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 com­pa­ny has of­fi­cial­ly pulled out of the EU’s pri­or­i­ty med­i­cines scheme, known as PRIME.

First grant­ed en­try in­to the PRIME pro­gram back in May 2016, the EMA said re­cent­ly that ad­u­canum­ab’s PRIME el­i­gi­bil­i­ty was with­drawn at the re­quest of Bio­gen. The EMA al­so not­ed that Bio­gen’s Phase III tri­als have been dis­con­tin­ued, like­ly less­en­ing the odds that Bio­gen would re-sub­mit its ap­pli­ca­tion in Eu­rope.

The neg­a­tive news for Bio­gen 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

Australia’s Avance Clinical: no IND required and a 43.5% rebate on clinical spend for CGT biotechs

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The cell and gene therapies (CGT) sector offers unprecedented opportunities for patient disease management across virtually all therapeutic areas. However, finding the right accredited clinical teams to take a therapy through to the clinic and manage the regulatory process can be a major challenge for biotechs with a CGT product.

Joan Perelló, Sanifit CEO

Joan Perelló beat all the odds with his little Spanish biotech startup Sanifit.

Working on the far perimeter of the big US/European drug development scene, he took a drug born out of his PhD work and got enough seed cash to get started. That’s one near miracle. In the second near miracle he gathered a previously unheard of venture raise in Spain — helping build an industry ecosystem from scratch — to pursue a successful search for solid human data for his drug, SNF472. And while gathering a virtual team of developers from Europe and the US, the CEO/co-founder steered it into the late-stage arena.

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Most people know if they’re ‘Team Pfizer’ or ‘Team Moderna,’ but few know if they got the Comirnaty or Spikevax Covid-19 vaccine. Those are the brand names of Pfizer and Moderna vaccines, respectively, however they have yet to take hold with consumers, media or even medical professionals.

And there are others. Covid vaccine brand names also include AstraZeneca’s Vaxzevria, Novovax’s Nuvaxovid, and Sanofi and GlaxoSmithKline’s Vidprevtyn. J&J’s Janssen-developed Covid vaccine is the lone major holdout and is still yet to be named, if ever. In EMA filings approving its conditional use, the brand name is listed simply as ‘Covid-19 Vaccine Janssen.’

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Paul Hudson, Sanofi CEO (Eric Piermont/AFP via Getty Images)

Back in June, Sanofi unveiled a big project to reshape its R&D around the future of mRNA, and followed that up Monday by taking a step toward achieving that goal.

The French drugmaker signed a deal with Chinese tech giant Baidu to access its AI algorithm for mRNA-based therapeutics, Baidu said Monday morning. It’s for an undisclosed sum, but Baidu noted its platforms will be used to ‘contribute to the optimization of mRNA sequences’ in Sanofi’s drug development processes.

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Ronald Lorijn, NeuExcell CEO

Pennsylvania’s already well-established biotech scene got word of a boost last week with several announcements, including the building of a massive life sciences manufacturing center in Pittsburgh thanks to some funding from an area nonprofit and a local university. But those jawns in Philadelphia aren’t letting go of its stranglehold on the state easily.

NeuExcell Therapeutics, a preclinical gene therapy biotech that focuses on neurodegenerative diseases, announced that it signed a deal with The Discovery Labs in King of Prussia, about 25 miles northwest of downtown Philly.

Ameet Mallik, Rafael Holdings CEO

Ameet Mallik left Novartis to claim the CEO spot at Rafael Holdings back in May, taking the reins from founder Howard Jonas. Now — one month after a stock-crushing pivotal failure in pancreatic cancer that sent Rafael’s team back to the drawing board — Mallik is taking off for greener pastures.

Mallik will hand his chief executive responsibilities back to Jonas on Feb. 1 as part of an overhaul that’s set to shake up the highest rungs of the company, Rafael announced Monday.

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Bluebird bio may, at long last, get a gene therapy approved in the US.

The Cambridge, MA biotech announced Monday that the FDA had accepted and given priority review for Zynteglo, its gene therapy for the rare blood disorder beta-thalassemia. The announcement sets up an expedited FDA decision by May 20, 2022.

A priority review doesn’t guarantee approval, and more than a few recent biotechs have been spurned after receiving the designation, including Incyte, Sesen, and Provention. But it represents a substantial step forward for a therapy that has seen repeated setbacks and an application that was slapped down with a refuse-to-file letter.

Ugur Sahin (L) and Özlem Türeci (Bernd von Jutrczenka/picture-alliance/dpa/AP Images)

Pfizer and BioNTech are planning to file for full approval of their Covid-19 vaccine for all of those over the age of 12 after they said longer-term analysis of the vaccine in teens continued to show strong protection against symptomatic cases of Covid-19 more than four months after the second dose.

With no serious safety concerns at least 6 months after the second dose for those ages 12 through 15, the companies said the data will form the basis for a planned upgrade from EUA to supplemental Biologics License Application (sBLA).

German biotech Affimed caught some attention earlier this year with a pair of complete responses in an early study of its NK cell regimen for lymphoma. The biotech is back with more data from that study, and the results look promising — but will durability hold up?

A combination regimen of donor NK cells and Affimed’s CD30-targeting innate cell engager AFM13 spurred responses in 16 of 18 patients with relapsed or refractory Hodgkin and non-Hodgkin lymphomas, including seven complete responses, as part of the first of two rounds of treatment in a Phase I/II study, the biotech said Monday.
https://endpts.com/biogen-pulls-prime-designation-for-aducanumab-in-europe-merck-closes-merger-with-acceleron/