So­sei and Ver­i­ly part­ner on GPCRs; Ob­sE­va touts PhI­II da­ta in en­dometrio­sis pain

So­sei Hep­tares is team­ing up with a big-name part­ner: Al­pha­bet’s Ver­i­ly.

No fi­nan­cials were dis­closed, but the pair will aim to use Ver­i­ly’s im­mune pro­fil­ing and So­sei Hep­tares’ GPCR drug de­sign ca­pa­bil­i­ties to de­vel­op a va­ri­ety of new ther­a­peu­tics. The col­lab­o­ra­tion will fo­cus on GPCR drugs in the im­munol­o­gy, gas­troen­terol­o­gy and im­muno-on­col­o­gy spaces, as well as oth­er dis­or­ders with im­muno­pro­tec­tive or im­munopath­o­gen­ic mech­a­nisms, the com­pa­nies said.

“Im­munol­o­gy is a key area of fo­cus for So­sei Hep­tares and this new col­lab­o­ra­tion brings to­geth­er two world-class tech­nolo­gies and teams with the skills and ex­per­tise to de­fine key GPCRs as tar­gets for the dis­cov­ery of new med­i­cines that could have sig­nif­i­cant im­pact on pa­tients with im­mune-based dis­eases world­wide,” So­sei VP for drug dis­cov­ery Matt Barnes said in a state­ment. — Max Gel­man

Ob­sE­va un­veils new PhI­II da­ta for en­dometrio­sis pain 

Just a month af­ter women’s health biotech Ob­sE­va brought on a new CFO, the com­pa­ny has some Phase III tri­al da­ta for pain as­so­ci­at­ed with en­dometrio­sis.

The tri­al was for lin­zagolix, an oral GnRH an­tag­o­nist can­di­date for women with mod­er­ate-to-se­vere en­dometrio­sis-as­so­ci­at­ed pain, al­so known as EAP. Two dos­es — 200 mg once-dai­ly with add-back ther­a­py (ABT) and 75 mg dai­ly with­out back ther­a­py — were test­ed.

The 200 mg dose, ac­cord­ing to Ob­sE­va, met the study’s co-pri­ma­ry ef­fi­ca­cy ob­jec­tives: re­duc­ing dys­men­or­rhea (DYS) and non-men­stru­al pelvic pain (NMPP) at 3 months. At 6 months of treat­ment at 200 mg, there were list­ed im­prove­ments in five sec­ondary end­points: dys­men­or­rhea, non-men­stru­al pelvic pain, dyschezia, over­all pelvic pain, and abil­i­ty to do dai­ly ac­tiv­i­ties.

The 75 mg dose did show a sta­tis­ti­cal­ly sig­nif­i­cant re­duc­tion ver­sus place­bo in DYS at 3 months. Al­though it showed im­prove­ment in NMPP at 3 months, it did not reach sta­tis­ti­cal sig­nif­i­cance ver­sus place­bo.

Ob­sE­va CMO Eliz­a­beth Gar­ner praised the re­sults, say­ing in a state­ment that the biotech plans to com­plete its Phase III pro­gram for EAP, and said that it would ex­plore a non-ABT op­tion for that in­di­ca­tion. — Paul Schloess­er

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,300+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,300+ biopharma pros reading Endpoints daily — and it's free.

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.”

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.

FDA un­veils new draft guid­ance to help with oligonu­cleotide ther­a­peu­tics de­vel­op­ment

While oligonucleotides, a wide variety of synthetically modified RNA or RNA/DNA hybrids that bind to a target RNA sequence to alter RNA and/or protein expression, have been winning approvals in recent years (e.g. Novartis’ cholesterol drug Leqvio), the regulatory agency is offering new draft guidance for those looking to follow a similar path.

The non-binding guidance, titled “Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics Guidance for Industry” deals with pharmacokinetic, pharmacodynamic, and safety assessments required as part of oligonucleotide therapeutics R&D.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,300+ biopharma pros reading Endpoints daily — and it's free.

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.”