My­lan at­tacks Al­ler­gan over its Mo­hawk-al­lied patent strat­e­gy — but the CEO is stick­ing to his guns

Brent Saun­ders (cen­ter, with mi­cro­phone) speaks at an End­points News event at the JP Mor­gan con­fer­ence ear­li­er this year End­points News


My­lan didn’t wait long be­fore chal­leng­ing Al­ler­gan’s bid to safe­guard its patents for its block­buster eye drug Resta­sis by flip­ping the rights to the drug to a Mo­hawk In­di­an tribe and then li­cens­ing them back.

Last week’s le­gal gam­bit, My­lan said in a court fil­ing, is a sim­ple at­tempt to “mis­use Na­tive Amer­i­can sov­er­eign­ty to shield in­valid patents from can­cel­la­tion.”

But don’t look for Al­ler­gan — or its lawyers — to cave in now or any­time. No mat­ter what re­ac­tion they get, they plan to fight this one out.

The move by Al­ler­gan trig­gered a num­ber of crit­i­cal re­views, in­clud­ing one of my own late last week that un­der­scored my thoughts that Al­ler­gan had squan­dered what­ev­er moral ad­van­tage it had gained by show­ing re­straint on drug pric­ing last fall with a bit of le­gal trick­ery that would on­ly reignite the pub­lic’s scorn for un­scrupu­lous phar­ma com­pa­nies and their lawyers.

Al­ler­gan CEO Brent Saun­ders and chief le­gal of­fi­cer Bob Bai­ley took a few min­utes on Mon­day to ex­plain their po­si­tion. (They can re­ply to My­lan in court.)

“We can cer­tain­ly agree to dis­agree,” Saun­ders told me, adding adamant­ly that “every­thing we have done here is com­plete­ly con­sis­tent with our so­cial con­tract.”

The CEO and chief le­gal of­fi­cer at Al­ler­gan say what’s un­fair is be­ing forced to square off si­mul­ta­ne­ous­ly on two sep­a­rate le­gal fronts as it fights to keep con­trol of its big fran­chise ther­a­py. The IRP chal­lenge, adds Saun­ders, is a flawed process that hedge funds and oth­ers have grabbed on to in search of an Achilles heel they can tar­get. Patent chal­lenges should be re­strict­ed to the fed­er­al court.

Be­sides, they add, state uni­ver­si­ties have the same pro­tect­ed patent sta­tus as the tribes achieve with sov­er­eign im­mu­ni­ty, and no one makes a fuss about that. Pay­ing the Saint Reg­is Mo­hawk tribe — look­ing to di­ver­si­fy be­yond its casi­no op­er­a­tion — $13.75 mil­lion for this, they ar­gue, al­so is an op­por­tu­ni­ty to help out an im­pov­er­ished peo­ple who can use the mon­ey for health­care and oth­er ser­vices.

“We are ab­solute­ly go­ing to stick with this,” adds the CEO, as a nec­es­sary strat­e­gy for bal­anc­ing the needs of the mar­ket and in­vestors against the un­cer­tain world of drug R&D, where the risk of fail­ure runs deep.

To in­vest in R&D, they add, “we need the full pro­tec­tion of the courts.” If any­thing, the fo­cus should be on patent re­form.

To me, it all just looks like an “any­thing goes” ap­proach that land­ed the in­dus­try in a tub of boil­ing hot pub­lic dis­gust on mar­ket­ing prac­tices — which con­tin­ues to taint the in­dus­try. And there are plen­ty of ways they can help im­pov­er­ished peo­ple with­out get­ting patent at­tor­neys in­volved.

But I’m not chang­ing any­one’s mind at Al­ler­gan ei­ther. The con­tro­ver­sy over the ma­neu­ver, though, will on­ly grow. Reuters re­ports to­day that a tech group has al­so trans­ferred patents to the tribe, and an at­tor­ney in­volved says that you can ex­pect plen­ty more such cas­es to fol­low.

