Werner Baumann, Bayer CEO (Malte Ossowski/SVEN SIMON/picture-alliance/dpa/AP Images)

Bay­er CEO Wern­er Bau­mann says com­pa­ny is 'putting ma­jor lit­i­ga­tion be­hind us' while high­light­ing Q2 growth

Bay­er CEO Wern­er Bau­mann high­light­ed “strong op­er­a­tional per­for­mance” on Thurs­day while rais­ing the full-year guid­ance. But be­fore div­ing in­to the de­tails, he sum­ma­rized Bay­er’s plan to set­tle a slate of on­go­ing lit­i­ga­tion.

“We are mak­ing good progress in putting ma­jor lit­i­ga­tion be­hind us,” Bau­mann said on a Q2 call with in­vestors and an­a­lysts.

He added that the com­pa­ny is “con­fi­dent in the lit­i­ga­tion strat­e­gy” when it comes to glyphosate, the ac­tive in­gre­di­ent in the weed­killer Roundup. Bay­er has faced mul­ti­ple cas­es al­leg­ing that Roundup caused can­cer, and re­cent­ly an­nounced a five-point plan to “a clear path to clo­sure of the U.S. glyphosate lit­i­ga­tion.”

The com­pa­ny has al­ready set­tled 107,000 of 138,000 cas­es, ac­cord­ing to its web­site.

“From to­day’s per­spec­tive, we are suf­fi­cient­ly pro­vi­sioned to deal with the cur­rent and al­so the fu­ture cas­es,” Bau­mann said.

Bay­er has faced scruti­ny since clos­ing $30 bil­lion in val­u­a­tion af­ter its $63 bil­lion buy­out of US agri­cul­tur­al gi­ant Mon­san­to in 2018.

As for law­suits al­leg­ing Mon­san­to and oth­er com­pa­nies should be held re­spon­si­ble for en­vi­ron­men­tal im­pacts from car­cino­genic chem­i­cals called poly­chlo­ri­nat­ed biphenyls (PCBs), Bay­er said a class ac­tion set­tle­ment is like­ly com­ing in Q4.

“The opt out pe­ri­od for the class set­tle­ment re­cent­ly ex­pired and we ex­pect to fi­nal­ize the na­tion­al class ac­tion set­tle­ment in quar­ter four,” Bau­mann said.

He al­so said an ar­bi­tra­tion rul­ing is ex­pect­ed soon in its case with BASF, which claimed Bay­er didn’t ful­ly dis­close per­son­nel costs when it ne­go­ti­at­ed as­sets from the crop sci­ence port­fo­lio.

“We ex­pect the de­ci­sion by the ar­bi­tral tri­bunal to be is­sued short­ly,” the com­pa­ny said.

As for the phar­ma busi­ness, sales were slight­ly up thanks to gains from Eylea, Bay­er’s vas­cu­lar en­dothe­lial growth fac­tor (VEGF) in­hibitor used to treat sev­er­al eye-re­lat­ed con­di­tions, in­clud­ing neo­vas­cu­lar (wet) age-re­lat­ed mac­u­lar de­gen­er­a­tion (AMD), mac­u­lar ede­ma fol­low­ing reti­nal vein oc­clu­sion (RVO), di­a­bet­ic mac­u­lar ede­ma (DME) and di­a­bet­ic retinopa­thy (DR).

Eylea earned rough­ly $826 mil­lion last quar­ter (€807 mil­lion), up from $728 mil­lion (€711 mil­lion) in Q2 of 2021.

Bay­er main­tained its con­fi­dence in Eylea de­spite the emer­gence of com­peti­tors, in­clud­ing Roche’s two prod­ucts Susvi­mo and Vabysmo. Back in May, a Spher­ix study re­vealed that while most oph­thal­mol­o­gists have heard of Susvi­mo, a ma­jor­i­ty of the re­spon­dents said they’d turn to Eylea as a safer and more ac­ces­si­ble op­tion.

How­ev­er, Bay­er not­ed that phar­ma growth was held back by “price- and vol­ume-re­lat­ed de­clines for Xarel­to that were large­ly due to ten­der pro­ce­dures in Chi­na and the ex­pi­ra­tion of our patent in Brazil.”

Xarel­to earned rough­ly $1.1 bil­lion (€1.1 bil­lion) in Q2, down slight­ly from the near­ly $1.2 bil­lion it raked in for the sec­ond quar­ter last year.

Con­sumer health sales were up 6.8% this quar­ter, large­ly dri­ven by a 17% growth in al­ler­gy and sales as a high­er num­ber of cold in­ci­dents oc­curred due to less so­cial dis­tanc­ing, the com­pa­ny said.

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Uğur Şahin, BioNTech CEO (Kay Nietfeld/picture-alliance/dpa/AP Images)

De­spite falling Covid-19 sales, BioN­Tech main­tains '22 sales guid­ance

While Pfizer raked in almost $28 billion last quarter, its Covid-19 vaccine partner BioNTech reported a rise in total dose orders but a drop in sales.

