GSK, Sanofi en­list in a big ge­nomics project aim­ing to map genes of half a mil­lion Finns

Sev­er­al Eu­ro­pean coun­tries, in­clud­ing Ice­land and the Nether­lands, have an­a­lyzed ge­nom­ic in­for­ma­tion to study their pop­u­lace. Two years ago, Fin­land be­gan its very own large scale pub­lic-pri­vate ge­nomics project – aimed at map­ping the genomes of 500,000 cit­i­zens (or rough­ly 9% of the coun­try’s pop­u­la­tion) to de­code the ori­gins of dis­ease for pre­ven­tion, di­ag­no­sis and treat­ment. GSK and Sanofi have now joined the ef­fort, bring­ing the to­tal num­ber of phar­ma­ceu­ti­cal part­ners to nine.

The project, called FinnGen, uti­lizes blood sam­ples from biobanks to chart ge­nom­ic da­ta and then an­a­lyzes it with in­for­ma­tion from na­tion­al health records. It in­cludes the par­tic­i­pa­tion of both acad­e­mia and in­dus­try, such as the Finnish de­part­ment of health, hos­pi­tals, uni­ver­si­ties as well as 7 oth­er phar­ma com­pa­nies: Ab­b­Vie, As­traZeneca, Bio­gen, Cel­gene, Roche’s Genen­tech, Mer­ck and Pfiz­er. As of De­cem­ber 2018, 108,000 new biobank sam­ples — in­clud­ing more than 15,000 can­cer pa­tients and over 30,000 pa­tients with car­diometa­bol­ic dis­eases — had been col­lect­ed, ac­cord­ing to an an­nounce­ment ear­li­er this week.

The Fin­ish project, led by the Uni­ver­si­ty of Helsin­ki, us­es a ge­nom­ic map­ping ap­proach called genome-wide as­so­ci­a­tion study (GWAS) geno­typ­ing, which is es­sen­tial­ly de­signed to iden­ti­fy com­mon vari­ants that con­tribute to com­mon dis­eases. These com­mon vari­ants are usu­al­ly lo­cat­ed in re­gions of the chro­mo­some that don’t code for spe­cif­ic func­tion­al pro­teins. Mean­while, Eng­land’s genome project us­es a more com­pre­hen­sive, al­beit slow­er, ap­proach called whole genome se­quenc­ing. This strat­e­gy look in­to re­gions of the chro­mo­some that code for func­tion­al pro­teins and pin­point mu­ta­tions that can have a greater im­pact on dis­ease.

Eng­land’s flag­ship genome project was an­nounced in 2013 and five years lat­er the tar­get of se­quenc­ing 100,000 whole genomes from NHS pa­tients with rare dis­eases, and their fam­i­lies, as well as pa­tients with com­mon can­cers was achieved. How­ev­er, last Oc­to­ber the UK gov­ern­ment an­nounced the project would be ex­pand­ed to se­quence 1 mil­lion whole genomes in the com­ing five years.

Ge­nomics Eng­land has al­so been work­ing with com­pa­nies who fo­cus on drug dis­cov­ery, phar­ma­ceu­ti­cal de­vel­op­ment and da­ta analy­sis to put this ge­nom­ic da­ta to use. Their in­dus­try part­ners in­clude Google, Mi­crosoft and Iqvia, in ad­di­tion to the usu­al phar­ma sus­pects, such as As­traZeneca, GSK, Roche and Take­da.

In De­cem­ber As­traZeneca sharp­ened its fo­cus on ge­nomics by pour­ing its R&D heft in­to a new cen­ter in part­ner­ship with Can­cer Re­search UK, to de­vel­op per­son­al­ized can­cer drugs. Fel­low British drug­mak­er GSK $GSK, has tied up with 23andMe to gain ac­cess to the lat­ter’s data­base — to look for dis­ease rel­e­vant genes. Across the At­lantic, Re­gen­eron $REGN has carved out its own ge­net­ics cen­tre, Am­gen $AMGN has sharp­ened its abil­i­ty to iden­ti­fy and val­i­date dis­ease tar­gets with its in­vest­ment in Ox­ford Nanopore Tech­nolo­gies and ac­qui­si­tion of de­CODE ge­net­ics, while Ver­tex $VRTX has part­nered with UK-based Ge­nomics plc on their plat­form for ge­net­ics and ma­chine learn­ing.

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.