The deals an­nounced so far “are just the tip of the ice­berg,” said David Prid­ham, chief ex­ec­u­tive of the Dal­las-based Do­min­ion Har­bor Group. “There are dozens and dozens of tribes talk­ing to law firms about this struc­ture.”

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

15 LGBTQ lead­ers in bio­phar­ma; Paul Stof­fels’ Gala­pa­gos re­vamp; As­traZeneca catch­es up in AT­TR; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

A return to in-person conferences also marks a return to on-the-ground reporting. My colleagues Beth Synder Bulik and Nicole DeFeudis were on-site at Cannes Lions, bringing live coverage of pharma’s presence at the ad festival — accompanied by photos from Clara Bui, our virtual producer, that bring you right to the scene. You can find a recap (and links to all the stories) below.

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David Loew (Ipsen)

Ipsen snags an ap­proved can­cer drug in $247M M&A deal as an­oth­er bat­tered biotech sells cheap

You can add Paris-based Ipsen to the list of discount buyers patrolling the penny stock pack for a cheap M&A deal.

The French biotech, which has had plenty of its own problems to grapple with, has swooped in to buy Epizyme $EPZM for $247 million in cash and a CVR with milestones attached to it. Epizyme shareholders, who had to suffer through a painfully soft launch of their EZH2a inhibitor cancer drug Tazverik, will get $1.45 per share along with a $1 CVR tied to achieving $250 million in sales from the drug over four consecutive quarters as well as an OK for second-line follicular lymphoma by 1 Jan. 2028.

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AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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Joe Papa (Ryan Remiorz/The Canadian Press via AP, File)

Joe Pa­pa re­signs as chair of Bausch Health as bil­lion­aire John Paul­son takes over

Joe Papa, chair of Bausch Health, officially resigned on Thursday and the board appointed billionaire hedge fund manager John Paulson as the new chair, effective immediately.

The specialty pharma company sought to make clear that Papa’s abrupt departure “was not due to any dispute or disagreement with the Company, its management or the Board on any matter relating to the Company’s operations, policies or practices.”

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De­spite a slow start to the year for deals, PwC pre­dicts a flur­ry of ac­tiv­i­ty com­ing up

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.

Joe Wiley, Amryt Pharma CEO

Am­ryt Phar­ma sub­mits a for­mal dis­pute res­o­lu­tion to the FDA over re­ject­ed skin dis­ease drug

The story of Amryt Pharma’s candidate for the genetic skin condition epidermolysis bullosa, or EB, will soon enter another chapter.

After the Irish drugmaker’s candidate, dubbed Oleogel-S10 and marketed as Filsuvez, was handed a CRL earlier this year, the company announced in a press release that it plans to submit a formal dispute resolution request for the company’s NDA for Oleogel-S10.

Sen. Thom Tillis (R-NC) (J. Scott Applewhite/AP Images)

Phar­ma-friend­ly sen­a­tor calls on FDA for a third time to show patent pro­tec­tions should­n't be blamed for high drug prices

North Carolina Republican Sen. Thom Tillis made a name for himself in the 2020 election cycle as the darling of the pharma industry, accepting hundreds of thousands in campaign contributions, even from the likes of Pfizer CEO Albert Bourla.

Those contributions have led Tillis to attempt to re-write patent laws in pharma’s favor, a move which failed to gain steam in 2019, and request for a third time since January that the FDA should help stop “the false narrative that patent protections are to blame for high drug prices.”

EMA signs off on 3 drugs re­cent­ly re­ject­ed by FDA, in­clud­ing Bio­Mar­in's new he­mo­phil­ia gene ther­a­py

The EMA’s human medicines committee on Friday recommended three new drugs for approval or conditional approval, even as their US counterparts have rejected these three for various reasons.

In a major move, CHMP offered a thumbs-up to a conditional marketing authorization for the first gene therapy to treat severe hemophilia A, although the agency cautioned that it’s so far unknown how long the effects of infusion will last.

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