Amid re­peat­ed stum­bles, Pfiz­er and Eli Lil­ly tout their an­ti-NGF pain drug tanezum­ab — but ques­tions linger

Pfiz­er and Eli Lil­ly have start­ed to make their late-stage case for tanezum­ab, out­lin­ing some pos­i­tive re­sults on pain but rais­ing some se­ri­ous is­sues about just how ef­fec­tive this low-dose pain drug could be.

Ac­cord­ing to their re­searchers, the drug, an­gling for the non-opi­oid mar­ket the feds want to pro­mote, hit sta­tis­ti­cal sig­nif­i­cance against a place­bo — scor­ing on 3 out of 3 pri­ma­ry end­points.

But at least one promi­nent an­a­lyst, Ever­core ISI’s Umer Raf­fat, took a look at the re­spons­es for the low dos­es that made it in­to late-stage test­ing and start­ed to raise some se­ri­ous ques­tions about the com­mer­cial val­ue of an an­ti-NGF.

Ac­cord­ing to Raf­fat:

70% re­spon­ders are 10-12% high­er than (place­bo) to­day (vs ~17% in pri­or tri­als). Sim­i­lar­ly, 90% re­spon­ders are on­ly ~5% high­er than pbo (vs 10-11% in pri­or tri­als).

This mod­er­ate ef­fi­ca­cy is a big­ger is­sue: in the past, a naprox­en ac­tive com­para­tor was tried … and re­sults to­day on pbo-adj ba­sis sort of mir­ror those naprox­en re­sults on sev­er­al met­rics.

A decade ago, an­a­lysts were com­pet­ing in pro­ject­ing multi­bil­lion-dol­lar mar­kets for the NGF crowd. But ex­pec­ta­tions have dropped af­ter the de­vel­op­ment world was forced to cut back on dos­es — 20 mg to 10 mg for Pfiz­er — in or­der to over­come the se­vere safe­ty chal­lenges that had tem­porar­i­ly frozen the en­tire field.

Lil­ly nev­er­the­less agreed to put up as much as $1.8 bil­lion to buy in­to the Pfiz­er drug.

George Yan­copou­los

Reg­u­la­tors halt­ed test­ing af­ter pa­tients in the stud­ies be­gan to blow their joints out. Con­cerns about rapid­ly pro­gres­sive os­teoarthri­tis re­cent­ly forced Te­va and Re­gen­eron to back off their two high dos­es for fas­inum­ab.

“(T)his is a high-risk, high-re­ward pro­gram as we’ve de­scribed in the past,” Re­gen­eron R&D chief George Yan­copou­los told an­a­lysts in May. “It’s pret­ty well-demon­strat­ed that the mol­e­cule has ac­tiv­i­ty, but it al­so has cer­tain side ef­fects. It’s not os­teonecro­sis, it’s more de­fined as rapid pro­gres­sion of the os­teoarthri­tis in some pa­tients. And this is some­thing that ob­vi­ous­ly has been seen with this class and with our mol­e­cule be­fore. And so what the in­de­pen­dent da­ta mon­i­tor­ing com­mit­tee did was they ob­vi­ous­ly took an analy­sis to look at the ben­e­fit and the risk that is the ther­a­peu­tic ben­e­fit com­pared to their analy­sis of the risk com­ing from these rapid­ly pro­gres­sive os­teoarthri­tis events and they de­cid­ed that we should ter­mi­nate the up­per two dos­es and con­tin­ue with the two low­er dos­es.”

Raf­fat ap­pears more sat­is­fied with the safe­ty of tanezum­ab, but re­searchers did track a 1.3% rate of ag­gres­sive os­teoarthri­tis in the drug arm, with none in the place­bo group.

J&J, mean­while, dropped ful­ranum­ab 2 years ago. As­traZeneca aban­doned its Me­di-578 can­di­date in 2010 and Ab­b­Vie has al­so dropped an­oth­er NGF block­er called ABT-110.

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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