINE PHARMA- ORDER FROM PUNJAB GST AUTHORITIES DROPPING PROCEEDINGS OF SHOW CAUSE NOTICE

Source text for Eikon: ID:nBSE3xk4Wb

Further company coverage: GLAX.NS

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Aug 8 (Reuters) - GlaxoSmithKline Pharmaceuticals Ltd GLAX.NS:

• GLAXOSMITHKLINE PHARMACEUTICALS - GOT TAX DEMAND AGGREGATING TO 9.8 MILLION RUPEES

Source text for Eikon: ID:nBSE6gW1mq

Further company coverage: GLAX.NS

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June 25 (Reuters) - GlaxoSmithKline Pharmaceuticals Ltd GLAX.NS:

• GOT ORDER FROM GST OFFICE RAISING DEMAND OF 716.6 MILLION RUPEES

Further company coverage: GLAX.NS

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BENGALURU, May 17 (Reuters) - Drugmaker GlaxoSmithKline Pharma India GLAX.NS reported a 49% rise in fourth-quarter adjusted profit on Friday, as strong demand for its generic medicines offset the impact of the government's ongoing price curbs on its key drugs.

The company reported consolidated profit before exceptional items and taxes of 2.68 billion rupees ($32.1 million) for the quarter ended March 31, compared to 1.80 billion rupees a year earlier.

In the year-ago period, the Indian unit of UK's GSK GSK.L had an exceptional charge of 104 million rupees which comprised restructuring and other costs.

The company's shares closed up 13.7% after the results.

Revenue from operations rose 18% to 9.30 billion rupees, led by a 12% growth in its generic medicines portfolio which the company attributed to key focus brands Augmentin, Ceftum and Calpol.

Earnings at drugmakers like GlaxoSmithKline Pharma and Abbott India ABOT.NS have been pressured as prices of some of their key drugs were capped under the Indian government's essential medicines list (NLEM) since September 2022.

However, "despite the NLEM impact in previous quarters, all promoted brands outpaced their respective categories in growth and gained market share," the company said in a statement.

Last week, rival Abbott India reported a higher fourth-quarter profit, led by strong sales.

($1 = 83.3825 Indian rupees)

(Reporting by Kashish Tandon in Bengaluru; Editing by Varun H K)

(([email protected]; 8800437922;))

BENGALURU, May 9 (Reuters) - Indian drugmaker Abbott India ABOT.NS reported a 24% rise in fourth-quarter profit on Thursday, as strong sales outpaced the impact of government pricing caps on certain medicines.

The company, which makes the popular antacid medicine Digene, said its profit rose to 2.87 billion rupees ($34.3 million) for the three months ended March 31, from 2.31 billion rupees a year earlier.

Revenues of drugmakers such as Abbott India and GlaxoSmithKline Pharma India GLAX.NS, which get most of their business from India, have been impacted after the inclusion of some of their drugs in the government's essential medicines list in September 2022, making them susceptible to price caps.

Abbott, which is a unit of U.S. healthcare firm Abbott Laboratories ABT.N, has been trying to mitigate the impact of pricing curbs by driving up sales and cutting back on expenses.

The company, which makes drugs including hypothyroidism treatment tablets Thyronorm, said its revenue from operations rose 7% to 14.39 billion rupees in the fourth quarter.

The company declared a dividend of 410 rupees per share for fiscal year 2024.

($1 = 83.4760 Indian rupees)

(Reporting by Kashish Tandon in Bengaluru; Editing by Mrigank Dhaniwala)

(([email protected]; 8800437922;))

Adds response from BioNTech in paragraph 3

By Blake Brittain

April 25 (Reuters) - GlaxoSmithKline GLAX.NS sued Pfizer PFE.N and BioNTech 22UAy.DE in Delaware federal court on Thursday, accusing them of infringing GSK patents related to messenger RNA (mRNA) technology in the companies' blockbuster COVID-19 vaccines.

GSK said in the lawsuit that Pfizer and BioNTech's Comirnaty vaccines violate the company's patent rights in mRNA-vaccine innovations developed "more than a decade before" the outbreak of the COVID-19 pandemic.

A Pfizer spokesperson said in a statement that the company is "confident in our IP position around Comirnaty" and intends to "vigorously defend" against GSK's claims. A BioNTech spokesperson declined to comment on the complaint.

A GSK spokesperson said the company believes its patents "provided the foundational technology used in Pfizer and BioNTech’s COVID-19 mRNA vaccines," and that it is "willing to license these patents on commercially reasonable terms and to ensure continued patient access" to the shots.

The lawsuit adds to a web of high-stakes U.S. court cases involving Pfizer, BioNTech and Moderna over patent royalties for technology used in their vaccines, including a case brought by Moderna against Pfizer in 2022.

