Pfiz­er plans $465M man­u­fac­tur­ing fa­cil­i­ty at Michi­gan base; Chi­na's Ts­inghua Uni­ver­si­ty inks dis­cov­ery deal with Bris­tol-My­ers

→ Re­cent­ly bat­tling some trou­bling short­ages in ster­ile in­jecta­bles, Pfiz­er $PFE an­nounced it’s step­ping up its man­u­fac­tur­ing game by spend­ing $465 mil­lion on a new fa­cil­i­ty on its Portage, MI site. Com­mand­ing 400,000 square feet, con­struc­tion of the new fa­cil­i­ty is planned for next spring and sched­uled to wrap up in 2021, with goals to be­gin pro­duc­tion by 2024. The ex­pan­sion will add 450 staffers to the 2,200 Pfiz­er al­ready em­ploys at its Portage plant un­der the unit name Mod­u­lar Asep­tic Pro­cess­ing.

→ Six years af­ter Bris­tol-My­ers Squibb $BMY first tapped ex­perts at Chi­na’s pres­ti­gious Ts­inghua Uni­ver­si­ty to re­search on au­toim­mune tar­gets, the phar­ma gi­ant is dou­bling down the col­lab­o­ra­tion. In the new deal, Ts­inghua’s In­no­va­tion Cen­ter for Im­mune Ther­a­py will iden­ti­fy ther­a­peu­tic agents against nov­el tar­gets for au­toim­mune dis­eases and can­cer, which Bris­tol-My­ers will then have an op­tion to ex­clu­sive­ly li­cense. Oth­er than tar­get dis­cov­ery, Ts­inghua was al­so con­duct­ing struc­tur­al bi­ol­o­gy re­search and map­ping 3D pro­tein struc­ture of bi­o­log­i­cal mol­e­c­u­lar tar­gets for its phar­ma part­ner.

In­ver­sa­go Phar­ma’s promise to bring back cannabi­noid-1 re­cep­tor block­ers — a class doomed by psy­chi­atric ad­verse events — has at­tract­ed them $7 mil­lion in Se­ries A fi­nanc­ing. Com­ing main­ly from Genesys Cap­i­tal and Amorchem with as­sists from the JDRF T1D Fund, Ac­cel-Rx, Anges Québec Cap­i­tal, Tar­nag­ul­la Ven­tures and oth­ers, the in­vest­ment marks the of­fi­cial launch of the Mon­tre­al-based biotech out of George Kunos’ lab at the NIH. While the sec­ond-gen CB1 block­ers tend to fo­cus on obe­si­ty and NASH, In­ver­sa­go be­lieves their pe­riph­er­al­ly re­strict­ed drug al­so has po­ten­tial to treat liv­er fi­bro­sis, di­a­betes and a rare ge­net­ic con­di­tion called Prad­er-Willi syn­drome. “The clear demon­stra­tion of pe­riph­er­al ac­tion with very low brain oc­cu­pan­cy shapes the path to­ward the re­in­stat­ed first-in-class ther­a­peu­tics for sev­er­al un­met med­ical needs,” com­ment­ed Eliz­a­beth Dou­ville, man­ag­ing part­ner at AmorChem, in a state­ment.

→  Eli Lil­ly $LLY has inked a deal with a Sil­i­con Val­ley tech com­pa­ny that makes a ro­bot­ic cloud lab­o­ra­to­ry plat­form, with plans to im­ple­ment the tech in­to its San Diego drug dis­cov­ery site. The com­pa­ny, called Tran­scrip­tic, brings to­geth­er lab process­es, pro­to­cols, and in­stru­ments with “in­ter­net-of-things tech­nolo­gies” through one user in­ter­face. The idea is to en­able au­toma­tion of lab work­flow tasks, boost scal­a­bil­i­ty, and al­low re­mote in­stru­ment mon­i­tor­ing. The tech, they say, will al­low re­searchers across the globe to re­mote­ly de­sign, syn­the­size, and screen in­ves­ti­ga­tion­al mol­e­cules at the Lil­ly Life Sci­ence Stu­dio.

