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

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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UP­DAT­ED: Leg­end fetch­es $424 mil­lion, emerges as biggest win­ner yet in pan­dem­ic IPO boom as shares soar

Amid a flurry of splashy pandemic IPOs, a J&J-partnered Chinese biotech has emerged with one of the largest public raises in biotech history.

Legend Biotech, the Nanjing-based CAR-T developer, has raised $424 million on NASDAQ. The biotech had originally filed for a still-hefty $350 million, based on a range of $18-$20, but managed to fetch $23 per share, allowing them to well-eclipse the massive raises from companies like Allogene, Juno, Galapagos, though they’ll still fall a few dollars short of Moderna’s record-setting $600 million raise from 2018.

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Mer­ck wins a third FDA nod for an­tibi­ot­ic; Mereo tack­les TIG­IT with $70M raise in hand

Merck — one of the last big pharma bastions in the beleaguered field of antibiotic drug development — on Friday said the FDA had signed off on using its combination drug, Recarbrio, with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia. The drug could come handy for use in hospitalized patients who are afflicted with Covid-19, who carry a higher risk of contracting secondary bacterial infections. Once SARS-CoV-2, the virus behind Covid-19, infects the airways, it engages the immune system, giving other pathogens free rein to pillage and plunder as they please — the issue is particularly pertinent in patients on ventilators, which in any case are breeding grounds for infectious bacteria.

As it hap­pened: A bid­ding war for an an­tibi­ot­ic mak­er in a mar­ket that has rav­aged its peers

In a bewildering twist to the long-suffering market for antibiotics — there has actually been a bidding war for an antibiotic company: Tetraphase.

It all started back in March, when the maker of Xerava (an FDA approved therapy for complicated intra-abdominal infections) said it had received an offer from AcelRx for an all-stock deal valued at $14.4 million.

The offer was well-timed. Xerava was approved in 2018, four years after Tetraphase posted its first batch of pivotal trial data, and sales were nowhere near where they needed to be in order for the company to keep its head above water.

Drug man­u­fac­tur­ing gi­ant Lon­za taps Roche/phar­ma ‘rein­ven­tion’ vet as its new CEO

Lonza chairman Albert Baehny took his time headhunting a new CEO for the company, making it absolutely clear he wanted a Big Pharma or biotech CEO with a good long track record in the business for the top spot. In the end, he went with the gold standard, turning to Roche’s ranks to recruit Pierre-Alain Ruffieux for the job.

Ruffieux, a member of the pharma leadership team at Roche, spent close to 5 years at the company. But like a small army of manufacturing execs, he gained much of his experience at the other Big Pharma in Basel, remaining at Novartis for 12 years before expanding his horizons.

Covid-19 roundup: Ab­b­Vie jumps in­to Covid-19 an­ti­body hunt; As­traZeneca shoots for 2B dos­es of Ox­ford vac­cine — with $750M from CEPI, Gavi

Another Big Pharma is entering the Covid-19 antibody hunt.

AbbVie has announced a collaboration with the Netherlands’ Utrecht University and Erasmus Medical Center and the Chinese-Dutch biotech Harbour Biomed to develop a neutralizing antibody that can treat Covid-19. The antibody, called 47D11, was discovered by AbbVie’s three partners, and AbbVie will support early preclinical work, while preparing for later preclinical and clinical development. Researchers described the antibody in Nature Communications last month.

Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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Bris­tol My­ers is clean­ing up the post-Cel­gene merg­er pipeline, and they’re sweep­ing out an ex­per­i­men­tal check­point in the process

Back during the lead up to the $74 billion buyout of Celgene, the big biotech’s leadership did a little housecleaning with a major pact it had forged with Jounce. Out went the $2.6 billion deal and a collaboration on ICOS and PD-1.

Celgene, though, also added a $530 million deal — $50 million up front — to get the worldwide rights to JTX-8064, a drug that targets the LILRB2 receptor on macrophages.

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RA Cap­i­tal, Hill­house join $310M rush to back Ever­est's climb to com­mer­cial heights in Chi­na

Money has never been an issue for Everest Medicines. With an essentially open tab from their founders at C-Bridge Capital, the biotech has gone two and a half years racking up drug after drug, bringing in top exec after top exec, and issuing clinical update after update.

But now other investors want in — and they’re betting big.

Everest is closing its Series C at $310 million. The first $50 million comes from the Jiashan National Economic and Technological Development Zone; the remaining C-2 tranche was led by Janchor Partners, with RA Capital Management and Hillhouse Capital as co-leaders. Decheng Capital, GT Fund, Janus Henderson Investors, Rock Springs Capital, Octagon Investments all joined.