Mer­ck KGaA gets a thumbs up for once-dead MS drug; Aveo shares soar as ti­vo makes a come­back

→  Cladrib­ine is back. Once giv­en up for dead by Mer­ck KGaA, the mul­ti­ple scle­ro­sis drug has been en­dorsed by the CHMP in Eu­rope, set­ting up a like­ly ap­proval. Long­time Mer­ck KGaA watch­ers will re­call that Mer­ck killed the pro­gram af­ter the FDA and the EMA quashed in­ad­e­quate ap­pli­ca­tions 6 years ago — an em­bar­rass­ing set­back that trig­gered a ma­jor over­haul of the com­pa­ny’s R&D group. “The pos­i­tive opin­ion from the CHMP is an ex­tra­or­di­nary de­vel­op­ment for Mer­ck, af­firm­ing our be­lief in Cladrib­ine Tablets as a po­ten­tial im­por­tant treat­ment op­tion for pa­tients liv­ing with mul­ti­ple scle­ro­sis,” said Belén Gar­i­jo, CEO Health­care and mem­ber of the ex­ec­u­tive board of Mer­ck. “We now ea­ger­ly await the Eu­ro­pean Com­mis­sion de­ci­sion, and the op­por­tu­ni­ty to make a dif­fer­ence in the MS treat­ment par­a­digm.”

 Cladrib­ine wasn’t the on­ly come­back sto­ry of the day. The CHMP al­so rec­om­mend­ed ap­proval of Aveo’s $AVEO drug tivozanib (Fo­tiv­da) for ad­vanced re­nal cell car­ci­no­ma, send­ing the mi­cro­cap’s shares up more than 70% Fri­day morn­ing.  The Eu­ro­pean Com­mis­sion is ex­pect­ed to make its fi­nal de­ci­sion with­in 67 days. Its ap­proval would trig­ger a $4 mil­lion re­search and de­vel­op­ment re­im­burse­ment pay­ment from EU­SA, and the pos­si­bil­i­ty of up to $12 mil­lion in ad­di­tion­al mile­stones.

→  Ex­ec­u­tives are un­der fire for sell­ing drugs that trig­gered se­ri­ous ad­verse events for three in­fants. Paul Elmer, pres­i­dent and own­er of Phar­makon, and Caprice Bear­den, di­rec­tor of com­pli­ance, are fac­ing fed­er­al charges of en­gag­ing in com­merce with adul­ter­at­ed drugs in an in­dict­ment un­sealed on Thurs­day. The in­dict­ment al­leges that the com­pa­ny was no­ti­fied 70 times that the po­ten­cy of their drugs did not match the la­bels, but that they con­tin­ued to send them out re­gard­less, with­out no­ti­fy­ing the FDA or care providers.

→  Bio­pro­cess­ing com­pa­ny Repli­gen is merg­ing with Spec­trum, which spe­cial­izes in fil­tra­tion and pu­rifi­ca­tion, for $359 mil­lion in cash and stock.

→  Gen­Sight Bi­o­log­ics (Eu­ronext: SIGHT) raised €22.5 mil­lion in a stock of­fer­ing. The gene ther­a­py com­pa­ny says it will use the cash to prep for a mar­ket launch of GS010 in Eu­rope and the US.

→  GSK is pre­sent­ing re­sults from its Phase III Zoster-048 study at the US Cen­ters for Dis­ease Con­trol and Pre­ven­tion’s Ad­vi­so­ry Com­mit­tee on Im­mu­niza­tion Prac­tices meet­ing. The re­sults are promis­ing, show­ing that its can­di­date vac­cine, Shin­grix, for the pre­ven­tion of her­pes zoster (shin­gles) in­duces a strong im­mune re­sponse in old­er adults who have pre­vi­ous­ly been vac­ci­nat­ed against shin­gles with the cur­rent­ly avail­able live-at­ten­u­at­ed zoster vac­cine.

Image courtesy of The Janssen Pharmaceutical Companies of Johnson & Johnson.

Pro­tect­ing the glob­al phar­ma­ceu­ti­cal in­no­va­tion ecosys­tem – what’s at stake?

We are living in a new era of healthcare that is rapidly advancing progress impacting patient outcomes and experiences. We’ve seen a remarkable pace of transformational innovation, applied research, and advanced clinical development over the last decade.

Despite this tremendous progress, there is much more work to be done, and patients are counting on us – now more than ever – to continue that momentum. At the heart of our industry is a focus on developing and delivering medicines for some of the world’s most challenging diseases, including those that have few or no effective treatments today.

Roger Perlmutter, Eikon Therapeutics CEO

Roger Perl­mut­ter builds Eikon's pipeline with deal-mak­ing flur­ry, rais­ing $106M more

Eikon Therapeutics announced three business development deals on Thursday, effectively dropping in a pipeline of cancer drugs alongside more than $100 million in fresh funding.

