Eveni­ty fi­nal­ly wins EU ap­proval; US-Chi­na bi­o­log­ics CD­MO rais­es $60M

Am­gen and part­ner UCB have man­aged to con­vince the EMA to fi­nal­ly ap­prove their bone-build­ing drug, Eveni­ty, to treat os­teo­poro­sis. The drug, which was orig­i­nal­ly slapped with a neg­a­tive rec­om­men­da­tion by the EU reg­u­la­tor, was test­ed in three late-stage stud­ies. Da­ta showed the drug was ef­fec­tive, but se­ri­ous CV ad­verse events were ob­served in one tri­al — trig­ger­ing reg­u­la­to­ry con­cern in the Unit­ed States and Eu­rope. The FDA grant­ed Eveni­ty ap­proval in April, but the man­u­fac­tur­ers view the EU as the least valu­able re­gion in terms of Eveni­ty, Cred­it Su­isse an­a­lysts wrote in a note in June, pre­dict­ing mod­est EU sales and es­ti­mat­ing the EU op­por­tu­ni­ty is worth $1-2 per share.

→ A lit­tle more than a year af­ter bag­ging a $75 mil­lion round de­signed to boost its lead drug, Bel­gian biotech iTeos has inked an agree­ment with Mer­ck to test the com­pound, EOS100850, in com­bi­na­tion with Keytru­da. The Phase I/II tri­al will fo­cus on pa­tients with sol­id tu­mors and en­roll­ment will be­gin in ear­ly 2020.

Emory Uni­ver­si­ty’s drug de­vel­op­ment arm has sealed a li­cens­ing deal with its part­ners at Neu­ro­Trau­ma Sci­ences, who are ex­er­cis­ing their op­tion af­ter con­duct­ing pre­clin­i­cal re­search on Emory’s neu­ro­pro­tec­tant com­pounds in the past year. The lead can­di­date is NTS-1104, but the deal al­so cov­ers re­lat­ed small mol­e­cules en­gi­neered to pen­e­trate the blood-brain bar­ri­er and po­ten­tial­ly treat ac­quired brain in­jury — a cat­e­go­ry that spans is­chemic stroke and trau­mat­ic brain in­jury, in­clud­ing con­cus­sion. Neu­ro­Trau­ma plans to pri­or­i­tize their work in stroke ini­tial­ly.

→ US-Chi­na bi­o­log­ics CD­MO JOINN Bio, a sub­sidiary of JOINN Lab­o­ra­to­ries, has hauled in $60 mil­lion in Se­ries A fi­nanc­ing led by HG Cap­i­tal, with par­tic­i­pa­tion from Nest­bio Cap­i­tal, Hong Kong LINK­AGE Hold­ings, Xi­ang­tang Cap­i­tal and oth­ers. Pro­ceeds from the fund­ing will be used to­ward the con­struc­tion of a 100,000-liter pro­duc­tion base in Bei­jing and ex­pan­sion of its bi­o­log­ics busi­ness in Chi­na and the US.

Mati­nas Bio­Phar­ma, which is get­ting some re­newed love from in­vestors af­ter Bak­er Bros took a stake in it, is boast­ing of a new agree­ment with Roche. The phar­ma gi­ant will eval­u­ate the fea­si­bil­i­ty of de­vel­op­ing oral for­mu­la­tions of its drugs us­ing Mati­nas’ lipid nano-crys­tal de­liv­ery tech.

The Avance Clinical leadership team: CEO Yvonne Lungershausen, Sandrien Louwaars - Director Business Development Operations, Gabriel Kremmidiotis - Chief Scientific Officer, Ben Edwards - Chief Strategy Officer

How Aus­tralia De­liv­ers Rapid Start-up and 43.5% Re­bate for Ear­ly Phase On­col­o­gy Tri­als

About Avance Clinical

Avance Clinical is an Australian owned Contract Research Organisation that has been providing high-quality clinical research services to the local and international drug development industry for 20 years. They specialise in working with biotech companies to execute Phase 1 and Phase 2 clinical trials to deliver high-quality outcomes fit for global regulatory standards.

As oncology sponsors look internationally to speed-up trials after unprecedented COVID-19 suspensions and delays, Australia, which has led the world in minimizing the pandemic’s impact, stands out as an attractive destination for early phase trials. This in combination with the streamlined regulatory system and the financial benefits including a very favourable exchange rate and the R & D cash rebate makes Australia the perfect location for accelerating biotech clinical programs.

Sanofi brings in 4 new ex­ec­u­tives in con­tin­ued shake-up, as vac­cines and con­sumer health chief head out the door

In the middle of Sanofi’s multi-pronged race to develop a Covid-19 vaccine, David Loew, the head of their sprawling vaccines unit, is leaving – part of the final flurry of moves in the French giant’ months-long corporate shuffle that will give them new-look leadership under new CEO Paul Hudson.

The company also said today that Alan Main, the head of their consumer healthcare unit, is out, and they named 4 executives to fill new or newly vacated positions, 3 of whom come from both outside both Sanofi and from Pharma.