Pfizer made $11.2 billion from sales of Comirnaty last year, while Moderna earned $6.7 billion in revenue from its vaccine Spikevax. Sales of both vaccines declined significantly last year from 2022.

London-based GSK asked the court for an unspecified amount of monetary damages from Pfizer and BioNTech that includes an ongoing patent-licensing fee.

GSK said in the complaint that its patents cover technology for transporting fragile mRNA into human cells that scientists began developing in 2008. GSK said it bought the rights to the inventions when it acquired part of Novartis' NOVN.S vaccines business in 2015.

GSK also sued Pfizer for patent infringement last year over technology used in Pfizer's respiratory syncytial virus (RSV) vaccine Abrysvo. Pfizer has denied GSK's claims in that case.

(Reporting by Blake Brittain
Editing by David Bario and Chizu Nomiyama and Franklin Paul)

(([email protected]))

BENGALURU, Feb 12 (Reuters) - GlaxoSmithKline Pharmaceuticals GLAX.NS, the Indian unit of the UK's GSK GSK.L, reported a 3% fall in third-quarter profit on Monday, hurt by the government's pricing cap on certain medicines.

Consolidated profit before exceptional items and tax for the quarter ended Dec. 31 was 2.29 billion rupees ($27.6 million), compared with 2.36 billion rupees a year earlier.

GlaxoSmithKline, which derives most of its revenue from India, continued to grapple with challenges following the inclusion of its key products such as Ceftum antibiotic and T-Bact ointment in the country's National List of Essential Medicines (NLEM) in September 2022, mandating sales below a government-set price ceiling.

It's revenue declined for three straight quarters following the adoption of the list before rebounding on the growth in its vaccine business in the June quarter of last fiscal year.

Revenue from operations rose a meagre 0.4% to 8.05 billion rupees in the latest quarter.

The company, which makes Augmentin antibiotic, incurred a one-time charge of 1.63 billion rupees, related to the cost of a voluntary retirement scheme and other employee dues.

It also had a one-time charge of 113.7 million rupees in the year-ago period, due to restructuring costs.

Last month, parent GSK beat market estimates for its fourth-quarter results and provided an upbeat forecast for 2024 and beyond, citing the expansion of its vaccines and cancer drugs pipeline.

Earlier this month, rival Abbott India ABOT.NS reported a 26% jump in third-quarter profit on elevated sales.

($1 = 82.9720 Indian rupees)

(Reporting by Kashish Tandon in Bengaluru; Editing by Dhanya Ann Thoppil)

(([email protected];))

BENGALURU, Feb 1 (Reuters) - Pharmaceutical firm Abbott India ABOT.NS reported a 26% rise in third-quarter profit on Thursday, as higher sales outpaced the impact of a pricing cap on certain medicines.

The company, which makes popular antacid medicine Digene, said its profit rose to 3.11 billion rupees ($37.5 million) from 2.47 billion rupees a year earlier.

Revenues of drugmakers such as Abbott India, which get most of their business from India, continued to be affected during the quarter as some of their key drugs were included in the government's essential medicines list in September 2022, making them susceptible to price caps.

This was also highlighted by GlaxoSmithKline Pharma GLAX.NS in its previous earnings.

Abbott, which is a unit of U.S. healthcare firm Abbott Laboratories ABT.N, has been trying to mitigate the impact of pricing curbs by driving up sales and cutting back on expenses.

The company, which makes drugs including hypothyroidism treatment tablets Thyronorm, said its revenue from operations rose nearly 9% to 14.37 billion rupees.

Peer GlaxoSmithKline Pharma is set to report its December-quarter results next week.

Shares of Abbott India settled flat ahead of results.

($1 = 82.9510 Indian rupees)

(Reporting by Kashish Tandon in Bengaluru; Editing by Sonia Cheema and Mrigank Dhaniwala)

(([email protected];))

** Shares of GlaxoSmithKline Pharmaceuticals GLAX.NS rise as much as 8.3% to a record 2,259 rupees; last up 4.9%

** Reuters could not immediately verify the reason for the move

** Stock last hit all-time highs in December while logging gains for 11 straight sessions

** Stock has risen about 5% twice so far in January and had risen about 5% thrice throughout 2023

** Avg analyst rating on GLAX stock is "hold", same as rival Dr Reddy's REDY.NS; Sun Pharma SUN.NS, Cipla's CIPL.NS avg rating is "buy" - LSEG data

** GLAX's avg PT is 1,686.5 rupees, 23% lower than current price - LSEG data

(Reporting by Varun Vyas in Bengaluru)

(([email protected]))

GlaxoSmithKline Pharmaceuticals Ltd GLAX.NS:

