GSK plans $100M makeover of US man­u­fac­tur­ing site; La Jol­la Phar­ma gets a 'break­through' with late-stage drug

GSK $GSK an­nounced to­day that it will be in­vest­ing $100 mil­lion in­to its fa­cil­i­ty in Hamil­ton, MT to ex­pand long-term vac­cine man­u­fac­tur­ing ca­pa­bil­i­ties. The ex­pan­sion will boost pro­duc­tion ca­pac­i­ty of key com­po­nents of the ad­ju­vant sys­tem used in sev­er­al of its vac­cines and fos­ter new jobs, in­clud­ing tem­po­rary con­struc­tion and var­i­ous per­ma­nent po­si­tions like sci­en­tists, en­gi­neers and man­u­fac­tur­ing and qual­i­ty pro­fes­sion­als.

Jack Bai­ley

“For more than a decade, our Hamil­ton fa­cil­i­ty has sup­port­ed GSK’s ad­ju­vant sys­tem de­vel­op­ment pro­gram,” said Jack Bai­ley, pres­i­dent of US Phar­ma­ceu­ti­cals, GSK. “By ex­pand­ing the ad­ju­vant sys­tem pro­duc­tion ca­pa­bil­i­ties in Hamil­ton, we will con­tin­ue to de­liv­er long-term and sus­tain­able sup­ply for key vac­cines, in­clud­ing Shin­grix.”

→ The FDA gave the green light to La Jol­la Phar­ma­ceu­ti­cal Com­pa­ny $LJPC  to­day for its break­through ther­a­py des­ig­na­tion for the new in­ves­ti­ga­tion­al drug prod­uct, LJPC-0118, for the treat­ment of se­vere malar­ia.

George Tid­marsh

“We are com­mit­ted to the rapid de­vel­op­ment of LJPC-0118 to help pa­tients suf­fer­ing from se­vere malar­ia, a se­ri­ous and life-threat­en­ing dis­ease with­out a cur­rent FDA-ap­proved ther­a­py. We are very pleased to re­ceive the Break­through Ther­a­py des­ig­na­tion from the FDA and are com­mit­ted to pro­vid­ing LJPC-0118 to pa­tients in the US,” said George Tid­marsh, La Jol­la’s pres­i­dent and CEO.

La Jol­la plans to file an NDA with the FDA in the fourth quar­ter of 2019. In two ran­dom­ized, con­trolled, clin­i­cal stud­ies, LJPC-0118 was shown to be su­pe­ri­or to qui­nine in re­duc­ing mor­tal­i­ty in pa­tients with se­vere fal­ci­parum malar­ia in­fec­tion.

→ The Uni­ver­si­ty of Illi­nois at Chica­go and Deer­field Man­age­ment an­nounced to­day the es­tab­lish­ment of West Loop In­no­va­tions, which will help ac­cel­er­ate the com­mer­cial­iza­tion for ther­a­peu­tics de­vel­oped at UIC. Deer­field will pro­vide up to $65 mil­lion in trans­la­tion­al re­search fund­ing and com­mer­cial­iza­tion ex­per­tise to ad­vance promis­ing UIC dis­cov­er­ies.

TJ Au­gus­tine

“One of our core com­pe­ten­cies at UIC is drug dis­cov­ery,” said TJ Au­gus­tine, in­ter­im vice chan­cel­lor for in­no­va­tion at UIC. “We have three ma­jor drugs in the mar­ket­place, plac­ing UIC among a very small num­ber of re­search uni­ver­si­ties. Our new part­ner­ship with Deer­field not on­ly adds sig­nif­i­cant trans­la­tion­al re­search fund­ing, but al­so brings crit­i­cal sup­port for the start­up com­pa­nies that will take UIC’s dis­cov­er­ies and turn them in­to prod­ucts.”

→ Sources told Reuters that Black­Rock $BLK, Bay­er’s $BAYRY largest share­hold­er, will not sup­port the com­pa­ny’s man­age­ment in a key vote at its AGM on Fri­day. Black­Rock, which owns 7.2% of Bay­er’s vot­ing rights, plans to ei­ther ab­stain from or vote against rat­i­fy­ing the man­age­ment board’s ac­tions dur­ing the year un­der re­view, the sources said.

Kite, a Gilead $GILD sub­sidiary, un­veiled plans to­day for a new fa­cil­i­ty in Fred­er­ick Coun­ty, Mary­land, which will pro­duce in­no­v­a­tive cell ther­a­pies for can­cer pa­tients.

“This new fa­cil­i­ty in Fred­er­ick Coun­ty builds on our sub­stan­tial tech­ni­cal ca­pa­bil­i­ties and rapid progress in mak­ing per­son­al­ized CAR T and TCR cell ther­a­pies for peo­ple with can­cer. As we ad­vance our in­dus­try-lead­ing cell ther­a­py pipeline and seek to help a grow­ing num­ber of peo­ple with can­cer, ex­pand­ing and in­vest­ing in our man­u­fac­tur­ing ca­pa­bil­i­ties is es­sen­tial,” said Tim Moore, ex­ec­u­tive vice pres­i­dent of tech­ni­cal op­er­a­tions at Kite. “With the Fred­er­ick Coun­ty site, we will have the op­por­tu­ni­ty to build and de­sign the fa­cil­i­ty tai­lored to our own in­no­v­a­tive process­es and with state-of-the-art fea­tures that will en­able us to meet the fu­ture needs for cell ther­a­pies.”

Tim Moore

Novotech CRO Ex­pands Chi­na Team as Biotech De­mand for Clin­i­cal Tri­als In­creas­es up to 79%

An increase in demand of up to 79% for clinical trials in China has prompted Novotech the Asia-Pacific CRO to rapidly expand the China team, appointing expert local clinical executives to their Shanghai and Hong Kong offices. The company is planning to expand their team by 30% over the next quarter.

