With $100M in fresh back­ing and a new TCR ini­tia­tive, Athenex launch­es Chi­na JV

A year af­ter John­son Lau out­lined the full mea­sure of his plans for a biotech come­back in an S-1 fil­ing for Athenex $AT­NX, the biotech ex­ec has fol­lowed up with a $100 mil­lion in­vest­ment/loan from Per­cep­tive along with a new Chi­nese joint ven­ture which will set out to en­gi­neer TCRs for can­cer.

The Buf­fa­lo-based com­pa­ny had kept some­thing of a low pro­file, but that’s all long over now as Athenex looks to grab some head­lines.

John­son Lau

Lau and his com­pa­ny are pro­mot­ing a plat­form tech that they say gives them the tools need­ed to make IV chemother­a­pies in­to oral drugs that can be more ef­fec­tive in treat­ing can­cer. That has pro­duced them Orax­ol (oral pa­cli­tax­el) along with oral irinote­can, do­c­etax­el and topote­can. On top of the pipeline, the com­pa­ny al­so has a man­u­fac­tur­ing arm to de­liv­er ac­tive phar­ma­ceu­ti­cal in­gre­di­ents for it­self and clients. 

In this new deal, Per­cep­tive is buy­ing $50 mil­lion in eq­ui­ty and pro­vid­ing $50 mil­lion in debt. The biotech al­so in-li­censed a pe­gy­lat­ed ge­net­i­cal­ly mod­i­fied hu­man arginase de­vel­oped by the Hong Kong Poly­tech­nic Uni­ver­si­ty and then li­censed to Poly­Tom with plans for clin­i­cal de­vel­op­ment.

And Athenex is cre­at­ing a joint ven­ture — Ax­is Ther­a­peu­tics — with Xi­angx­ue Life Sci­ences, a sub­sidiary of Guangzhou Xi­angx­ue Phar­ma­ceu­ti­cal, work­ing on TCR cell ther­a­pies for can­cer.

Athenex is is­su­ing $5 mil­lion in stock to Xi­angx­ue Life Sci­ences as an up­front pay­ment and con­tribut­ing $30 mil­lion in cash to the joint ven­ture. Ax­is Ther­a­peu­tics will pay mile­stones of up to $110 mil­lion to Xi­angx­ue Life Sci­ences, which will re­tain the Chi­na rights to the tech­nol­o­gy.

Athenex scored an unim­pres­sive $66 mil­lion from its IPO last year, pric­ing at $11. But the shares quick­ly gained steam, and the price now is over $18 a share, with a mar­ket cap of more that $1 bil­lion.

Lau, a for­mer man­ag­ing part­ner at Roth and a rec­og­nized an­tivi­ral spe­cial­ist who once worked for Scher­ing-Plough, was at the cen­ter of a colos­sal scrap way back in 2002 over a then-record $260 mil­lion biotech IPO for a biotech com­pa­ny called Rib­apharm. Rib­apharm was cre­at­ed by ICN Phar­ma­ceu­ti­cals and gift­ed with rib­avirin, a long­time main­stay in hep C cock­tails be­fore the new gen­er­a­tion of drugs came along. ICN sold 20% of the com­pa­ny to the pub­lic, well be­low the range Lau shot for, then balked at spin­ning off the rest of the shares. Lau and his team got in­to a pub­lic brawl with ICN and then re­signed en masse af­ter telling re­porters that the com­pa­ny was schem­ing to buy back the shares cheap.

In 2003, ICN — which did re­trieve the shares at a big dis­count — changed its name to Valeant. The rest, as they say, is his­to­ry.

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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Alk­er­mes adds bipo­lar de­pres­sion to its FDA wish list; Con­go con­firms first Ebo­la case in large city

→ An ever-ambitious Alkermes $ALKS team plans to add bipolar depression 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 depression 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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Hal Barron [File photo]

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.

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.