• GLAXOSMITHKLINE PHARMACEUTICALS LTD- GOT ORDER FOR GST DEMAND AT 10.7 MILLION RUPEES

Source text for Eikon: ID:nBSE4jZJMb

Further company coverage: GLAX.NS

** Shares of GlaxoSmithKline Pharmaceuticals GLAX.NS rise ~5% to 1,848 rupees, an all-time high

** Stock among top gainers on 20-member nifty pharma index .NIPHARM

** Reuters could not immediately ascertain a reason for the stock move

** Drugmaker's stock currently trading up ~2%; on track for fourth consecutive session of gains, if trend holds

** GLAX set for best quarter since Dec-qtr in 2021

** Stock trading ~19% above its median PT of 1,515 rupees - LSEG

** Trading volume 1.4x the 30-day moving average

** Avg rating of five analysts on GLAX at "hold" - LSEG data

** Stock up ~36% YTD vs a ~31% climb in the pharma index

(Reporting by Kashish Tandon in Bengaluru)

(([email protected]))

Dec 26 (Reuters) - GlaxoSmithKline Pharmaceuticals Ltd GLAX.NS:

• GST TAX OFFICERS VISITED CO CFA'S PREMISES IN CHENNAI & HOSUR ON DEC 24 FOR INSPECTION OF GOODS AND DOCUMENTS

• VISIT FOR SUPPRESS OF TRANSACTIONS RELATING TO SUPPLY OF GOODS AND / OR SERVICES UNDER GST

• NO IMPACT ON GSK

• RECEIVED ORDER DATED DEC 23 FROM ANDHRA PRADESH STATE GST AUTHORITIES DISALLOWING CERTAIN GST CREDITS

• RECEIVED ORDER DATED DEC 20 FROM WEST BENGAL CENTRAL GST AUTHORITIES

Source text for Eikon: ID:nBSE57kMTy

Further company coverage: GLAX.NS

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ANKARA, Nov 30 (Reuters) - Turkey's competition authority has launched a probe into 19 pharmaceutical companies including AstraZeneca AZN.L, Bayer BAYGn.DE, Glaxosmithkline GLAX.NS, Johnson & Johnson JNJ.N, Bausch & Lomb BLCO.TO, Sanofi SASY.PA and Pfizer PFE.N, it said in a statement on Thursday.

The competition authority did not provide any further details on the investigation.

(Reporting by Ezgi Erkoyun and Huseyin Hayatsever; Editing by Sharon Singleton)

(([email protected];))

** Shares of GlaxoSmithKline Pharmaceuticals GLAX.NS rise as much as 6.2% to 1,675 rupees, highest since Jan. 24, 2022

** Reuters could not immediately ascertain the reason for the stock movement

** Stock has risen 13.7% since reporting Q2 profit climb on Nov. 9

** Over 553,000 shares change hands as of 3:26 p.m. IST, 5X the 30-day moving average

** Mean rating of five analysts is "hold"; median PT is 1,515 rupees - LSEG data

** Stock up 25% YTD

(Reporting by Varun Vyas in Bengaluru)

(([email protected]))

Nov 16 (Reuters) - GlaxoSmithKline Pharmaceuticals Ltd GLAX.NS:

• GLAXOSMITHKLINE PHARMACEUTICALS LTD - APPROVED COMMERCIAL TRANSFORMATION INITIATIVE

• GLAXOSMITHKLINE PHARMACEUTICALS LTD - WILL EXPLORE NEW INNOVATIVE SOLUTIONS INCLUDING OMNICHANNEL STRATEGY TO EXPAND ITS REACH AND COVERAGE TO TARGET SEGMENTS

• GLAXOSMITHKLINE PHARMACEUTICALS - LAUNCHED VOLUNTARY RETIREMENT SCHEME FOR COMMERCIAL FUNCTION EMPLOYEES

Source text for Eikon: ID:nBSE1x4wMG

Further company coverage: GLAX.NS

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Corrects spelling of Managing Director's name in paragraph 5

BENGALURU, Nov 9 (Reuters) - GlaxoSmithKline Pharmaceuticals GLAX.NS reported a 12.5% rise in quarterly profit on Thursday as the Indian unit of UK's GSK plc saw strong demand for its vaccines and general medicine.

Consolidated profit for the quarter ended September 30 rose to 2.18 billion rupees ($26.18 million) from 1.93 billion rupees a year earlier.

Sales of general medicine grew 5% during the quarter, while those of vaccines rose 10% led by demand for its shingles vaccine, Shingrix, the company said in a statement.

Revenue from operations rose 4.4% to 9.57 billion rupees. Cost of materials consumed fell 31.2% during the quarter.

"We held leadership position for our key brands in relevant therapy areas such as anti-infectives and dermatology," said Bhushan Akshikar, managing director of GSK India.

