$21B or bust! Ab­b­Vie en­sures its block­buster US marathon on Hu­mi­ra will run in­to 2023

Ab­b­Vie has fin­ished an­oth­er big sec­tion in its great wall of pro­tec­tive IP deals that will keep the world’s biggest block­buster un­marked by biosim­i­lar com­pe­ti­tion in the US for 5 long years.

Lau­ra Schu­mach­er

Six months af­ter Ab­b­Vie struck a deal with Am­gen that al­lows a knock­off of Hu­mi­ra to hit US shores on Jan­u­ary 31, 2023, Sam­sung Bioepis and Mer­ck signed off on an agree­ment to un­veil their biosim­i­lar on June 30, 2023. In most coun­tries in the EU, though, the de­but will come this fall, on Oc­to­ber 16.

“We con­tin­ue to be­lieve biosim­i­lars will play an im­por­tant role in our health­care sys­tem, but we al­so be­lieve it is im­por­tant to pro­tect our in­vest­ment in in­no­va­tion,” not­ed Ab­b­Vie EVP and gen­er­al coun­sel Lau­ra Schu­mach­er. “This agree­ment ac­com­plish­es both ob­jec­tives.”

How im­por­tant is this for Ab­b­Vie?

The bio­phar­ma com­pa­ny has been fight­ing for time to get new drugs lined up for the mar­ket so it can re­place a drug that pro­vides the li­on’s share of its rev­enue. Ab­b­Vie earned more than $18 bil­lion from Hu­mi­ra last year, with the rev­enue ris­ing steadi­ly as it con­tin­ues to push through an­nu­al hikes in the price.

Richard Gon­za­lez

In its Q3 re­port last year the com­pa­ny re­port­ed that it now ex­pects to see Hu­mi­ra sales climb to close to $21 bil­lion in 2020. To put that in some per­spec­tive, CEO Rick Gon­za­lez had fore­cast peak sales at $18 bil­lion by 2020 less than two years ago. That $3 bil­lion in ex­tra sales rep­re­sents the kind of block­buster rev­enue most bio­phar­mas would be hap­py to see from any one of its drugs. And most of it was de­liv­ered by con­tro­ver­sial price in­creas­es.

The deal comes as US of­fi­cials are work­ing on a plan to strip away some of the de­fen­sive moves that big play­ers like J&J have used to keep biosim­i­lar com­pe­ti­tion at bay. That’s an­oth­er threat that Ab­b­Vie won’t have to fret about.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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Cracks in the fa­cade: Is phar­ma's pan­dem­ic ‘feel good fac­tor’ wan­ing?

The discordant effects of the Covid-19 pandemic on pharma reputation continues. While the overall industry still retains a respectable halo from its Covid-19 quick response and leadership, a new patient group study reveals a different story emerging in the details.

On one hand, US patient advocacy groups rated the industry higher-than-ever overall. More than two-thirds (67%) of groups gave the industry a thumbs up for 2021, a whopping 10 percentage point increase over the year before, according to the PatientView annual study, now in its 9th year.

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Bris­tol My­ers Squibb sues No­var­tis for roy­al­ties sur­round­ing the use of trans­genic mice

Two Big Pharma companies are going to the mat over genetically modified mice in a licensing dispute.

Bristol Myers Squibb is suing Novartis in New York over a dispute concerning an evaluation, research and commercialization agreement stretching back to the late ’90s initially inked between Novartis and BMS’ predecessor Medarex. The deal in question allowed Novartis to use Medarex’s patented transgenic mice to develop therapeutic drugs. Novartis agreed to pay Medarex – and subsequently BMS – a royalty on sales of drugs it developed using the mice.

Anthony Fauci (AP Images)

West Vir­ginia man faces prison time for threat­en­ing emails to Fau­ci, oth­er health of­fi­cials

NIAID director Anthony Fauci gained hero status amid the pandemic, earning Americans’ trust and even Time magazine’s Guardian of the Year title. But he and other federal health officials have also faced intense threats, according to charges brought by the US Department of Justice.

A West Virginia man is facing up to 10 years in prison after threatening Fauci, former NIH director Francis Collins, and HHS assistant secretary for health Rachel Levine via email, the DOJ said on Monday. Thomas Patrick Connally, Jr., pleaded guilty on Monday to using an anonymous email address to threaten the officials for performing their official duties, including discussing Covid-19 testing and prevention.

Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

Phar­ma com­pa­ny con­tin­ues its FDA law­suit spree, this time af­ter agency de­nies fast-track des­ig­na­tion

Vanda Pharmaceuticals is making a name for itself, at least in terms of suing the FDA.

The DC-headquartered firm on Monday filed its latest suit against the agency, with the company raising concerns over the FDA’s failure to grant a fast track designation for Vanda’s potential chronic digestive disorder drug tradipitant, which is a neurokinin 1 receptor antagonist.

Specifically, Vanda said FDA’s “essential point” in its one-page denial letter on the designation pointed to “the lack of necessary safety data,” which was “inconsistent with the criteria for … Fast Track designation.”

Stéphane Bancel, Moderna CEO (Charles Krupa/AP Images)

Mod­er­na chief Ban­cel to do­nate about $355M worth of ear­ly stock to char­i­ty

Four days ago, Moderna CEO Stéphane Bancel was made a Chevalier — basically knighted — in his home country of France. And now the billionaire CEO said he will exercise and donate about  $355 million in stock options.

Bancel announced early Tuesday via a blog post that he and his wife Brenda will be donating the after-tax proceeds of his original stock options to charity — the stock options Bancel was granted back in 2013 after he became CEO, two years after he first joined the mRNA specialist outfit.

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Co­pay coupons gone wrong, again: Pfiz­er pays al­most $300K to set­tle com­plaints in four states

Pfizer has agreed to pay $290,000 to settle allegations of questionable copay coupon practices in Arizona, Colorado, Kansas, and Vermont from 2014 to 2018.

While the company has not admitted any wrongdoing as part of the settlement, Pfizer has agreed to issue restitution checks to about 5,000 consumers.

A Pfizer spokesperson said the company has “enhanced its co-pay coupons to alleviate the concerns raised by states and agreed to a $30,000 payment to each.”

Delaware court rules against Gilead and Astel­las in years-long patent case

A judge in Delaware has ruled against Astellas Pharma and Gilead in a long-running patent case over Pfizer-onwed Hospira’s generic version of Lexiscan.

The case kicked off in 2018, after Hospira submitted an Abbreviated New Drug Application (ANDA) for approval to market a generic version of Gilead’s Lexiscan. The drug is used in myocardial perfusion imaging (MPI), a type of nuclear stress test.

Taye Diggs (courtesy Idorsia)

Idor­sia inks an­oth­er celebri­ty en­dors­er deal with ac­tor and dad Taye Dig­gs as Qu­viviq in­som­nia am­bas­sador

Idorsia’s latest Quviviq insomnia campaign details the relatable dad story of a well-known celebrity — actor and Broadway star Taye Diggs.

Diggs stopped sleeping well after the birth of his son, now more than 10 years ago. Switching mom-and-dad nightly shifts to take care of a baby interrupted his sleep patterns and led to insomnia.

“When you’re lucky enough to be living out your dream and doing what you want, but because of something as simple as a lack of sleep, you’re unable to do that, it felt absolutely — it was treacherous,” he says in an interview-style video on the Quviviq website.

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