Brent Saunders [Getty Photos]

UP­DAT­ED: Ab­b­Vie seals $63B deal to buy a trou­bled Al­ler­gan — spelling out $1B in R&D cuts

Brent Saunders has found his way out of the current fix he’s in at Allergan $AGN. He’s selling the company to AbbVie for $63 billion in the latest example of the hot M&A market in biopharma.

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Turned back at the FDA, Im­muno­Gen is ax­ing 220 staffers, sell­ing pro­grams and hun­ker­ing down for a new PhI­II gam­ble

After being stymied by FDA regulators who were unconvinced by ImmunoGen’s $IMGN desperation shot at an accelerated OK based on a secondary endpoint, the struggling biotech is slashing its workforce, shuttering R&D projects and looking for buyers to pick up some of its experimental cancer assets as it goes back into a new Phase III with the lead drug.

We found out last month that the FDA had batted back their case for an accelerated approval of their antibody-drug conjugate mirvetuximab soravtansine, which had earlier failed a Phase III study for ovarian cancer. Now the other shoe is dropping.

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Bridge­Bio takes crown for biggest biotech IPO of 2019, as fel­low uni­corn Adap­tive rais­es of­fer­ing size and price

Bridge­Bio Phar­ma and Adap­tive Biotech­nolo­gies have not just up­sized IPO of­fer­ings — the pair of uni­corns have al­so raised their of­fer­ing prices above the range, haul­ing in a com­bined $648.5 mil­lion.

Neil Ku­mar’s Bridge­Bio Phar­ma, found­ed in 2015, has a sta­ble of com­pa­nies fo­cused on dis­eases that are dri­ven by de­fects in a sin­gle gene — en­com­pass­ing der­ma­tol­ogy, car­di­ol­o­gy, neu­rol­o­gy, en­docrinol­o­gy, re­nal dis­ease, and oph­thal­mol­o­gy — and can­cers with clear ge­net­ic dri­vers. The start­up mill birthed a pletho­ra of firms such as Ei­dos, Navire, QED Ther­a­peu­tics and Pelle­Pharm, which func­tion as its sub­sidiaries.

As­traZeneca chal­lenges Roche on front­line SCLC af­ter seiz­ing an in­ter­im win — and Mer­ck may not be far be­hind

The crowded playing field in the PD-1/L1 marketing game is about to get a little more complex.

This morning AstraZeneca reported that its CASPIAN study delivered a hit in an interim readout for their PD-L1 Imfinzi combined with etoposide and platinum-based chemotherapy options for frontline cases of small cell lung cancer, a tough target which has already knocked back Bristol-Myers’ shot in second-line cases. The positive data  — which we won’t see before they roll it out at an upcoming scientific conference — give AstraZeneca excellent odds of a quick vault to challenging Roche’s Tecentriq-chemo combo, approved 3 months ago for frontline SCLC in a landmark advance.

“This is the first trial offering the flexibility of combining immunotherapy with different platinum-based regimens in small cell lung cancer, expanding treatment options,” noted AstraZeneca cancer R&D chief José Baselga in a statement.

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Novotech CEO Dr. John Moller

Novotech CRO Award­ed Frost & Sul­li­van Best Biotech CRO Asia-Pa­cif­ic 2019

Known in the in­dus­try as the Asia-Pa­cif­ic CRO, Novotech is now lead CRO ser­vices provider for the grow­ing num­ber of in­ter­na­tion­al biotechs se­lect­ing the re­gion for their stud­ies.

Re­flect­ing this Asia-Pa­cif­ic growth, Novotech staff num­bers are up 20% since De­cem­ber 2018 to 600 in-house clin­i­cal re­search peo­ple across a full range of ser­vices, across the re­gion.

