FDA ap­proves the first gener­ic for life-sav­ing opi­oid over­dose treat­ment nalox­one that can be car­ried by un­trained in­di­vid­u­als

On av­er­age, opi­oids kill more than 130 Amer­i­cans every day. An ef­fec­tive agent to halt or re­verse the ef­fects of an opi­oid over­dose is nalox­one, which is avail­able as a nasal spray, an in­jec­tion, or as an in­tra­venous in­fu­sion, and works by tem­porar­i­ly pre­vent­ing the opi­oids from at­tach­ing to opi­oid re­cep­tors in the brain. On Fri­day, the FDA ap­proved the first gener­ic ver­sion of nalox­one nasal spray that can be used to re­verse sus­pect­ed over­dose in the com­mu­ni­ty set­ting, made by Is­rael’s Te­va $TE­VA.

The ap­proval came one day af­ter the Na­tion­al In­sti­tutes of Health un­veiled a study — sup­port­ed by a $350 mil­lion grant — en­gi­neered to cut over­dose deaths by 40% over three years in se­lect­ed hard hit com­mu­ni­ties by adopt­ing ev­i­dence-based pre­ven­tion, treat­ment and re­cov­ery mech­a­nisms across pri­ma­ry care, be­hav­ioral health, jus­tice and oth­er set­tings, such as the dis­tri­b­u­tion of nalox­one to re­verse over­dose and link­ing in­di­vid­u­als in the crim­i­nal jus­tice sys­tem with treat­ment for opi­oid ad­dic­tion. The study will serve as a lit­mus test for a po­ten­tial na­tion­al cam­paign.

The cri­sis of opi­oid abuse, mis­use and ad­dic­tion has in­spired var­i­ous US agen­cies to take steps to curb opi­oid use at the physi­cian’s of­fice and to pre­vent and treat ad­dic­tion and over­dose. But for those who are al­ready de­pen­dent — of­ten af­ter be­ing pre­scribed po­tent painkillers fol­low­ing rou­tine surgery and end up scor­ing street opi­ates such as hero­in for their next fix — the stig­ma of med­ica­tion-as­sist­ed treat­ment per­sists. In 2018, the US Sur­geon Gen­er­al re­leased a pub­lic health ad­vi­so­ry urg­ing more Amer­i­cans to car­ry nalox­one.

Of­ten car­ried by first re­spon­ders, Nar­can (a 2015-ap­proved nasal spray ver­sion of nalox­one hy­drochlo­ride) is made by Adapt Phar­ma, which was swal­lowed by Emer­gent Bioso­lu­tions $EBS last year in a deal worth up to $735 mil­lion. The drug — which gen­er­at­ed sales of $41.7 mil­lion in the fourth quar­ter of 2018 — is avail­able at a 40% dis­count to state and lo­cal gov­ern­ments and non-prof­it or­ga­ni­za­tions.

Fri­day’s Nar­can copy­cat ap­proval marks the first gener­ic nalox­one nasal spray for use in a com­mu­ni­ty set­ting by in­di­vid­u­als with­out med­ical train­ing — how­ev­er, gener­ic in­jectable nalox­one prod­ucts have been avail­able for years for use in a health care set­ting, the FDA said.

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 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.

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.

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.