Lam­bast­ed by AIDS ac­tivists about Tru­va­da pric­ing, Gilead of­fers CDC drug sup­ply deal; Fi­bro­Gen MACE mis­com­mu­ni­ca­tion leaves in­vestors dis­ori­ent­ed

→ Chas­tised by AIDS ac­tivists for its pric­ing pol­i­cy on Tru­va­da, Gilead $GILD has agreed to pro­vide to CDC with up to 2.4 mil­lion bot­tles of the HIV-pre­ven­tion pill an­nu­al­ly for unin­sured Amer­i­cans at risk for HIV.  The do­na­tion, which ex­tends up to 2030, will tran­si­tion to De­scovy if it is ap­proved for use as a pre­ven­ta­tive treat­ment or PrEP (pre-ex­po­sure pro­phy­lax­is), in which in­di­vid­u­als at high risk for HIV take med­i­cines dai­ly to low­er their chances of con­tract­ing the in­fec­tion.

About 200,000 of the es­ti­mat­ed 1.1 mil­lion Amer­i­cans at risk for HIV cur­rent­ly re­ceive Tru­va­da for PrEP, Gilead said.

→ On Thurs­day, Fi­bro­Gen re­port­ed its first-quar­ter re­sults and dis­closed the keen­ly-an­tic­i­pat­ed MACE (ma­jor ad­verse car­dio­vas­cu­lar events) in­te­grat­ed-safe­ty analy­sis for its As­traZeneca $AZN-part­nered po­ten­tial block­buster treat­ment, rox­adu­s­tat. The ane­mia drug for chron­ic kid­ney dis­ease — de­signed to stim­u­late the pro­duc­tion of red blood cells by mim­ic­k­ing the ef­fect of high al­ti­tude — is be­ing de­vel­oped as a safer al­ter­na­tive to the cur­rent stan­dard-of-care: ery­thro­poiesis-stim­u­lat­ing agents, which are as­so­ci­at­ed with CV is­sues. But the MACE dis­clo­sure, stem­ming from the analy­sis of sev­en late-stage tri­als, en­com­pass­ing more than 8,000 pa­tients, left in­vestors dazed and con­fused. The stock $FGEN tum­bled af­ter-mar­ket and was down near­ly 24% at 34.76 in Fri­day morn­ing trad­ing.

For starters, the com­pa­ny did not dis­close the ac­tu­al da­ta. For one 4,300 pa­tient-tri­al, which in­clud­ed the sig­nif­i­cant pop­u­la­tion of dial­y­sis-in­de­pen­dent kid­ney dis­ease pa­tients, Fi­bro­Gen vague­ly said it be­lieved there was no clin­i­cal­ly mean­ing­ful dif­fer­ence in risk of MACE be­tween rox­adu­s­tat and place­bo.”In­vestors in­ter­pret­ed this to mean that the tri­al had failed on the MACE non-in­fe­ri­or­i­ty sta­tis­ti­cal analy­sis, since oth­er­wise why wouldn’t the com­pa­ny have dis­closed that it had met that stan­dard,” SVB’s Leerink’s Ge­of­frey Porges ac­knowl­edged in a note.

Ge­of­frey Porges

In Eu­rope, where rox­adu­s­tat is part­nered with Astel­las, the com­pa­nies are held to a dif­fer­ent end­point called MACE+, which Fi­bro­Gen was more forth­com­ing and con­clu­sive­ly pos­i­tive about hit­ting, dur­ing the course of the call. “The re­al­i­ty is that the MACE out­comes ap­pear to have trend­ed sim­i­lar­ly to the pos­i­tive MACE+ out­comes, and roxa’s per­for­mance was not ma­te­ri­al­ly worse in MACE. The dif­fer­ent dis­clo­sure ap­pears to pri­mar­i­ly re­late to the cau­tion of Fi­bro­Gen’s part­ner As­traZeneca about de­clar­ing such an out­come, in the ab­sence of agree­ment with the FDA about the bound­aries for de­clar­ing the two pop­u­la­tions non-in­fe­ri­or,” Porges said.

Norbert Bischofberger. Kronos

Backed by some of the biggest names in biotech, Nor­bert Bischof­berg­er gets his megaround for plat­form tech out of MIT

A little over a year ago when I reported on Norbert Bischofberger’s jump from the CSO job at giant Gilead to a tiny upstart called Kronos, I noted that with his connections in biotech finance, that $18 million launch round he was starting off with could just as easily have been $100 million or more.