Novotech’s ca­pa­bil­i­ties have been rec­og­nized by an­a­lysts like Frost & Sul­li­van, most re­cent­ly with the pres­ti­gious Asia-Pa­cif­ic CRO Biotech of the year award for best prac­tices in clin­i­cal re­search for biotechs for the fifth year. See oth­er awards here.

Af­ter rais­ing $158M, this up­start's founders have star back­ers and plans to break new ground in gene ther­a­py

Back in 2014, Stephanie Tagliatela opted to take an early exit out of her PhD program after working in Mark Bear’s lab at MIT, where she specialized in the synaptic connections between neuronal cells in the brain. She never finished that PhD, but she and fellow MIT student Kartik Ramamoorthi — who was on the founding team at Voyager — came away with some ideas for a gene therapy startup.

Today, fully 5 years later, she and Ramamoorthi are taking the wraps off of a $104 million mega-round designed to take the cumulative work of their preclinical formative stage for Encoded Therapeutics into human studies. They’ve now raised $158 million since starting out in Illumina’s incubator in the Bay Area, and they believe they are firmly on track to do something unique in gene therapy.

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SQZ, Ery­tech kick off $57M cell ther­a­py part­ner­ship; Jean-Paul Kress lands new CEO gig at Mor­phoSys

→ In a mar­riage of two tech­nolo­gies meant to make cell ther­a­pies more pow­er­ful, SQZ Biotech is team­ing up with France’s Ery­tech Phar­ma for a col­lab­o­ra­tion, with $57 mil­lion re­served for the first project and $50 mil­lion for each sub­se­quent ap­proval (prod­uct or in­di­ca­tion). Hav­ing ac­cess to Ery­tech’s method of fash­ion­ing ther­a­peu­tics from red blood cells, the Cam­bridge, MA-based com­pa­ny said, will am­pli­fy SQZ’s cell en­gi­neer­ing ca­pa­bil­i­ties and al­low them to de­vleop a new class of im­munomod­u­la­to­ry ther­a­pies. Its own tech — so far ap­plied in can­cer but al­so has po­ten­tial in di­a­betes — tem­po­rary dis­rupts the cell mem­brane by squeez­ing the cell, thus cre­at­ing a brief win­dow for tar­get ma­te­ri­als such as anti­gens to en­ter.

Richard Gonzalez testifying in front of Senate Finance Committee, February 2019 [AP Images]

Ab­b­Vie's $63B buy­out spot­lights the re­turn of ma­jor M&A deals — de­spite the back­lash

Big time M&A is back. But for how long?

Over the past 18 months we’ve now seen three major buyouts announced: Takeda/Shire; Bristol-Myers/Celgene and now AbbVie/Allergan. And with this latest deal it’s increasingly clear that the sharp fall from grace suffered by high-profile players which have seen their share prices blasted has created an opening for the growth players in big pharma to up their game — in sharp contrast to the popular bolt-on deals that have been driving the growth strategy at Novartis, Merck, Roche and others.

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Sanofi/Re­gen­eron mus­cle ahead of a ri­val No­var­tis/Roche team, win first ap­proval in key rhi­nos­i­nusi­tis field

Re­gen­eron and their part­ners at Sanofi have beat the No­var­tis/Roche team to the punch on an­oth­er key in­di­ca­tion for their block­buster an­ti-in­flam­ma­to­ry drug Dupix­ent. The drug team scored an ac­cel­er­at­ed FDA ap­proval for chron­ic rhi­nos­i­nusi­tis with nasal polyps, mak­ing this the first such NDA for the field.

An­a­lysts have been watch­ing this race for awhile now, as Sanofi/Re­gen­eron won a snap pri­or­i­ty re­view for what is now their third dis­ease in­di­ca­tion for this treat­ment. And they’re not near­ly done, build­ing up hopes for a ma­jor fran­chise.