The Hayward, CA-based company has become one of biotech’s richest startups since its 2019 founding, having raised nearly $775 million. It’s developing a massive, automated research approach built around Nobel Prize-winning microscope science to peer inside cells and watch proteins in action. After its Series B last year, PitchBook reported a $3.02 billion valuation. And while CEO Roger Perlmutter declined to comment on that figure, he said its first tranche of nearly $106 million in Series C funding is a “meaningful step-up to our Series B valuation.”

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Eu­ro­pean Par­lia­ment calls mem­ber states to ac­tion on an­timi­cro­bial re­sis­tance

Members of the European Parliament have called on EU countries to develop national action plans against antimicrobial resistance (AMR), calling it a top-three priority health threat.

Parliament on Thursday announced recommendations for the fight against AMR, including national action plans that must be updated at least every two years, an EU-level database tracking AMR and antimicrobial use and increased partnership between the pharma industry, patient groups and academia.

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Bay­er buys li­cense to Cedil­la pre­clin­i­cal can­cer pro­gram; MEI Phar­ma says no to un­so­licit­ed of­fer

Bayer has acquired exclusive rights to Cedilla Therapeutics’ preclinical cancer drug candidates for an undisclosed amount.

Bayer announced Thursday morning that it is acquiring the license for Cedilla’s preclinical Cyclin E1/CDK2 complex inhibitors. Cyclin E1 activates CDK2, and the two drive cancer progression and are overexpressed in cancer cells.

Bayer did not disclose what indications it will be pursuing under this partnership. The deal is structured traditionally — Bayer will pay Cedilla an undisclosed amount upfront, and the latter is also eligible for potential development and commercial milestones and royalties. — Lei Lei Wu

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Roche plans to di­vest from lega­cy Genen­tech man­u­fac­tur­ing fa­cil­i­ty in Cal­i­for­nia

Roche is planning to make some changes to its subsidiary’s manufacturing network in California.

The Swiss pharma announced Wednesday that it plans to divest from Genentech’s manufacturing facility in Vacaville, CA, around 58 miles northeast of San Francisco. According to a statement from Roche, the move is part of a “broader strategy” to bring its manufacturing capabilities in line with its future pipeline. Roche is starting the process of finding a buyer for the site but has not named any candidates yet.

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Peter van de Sande, Synaffix CEO

Lon­za shells out $107M cash to snap up Synaf­fix and its ADC plat­form

After lining up a string of partnerships over the years, Dutch antibody-drug conjugate specialist Synaffix has found a new home: Lonza, the contract development and manufacturing giant.

Lonza is paying about $107 million (€100 million) in cash to acquire Synaffix, with up to $64 million (€60 million) in “additional performance-based consideration” on the table. Synaffix’s ADC tech platform will now become part of Lonza’s offering for biopharma clients, lending its bioconjugate technologies to not just ADCs but also targeted gene therapy, immune cell engagers and other applications.

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Who's con­fi­dent­ly in­vest­ing in biotech star­tups dur­ing these tense days? We've got some an­swers

We’ve got a changeup to our event schedule in Boston next week, where we’ll be doing a mix of live/streaming events at our base at The Seaport Hotel as part of a two-day lineup of webinars, virtual firesides and a cocktail hour Q&A with a veteran of the biotech financing scene.

The 9:30-10:30 am ET live slot on Tuesday, June 6, will now feature a panel conversation on the current state of affairs for VC investing in biotech, focusing on what startups are getting cash — and how. Alaa Halawa, head of US ventures at Mubadala, is confirmed, along with Brian Goodman at MPM and Geoff von Maltzahn, a general partner at Moderna-buoyed Flagship. I have a couple of other invites out and will let you know how that plays out.

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The Modulo Bio team with CEO Michael Horowitz (fourth from right in semicircle)

Ex­clu­sive: With $8M, neu­ro start­up Mod­u­lo Bio emerges to test small mol­e­cules for ALS, de­men­tia in CEO’s per­son­al mis­sion

Embarking on a personal mission after his best friend’s mother was diagnosed with a mutation-driven case of frontotemporal dementia, Michael Horowitz has pulled together $8 million in venture funding at Modulo Bio to create small molecules for neurodegenerative diseases.

The San Diego and Bay Area biotech will select its lead development candidate and some backup options within six months and then raise a Series A to investigate therapeutics for C9orf72 mutation-driven cases of ALS and frontotemporal dementia, Horowitz told Endpoints News.

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Albert Bourla, Pfizer CEO (Michel Euler/AP Images, Pool)

FDA ap­proves Pfiz­er’s RSV shot for old­er adults, tee­ing up a com­pet­i­tive $17B vac­cine mar­ket

The FDA approved Pfizer’s RSV vaccine called Abrysvo for older adults on Wednesday, placing another Big Pharma onto the commercial stage ahead of the next RSV season.

Pfizer’s approval comes weeks after GSK won approval for its rival shot, Arexvy. Those two vaccines are both approved for use in adults 60 years and older and will be reviewed by a CDC panel in June before they’re expected to commercially launch this fall. Wall Street analysts see RSV as the next multibillion-dollar vaccine market, with Jefferies analysts recently forecasting the RSV market will grow to $17 billion over the next decade.

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