The German biotech reported over $3.2 billion in revenue in Q2 on Monday, down from more than $6.7 billion in Q1, in part due to falling Covid sales. While management said last quarter that they anticipated a Covid sales drop — CEO Uğur Şahin said at the time that “the pandemic situation is still very much uncertain” — Q2 sales still missed consensus by 14%.

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Pascal Soriot, AstraZeneca CEO (David Zorrakino/Europa Press via AP Images)

As­traZeneca and Dai­ichi Sankyo sprint to mar­ket af­ter FDA clears En­her­tu in just two weeks

Regulators didn’t keep AstraZeneca and Daiichi Sankyo waiting long at all for their latest Enhertu approval.

The partners pulled a win on Friday in HER2-low breast cancer patients who’ve already failed on chemotherapy, just two weeks after submitting a supplemental BLA. While this isn’t the FDA’s fastest approval — Bristol Myers Squibb won an OK for its blockbuster checkpoint inhibitor Opdivo in just five days back in March — it comes well ahead of Enhertu’s original Q4 PDUFA date.

Ted Love, Global Blood Therapeutics CEO

Up­dat­ed: Pfiz­er scoops up Glob­al Blood Ther­a­peu­tics and its sick­le cell ther­a­pies for $5.4B

Pfizer is dropping $5.4 billion to acquire Global Blood Therapeutics.

Just ahead of the weekend, word got out that Pfizer was close to clinching a $5 billion buyout — albeit with other potential buyers still at the table. The pharma giant, flush with cash from Covid-19 vaccine sales, apparently got out on top.

The deal immediately swells Pfizer’s previously tiny sickle cell disease portfolio from just a Phase I program to one with an approved drug, Oxbryta, plus a whole pipeline that, if all approved, the company believes could make for a $3 billion franchise at peak.

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David Reese, Amgen R&D chief

UP­DAT­ED: In a fresh dis­ap­point­ment, Am­gen spot­lights a ma­jor safe­ty is­sue with KRAS com­bo

Amgen had hoped that its latest study matching its landmark KRAS G12C drug Lumakras with checkpoint inhibitors would open up its treatment horizons and expand its commercial potential. Instead, the combo spurred safety issues that blunted efficacy and forced the pharma giant to alter course on its treatment strategy, once again disappointing analysts who have been tracking the drug’s faltering sales and limited therapeutic reach.

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FDA commissioner Rob Califf (Tom Williams/CQ Roll Call via AP Images)

With drug pric­ing al­most done, Con­gress looks to wrap up FDA user fee leg­is­la­tion

The Senate won’t return from its summer recess until Sept. 6, but when it does, it officially has 18 business days to finalize the reauthorization of the FDA user fee programs for the next 5 years, or else thousands of drug and biologics reviewers will be laid off and PDUFA dates will vanish in the interim.

FDA commissioner Rob Califf recently sent agency staff a memo explaining how, “Our latest estimates are that we have carryover for PDUFA [Prescription Drug User Fee Act], the user fee funding program that will run out of funding first, to cover only about 5 weeks into the next fiscal year.”

GSK and IQVIA launch plat­form of US vac­ci­na­tion da­ta, show­ing drop in adult rates

Throughout the Covid-19 pandemic, the issue of vaccine uptake has been a point of contention, but a new platform from GSK and IQVIA is hoping to shed more light on vaccine data, via new transparency and general awareness.

The two companies have launched Vaccine Track, a platform intended to be used by public health officials, medical professionals and others to strengthen data transparency and display vaccination trends. According to the companies, the platform is intended to aid in increasing vaccine rates and will provide data on trends to assist public health efforts.

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Ab­b­Vie sur­veys emo­tion­al im­pact of chron­ic leukemia con­di­tion, finds 'roller coast­er' of emo­tions

Rare diseases often have more than just physical effects on patients — especially when it comes to chronic conditions. In the case of the rare slow-growing blood cancer chronic lymphocytic leukemia (CLL), AbbVie wanted to try to assess the mental and emotional toll on patients.

So it surveyed more than 300 CLL patients, caregivers and physicians. While each group differed in how they felt — caregivers overwhelmingly (81%) felt positive about their role, for instance — patients described a “roller coaster” of emotions traversing diagnosis to treatment to remission and even relapse for some.

Sen­ate Dems cling to a sim­ple ma­jor­i­ty to pass some of the biggest drug pric­ing re­forms ever

The Pharmaceutical Research and Manufacturers of America — and their fleet of drug industry lobbyists on Capitol Hill — are known for never losing.

Whenever a big drug pricing bill comes up, an army of the industry group’s lobbyists descend onto the Hill and either smash it outright or dismantle it piece by piece.

But for perhaps the largest drug pricing reforms ever enacted, after more than a decade of Congress trying and failing to allow Medicare to negotiate prescription drug prices, those same lobbyists and their biopharma clients were dealt a stunning blow on Sunday afternoon.