UP­DAT­ED: Bio­gen pulls PRIME des­ig­na­tion for ad­u­canum­ab in Eu­rope; Mer­ck clos­es merg­er with Ac­celeron

Fol­low­ing news last week that Bio­gen re­ceived “a neg­a­tive trend vote” in Eu­rope for its con­tro­ver­sial Alzheimer’s drug ad­u­canum­ab, the EMA up­dat­ed a list of PRIME des­ig­na­tions in­di­cat­ing that some, in­clud­ing Bio­gen, pulled out of the EU’s pri­or­i­ty med­i­cines scheme, known as PRIME.

But Bio­gen said in a state­ment to End­points News that it ac­tu­al­ly pulled the PRIME des­ig­na­tion for ad­u­canum­ab in 2019, not­ing that it oc­curred “fol­low­ing the dis­con­tin­u­a­tion of the EMERGE and EN­GAGE stud­ies,” and that it “was a pro­ce­dur­al re­quire­ment at the time.”

Ad­u­canum­ab was first grant­ed en­try in­to the PRIME pro­gram back in May 2016, EMA said in its run­ning list of PRIME des­ig­na­tions.

The neg­a­tive news for Bio­gen in Eu­rope fol­lows an ex­treme­ly slow start in sell­ing the in­fused drug in the US. But the Cam­bridge, MA-based biotech is still await­ing a ma­jor de­ci­sion from the Cen­ters for Medicare and Med­ic­aid Ser­vices on whether the US fed­er­al gov­ern­ment will pay for use of the drug. A draft of that de­ci­sion is ex­pect­ed on Jan. 12. — Zachary Bren­nan

Mer­ck com­pletes ac­qui­si­tion of Ac­celeron

Mer­ck’s high­ly pub­li­cized ac­qui­si­tion of Ac­celeron Phar­ma is now com­plete, Mer­ck an­nounced this morn­ing — mak­ing it the biggest biotech merg­er of the year.

The $11.5 bil­lion deal to ac­quire the biotech and its lead pul­monary ar­te­r­i­al hy­per­ten­sion drug so­tater­cept had been high­ly pub­li­cized — and con­firmed days of ru­mors and in­sid­er leaks when it was of­fi­cial­ly an­nounced at the end of Sep­tem­ber.

“This is an im­por­tant and strate­gic op­por­tu­ni­ty for our com­pa­ny to con­tin­ue grow­ing our car­dio­vas­cu­lar port­fo­lio and pipeline,” Mer­ck pres­i­dent and CEO Rob Davis said in a state­ment.

So­tater­cept, which had been in test­ing to im­prove out­comes in pa­tients with PAH, is cur­rent­ly in Phase III tri­als as an add-on to cur­rent stan­dard of care treat­ments. — Paul Schloess­er

Deci­bel’s R&D deal with Re­gen­eron is get­ting an ex­ten­sion

Deci­bel Ther­a­peu­tics’ re­search col­lab­o­ra­tion with Re­gen­eron is get­ting ex­tend­ed.

The col­lab­o­ra­tion, which start­ed in 2017 to dis­cov­er and de­vel­op gene ther­a­pies for hear­ing loss, will be ex­tend­ed to Nov. 15, 2023, and Re­gen­eron will pay $10 mil­lion as an ex­ten­sion fee in Q4 2022.

Un­der the col­lab­o­ra­tion, Deci­bel is de­vel­op­ing three gene ther­a­py pro­grams with Re­gen­eron — tar­get­ing con­gen­i­tal, mono­genic hear­ing loss. Deci­bel plans to ini­ti­ate a Phase I/II clin­i­cal tri­al of DB-OTO, its lead gene ther­a­py prod­uct can­di­date, next year. Deci­bel is al­so ad­vanc­ing two oth­er gene ther­a­py pro­grams tar­get­ing oth­er mono­genic forms of hear­ing loss as part of the col­lab — AAV.103 and AAV.104.

“We are pleased that Re­gen­eron has elect­ed to ex­tend the re­search term, which ex­tends our ac­cess to Re­gen­eron’s world-lead­ing ge­nom­ic and ge­net­ic tech­nolo­gies, and ther­a­peu­tic dis­cov­ery and de­vel­op­ment ex­per­tise,” said Deci­bel’s CEO Lau­rence Reid. — Paul Schloess­er

Ka­ma­da buys port­fo­lio from Saol Ther­a­peu­tics in deal with $95M up­front

Is­raeli biotech Ka­ma­da ac­quired a port­fo­lio of four FDA-ap­proved prod­ucts from Saol Ther­a­peu­tics for $95 mil­lion up­front.

