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.

2019 Trin­i­ty Drug In­dex Eval­u­ates Ac­tu­al Com­mer­cial Per­for­mance of Nov­el Drugs Ap­proved in 2016

Fewer Approvals, but Neurology Rivals Oncology and Sees Major Innovations

This report, the fourth in our Trinity Drug Index series, outlines key themes and emerging trends in the industry as we progress towards a new world of targeted and innovative products. It provides a comprehensive evaluation of the performance of novel drugs approved by the FDA in 2016, scoring each on its commercial performance, therapeutic value, and R&D investment (Table 1: Drug ranking – Ratings on a 1-5 scale).

UP­DAT­ED: FDA’s golodirsen CRL: Sarep­ta’s Duchenne drugs are dan­ger­ous to pa­tients, of­fer­ing on­ly a small ben­e­fit. And where's that con­fir­ma­to­ry tri­al?

Back last summer, Sarepta CEO Doug Ingram told Duchenne MD families and investors that the FDA’s shock rejection of their second Duchenne MD drug golodirsen was due to some concerns regulators raised about the risk of infection and the possibility of kidney toxicity. But when pressed to release the letter for all to see, he declined, according to a report from BioPharmaDive, saying that kind of move “might not look like we’re being as respectful as we’d like to be.”

He went on to assure everyone that he hadn’t misrepresented the CRL.

But Ingram’s public remarks didn’t include everything in the letter, which — following the FDA’s surprise about-face and unexplained approval — has now been posted on the FDA’s website and broadly circulated on Twitter early Wednesday.

The CRL raises plenty of fresh questions about why the FDA abruptly decided to reverse itself and hand out an OK for a drug a senior regulator at the FDA believed — 5 months ago, when he wrote the letter — is dangerous to patients. It also puts the spotlight back on Sarepta $SRPT, which failed to launch a confirmatory study of eteplirsen, which was only approved after a heated internal controversy at the FDA. Ellis Unger, director of CDER’s Office of Drug Evaluation I, notes that study could have clarified quite a lot about the benefit and risks associated with their drugs — which can cost as much as a million dollars per patient per year, depending on weight.

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For start-up biotechnology companies and resource stretched pharmaceutical organisations, launching a novel product can be challenging. Lean teams can make setting a launch strategy and achieving your commercial goals seem like a colossal undertaking, but can these barriers be transformed into opportunities that work to your brand’s advantage?
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Things are no different, as the coronavirus outbreak in Wuhan, China takes hold. There have been close to 300 confirmed human infections in China, and at least four deaths. Coronaviruses are a large family of viruses, which include MERS and SARS. On Tuesday, the CDC reported the virus was detected in a US traveler returning from Wuhan.

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BeiGene lines up its first shot at crack­ing the megablock­buster PD-1 mar­ket for lung can­cer. But can they over­come un­der­dog sta­tus?

BeiGene took another big step towards challenging Merck, Bristol-Myers Squibb, AstraZeneca and some other Big Pharma heavyweights for a share of the lucrative lung cancer market for the PD-(L)1s racking up billions in annual revenue.

The China-based biotech $BGNE run by CEO John Oyler posted positive top-line progression-free survival results for their pivotal Chinese study on their PD-1 antibody tislelizumab combined with chemo for squamous non-small cell lung cancer in frontline cases. Squamous NSCLC accounts for about 30% of the overall lung cancer market.

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Brex­it fears, Wood­ford woes over­shad­owed UK biotech and cut 2019 fi­nanc­ing by al­most half

The venture tide might have subsided, the IPO window may be closing and certain listed biotechs may be having a tough time amid Neil Woodford’s well-publicized demised, but there’s still plenty to celebrate in the UK BioIndustry Association’s eyes.

Overall investment in UK biotech last year fell from the record-breaking £2.2 billion levels of 2018 to £1.3 billion — including £679 million in venture capital, a meager £64 million in IPOs plus £596 million when you add up all public financings, according to a new report from the BIA.

Blue­print Med­i­cines po­ten­tial­ly de­lays Ay­vak­it de­ci­sion; Con­trol beats treat­ment in mesothe­lioma tri­al

→ Blueprint Medicines filed an amendment to its application to get the gastrointestinal stromal tumor (GIST) drug Ayvakit approved in fourth-line GIST, the company disclosed in the prospectus for a new $325 million public offering.  Blueprint got a big accelerated OK on the drug this month in a particular mutation, but because the FDA decided to split their review in two, they didn’t hear on fourth-line GIST. They were supposed to hear before February 14, but this amendment could push that date back by 3 months. Blueprint wrote that the amendment is designed to allow the company to comply with the FDA’s request for data from the Phase III VOYAGER before they give a judgment.