GSK GSK.L raised its full-year profit and sales guidance for the second time after its third-quarter earnings beat expectations earlier this month. The raise in forecast is following the strong launch of its respiratory syncytial virus (RSV) vaccine in the United States

Shares in GSK India closed up 0.3% ahead of results on Thursday, where the Nifty Pharma index .NIPHARM. closed down 0.03% today.

($1 = 83.2810 Indian rupees)

(Reporting by Ashna Teresa Britto in Bengaluru; Editing by Nivedita Bhattacharjee)

(([email protected];))

Aug 31 (Reuters) - GlaxoSmithKline Pharmaceuticals Ltd GLAX.NS:

• ASSISTANT COMMISSIONER OF STATE TAX INITIATED SEARCH AT PREMISES OF CO

• BUSINESS OPERATIONS OF CO CONTINUE AS USUAL

Source text for Eikon: ID:nBSE9c1PPJ

Further company coverage: GLAX.NS

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BENGALURU, Aug 9 (Reuters) - Abbott India ABOT.NS, the Indian arm of U.S. healthcare firm Abbott Laboratories ABT.N, reported a 41% rise in its first-quarter profit on Wednesday, driven by strong sales in its mainstay pharmaceuticals segment.

The company, which makes pain-reliever ibuprofen under the brand name Brufen, said its profit rose to 2.90 billion rupees ($35.02 million), compared with 2.06 billion rupees a year earlier.

Revenue from operations rose 13.4% to 14.79 billion rupees for the quarter.

For further earnings highlights, click here.

KEY CONTEXT

Abbott India, for which the pharmaceutical segment is the sole revenue generator, develops and distributes over 600 products in India, including vitamins, anti-allergic drugs and consumer care.

The company has reported a double-digit growth in its revenue for the past three quarters, led by falling operating expenses and steady sales.

Last month, peer GlaxoSmithKline Pharmaceuticals GLAX.NS posted an 11% rise in its first-quarter profit, helped by a steady vaccines business.

PEER COMPARISON

* Mean of analysts' ratings standardised to a scale of Strong Buy, Buy, Hold, Sell, and Strong Sell

** Ratio of the stock's last close to analysts' mean price target; a ratio above 1 means the stock is trading above the PT

APRIL TO JUNE STOCK PERFORMANCE

-- All data from Refinitiv

-- $1 = 82.8150 Indian rupees

(Reporting by Kashish Tandon and Biplob Kumar Das in Bengaluru; Editing by Janane Venkatraman)

(([email protected];))

July 26 (Reuters) - GlaxoSmithKline Pharmaceuticals Ltd GLAX.NS:

• JUNE-QUARTER CONSOL PROFIT 1.32 BILLION RUPEES VERSUS 1.19 BILLION RUPEES

• JUNE-QUARTER CONSOL REVENUE FROM OPERATIONS 7.62 BILLION RUPEES VERSUS 7.45 BILLION RUPEES

Source text for Eikon: ID:nBSE8GVhV0

Further company coverage: GLAX.NS

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For more Reuters Special Reports, click on SPECIAL/

By Dan Levine, Robin Respaut, Kristina Cooke, Mike Spector and Benjamin Lesser

June 26 (Reuters) - Nicholas England, a healthy 22-year-old from Virginia, shot himself in the head in 2017, less than two weeks after he started taking an allergy medicine that had been linked for years to episodes of depression and suicidal thinking.

His parents soon started exploring a lawsuit against Merck MRK.N, the developer of the blockbuster asthma and allergy drug, Singulair, along with the manufacturer of the generic version their son took. Nicholas had no history of mental-health problems, they said.

The Englands were shocked to learn from legal advisers that they had no case. Like countless other potential plaintiffs, they had run into one of Corporate America’s most effective liability shields: the legal doctrine of preemption, the principle that federal law supersedes state law.

Armed with U.S. Supreme Court rulings on preemption starting in the 1990s, companies increasingly argue that federally regulated products or services should be immune from lawsuits alleging state-law violations. In a new reading of an old constitutional principle, judges have held that federal law, including the decisions of U.S. regulatory agencies, should preempt, or override, state statutes that seek to hold companies accountable for harming consumers.

State laws historically have provided the legal basis for some of the most common lawsuits against U.S. companies alleging injuries, deaths or illnesses caused by negligence or defective products.

These legal dynamics left the England family with no legal remedy at all. A pair of U.S. Supreme Court rulings, in 2011 and 2013, essentially barred lawsuits against generic drugmakers based on state laws that enabled claims over design defects or a failure to warn consumers of potential dangers. The court’s reasoning: Such claims were preempted by federal regulations preventing generic drugmakers, when copying name-brand drugs, from changing the formulation or the warning label.

That meant Merck had written the warning label, with federal approval, on the generic version of Singulair that Nicholas England took. But his parents couldn’t sue Merck, either, because their son had never taken its name-brand version of Singulair.

