As­traZeneca sells off more as­sets from its is­land of mis­fit drugs in $1.6B Pfiz­er deal

As­traZeneca has com­plet­ed an­oth­er stage in its sys­tem­at­ic re­treat from the an­tibi­otics busi­ness, sell­ing a port­fo­lio of mar­ket­ed and ex­per­i­men­tal small mol­e­cule an­tibi­otics to an ac­quis­i­tive Pfiz­er for $725 mil­lion in cash and an­oth­er $850 mil­lion in mile­stones.

As­traZeneca CEO Pas­cal So­ri­ot

The first stage in the re­treat start­ed in 2014, as it be­gan to wind down its ear­ly-stage an­tibi­otics re­search group in Waltham, MA, which had 175 staffers when Pas­cal So­ri­ot took over as CEO at the phar­ma gi­ant. In­dus­try sources at the time tipped me off to the com­pa­ny’s de­ci­sion to see if it could find a buy­er for the group. But when no deal emerged, As­traZeneca de­cid­ed to spin out a small group of sur­vivors in a new ven­ture dubbed En­ta­sis, with a $40 mil­lion round to get it set up.

This new deal gives Pfiz­er Za­v­icef­ta, Zin­foro and Mer­rem, with a pair of ex­per­i­men­tal pro­grams – a Phase III-ready CXL, an in­jectable bac­te­ri­ci­dal β-lac­tam/β-lac­ta­mase in­hibitor com­bi­na­tion of Zin­foro and Avibac­tam (AVI, NXL104) and ATM-AVI, a bac­te­ri­ci­dal, in­jectable com­bi­na­tion of aztre­on­am (ATM) and a β-lac­ta­mase in­hibitor, Avibac­tam (AVI, NXL104). Just a few weeks ago As­traZeneca flagged a suc­cess­ful Phase III ef­fort for Za­v­icef­ta  (cef­tazidime-avibac­tam), which fol­lowed close on the heels of an ap­proval in Eu­rope. Al­ler­gan has been part­nered with As­traZeneca on the ef­fort and holds North Amer­i­can rights.

Not in­clud­ed: A fi­nal group of bi­o­log­ics un­der Med­Im­mune’s ban­ner in Mary­land as well as its stake in En­ta­sis.

As­traZeneca has been run­ning a brisk busi­ness in sell­ing off as­sets it ei­ther no longer sees as a good fit for So­ri­ot’s core drug strat­e­gy or drugs that have lost a con­sid­er­able amount of lus­ter. The sales in­clude a deal to hive off anes­thet­ics to As­pen for up to $770 mil­lion. The re­jects ex­iled to its is­land of mis­fit as­sets in­clude lesin­u­rad and bro­dalum­ab, which pro­duced mixed da­ta in the clin­ic and were then li­censed out. And now there’s a ques­tion whether selume­tinib might wind up at the bar­gain base­ment as well af­ter back-to-back late-stage fail­ures.

There has been some in­ter­est in an­tibi­otics among the phar­ma ma­jors, wit­nessed by Mer­ck’s ac­qui­si­tion of Cu­bist. But Mer­ck al­so shut­tered ear­ly stage ef­forts there and Big Phar­ma in gen­er­al has been deeply skep­ti­cal of a field that typ­i­cal­ly de­liv­ers on­ly small mar­gins. An­tibi­ot­ic re­sis­tance, mean­while, has on­ly grown worse around the globe.

As­traZeneca has been beef­ing up weak rev­enue with these deals as it con­tin­ues a years-long ef­fort to re­tool in a turn­around aimed at adding bil­lions of dol­lars in new sales. The phar­ma gi­ant sees its can­cer pipeline, in­clud­ing the re­cent­ly ap­proved Tagris­so as well as the late-stage check­point dur­val­um­ab, as its best chance for a come­back. Pfiz­er, on the oth­er hand, has been buy­ing, pur­su­ing an ac­qui­si­tion strat­e­gy high­light­ed by its $14 bil­lion buy­out of Medi­va­tion.

An em­bold­ened As­traZeneca splurges $95M on a pri­or­i­ty re­view vouch­er. Can an FDA hus­tle up on trastuzum­ab be far be­hind?

AstraZeneca is in a hurry.

We learned this morning that the pharma giant — not known as a big spender, until recently — forked over $95 million to get its hands on a priority review voucher from Sobi, otherwise known as Swedish Orphan Biovitrum.

That marks another step down on price for a PRV, which allows the holder to slash 4 months off of any FDA review time.

