Michael Goettler, Viatris CEO

Vi­a­tris agrees to pay $264M to set­tle EpiPen class ac­tion case

Just as Bio­con signs off on a $3.3 bil­lion buy­out of their shared biosim­i­lars busi­ness, Vi­a­tris’s pend­ing law­suit for its con­tro­ver­sial EpiPen might be no more — if the court signs off on it.

Keep­ing de­tails short, the phar­ma snuck in an an­nounce­ment about its EpiPen prod­uct in its Q4 re­port:

The Com­pa­ny has agreed, sub­ject to ap­proval by the Court, to a $264 mil­lion set­tle­ment, while deny­ing any al­le­ga­tion of wrong­do­ing, to re­solve the EpiPen Au­to-In­jec­tor in­di­rect pur­chas­er class ac­tion cas­es pend­ing in the U.S. Dis­trict Court for the Dis­trict of Kansas.

The phar­ma added that “the Board of Di­rec­tors be­lieves that this set­tle­ment is in the best in­ter­ests of the Com­pa­ny and its stake­hold­ers. The res­o­lu­tion of these in­di­rect pur­chas­er cas­es will al­low the Com­pa­ny to move for­ward and con­tin­ue fo­cus­ing on its strate­gic pri­or­i­ties.”

Heather Bresch

The phar­ma play­er, cre­at­ed out of the merg­er of Up­john and My­lan, came un­der heavy fire amid ac­cu­sa­tions of greed and price goug­ing af­ter news sur­faced in 2016 that the price of My­lan’s EpiPen, an au­to-in­jec­tor to treat se­vere al­ler­gic re­ac­tions, in­creased from about $100 in 2007 to $608 for a two-pack. At the time, the com­pa­ny had rev­enues of $11 bil­lion a year — fu­el­ing scathing cri­tiques about ris­ing US drug prices.

Then-My­lan CEO Heather Bresch, daugh­ter of De­mo­c­ra­t­ic sen­a­tor Joe Manchin, left the com­pa­ny af­ter the merg­er in 2020. But she vig­or­ous­ly de­fend­ed the price in­crease at the time be­fore the Con­gress Over­sight and Gov­ern­ment Re­form Com­mit­tee, say­ing that “Price and ac­cess ex­ist in a bal­ance, and we be­lieve we have struck that bal­ance.”

Fast for­ward one year, and My­lan fi­nal­ized a $465 mil­lion set­tle­ment with the US De­part­ment of Jus­tice to re­solve claims that it over­charged the gov­ern­ment for the EpiPen.

Daniel Crab­tree

The class-ac­tion case, brought be­fore Kansas City, KS judge Daniel Crab­tree, was on be­half of con­sumers and third-par­ty pay­ers such as in­sur­ers — with the plain­tiffs seek­ing $1 bil­lion in dam­ages, a sum that un­der some state an­titrust laws could have been mul­ti­plied.

The law­suit ac­cused both My­lan and Pfiz­er, which man­u­fac­tured the EpiPen, of en­gag­ing in an­ti­com­pet­i­tive con­duct — po­ten­tial­ly al­low­ing the com­pa­nies to main­tain a mo­nop­oly over the mar­ket for the de­vices. While the case was slat­ed to go on tri­al this month, Crab­tree dis­missed much of the case against My­lan last June, leav­ing on­ly a claim con­cern­ing a 2012 patent lit­i­ga­tion set­tle­ment with gener­ic drug­mak­er Te­va.

Pfiz­er had al­so set­tled last year for $345 mil­lion.

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Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance Chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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Seagen interim CEO Roger Dansey and Daiichi Sankyo CEO Sunao Manabe

Paving the way for Mer­ck­'s buy­out, Seagen los­es ar­bi­tra­tion dis­pute with Dai­ichi over ADC tech

As Seagen awaits a final buyout offer from Merck that could be in the territory of $40 billion, Seagen revealed Friday afternoon that it lost an arbitration dispute with Daiichi Sankyo relating to the companies’ 2008 collaboration around the use of antibody-drug conjugate (ADC) technology.

But that loss likely won’t matter much when it comes to Merck’s deal.

After breaking off its pact with Daiichi in mid-2015, the two companies battled over “linker” tech — a chemical bridge between an ADC’s antibody component and the cytotoxic payload — that Seagen claims Daiichi would improve upon and implement in its current generation of ADCs.

FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

CSL is gathering its four business units under a unified brand identity strategy (Credit: CSL company site)

CSL brings Se­qirus, Vi­for un­der par­ent um­brel­la brand in iden­ti­ty re­vamp

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

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Sanofi, GSK, Ha­le­on see stock prices dip and dive amid lit­i­ga­tion for re­called heart­burn drug

Zantac became one of the most well-known drugs on the market after being FDA-approved in 1983 — and now close to four decades later, lawsuits over safety concerns are rattling analysts and investors.

Sanofi, GSK and Haleon, GSK’s former consumer healthcare unit, have lost billions of dollars in market cap since Tuesday’s market close, according to Bloomberg. While Zantac is no longer on the market, the drop came after a suite of analysts, from Morgan Stanley and other firms, sounded the alarm on the potential impact of ongoing personal injury litigation.

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Ab­bott pumps $450M+ in­to new Ire­land-based man­u­fac­tur­ing site project and hir­ing spree

As Ireland continues to see more investments and building projects from pharma companies, another contender is looking to place more investment in the Emerald Isle.

According to a report from The Irish Times on Friday, Abbott Laboratories is investing €440 million, or about $451 million, to build a new manufacturing plant in Kilkenny, located in the country’s southeast, to make more of its glucose monitors.