“The emotion of losing your child is so difficult on its own,” said Jennifer England, Nicholas’s mother. “It is very frustrating to realize that’s a loophole. I’m a small person in southwestern Virginia, and that’s a loophole there to protect companies much bigger than we could fight.”

Merck declined to comment for this report, referring all questions to Organon, a Merck spinoff created in 2021 that now markets Singulair. Organon declined to answer detailed questions from Reuters but said in a statement that it’s confident doctors and patients have gotten “complete and appropriate information” on Singulair’s safety. The generic drug manufacturer that made the pills England took, Teva Pharmaceuticals TEVA.TA, did not respond to inquiries.

Corporate preemption defenses have proved broadly effective, according to a Reuters analysis of court cases and dozens of interviews with attorneys, legal scholars and plaintiffs or potential plaintiffs affected by preemption rulings. The analysis of federal appeals and Supreme Court rulings involving preemption found that judges ruled two-thirds of the time to weaken or kill lawsuits alleging deaths or injuries caused by corporate negligence or defective products.

Preemption defenses often deliver companies a swift procedural win, allowing them to avoid addressing the substance of plaintiffs’ allegations. It has been used across a range of federally regulated sectors, from railroads to agricultural chemicals to airlines and automobiles, the Reuters review found.

The preemption defense has had a particularly profound impact in the pharmaceutical industry, the review showed. The high court’s ban on certain lawsuits against generic drug manufacturers has extraordinary reach because generics account for 91% of U.S. prescriptions, according to data from the U.S. Food and Drug Administration (FDA).

Name-brand drugmakers can still be sued, but preemption defenses can make it much harder for plaintiffs to prevail, drug-industry litigation experts said. In many product-liability cases, plaintiffs must prove simply that a company’s product was unsafe. Those facing drugmakers’ preemption defenses must often demonstrate that a company failed to disclose safety information to federal regulators – and that the information could have spurred new government restrictions or warnings before the alleged harm occurred.

Pending lawsuits against Merck allege that the company’s own early research indicated the drug could impact the brain but that Merck downplayed any risks in statements to regulators.

England’s family had hoped to force executives from Merck and the generic manufacturer to reveal what they knew, and when, about the drug’s dangers. In the decade before England’s death, the FDA received more than 4,800 reports of patients, including many children, experiencing depression, suicidal thoughts or other psychiatric problems after taking Singulair or a generic version, according to a Reuters review of FDA data.

But it wasn’t until 2020 that the FDA slapped its most serious warning, called a “black box,” on the drug’s label. By that time, the FDA had received more than 80 reports of suicides in people taking the medicine.

Singulair, one of the best-selling drugs in U.S. history, has provided Merck with about $50 billion in revenue, company disclosures show. Since Merck’s patent on Singulair expired in 2012, major generic drug manufacturers have sold millions of prescriptions under the drug’s scientific name, montelukast.

The FDA said in a statement that it has “diligently monitored reports of side effects possibly associated with montelukast, as well as communicated findings and taken regulatory action, when appropriate.” The agency said it “continues to monitor and investigate this important issue.”

The FDA declined to comment on how modern preemption defenses and court rulings have impacted pharmaceutical regulation and litigation.

BIG TOBACCO PRECEDENT

The doctrine of preemption is based on the U.S. Constitution’s supremacy clause. The original intent: to resolve conflicts between federal and state statutes and discourage state legislatures from passing laws that undermine federal policy.

Preemption-based corporate defenses are a modern phenomenon. American courts have historically viewed product-liability lawsuits, largely based on state laws, as vital to holding companies accountable when federal laws and regulations fail to do so. Courts recognized drugmaker liability for harmful medicines as early as the 1850s, according to a Supreme Court filing. FDA regulations once routinely specified that its decisions had no impact on drugmakers’ liability.

That started to change in 1992, in a case involving a smoker who died of cancer. The Supreme Court ruled that federal requirements for cigarette labels, which had included smoking warnings since the 1960s, overrode some of her family’s state-law claims that a tobacco company failed to warn her about smoking hazards.

States ultimately used different theories to force Big Tobacco into a $246 billion settlement. Still, the precedent gave Corporate America a blueprint for defeating similar lawsuits on preemption grounds.

Corporations got more help in the political arena. U.S. President George W. Bush had promised in his 2000 campaign to attack what Republicans derided as frivolous litigation targeting American industry. Administration officials undertook what critics dubbed “stealth” tort reform: intervening in lawsuits on the side of corporate defendants, with the goal of convincing judges to set precedents making it harder to sue companies.

Bush’s FDA exemplified the tactic. Daniel Troy, the agency’s chief counsel, interpreted preemption to mean that courts can’t undermine federal regulators based on alleged state-law violations. He aimed to make that argument in high-profile lawsuits. At a 2003 conference, Troy invited an audience of drug-industry lawyers to pitch the FDA on intervening in their cases.