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As­traZeneca trum­pets the good da­ta they found for Tagris­so in an ad­ju­vant set­ting for NSCLC — but many of the ex­perts aren’t cheer­ing along

AstraZeneca is rolling out the big guns this evening to provide a salute to their ADAURA data on Tagrisso at ASCO.

Cancer R&D chief José Baselga calls the disease-free survival data for their drug in an adjuvant setting of early stage, epidermal growth factor receptor-mutated NSCLC patients following surgery “momentous.” Roy Herbst, the principal investigator out of Yale, calls it “transformative.”

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Pablo Legorreta, founder and CEO of Royalty Pharma AG, speaks at the annual Milken Institute Global Conference in Beverly Hills, California (Patrick T. Fallon/Bloomberg via Getty Images)

Cap­i­tal­iz­ing Pablo: The world’s biggest drug roy­al­ty buy­er is go­ing pub­lic. And the low-key CEO di­vulges a few se­crets along the way

Pablo Legorreta is one of the most influential players in biopharma you likely never heard of.

Over the last 24 years, Legorreta’s Royalty Pharma group has become, by its own reckoning, the biggest buyer of drug royalties in the world. The CEO and founder has bought up a stake in a lengthy list of the world’s biggest drug franchises, spending $18 billion in the process — $2.2 billion last year alone. And he’s become one of the best-paid execs in the industry, reaping $28 million from the cash flow last year while reserving 20% of the cash flow, less expenses, for himself.

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Paul Hudson, Sanofi CEO (Getty Images)

Sanofi CEO Paul Hud­son has $23B burn­ing a hole in his pock­et. And here are some hints on how he plans to spend that

Sanofi has reaped $11.1 billion after selling off a big chunk of its Regeneron stock at $515 a share. And now everyone on the M&A side of the business is focused on how CEO Paul Hudson plans to spend it.

After getting stung in France for some awkward politicking — suggesting the US was in the front of the line for Sanofi’s vaccines given American financial support for their work, versus little help from European powers — Hudson now has the much more popular task of managing a major cash cache to pull off something in the order of a big bolt-on. Or two.

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Pfiz­er, Mer­ck KGaA ce­ment Baven­cio blad­der can­cer win with OS da­ta — while carv­ing an­oth­er niche in rare can­cer

Pfizer and Merck KGaA have detailed the Phase III data that inspired FDA regulators to designate Bavencio a “breakthrough” for first-line advanced bladder cancer and offered an early glance at how the PD-L1 can help patients with a rare gynecological cancer — carving out niches in the checkpoint space for itself after being shut out of numerous others.

In JAVELIN Bladder 100, Bavencio led to a 31% reduction in risk of death compared to standard care alone. It also extended median survival by more than seven months — a historic feat in this setting, according to investigators at Queen Mary University of London.

Look­ing to move past an R&D fi­as­co, Ipsen poach­es their new CEO from Sanofi

Ipsen has turned to another Paris-based biopharma company for its next CEO.

Sanofi Pasteur chief David Loew — who’s been leading one of the most advanced efforts to develop vaccines for Covid-19 — is making the journey to Ipsen, 5 months after David Meek jumped ship to run a startup in late-stage development.

Loew arrives as Ipsen works to get back on track with their rare bone disease drug palovarotene, picked up in the $1.3 billion Clementia buyout, which was slammed with a partial hold after researchers observed cases of “early growth plate closure” in patients under the age of 14. But they are pushing ahead with the over-14 crowd after writing down slightly more than half of its initial development.

Dan O'Day, Gilead CEO (Andrew Harnik, AP Images)

UP­DAT­ED: Gilead leas­es part­ner rights to TIG­IT, PD-1 in a $2B deal with Ar­cus. Now comes the hard part

Gilead CEO Dan O’Day has brokered his way to a PD-1 and lined up a front row seat in the TIGIT arena, inking a deal worth close to $2 billion to align the big biotech closely with Terry Rosen’s Arcus. And $375 million of that comes upfront, with cash for the buy-in plus equity, along with $400 million for R&D and $1.22 billion in reserve to cover opt-in payments and milestones..

Hotly rumored for weeks, the 2 players have formalized a 10-year alliance that starts with rights to the PD-1, zimberelimab. O’Day also has first dibs on TIGIT and 2 other leading programs, agreeing to an opt-in fee ranging from $200 million to $275 million on each. There’s $500 million in potential TIGIT milestones on US regulatory events — likely capped by an approval — if Gilead partners on it and the stars align on the data. And there’s another $150 million opt-in payments for the rest of the Arcus pipeline.

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Iron­wood, Ab­b­Vie kick de­layed-re­lease Linzess for­mu­la­tion to the curb af­ter tri­al fail­ure

The delayed-release formulation of Ironwood and Allergan’s bowel drug Linzess will not see the light of day.

The experimental drug, MD-7246, failed to help patients with abdominal pain associated with irritable bowel syndrome with diarrhea (IBS-D) in a mid-stage study, prompting the partners to abandon the therapy.

First approved in 2012, Linzess (known chemically as linaclotide) enhances the activity of the intestinal enzyme guanylate cyclase-C to increase the secretion of intestinal fluid and then transit through the intestinal tract, as well as reduce visceral pain, to relieve pain and constipation associated with IBS.