As­traZeneca auc­tions off rights to an­oth­er pipeline drug as Take­da grabs $400M Parkin­son's deal

As­traZeneca has sold off mar­ket­ing and de­vel­op­ment rights to an­oth­er one of its pipeline as­sets.

This time it’s Take­da that’s step­ping up, ink­ing a deal pack­age to­tal­ing $400 mil­lion for de­vel­op­ment and com­mer­cial­iza­tion rights to its home grown ME­DI1341, an al­pha-synu­cle­in an­ti­body de­signed to com­bat Parkin­son’s dis­ease.

An­drew Plump

As­traZeneca’s re­search team will hand the drug over to Take­da at the end of a Phase I study. Then the strug­gling phar­ma gi­ant will share in the cost of de­vel­op­ment and com­mer­cial­iza­tion — if it comes to that — while al­so shar­ing any prof­its.

For As­traZeneca this is just the lat­est in a grow­ing line­up of of­fload­ing deals. The phar­ma gi­ant has ei­ther been sell­ing off or part­ner­ing off its dis­ap­point­ments as well as its next-gen drugs as CEO Pas­cal So­ri­ot grabs some quick rev­enue and out­li­cens­es drugs the com­pa­ny ei­ther can’t af­ford to de­vel­op on its own or doesn’t want to af­ter re­jig­ging R&D pri­or­i­ties.

So­ri­ot has gam­bled evey­thing on big plans for grow­ing the on­col­o­gy port­fo­lio, which has been on a roller coast­er ride of suc­cess­es and fail­ures.

Take­da, mean­while, has been do­ing every­thing it can to grow its own pipeline as CEO Christophe We­ber and R&D chief Andy Plump rip up their old R&D group and re­vamp de­vel­op­ment ac­tiv­i­ties at the ag­ing Japan­ese phar­ma. Take­da is keep­ing a big fo­cus on neu­ro­sciences, though, which makes it a good part­ner for As­traZeneca, which has pret­ty much bowed out of the field.

Mene Pan­ga­los

In this case it’s jump­ing in­to a field where re­searchers are ex­plor­ing the po­ten­tial of flush­ing tox­ic clus­ters of al­pha-synu­cle­in in Parkin­son’s pa­tients, which some be­lieve play a role in trig­ger­ing Parkin­son’s — fol­low­ing a sim­i­lar the­o­ry that amy­loid be­ta or tau launch­es Alzheimer’s. Just last April Roche and its part­ner Prothena out­lined bio­mark­er da­ta from their Phase I, look­ing to jump in­to a mid-stage tri­al as they set out to see if they can ac­tu­al­ly change the course of this dis­ease or per­haps pre­vent it from oc­cur­ring.

Not­ed As­traZeneca EVP Mene Pan­ga­los: “To­day there are no med­i­cines that can slow or halt the de­gen­er­a­tive progress of Parkin­son’s dis­ease so this re­mains a large area of un­met med­ical need. Take­da has an ex­cel­lent track record in neu­ro­science re­search and we are ex­cit­ed to be work­ing to­geth­er. By com­bin­ing our sci­en­tif­ic ex­per­tise and shar­ing the risks and cost of de­vel­op­ment, we hope to ac­cel­er­ate the ad­vance­ment of ME­DI1341 as a promis­ing new ap­proach to sup­port the treat­ment of peo­ple with Parkin­son’s dis­ease around the world.”

The Advance Clinical leadership team: CEO Yvonne Lungershausen, Sandrien Louwaars - Director Business Development Operations, Gabriel Kremmidiotis - Chief Scientific Officer, Ben Edwards - Chief Strategy Officer

How Aus­tralia De­liv­ers Rapid Start-up and 43.5% Re­bate for Ear­ly Phase On­col­o­gy Tri­als

About Avance Clinical

Avance Clinical is an Australian owned Contract Research Organisation that has been providing high-quality clinical research services to the local and international drug development industry for 20 years. They specialise in working with biotech companies to execute Phase 1 and Phase 2 clinical trials to deliver high-quality outcomes fit for global regulatory standards.

As oncology sponsors look internationally to speed-up trials after unprecedented COVID-19 suspensions and delays, Australia, which has led the world in minimizing the pandemic’s impact, stands out as an attractive destination for early phase trials. This in combination with the streamlined regulatory system and the financial benefits including a very favourable exchange rate and the R & D cash rebate makes Australia the perfect location for accelerating biotech clinical programs.