The prod­ucts, which are “plas­ma-de­rived hy­per­im­mune com­mer­cial prod­ucts” ac­cord­ing to a com­pa­ny state­ment, have an ex­pect­ed com­bined an­nu­al glob­al rev­enue of be­tween $40 and $45 mil­lion, with ap­prox­i­mate­ly 95% of sales be­tween the US and Cana­da.

The four ac­quired prod­ucts in­clude:

  • Cy­togam (Cy­tomegalovirus Im­mune Glob­u­lin In­tra­venous [Hu­man]) for the pro­phy­lax­is of cy­tomegalovirus dis­ease as­so­ci­at­ed with the trans­plan­ta­tion of the kid­ney, lung, liv­er, pan­creas, and heart.
  • Win­rho SDF, which is in­di­cat­ed to in­crease platelet counts to pre­vent ex­ces­sive he­m­or­rhage in the treat­ment of non-splenec­tomies, for Rho(D)-pos­i­tive chil­dren with chron­ic or acute im­mune throm­bo­cy­tope­nia (ITP), adults with chron­ic ITP, and chil­dren and adults with ITP sec­ondary to HIV in­fec­tion.
  • He­pagam B, a he­pati­tis B im­mune glob­u­lin prod­uct in­di­cat­ed to both pre­vent he­pati­tis B virus re­cur­rence fol­low­ing liv­er trans­plan­ta­tion in he­pati­tis B sur­face anti­gen pos­i­tive (HB­sAg- pos­i­tive) pa­tients and pro­vide post-ex­po­sure pro­phy­lax­is.
  • Varizig, which con­tains an­ti­bod­ies spe­cif­ic to the vari­cel­la zoster virus, and is in­di­cat­ed for post-ex­po­sure pro­phy­lax­is of vari­cel­la (chick­en­pox) in high-risk pa­tient groups, in­clud­ing im­muno­com­pro­mised chil­dren, new­borns, and preg­nant women.

Ac­cord­ing to Ka­ma­da CEO Amir Lon­don, the com­pa­ny hopes to ex­pand fur­ther in­to the US next year. Along­side the $95 mil­lion up­front to Saol, Ka­ma­da will pay up to an ad­di­tion­al $50 mil­lion in sales mile­stones un­til 2034. — Paul Schloess­er

Ed­i­tor’s note: Ar­ti­cle cor­rect­ed to note that Bio­gen ac­tu­al­ly pulled its PRIME des­ig­na­tion from the EMA in 2019 when it dis­con­tin­ued the two stud­ies of its Alzheimer’s drug. Re­analy­ses of those halt­ed stud­ies helped ad­u­canum­ab win its ap­proval in the US.

Albert Bourla (Photo by Steven Ferdman/Getty Images)

UP­DAT­ED: Pfiz­er fields a CRL for a $295M rare dis­ease play, giv­ing ri­val a big head start

Pfizer won’t be adding a new rare disease drug to the franchise club — for now, anyway.

The pharma giant put out word that their FDA application for the growth hormone therapy somatrogon got the regulatory heave-ho, though they didn’t even hint at a reason for the CRL. Following standard operating procedure, Pfizer said in a terse missive that they would be working with regulators on a followup.

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Graphic: Alexander Lefterov for Endpoints News

Small biotechs with big drug am­bi­tions threat­en to up­end the tra­di­tion­al drug launch play­book

Of the countless decisions Vlad Coric had to make as Biohaven’s CEO over the past seven years, there was one that felt particularly nerve-wracking: Instead of selling to a Big Pharma, the company decided it would commercialize its migraine drug itself.

“I remember some investors yelling and pounding on the table like, you can’t do this. What are you thinking? You’re going to get crushed by AbbVie,” he recalled.

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Mar­ket­ingRx roundup: Pfiz­er de­buts Pre­vnar 20 TV ads; Lil­ly gets first FDA 2022 pro­mo slap down let­ter

Pfizer debuted its first TV ad for its Prevnar 20 next-generation pneumococcal pneumonia vaccine. In the 60-second spot, several people (actor portrayals) with their ages listed as 65 or older are shown walking into a clinic as they turn to say they’re getting vaccinated with Prevnar 20 because they’re at risk.

