Gilead gets in on the mi­cro­bio­me game with a $38M pact, up to $1.5B in mile­stones

In what had been shap­ing up to be a ma­jor year for mi­cro­bio­me biotechs, Gilead is get­ting in on the ac­tion.

Amer­i­ca’s new­ly most watched big biotech an­nounced a four-year, $38 mil­lion up­front pact with Sec­ond Genome to iden­ti­fy bio­mark­ers that can mea­sure clin­i­cal re­sponse to Gilead’s in­flam­ma­tion and fi­bro­sis drugs, among oth­ers, and to find up to 5 new in­flam­ma­to­ry bow­el dis­ease tar­gets or drug can­di­dates. If all five of those can­di­dates reach mar­ket — a rather un­like­ly oc­cur­rence — the deal could be worth up to $1.5 bil­lion.

The pact comes as the mi­cro­bio­me field — the study of the tril­lions of bac­te­ria in the gut, their role in dis­ease, and their po­ten­tial as both drugs and drug tar­gets — awaits some of its first large read­outs since 2016, when a ma­jor fail­ure in a tri­al to treat C. diff in­fec­tion cur­tailed the field. Seres, Finch and Re­bi­otix are all ex­pect­ed to read­out for new C. diff tri­als lat­er this year.

The bac­te­r­i­al in­fec­tion is a first step, but the field broad­ly hopes to even­tu­al­ly ex­pand in­to the in­flam­ma­to­ry bow­el dis­eases cov­ered in the Gilead pact. All three of those biotechs al­so have ear­li­er stage pro­grams for IBD dis­eases such as ul­cer­a­tive col­i­tis or Crohn’s dis­ease, and Sec­ond Genome has one in the “dis­cov­ery” phase.

The con­nec­tion be­tween the mi­cro­bio­me and IBD or oth­er in­flam­ma­to­ry dis­eases is not ful­ly un­der­stood, but a large group has linked changes in gut bac­te­ria to the dis­ease. One the­o­ry is that these changes in the mi­cro­bio­me lead to bac­te­ria ac­tu­al­ly tear­ing through the bar­ri­er lin­ing of the in­tes­tine, al­low­ing bac­te­ria to leak out in­to the mus­cles and trig­ger­ing an im­mune re­sponse. Change the bac­te­ria, some biotechs think, and fix the lin­ing.

Al­though Big Phar­ma has not em­braced the mi­cro­bio­me with the same vig­or they have oth­er emer­gent fields, this is far from the first such deal. J&J and Bris­tol My­ers Squibb signed sim­i­lar bio­mark­er dis­cov­ery pacts with mi­cro­bio­me biotechs in 2018 and 2016.

Gilead is not new to the IBD field. Their JAK-1 in­hibitor fil­go­tinib is ex­pect­ed to be ap­proved this year and even­tu­al­ly be­come a block­buster. They al­so have a se­ries of ear­li­er stage can­di­dates for in­flam­ma­to­ry dis­ease, de­vel­oped both in house and with their part­ner Gala­pa­gos. The Cal­i­for­nia-based drug­mak­er rose to pub­lic and fi­nan­cial promi­nence build­ing an­tivi­ral drugs for life-threat­en­ing in­fec­tions — a role that has be­come acute amid the Covid-19 pan­dem­ic — but they have in re­cent years in­vest­ed bil­lions to ex­pand their ar­se­nal.

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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invoX Pharma CEO Ben Toogood (L) and F-star CEO Eliot Forster

F-star bought out in $161M all-cash deal as Hong Kong's Sino Bio­pharm looks to­ward in­ter­na­tion­al ex­pan­sion

After more than a decade and a half of charting its own course, F-star Therapeutics will now settle under a new umbrella company.

The UK biotech will be acquired by invoX Pharma, a subsidiary of Hong Kong’s Sino Biopharm, in a roughly $161 million all-cash deal, the companies announced Thursday morning. F-star’s buyout will value its shares $FSTX at $7.12 apiece, nearly an 80% premium above Wednesday’s closing price.

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GSK says its drug for chron­ic hep B could ‘lead to a func­tion­al cure’ — but will it be alone or in com­bi­na­tion?

GSK, newly branded and soon-to-be demerged, shared interim results from its Phase II trial on its chronic hepatitis B treatment, one that it says has the “potential to lead to a functional cure.”

At a presentation at the EASL International Liver Congress, GSK shared that in around 450 patients who received its hep B drug bepirovirsen for 24 weeks, just under 30% had hepatitis B surface antigen and viral DNA levels that were too low to detect.

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.

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.”

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.