Al­ler­gan shows how you can de­stroy your rep and get mobbed by law­mak­ers in 4 easy steps

The view from End­points
John Car­roll, Ed­i­tor

First came the on­slaught of me­dia re­ports. Then came the out­raged let­ter from the US Sen­a­tors fol­lowed by the launch of a House probe and a bi­par­ti­san de­mand for doc­u­ments. Now, a few weeks in, comes the first piece of leg­is­la­tion aimed at killing the source of the out­rage.

Al­ler­gan’s Mo­hawk gam­bit on the patent front is fast be­com­ing a text­book study in how to shoot your­self in the foot while at­tract­ing a large and un­sym­pa­thet­ic crowd.

Claire Mc­Caskill, the De­mo­c­ra­t­ic Sen­a­tor from Mis­souri, has fol­lowed up a scold­ing let­ter to PhRMA chief Stephen Ubl about how Al­ler­gan was gam­ing the sys­tem, and her plans for leg­is­la­tion that would ban com­pa­nies from us­ing trib­al im­mu­ni­ty laws to pro­tect them­selves from in­ter partes re­view patent chal­lenges.

Al­ler­gan man­aged to cap­ture every­one’s at­ten­tion with a nifty lawyer’s trick. They paid the Saint Reg­is Mo­hawk Tribe $13.75 mil­lion for a deal that trans­ferred its patents for the $1.5 bil­lion drug Resta­sis to the tribe, then es­sen­tial­ly leased them back for roy­al­ties. And the tribe vir­tu­al­ly hung a big ban­ner say­ing it was open for busi­ness for the rest of the phar­ma in­dus­try and any­one else that would like them to claim im­mu­ni­ty against the IPR process and guard against gener­ics.

I’m doubt­ing that any oth­er phar­mas will fol­low, no mat­ter how bad­ly tempt­ed they may feel. This is how you can dam­age your com­pa­ny’s rep­u­ta­tion at con­sid­er­able ex­pense and an­tag­o­nize law­mak­ers with­out ben­e­fit­ing at all — not an ap­pe­tiz­ing prospect.

Mc­Caskill’s state­ment, re­port­ed by Reuters, neat­ly sum­ma­rizes Al­ler­gan’s dilem­ma.

Any think­ing per­son would look at what this com­pa­ny did and say, ‘That should be il­le­gal.’ Well, I agree. Con­gress nev­er imag­ined tribes would al­low them­selves to be used by phar­ma­ceu­ti­cal com­pa­nies to avoid chal­lenges to patents, and this bill will shut the prac­tice down be­fore oth­ers fol­low suit.

Al­ler­gan CEO Brent Saun­ders has been try­ing might­i­ly hard to make this in­to a con­tro­ver­sy over the IPR process, which they say is in­her­ent­ly un­fair, forc­ing them to fight si­mul­ta­ne­ous­ly on two le­gal fronts.

He may be right. But no one is pay­ing much at­ten­tion. He’s giv­en Con­gress too much to dis­tract them.

The Saint Reg­is Mo­hawk Tribe says it’s “out­raged” that law­mak­ers would sin­gle out strug­gling In­di­an tribes while al­low­ing state uni­ver­si­ties to re­tain their own im­mu­ni­ty.

The Tribe re­mains com­mit­ted to work­ing with all Mem­bers of Con­gress to dis­cuss how its re­cent eco­nom­ic di­ver­si­fi­ca­tion ef­forts ben­e­fits the Tribe, its mem­bers, and the sur­round­ing com­mu­ni­ties with­out harm­ing com­pe­ti­tion among phar­ma­ceu­ti­cal com­pa­nies (both pri­vate and gener­ic) or ar­ti­fi­cial­ly in­flat­ing drug prices.

The Mo­hawks al­ready made it clear that their casi­no isn’t enough. But it’s un­like­ly that the eco­nom­ic di­ver­si­fi­ca­tion ar­gu­ment will be a big win­ner in Con­gress, where high drug prices and ac­cess to cheap gener­ics re­main a source of con­sid­er­able pub­lic rage.

This doesn’t end well for Al­ler­gan. The ques­tion is, can they stop dig­ging and climb out of the hole they’re in.

Im­age: Brent Saun­ders AP Im­ages

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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Serhat Gumrukçu, Enochian BioSciences co-founder (Seraph Research Institute)

LA biotech founder ar­rest­ed, charged in mur­der-for-hire scheme be­hind 2018 death

A biotech founder has been arrested and charged for his role in a murder-for-hire scheme that resulted in the death of a man in Vermont back in 2018.

