Pfiz­er los­es key Lyri­ca patent bat­tle in the UK; Kleo Phar­ma clos­es $21M Se­ries B round

→ The UK Supreme Court ruled against Pfiz­er $PFE and a patent in­volv­ing its block­buster painkiller Lyri­ca, in a ma­jor blow to the US drug­mak­er on Wednes­day. Orig­i­nal­ly de­vel­oped for epilep­sy, the drug was even­tu­al­ly cleared for use in neu­ro­path­ic pain that lat­er be­came its key mar­ket, mak­ing it one of Pfiz­er’s most suc­cess­ful drugs in the UK. Pfiz­er was hop­ing to pro­long a sec­ondary med­ical use patent for neu­ro­path­ic pain for the prod­uct, as the ba­sic patent on Lyri­ca that ex­pired five years ago al­lowed gener­ic drug­mak­ers to launch cheap­er ver­sions of the med­i­cine car­ry­ing a “skin­ny la­bel” lim­it­ing their use to epilep­sy and gen­er­al anx­i­ety dis­or­der, Reuters re­port­ed, These gener­ics would in­evitably be used as painkillers, Pfiz­er claimed in a law­suit, but af­ter the ap­peal was re­ject­ed in 2016, the case reached the SC. Pfiz­er’s sec­ondary neu­ro­path­ic pain patent ex­pired last year, the re­port added. The SC’s de­ci­sion con­sti­tutes a win for gener­ic drug­mak­ers Al­ler­gan $AGN and My­lan $MYL.

→ Im­muno-on­col­o­gy drug de­vel­op­er Kleo Phar­ma­ceu­ti­cals said it had closed an over­sub­scribed $21 mil­lion Se­ries B fi­nanc­ing round, led by its Tokyo-based part­ner Pep­tiDream and in­clud­ing par­tic­i­pa­tion of its strate­gic in­vestor and mi­graine drug de­vel­op­er Bio­haven $BHVN. Kleo is work­ing on a a new class of bi-spe­cif­ic, small mol­e­cule com­pounds de­signed to em­u­late or en­hance bi­o­log­ics against can­cer.

→ No­van $NOVN, which is de­vel­op­ing med­i­cines us­ing ni­tric ox­ide to tar­get der­ma­to­log­i­cal and on­covirus-me­di­at­ed dis­eases, said ini­tial mid-stage da­ta from its ex­per­i­men­tal drug SB206 showed promise in pa­tients with mol­lus­cum con­ta­gio­sum — a com­mon vi­ral in­fec­tion of the skin that is large­ly, if not ex­clu­sive­ly, a hu­man dis­ease.

→ Days af­ter an­nounc­ing it had se­cured the glob­al rights to der­mal pain patch Quten­za from Acor­da Ther­a­peu­tics $ACOR, Ger­many’s Grü­nen­thal said it had ac­quired the US-based Aver­i­tas Phar­ma to com­mer­cial­ize Quten­za. Fi­nan­cial de­tails of the deal were not dis­closed.

→ BioX­cel Ther­a­peu­tics $BTAI, which is fo­cused on drug de­vel­op­ment that uti­lizes ar­ti­fi­cial in­tel­li­gence, said an ear­ly-stage, 14-pa­tient study test­ing its in­tra­venous­ly ad­min­is­tered drug, dexmedeto­mi­dine, for acute treat­ment of ag­i­ta­tion in pa­tients suf­fer­ing from schiz­o­phre­nia suc­ceed­ed. Da­ta showed the drug in­duced mild seda­tive ef­fects that last­ed for 1.5 to 2 hours — a clin­i­cal­ly rel­e­vant du­ra­tion — in 9 out of the 10 pa­tients who were giv­en the drug.

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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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.

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.

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.