Mer­ck­'s wom­en's health spin­out snags mid-stage can­di­date for preterm birth; Keytru­da nails down TNBC ap­proval af­ter March CRL

Near­ly two months af­ter spin­ning out from Mer­ck, women’s health busi­ness Organon has struck its first half-bil­lion-dol­lar deal.

Organon $OGN has promised $25 mil­lion up­front and an­oth­er $475 mil­lion in biobucks for world­wide rights to ebopiprant, Ob­sE­va’s in­ves­ti­ga­tion­al treat­ment for preterm la­bor. Ebopiprant, a se­lec­tive prostaglandin F2α (PGF2α) re­cep­tor an­tag­o­nist, was orig­i­nal­ly li­censed from Mer­ck KGaA in 2015. The can­di­date works by re­duc­ing in­flam­ma­tion and uter­ine con­trac­tions.

“This de­vel­op­ment-stage as­set is be­ing stud­ied in one of the most cru­cial un­met needs for women glob­al­ly,” Organon CEO Kevin Ali said in a state­ment. There are cur­rent­ly no ap­proved drugs for the acute treat­ment of preterm la­bor in the US.

Back in No­vem­ber, Ob­sE­va said ebopiprant re­duced the de­liv­ery of preg­nan­cies (not in­clud­ing twin preg­nan­cies) by 55% at 48 hours when ad­min­is­tered with atosi­ban (the ex-US stan­dard of care), com­pared to atosi­ban alone. Over­all, 12.5% of women in the treat­ment arm de­liv­ered ba­bies with­in 48 hours of start­ing treat­ment, com­pared to 21.8% in the place­bo arm, Ob­sE­va said of the Phase IIa tri­al.

“The in­ci­dence of ma­ter­nal, fe­tal and neona­tal ad­verse events were com­pa­ra­ble be­tween sub­jects in the ebopiprant group and the place­bo group,” the com­pa­ny said.

Organon of­fi­cial­ly spun out from Mer­ck on June 3 with a port­fo­lio of more than 60 med­i­cines, in­clud­ing Nex­planon, its long-ac­tive re­versible con­tra­cep­tive. Nex­planon is one of the top hor­mon­al con­tra­cep­tives in the coun­try, ac­cord­ing to IQVIA da­ta, and grew at an an­nu­al com­pound growth rate of 9% be­tween 2014 and 2019. — Nicole De­Feud­is 

Keytru­da nails down TNBC ap­proval af­ter March CRL

Mer­ck’s block­buster check­point in­hibitor Keytru­da has won an­oth­er FDA ap­proval, this time in a line of triple-neg­a­tive breast can­cer.

Reg­u­la­tors hand­ed down the green­light for the treat­ment of pa­tients with high-risk ear­ly-stage TNBC in com­bi­na­tion with chemo, as neoad­ju­vant and then con­tin­ued as a sin­gle agent as ad­ju­vant treat­ment af­ter surgery. The thumbs up marks the 30th in­di­ca­tion for which the Keytru­da is ap­proved in the US, Mer­ck said.

Ad­di­tion­al­ly, the FDA con­vert­ed the Keytru­da-chemo com­bo ac­cel­er­at­ed ap­proval in lo­cal­ly re­cur­rent un­re­sectable or metasta­t­ic TNBC for tu­mors ex­press­ing PD-L1 to full ap­proval.

The TNBC ap­proval comes af­ter the FDA hand­ed Mer­ck a rare CRL for Keytru­da back in March, af­ter an ad­comm unan­i­mous­ly vot­ed to rec­om­mend wait­ing for more da­ta for the study in ques­tion. Ad­vis­ers and reg­u­la­tors point­ed to­ward con­cerns over the tri­al’s event-free sur­vival pri­ma­ry end­point over place­bo, say­ing re­searchers hadn’t watched pa­tients long enough af­ter treat­ment to de­ter­mine EFS and OS.

But a few weeks lat­er, Mer­ck claimed a win in the study af­ter claim­ing it reached the in­ter­im analy­sis check­point. The tri­al, known as KEYNOTE-522, met its dual pri­ma­ry end­points of event-free sur­vival and patho­log­i­cal com­plete re­sponse. — Max Gel­man

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.

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.”

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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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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Yong Dai, Frontera Therapeutics CEO

Scoop: Lit­tle-known Or­biMed-backed biotech clos­es $160M round to start gene ther­a­py tri­al

Frontera Therapeutics, a China and US biotech, has closed a $160 million Series B and received regulatory clearance to test its first gene therapy stateside, Endpoints News has learned.

Led by the largest shareholder, OrbiMed, the biotech has secured $195 million total since its September 2019 founding, according to an email reviewed by Endpoints. The lead AAV gene therapy program is for an undisclosed rare eye disease, according to the source.

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