Ra­maswamy’s Der­ma­vant bags GSK’s PhI­II-ready pso­ri­a­sis drug in $330M deal — eye­ing a ma­jor league con­test

Vivek Ra­maswamy got start­ed in biotech pay­ing a pit­tance for a failed Alzheimer’s drug at Glax­o­SmithK­line — which flopped mis­er­ably in Phase III. Now one of his biotech com­pa­nies is go­ing back to GSK for a new drug to put in the late-stage pipeline, but the pen­ny ante game is over.

Jack­ie Fouse

Der­ma­vant, helmed by Cel­gene vet Jack­ie Fouse, has inked a $330 mil­lion deal to buy the Phase III-ready tap­inarof (GSK2894512), with close to $200 mil­lion of that com­ing in an up­front pay­ment. The drug has scored pos­i­tive Phase II da­ta, putting it in­to the line­up of ex­per­i­men­tal drugs fol­low­ing Dupix­ent from Sanofi and Re­gen­eron. And that will set the bar for suc­cess in pso­ri­a­sis and atopic der­mati­tis at a very high lev­el.

The deal marks the lat­est move by Glax­o­SmithK­line chief Em­ma Walm­s­ley in re­vamp­ing the pipeline in an­tic­i­pa­tion of an evolv­ing strate­gic shift un­der new R&D boss Hal Bar­ron, which will in­clude a much big­ger fo­cus on late-stage on­col­o­gy pro­grams.

John Lep­ore

Not­ed GSK SVP John Lep­ore:

We have tak­en a strate­gic de­ci­sion to di­vest or part­ner med­i­cines in our R&D port­fo­lio that are a bet­ter fit for oth­er com­pa­nies al­low­ing us to con­cen­trate our re­sources on oth­er promis­ing as­sets.

If they’re suc­cess­ful, Der­ma­vant will be up against some big league ri­vals. But is it good enough?

The non­s­teroidal an­ti-in­flam­ma­to­ry top­i­cal cream— which ac­ti­vates the aryl hy­dro­car­bon re­cep­tor — hasn’t been a high-pro­file agent. But re­searchers have high­light­ed promis­ing da­ta to un­der­score its po­ten­tial.

The deal comes a year af­ter Roche out­li­censed a dis­ap­point­ing le­brik­izum­ab to Der­mi­ra.

It al­so fol­lows some big moves at Ra­maswamy’s Roivant com­pa­nies, which has been re­or­ga­nized in the wake of the Ax­o­vant fail­ures. The changes, though, haven’t changed Ra­maswamy’s in­ten­tion of build­ing a ma­jor play­er with many dif­fer­ent arms grap­pling with a wide va­ri­ety of dis­eases. 

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.

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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Abortion-rights protesters regroup and protest following Supreme Court's decision to overturn Roe v. Wade. (AP Photo/Gemunu Amarasinghe)

Fol­low­ing SCO­TUS de­ci­sion to over­turn abor­tion pro­tec­tions, AG Gar­land says states can't ban the abor­tion pill

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

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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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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Sanofi, GSK tout 72% Omi­cron ef­fi­ca­cy in PhI­II tri­al of next-gen, bi­va­lent shot — with an eye to year-end roll­out

Sometimes, being late can give you an advantage.

That’s what Sanofi and GSK are trying to say as the Big Pharma partners report positive results from a late-stage trial of their next-gen bivalent Covid-19 vaccine, which was designed to protect against both the original strain of the SARS-CoV-2 virus and the Beta variant. Specifically, against Omicron, they note, the vaccine delivered 72% efficacy in all adults and 93.2% in those previously infected.