Serhat Gumrukçu, the co-founder of Enochian BioSciences, was arrested in Los Angeles, where the company is based, according to the Department of Justice. He was charged alongside Berk Eratay of Las Vegas, and a third person, Jerry Banks of Colorado, was previously arrested for kidnapping and allegedly murdering the victim, Gregory Davis.

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Adam Russell, ARPA-H's incoming acting deputy director

NI­H's new, in­de­pen­dent break­through drug ac­cel­er­a­tor ARPA-H gets its first em­ploy­ee

Despite the controversy of housing it in NIH, HHS Secretary Xavier Becerra on Wednesday afternoon formally announced the establishment of the Advanced Research Project Agency for Health (ARPA-H) as an independent entity within the NIH, as HHS had previously stipulated that “NIH may not subject ARPA-H to NIH policies.”

Becerra also announced the appointment of ARPA-H’s inaugural employee, Adam Russell, who will serve as acting deputy director.

ProFound Therapeutics founding team

Flag­ship's lat­est biotech could turn some of the thou­sands of new pro­teins it dis­cov­ered in­to ther­a­pies — and it has $75M to start

Flagship Pioneering, the incubator of Moderna and dozens of other biotechs, says it has landed upon tens of thousands of previously undiscovered human proteins. The VC shop wants to potentially turn them into therapeutics.

Like other drug developers that have turned proteins into therapeutics (think insulin for diabetes), Flagship’s latest creation, ProFound Therapeutics, wants to tap into this new trove of proteins as part of its mission to treat indications ranging from rare diseases to cancer to immunological diseases.

Richard Silverman, Akava Therapeutics founder and Northwestern professor

This time around, Lyri­ca's in­ven­tor is de­vel­op­ing his North­west­ern dis­cov­er­ies at his own biotech

Richard Silverman was left in the dark for the last five years of clinical development of the drug he discovered. The Northwestern University professor found out about the first approval of Lyrica, in the last few days of 2004, like most other people: in the newspaper.

What became one of Pfizer’s top-selling meds, at $5 billion in 2017 global sales before losing patent protection in 2019, started slipping out of his hands when Northwestern licensed it out to Parke-Davis, one of two biotechs that showed interest in developing the drug in the pre-email days, when the university’s two-person tech transfer team had to ship out letters to garner industry appetite.

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David Ricks, Eli Lilly CEO (David Paul Morris/Bloomberg via Getty Images)

Eli Lil­ly set to in­vest $2.1B in home state man­u­fac­tur­ing boost

Eli Lilly is looking to expand its footprint in its home Hoosier State by making a major investment in manufacturing.

The pharma is investing $2.1 billion in two new manufacturing sites at Indiana’s LEAP Lebanon Innovation and Research District in Boone County, northwest of Lilly’s headquarters in Indianapolis.

The two new facilities will expand Lilly’s manufacturing network for active ingredients and new therapeutic modalities, including genetic medicines, according to a press release.

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Up­dat­ed: US sees spike in Paxlovid us­age as Mer­ck­'s mol­nupi­ravir and As­traZeneca's Evusheld are slow­er off the shelf

New data from HHS show that more than 162,000 courses of Pfizer’s Covid-19 antiviral Paxlovid were administered across the US over the past week, continuing a streak of increased usage of the pill, and signaling not only rising case numbers but more awareness of how to access it.

In comparison to this week, about 670,000 courses of the Pfizer pill have been administered across the first five months since Paxlovid has been on the US market, averaging about 33,000 courses administered per week in that time.

Pfiz­er and CD­MOs ramp up Paxlovid man­u­fac­tur­ing with Kala­ma­zoo plant ex­pan­sion lead­ing the way

As the Covid-19 pandemic continues to evolve, pharma companies and manufacturers are exploring how to step up production on antivirals.

Pfizer is planning to expand its Kalamazoo-area facility to increase manufacturing capabilities for the oral Covid-19 antiviral Paxlovid, according to a report from Michigan-based news site MLive. The expansion of the facility, which serves as Pfizer’s largest manufacturing location, is expected to create hundreds of “high-skilled” STEM jobs, MLive reported. No details about the project’s cost and timeline have been released, but according to MLive, Pfizer will announce the details of the expansion at some point in early June.

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FDA spells out the rules and re­stric­tions for states seek­ing to im­port drugs from Cana­da

The FDA is offering more of an explanation of the guardrails around its program that may soon allow states to import prescription drugs in some select circumstances from Canada, but only if such imports will result in significant cost reductions for consumers.

While the agency has yet to sign off on any of the 5 state plans in the works so far, and PhRMA’s suit to block the Trump-era rule allowing such imports is stalled, the new Q&A guidance spells out the various restrictions that states will have to abide by, potentially signaling that a state approval is coming.