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Brian Kaspar. AveXis via Twitter

AveX­is sci­en­tif­ic founder fires back at No­var­tis CEO Vas Narasimhan, 'cat­e­gor­i­cal­ly de­nies any wrong­do­ing'

Brian Kaspar’s head was among the first to roll at Novartis after company execs became aware of the fact that manipulated data had been included in its application for Zolgensma, now the world’s most expensive therapy.

But in his first public response, the scientific founder at AveXis — acquired by Novartis for $8.7 billion — is firing back. And he says that not only was he not involved in any wrongdoing, he’s ready to defend his name as needed.

I reached out to Brian Kaspar after Novartis put out word that he and his brother Allen had been axed in mid-May, two months after the company became aware of the allegations related to manipulated data. His response came back through his attorneys.

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Martin Shkreli [via Getty]

Pris­on­er #87850-053 does not get to add drug de­vel­op­er to his list of cred­its

Just days after Retrophin shed its last ties to founder Martin Shkreli, the biotech is reporting that the lead drug he co-invented flopped in a pivotal trial. Fosmetpantotenate flunked both the primary and key secondary endpoints in a placebo-controlled trial for a rare disease called pantothenate kinase-associated neurodegeneration, or PKAN.

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We­bi­nar: Re­al World End­points — the brave new world com­ing in build­ing fran­chise ther­a­pies

Several biopharma companies have been working on expanding drug labels through the use of real world endpoints, combing through the data to find evidence of a drug’s efficacy for particular indications. But we’ve just begun. Real World Evidence is becoming an important part of every clinical development plan, in the soup-through-nuts approach used in building franchises.

I’ve recruited a panel of 3 top experts in the field — the first in a series of premium webinars — to look at the practical realities governing what can be done today, and where this is headed over the next few years, at the prodding of the FDA.

ZHEN SU — Mer­ck Serono’s Se­nior Vice Pres­i­dent and Glob­al Head of On­col­o­gy
EL­LIOTT LEVY — Am­gen’s Se­nior Vice Pres­i­dent of Glob­al De­vel­op­ment
CHRIS BOSHOFF — Pfiz­er On­col­o­gy’s Chief De­vel­op­ment Of­fi­cer

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Ver­sant-backed Chi­nook gets a $65M launch round for its dis­cov­ery quest in a resur­gent kid­ney field

Versant is once again stepping off the beaten track in biotech to see if they can blaze a trail of their own in a field that has looked too thorny to many investors for years.

The venture group and their partners at Apple Tree are bringing their latest creation out of stealth mode today. Born in Versant’s Inception Sciences’ Chinook Therapeutics is betting that its preclinical take on kidney disease can get an early lead among the companies starting up in the field.

Sir An­drew Dil­lon, NICE's first — and on­ly — chief ex­ec­u­tive to step down next year

Using a laptop borrowed from his former employer, South London’s St George’s Hospital, Sir Andrew Dillon set about establishing NICE — launched by the then health secretary Frank Dobson — in 1999.  On Thursday, the UK cost-effectiveness watchdog said its first and only chief executive — Dillon — is stepping down in March 2020.

Back in the day, decisions about which drugs and interventions were funded by the National Health Service (NHS) were made at the local level, but this ‘postcode prescribing’ system was fraught with skewed healthcare deployment making the structure unsustainable. A national system was deemed necessary — and NICE was formed to bridge that gap.

Eight weeks be­tween each HIV treat­ment? GSK notch­es PhI­II win as it chas­es OK for long-act­ing reg­i­men

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Finch grabs a $53M round de­signed to take their ‘break­through’ mi­cro­bio­me treat­ment through a po­ten­tial­ly piv­otal tri­al

With a breakthrough designation in one hand and a fresh $53 million in venture backing in the other, Somerville, MA-based Finch Therapeutics is taking a shot at a one-trial pathway to a possible FDA OK for their new treatment for preventing recurrent C. difficile infections.

The funding brings their total raise for the microbiome company to $130 million, CEO Mark Smith tells me — enough money to pave a runway past the FDA approval they’ve sketched into the most optimistic version for their near-term future. 

Bob Smith, Pfizer

Pfiz­er is mak­ing a $500M state­ment to­day: Here’s how you be­come a lead play­er in the boom­ing gene ther­a­py sec­tor

Three years ago, Pfizer anted up $150 million in cash to buy Bamboo Therapeutics in Chapel Hill, NC as it cautiously stuck a toe in the small gene therapy pool of research and development.

Company execs followed up a year later with a $100 million expansion of the manufacturing operations they picked up in that deal for the UNC spinout, which came with $495 million in milestones.

And now they’re really going for it.

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