The update to Pfizer’s blockbuster Prevnar 13 vaccine was approved in June, and as its name suggests is a vaccine for 20 serotypes — the original 13 plus seven more that cause pneumococcal disease. Pfizer used to spend heavily on TV ads to promote Prevnar 13 in 2018 and 2019 but cut back its TV budgets in the past two fall and winter seasonal spending cycles. Prevnar had been Pfizer’s top-selling drug, notching sales of just under $6 billion in 2020, and was the world’s top-selling vaccine before the Covid-19 vaccines came to market last year.

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A new can­cer im­munother­a­py brings cau­tious hope for a field long await­ing the next big break­through

Bob Seibert sat silent across from his daughter at their favorite Spanish restaurant near his home in Charleston County, SC, their paella growing cold as he read through all the places in his body doctors found tumors.

He had texted his wife, a pediatric intensive care nurse, when he got the alert that his online chart was ready. Although he saw immediately it was bad, many of the terms — peritoneal, right iliac — were inscrutable. But she was five hours downstate, at a loud group dinner the night before another daughter’s cheer competition.

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Roy Baynes, Merck

FDA bats back Mer­ck’s ‘pipeline in a prod­uct,’ de­mands more ef­fi­ca­cy da­ta

Despite some heavy blowback from analysts, Merck execs maintained an upbeat attitude about the market potential of its chronic cough drug gefapixant. But the confidence may be fading somewhat today as Merck puts out news that the FDA is handing back its application with a CRL.

Dubbed by Merck’s development chief Roy Baynes as a “pipeline in a product” with a variety of potential uses, Merck had fielded positive late-stage data demonstrating the drug’s ability to combat chronic cough. The drug dramatically reduced chronic cough in Phase III, but so did placebo, leaving Merck’s research team with a marginal success on the p-value side of the equation.

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Florida Gov. Ron DeSantis (AP Photo/Wilfredo Lee, File)

Opin­ion: Flori­da is so mAb crazy, Ron De­San­tis wants to use mAbs that don't work

Florida Gov. Ron DeSantis is trying so hard to politicize the FDA and demonize the federal government that he entered into an alternate universe on Monday evening in describing a recent FDA action to restrict the use of two monoclonal antibody, or mAb, treatments for Covid-19 that don’t work against Omicron.

Without further ado, let’s break down his statement from last night, line by line, adjective by adjective.

Not cheap­er by the dozen: Bris­tol My­ers be­comes the 12th phar­ma com­pa­ny to re­strict 340B sales

Bristol Myers Squibb recently joined 11 of its peer pharma companies in limiting how many contract pharmacies can access certain drugs discounted by a federal program known as 340B.

Bristol Myers is just the latest in a series of high-profile pharma companies moving in their own direction as the Biden administration’s Health Resources and Services Administration struggles to rein in the drug discount program for the neediest Americans.

Joaquin Duato, J&J CEO (Photo by Charles Sykes/Invision/AP)

New J&J CEO Joaquin Du­a­to promis­es an ag­gres­sive M&A hunt in quest to grow phar­ma sales

Joaquin Duato stepped away from the sideline and directly into the spotlight on Tuesday, delivering his first quarterly review for J&J as its newly-tapped CEO after an 11-year run in senior posts. And he had some mixed financial news to deliver today while laying claim to a string of blockbuster drugs in the making and outlining an appetite for small and medium-sized M&A deals.

Duato also didn’t exactly shun large buyouts when asked about the future of the company’s medtech business — where they look to be in either the top or number 2 position in every segment they’re in — even though the bar for getting those deals done is so much higher.

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Amgen's Twitter campaign #DearAsthma inspired thousands of people to express struggles and frustrations with the disease

Am­gen’s #Dear­Asth­ma spon­sored tweet lands big on game day, spark­ing thou­sands to re­spond

Amgen wanted to know how people with asthma really felt about daily life with the disease. So it bought a promoted tweet on Twitter noting the not-so-simple realities of life with asthma and ended the post with a #DearAsthma hashtag, a megaphone emoji and a re-tweet button.

That was just over one week ago and the responses haven’t stopped. More than 7,000 posts so far on Twitter replied to #DearAsthma to detail struggles of daily life, expressing humor, frustration and sometimes anger. More than a few f-bombs have been typed or gif-ed in reply to communicate just how much many people “hate” the disease.