Novotech China has seen considerable demand recently which is borne out by research from GlobalData:
A global migration of clinical research is occurring from high-income countries to low and middle-income countries with emerging economies. Over the period 2017 to 2018, for example, the number of clinical trial sites opened by biotech companies in Asia-Pacific increased by 35% compared to 8% in the rest of the world, with growth as high as 79% in China.
Novotech CEO Dr John Moller said China offers the largest population in the world, rapid economic growth, and an increasing willingness by government to invest in research and development.
Novotech’s 23 years of experience working in the region means we are the ideal CRO partner for USA biotechs wanting to tap the research expertise and opportunities that China offers.
There are over 22,000 active investigators in Greater China, with about 5,000 investigators with experience on at least 3 studies (source GlobalData).

Daniel O'Day [via AP Images]

UP­DAT­ED: Gilead un­leash­es a $5B late-stage cash al­liance with Gala­pa­gos — lay­ing out O'­Day's R&D strat­e­gy

Daniel O’Day is executing his first major development deal since taking over as CEO of Gilead $GILD. And he’s going in deep to ally himself with a longstanding partner.

O’Day announced today that he is spending $5 billion in cash to add new late-stage drugs to Gilead’s pipeline, picking up rights to Galapagos’ $GLPG Phase III IPF drug GLPG1690 alongside adoption of the biotech’s Phase IIb drug GLPG1972 for osteoarthritis. And Gilead is also putting billions more on the table for milestones, gaining options for everything else in Galapagos’ pipeline, with a shot at all rights outside of Europe.

Altogether, Gilead is gaining rights to 6 clinical-stage assets, 20 preclinical programs and everything else being hatched in translation.

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Hal Bar­ron's team at GSK scores a win with pos­i­tive Ze­ju­la PhI­II front­line study — now comes the hard part

Score one for Hal Barron and the new R&D team steering GlaxoSmithKline’s pipeline.

The pharma giant reported this morning that its recently acquired PARP, Zejula (niraparib), hit the primary endpoint on progression-free survival in a frontline maintenance setting for women suffering ovarian cancer — following chemo and regardless of their BRCA status.

GSK bet $5 billion on the Tesaro buyout primarily to get this drug, drawing the shaking heads of biopharma. Why pay a big premium for a drug like this when AstraZeneca was going from strength to strength with Lynparza, ran the argument, having won a hugely important accelerated approval to jump out ahead — way ahead — of the rest of the PARP players? Lynparza — now co-owned by a powerhouse cancer team at Merck — won the first approval in frontline maintenance in ovarian cancer.

Alk­er­mes adds bipo­lar I dis­or­der to its FDA wish­list; Con­go con­firms first Ebo­la case in large city

→ An ever-ambitious Alkermes $ALKS team plans to add bipolar I disorder to its list of conditions for ALKS-3831, which it plans to pitch to the FDA in Q4. Alkermes says they were persuaded to add bipolar I disorder after a pre-NDA meeting with the agency, which came about 7 months after the biotech reported positive data for schizophrenia. The drug is a combo using olanzapine/samidorphan, which they hope will be shown to be as effective as olanzapine without the substantial increase in the risk of weight gain.

Pe­ter Kolchin­sky and Raj Shah raise a $300M fund de­vot­ed to biotech star­tups

Peter Kolchinsky and Raj Shah have another $300 million-plus to play with on the biotech venture side of their investment business. 

The two announced Monday morning that they’ve put together their first pure-play venture fund at RA Capital Management, which has been known to bet on just about every angle in healthcare investing — from rounds to follow-on investments at public companies. This new fund of theirs arrives well into a go-go era of new startup financing, with a particular focus on building new biotechs.

Boehringer buys Swiss biotech in its lat­est M&A deal, go­ing the next-gen can­cer vac­cine route

Boehringer Ingelheim has snapped up a Swiss biotech startup and added their group as a new platform for the oncology pipeline. 

The German biopharma company has bagged Geneva-based AMAL Therapeutics, paying out an unspecified upfront in a $358 million deal — cash, milestones and everything else, all in. Plus there’s 100 million euros on the line for commercial milestones.

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Ab­b­Vie beefs up the on­col­o­gy pipeline, bag­ging an up­start STING play­er with its own unique ap­proach

AbbVie isn’t letting its $63 billion buyout of Allergan stop its M&A/deals team from continuing their work.

Monday morning we learned that the pharma giant is snapping up tiny Mavupharma out of Seattle, a Frazier-backed startup that has its own unique take on STING — which is on the threshold of their first clinical trial.

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Billing it­self as the first AI biotech to launch hu­man tri­als, Re­cur­sion adds $121M C round

Billing itself as the first AI biotech with programs in the clinic, Salt Lake City-based Recursion now has a $121 million bankroll to start gathering human data to see if it’s on the right track. 

“We’re trying to build this discovery engine,” Recursion CEO Chris Gibson tells me ahead of the C round news. “We now have the first two programs in the clinic.” And that, he adds, qualifies as a first for any AI establishment “that actually have something in the clinic.”

FDA bats back As­traZeneca's SGLT di­a­betes drug for Type 1 di­a­betes — block­ing a class on safe­ty fears

The FDA has just fired its latest salvo at the SGLT class of diabetes drugs, blowing up some commercial opportunity at AstraZeneca as part of the collateral damage.

The pharma giant reported early Monday that the FDA has rejected its blockbuster drug Farxiga for Type 1 diabetes that can’t be controlled by insulin. And while the pharma giant maintained its usual grim silence in the face of a setback, this one should be easy to interpret.