“We can’t afford to get involved in every case – we have to pick our shots,” he told the assembled lawyers. “So make it sound like a Hollywood pitch.”

Troy, now a veteran pharmaceutical industry lawyer himself, said his goal at the time was simply to defend and strengthen the FDA’s authority to regulate without interference.

“If you believe in a strong FDA,” he said, “we can’t have state courts, especially juries, second-guessing and undercutting the FDA’s judgments.”

The FDA formally changed its view of preemption in a 2006 regulation, stating the agency now believed that FDA labeling approval “preempts conflicting or contrary State law.”

In its statement to Reuters, the FDA declined to comment on the 2006 regulation or the agency’s current view of preemption.

One of the Bush-era FDA’s biggest victories came in 2008, when the Supreme Court cited preemption in dismissing a New York man’s lawsuit against Medtronic over a burst balloon catheter. The precedent has since effectively barred wide swaths of lawsuits against medical-device manufacturers.

To examine the impact of preemption defenses, Reuters reviewed 257 federal appeals and Supreme Court rulings, which are the most influential in establishing precedents. In the cases, dating back to 2001, the courts determined whether preemption nullified plaintiffs’ claims that deaths or injuries were caused by corporate negligence or defective products. Judges threw out some or all of the claims on preemption grounds in two-thirds of the cases.

Another industry benefit can’t be quantified: The number of potential lawsuits that were never filed – like the one over Nicholas England’s death – because preemption precedents favor corporations, legal experts said.

Adam Zimmerman, a professor at the University of Southern California’s Gould School of Law, said the Reuters analysis underscores how these preemption precedents, which bind lower courts, have delivered corporations critical courtroom wins and leverage in settlement negotiations.

“It is really meaningful for the business community,” Zimmerman said.

Jay Lefkowitz, a Kirkland & Ellis partner who has represented companies before the Supreme Court, called preemption a “firmly enshrined” constitutional principle. State court juries, he said, shouldn’t be deciding how drug labels read based on the evidence in one case.

“We want the scientists and doctors at the FDA to do so,” he said, “based on all of the accumulated data from clinical trials and real world experience.”

TRAIN WRECK

Corporate preemption defenses are now common across a host of federally regulated industries.

After a February train derailment in East Palestine, Ohio, released toxic chemicals, train operator Norfolk Southern NSC.N invoked preemption to counter pending lawsuits.

Asked about the legal strategy, the company told Reuters it was “following the legal process” and that it was committed to paying for the environmental clean-up and any damage to residents’ health, water supply or property values.

The Reuters analysis found about three dozen examples over the past two decades of companies in the railroad industry invoking preemption to avoid liability. They cite federal laws regulating the safety of railroads and hazardous materials transportation. In 2015, for instance, a Union Pacific UNP.N train struck a pickup in Louisiana, killing three people, according to court records. The truck’s driver was the last in a convoy, waiting to proceed through a gate that hadn’t yet opened. Seconds later, a Union Pacific train barreled down the tracks at about 50 miles an hour.

The crash victims’ families sued and lost, in part because the Federal Railroad Safety Act preempted their claims that a horn sounded by the conductor failed to adequately warn of the oncoming train. Plaintiffs had argued that several short horn blasts, for instance, would have been more effective. An appeals court ruled their case was preempted because federal regulation defers to an engineer’s “sole judgment” on sounding a horn in such instances.

Union Pacific said in a statement that the engineer complied with federal law and that preemption provides a “consistent, uniform law” for train operators transporting goods across state lines.

In another pharmaceutical case involving suicide, a woman whose husband threw himself in front of a train shortly after he started taking the antidepressant paroxetine was barred by preemption from suing the generic manufacturer. Then, an appeals court cited preemption in overturning a $3 million verdict the woman had won against GlaxoSmithKline GLAX.NS, which made the brand-name version of the drug and controlled its label. The court found that the FDA would have rejected an adult suicide warning at the time her husband took it.

GlaxoSmithKline said in a statement that preemption is a “well-established legal principle grounded in the U.S. Constitution” to address conflicts between federal and state law. The company said it repeatedly asked the FDA to add a warning about suicidal thinking in adults to the label but the agency refused. The FDA instead mandated the same label for all drugs in the class that included paroxetine, which did not include such a warning.

Agricultural giant Monsanto is now pinning its hopes on preemption to help defeat or weaken tens of thousands of legal claims alleging it failed to warn consumers that its popular weed killer Roundup could cause cancer. In June, the company, owned by Bayer BAYGn.DE, urged a federal appeals court in Atlanta to dismiss one of those cases on preemption grounds, arguing federal regulators did not require a cancer warning on Roundup’s label.