With his first anniversary now behind him, Bischofberger has that mega-round in the bank.

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Francesco De Rubertis

Medicxi is rolling out its biggest fund ever to back Eu­rope's top 'sci­en­tists with strange ideas'

Francesco De Rubertis built Medicxi to be the kind of biotech venture player he would have liked to have known back when he was a full time scientist.

“When I was a scientist 20 years ago I would have loved Medicxi,’ the co-founder tells me. It’s the kind of place run by and for investigators, what the Medicxi partner calls “scientists with strange ideas — a platform for the drug hunter and scientific entrepreneur. That’s what I wanted when I was a scientist.”

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Af­ter a decade, Vi­iV CSO John Pot­tage says it's time to step down — and he's hand­ing the job to long­time col­league Kim Smith

ViiV Healthcare has always been something unique in the global drug industry.

Owned by GlaxoSmithKline and Pfizer — with GSK in the lead as majority owner — it was created 10 years ago in a time of deep turmoil for the field as something independent of the pharma giants, but with access to lots of infrastructural support on demand. While R&D at the mother ship inside GSK was souring, a razor-focused ViiV provided a rare bright spot, challenging Gilead on a lucrative front in delivering new combinations that require fewer therapies with a more easily tolerated regimen.

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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).

On a glob­al romp, Boehringer BD team picks up its third R&D al­liance for Ju­ly — this time fo­cused on IPF with $50M up­front

Boehringer Ingelheim’s BD team is on a global deal spree. The German pharma company just wrapped its third deal in 3 weeks, going back to Korea for its latest pipeline pact — this time focused on idiopathic pulmonary fibrosis.

They’re handing over $50 million to get their hands on BBT-877, an ATX inhibitor from Korea’s Bridge Biotherapeutics that was on display at a science conference in Dallas recently. There’s not a whole lot of data to evaluate the prospects here.

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Servi­er scoots out of an­oth­er col­lab­o­ra­tion with Macro­Gen­ics, writ­ing off their $40M

Servier is walking out on a partnership with MacroGenics $MGNX — for the second time.

After the market closed on Wednesday MacroGenics put out word that Servier is severing a deal — inked close to 7 years ago — to collaborate on the development of flotetuzumab and other Dual-Affinity Re-Targeting (DART) drugs in its pipeline.

MacroGenics CEO Scott Koenig shrugged off the departure of Servier, which paid $20 million to kick off the alliance and $20 million to option flotetuzumab — putting a heavily back-ended $1 billion-plus in additional biobuck money on the table for the anti-CD123/CD3 bispecific and its companion therapies.

Den­mark's Gen­mab hits the jack­pot with $500M+ US IPO as small­er biotechs rake in a com­bined $147M

Danish drugmaker Genmab A/S is off to the races with perhaps one of the biggest biotech public listings in decades, having reaped over $500 million on the Nasdaq, as it positions itself as a bonafide player in antibody-based cancer therapies.

The company, which has long served as J&J’s $JNJ key partner on the blockbuster multiple myeloma therapy Darzalex, has asserted it has been looking to launch its own proprietary product — one it owns at least half of — by 2025.

FDA over­rides ad­comm opin­ions a fifth of the time, study finds — but why?

For drugmakers, FDA advisory panels are often an apprehended barometer of regulators’ final decisions. While the experts’ endorsement or criticism often translate directly to final outcomes, the FDA sometimes stun observers by diverging from recommendations.

A new paper out of Milbank Quarterly put a number on that trend by analyzing 376 voting meetings and subsequent actions from 2008 through 2015, confirming the general impression that regulators tend to agree with the adcomms most of the time — with discordances in only 22% of the cases.

UP­DAT­ED: With loom­ing ‘apoc­a­lypse of drug re­sis­tance,’ Mer­ck’s com­bi­na­tion an­tibi­ot­ic scores FDA ap­proval on two fronts

Merck — one of the last large biopharmaceuticals companies in the beleaguered field of antibiotic drug development — on Wednesday said the FDA had sanctioned the approval of its combination antibacterial for the treatment of complicated urinary tract and intra-abdominal infections.

To curb the rise of drug-resistant bacteria and maintain the efficacy of the therapy, Recarbrio (and other antibacterials) — the drug must be used to treat or prevent infections that are proven or strongly suspected to be caused by susceptible gram-negative bacteria, Merck $MRK said.

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