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.

At the end of January, the European Medicines Agency officially launched its new clinical trials info system (CTIS), although the migration to the new platform has only really just begun, and sponsors have until the end of January 2023 before all initial trial applications must be submitted through CTIS.

Overall, 56 clinical trial applications have been submitted in CTIS during the first 3 months since the launch of the system on Jan. 31, according to new data posted by the EMA. By comparison, about 4,000 new trials are authorized each year across Europe.

As concerns related to uptake and distribution continue to linger, Switzerland is among the first countries that plans to destroy hundreds of thousands of expired and unused Covid-19 vaccine doses.

The European country said it plans to destroy more than 600,000 doses of Moderna’s Spikevax Covid-19 vaccine as the doses have reached their expiration date.

However, Moderna CEO Stéphane Bancel told the World Economic Forum in Davos, Switzerland that he’s in the process of throwing 30 million doses in the garbage, exclaiming, “We have a big demand problem.”

The EU is reportedly working toward a centralized procurement deal for smallpox vaccines to tackle the rising number of cases of monkeypox, according to sources who spoke to the Financial Times.

Andrea Ammon, director of Europe’s CDC, told the FT that the European Commission is “definitely looking at what can be done centrally” and central procurement is “one of the options that are looked at but of course countries are also” looking into bilateral avenues.

More than 500 stakeholders sent comments to the FTC on whether the commission should look further into pharma middlemen, known as PBMs, with many of the commenters calling for more federal oversight.

Similar to the critical open comment period in a deadlocked FTC session last February, pharmacies and pharmacy groups are continuing to call out the lack of transparency among the top 3 PBMs, which control about 80% of the market.