Bayer said in a statement that these state-based claims are preempted because federal law expressly forbids states from instituting different labeling requirements. Federal regulators, Bayer said, have consistently found that Roundup and similar herbicides can be used safely and are not carcinogenic.

While preemption precedents favor corporations, judges’ tolerance for the argument has its limits. The Supreme Court in 2009 rejected the contention from drugmaker Wyeth, along with industry groups, that FDA approval should give name-brand drugmakers blanket immunity from certain types of lawsuits. The court ruled in favor of a Vermont woman who alleged the firm’s drug Phenegran led to the amputation of her arm.

'I WAS POISONING HIM'

Preemption defenses rely in part on the notion that state laws are not needed to protect citizens who are already safeguarded by federal regulators. But in the case of Singulair’s potentially deadly side effects, the FDA waited years, despite thousands of reported psychiatric problems, to require its most serious warning on the drug’s label.

By the time Nicholas England killed himself, the FDA had been reviewing Merck’s disclosures about health risks for nearly two decades. Parents who argue Singulair endangered their children view the FDA’s 2020 decision to add a black box warning as vindication, but many still want to sue Merck for not acting sooner.

In the years after Singulair’s 1998 launch, reports of related neuropsychiatric episodes piled up on internet forums and in the FDA’s early-warning detection system. The system compiles reports of “adverse events” from patients, doctors and others to track potential dangers discovered after a drug hits the market.

Jan Gilpin’s son was first prescribed Singulair for asthma in 2003, at age three. The boy soon seemed withdrawn and sullen. He would sometimes go “into a strange trance, mumbling to himself,” Gilpin wrote in 2008 in a report to the FDA. “Worst of all, he started talking about death – wanting to die, wishing he was dead, saying that he hated himself.”

Gilpin didn’t suspect Singulair for more than three years. In 2007, she stopped giving her son the drug after she stumbled on parents’ online posts about their children experiencing social anxiety while taking the medicine.

Soon, she noticed he began to skip and laugh.

“I realized he hadn’t laughed in two years,” said Gilpin, speaking through tears. “I didn’t realize that I was poisoning him with this medicine.”

The boy’s obsessive thoughts about death disappeared after he quit the medicine, Gilpin said, but he seemed to have some lingering effects, such as anxiety, that took longer to go away.

In August 2007, a 15-year-old boy in New York killed himself 17 days after first taking Singulair. Two months later, Merck proposed, and the FDA agreed, to amend Singulair’s label to add suicidal thinking and behavior to a list of adverse events reported to the company.

But the mention of suicidal thinking appeared in the middle of a list of more than three dozen side effects. Parent advocates argue the new label was grossly inadequate to warn of such a grave risk.

Three weeks after proposing the label change, Merck asked the FDA about getting permission to sell Singulair over-the-counter, without a prescription, for adults with hay fever. The FDA agreed to consider it but also wanted to understand more about suicide risks. A 2008 FDA review of the drug’s psychiatric affects and suicide risks recommended “further studies in animals and humans” and suggested the agency consider asking Merck to conduct an observational study.

The FDA did not require such a study, reasoning in part that serious side effects including suicidal thinking “were expected to be quite rare.”

In 2011, the agency rejected a petition from Gilpin and other parents seeking a black box warning, citing what it called insufficient evidence that the drug caused suicidal behavior.

82 SUICIDES

After Merck’s patent on Singulair expired in 2012, generic manufacturers started producing the drug. The number of patients prescribed the medicine climbed from about 7 million annually to more than 9 million, according to the FDA. Some years, nearly half of these patients were 16 or younger.

The FDA convened an advisory panel in 2014 to consider Merck’s request to offer Singulair over-the-counter. At the FDA’s request, Merck had re-analyzed its Singulair clinical-trial data in 2009. The company had reported that an 18-year-old trial participant had attempted suicide and a 12-year-old was hospitalized for depression and suicidal thoughts. In both cases, the trial investigator determined the events were not related to Singulair. In 2014, Stephane Bissonnette, a Merck manager at the time, told the FDA panel that “suicidality was quite rare” in the trials.

The FDA also analyzed Merck’s data and generally agreed with its conclusion, though the agency acknowledged the trials were short and not designed to detect neuropsychiatric effects.

The FDA panel recommended rejecting the request to sell Singulair over-the-counter because of safety concerns. The panel also called for new studies on its neuropsychiatric side effects, a patient registry, and an assessment of how well patients understood Singulair’s label.

Reports of neuropsychiatric side effects “really should give us pause that there may be something there we don’t understand,” Dr. Judith Kramer, Duke medical professor and an advisory committee member, said at the 2014 meeting.

The FDA followed only half the recommendation: It declined to authorize over-the-counter sales but also refused to order new studies, in part because neuropsychiatric side effects were already a “known safety issue,” an agency safety official said at the time.

The FDA told Reuters it declined to order more research because of “feasibility concerns.”

In 2019, the FDA convened another advisory panel on whether the drug’s side effects merited a black box warning. Before the meeting, the FDA tallied 82 suicides linked to Singulair and its generic versions reported to its adverse-event database since 1998. Only 64 of the reports provided an age; of those, 31 involved someone 19 or younger.

Still, agency staffers again said there was not enough evidence to merit a black box warning, noting that the label already warned of potential neuropsychiatric events.

FDA staff acknowledged the agency had the authority to require new studies. But Merck now had little incentive to conduct expensive research because its patent on Singulair had expired and its profits on the drug had plummeted. Instead, Merck might just pull Singulair off the market, an FDA official told the advisory committee in 2019.

Instead of requiring new studies, the FDA announced in March 2020 that it would add a black box to the labels of Singulair and its generic variations, warning of serious neuropsychiatric side effects including suicidal thinking and behavior. The agency cited independent research from 2015 showing the drug’s distribution in the brain. The FDA advised restricting use of the drug for treating allergies, saying it should not be the first-choice treatment.

'THIS DOES NOT MAKE SENSE'

Reuters interviewed 16 patients or their parents who suspect that Singulair caused psychiatric side effects. Many, like Nicholas England, took a generic version.

England grew up in the rural town of Wise, Virginia. He was easygoing and physically fit, and would refuse junk food when the rest of the family was having it, said his father, Robert England. He believed his son may have struggled to sleep after taking the drug, but otherwise seemed normal.

After Nicholas died, a police report noted that he didn’t have illicit drugs in his system. The case puzzled sheriff’s investigators, Robert said: “All these guys looked at me and said, ‘This does not make sense.’”

In the years when the FDA delayed action on Singulair, some parents began contacting lawyers to explore taking legal action. Most, like the Englands, were barred by court precedents from suing because their children took a generic version of the drug. Kim Beck, an attorney who eventually filed hundreds of lawsuits against Merck over Singulair, said her firm turned away thousands more potential clients who had taken generics.

The FDA’s 2020 regulatory action encouraged some patients to sue Merck. Most of those lawsuits are in early stages, but Merck has had some success with preemption defenses.

In Wisconsin, for instance, a mother sued Merck in 2020 claiming Singulair caused her son to be institutionalized with severe depression. The boy was prescribed Singulair in 2010, but switched to the generic version in 2012.

Merck argued the plaintiff couldn’t show the FDA would have approved a stronger warning before 2012, when the boy was taking brand-name Singulair. The drugmaker cited the agency’s 2011 rejection of the petition by Gilpin and other parents to add such a warning.

A judge agreed, ruling that “the relevant federal and state laws in this case irreconcilably conflict.” He dismissed nearly every claim in the lawsuit, which the mother then dropped.

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DATA METHODOLOGY: Reuters focused on federal appeals and Supreme Court decisions to measure the success of the preemption defense in lawsuits that alleged corporate negligence or defective products caused injuries or deaths. These cases are important because they usually establish legal precedents that other judges across the United States must follow.

Reporters worked with a specialist at Westlaw, a legal research service owned by Thomson Reuters, to identify cases since 2001 that involved the defense. They searched Westlaw’s database of federal court decisions for opinions that contained the phrase “preempt” as well as additional key words or phrases, such as “product liability,” “negligence,” “strict liability,” and “failure to warn.” Reporters consulted with several outside legal experts in developing the search terms.

The searches yielded nearly 800 opinions that a team of Reuters reporters manually reviewed to determine if the preemption defense was at issue in the opinion and if the case included allegations of physical harm to at least one person. The review narrowed the potential universe to 257 relevant cases.

The reporters then read each opinion in those 257 decisions to determine the outcome of the preemption defense. They marked cases “successful” when judges granted all preemption claims. Cases were marked “partially successful” when some claims were preempted but others were not. Cases were marked “unsuccessful” when no claims were preempted.

Each opinion was reviewed separately by two reporters to ensure the accuracy of the coding.

(Reporting by Dan Levine, Robin Respaut, Kristina Cooke, Mike Spector and Benjamin Lesser; Westlaw research by Eliot Warren; editing by Janet Roberts and Brian Thevenot)

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May 17 (Reuters) - GlaxoSmithKline Pharmaceuticals Ltd GLAX.NS:

• DIVIDEND 32 RUPEES PER SHARE

• MARCH-QUARTER CONSOL PROFIT 1.33 BILLION RUPEES VERSUS 12.19 BILLION RUPEES

• MARCH-QUARTER CONSOL REVENUE FROM OPERATIONS 7.87 BILLION RUPEES VERSUS 8.1 BILLION RUPEES

Source text for Eikon: ID:nBSE9y649g

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