BREAK­ING: Mer­ck makes a triple play on Covid-19: buy­ing out a vac­cine biotech, part­ner­ing on an­oth­er pro­gram and adding an an­tivi­ral to the mix

Merck is making a triple play in a sudden leap into the R&D campaign against Covid-19.

Tuesday morning the pharma giant simultaneously announced plans to buy an Austrian biotech that has been working on a preclinical vaccine candidate, added a collaboration on another vaccine with the nonprofit IAVI and inked a deal with Ridgeback Biotherapeutics on an early-stage antiviral.

The deal with IAVI covers recombinant vesicular stomatitis virus (rVSV) technology that is the basis for Merck’s successful Ebola Zaire virus vaccine. That’s going into the clinic later this year.

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Af­ter de­cou­pling from Re­gen­eron, Sanofi says it’s time to sell the $13B stake picked up in the mar­riage

With Regeneron shares going for a peak price — after doubling from last fall — Sanofi is putting a $13 billion stake in their longtime partner on the auction block. And Regeneron is taking $5 billion of that action for themselves.

Sanofi — which has been decoupling from Regeneron for more than a year now — bought in big in early 2013, back when Regeneron’s stock was going for around $165 a share. Small investors flocked to the deal, buzzing about an imminent takeover. The buyout chatter wound down long ago.

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Andrew Hopkins, Exscientia founder and CEO (Exscientia)

Af­ter years of part­ner­ships, AI biotech Ex­sci­en­tia lands first ma­jor fi­nanc­ing round at $60M

After years racking up partnerships with biotechs and Big Pharma, the AI drug developer Exscientia has landed its first large financing round.

The UK-based company raised $60 million in a Series C round led by Novo Holdings — more than double the $26 million it garnered in a Series B 18 months ago. The round will help further the company’s expansion into the US and further what it calls, borrowing a term from the software world, its “full-stack capabilities,” i.e. its ability to develop drugs from the earliest stage to the market.

Piv­otal myas­the­nia gravis da­ta from ar­genx au­gur well for FcRn in­hibitors in de­vel­op­ment

Leading the pack of biotechs vying for a piece of the generalized myasthenia gravis (gMG) market with an FcRn inhibitor, argenx on Tuesday unveiled keenly anticipated positive late-stage data on its lead asset, bringing it one step closer to regulatory approval.

Despite steroids, immunosuppressants, acetylcholinesterase inhibitors, and Alexion’s Soliris, patients with the rare, chronic neuromuscular disorder (more than 100,000 in the United States and Europe) don’t necessarily benefit from these existing options, leaving room for the crop of FcRn inhibitors in development.

Covid-19 roundup: Janet Wood­cock steps aside — for now — as FDA drug czar; WHO hits the brakes on hy­droxy study af­ter lat­est safe­ty alarm

The biopharma industry will soon get a look at what the FDA will look like once CDER’s powerful chief Janet Woodcock retires from her post.

Long considered one of the most influential regulators in the agency, if not its single most powerful official when it counts, Woodcock is being detached to devote herself full-time to the White House’s special project to fast-forward new drugs and vaccines for the pandemic. The move comes a week after some quick reshuffling as Woodcock and CBER chief Peter Marks joined Operation Warp Speed. Initially they opted to recuse themselves from any FDA decisions on pandemic treatments and vaccines, after consumer advocates criticized the move as a clear conflict of interest in how the agency exercises oversight on new approvals.

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Janet Woodcock, director of the Center for Drug Evaluation and Research (AP Images)

Covid-19 roundup: Hit with new con­flict ac­cu­sa­tions, Janet Wood­cock steps out of the agen­cy's Covid-19 chain of com­mand

Two weeks ago, FDA drug chieftain Janet Woodcock was assuring a top Wall Street analyst that any vaccine approved for combating Covid-19 would have to meet high agency standards on safety and efficacy before it’s approved. But over the weekend, after she and Peter Marks took top positions with the public-private operation meant to speed a new vaccine to lightning-fast approvals — they both recused themselves from the review process after an advocacy group argued their roles close to the White House could pose a conflict of interest.

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FDA ap­proves the first gener­ic for Amar­in's Vas­cepa — but is a fish oil price war im­mi­nent?

Late last year, enthusiasm for Amarin’s fish-oil pill Vascepa burgeoned when the FDA signed off on expanding the cholesterol fighter’s label to include the drug’s beneficial impact on cardiovascular risk, but months later the exuberance for the blockbuster-to-be took a big hit when a judge invalidated key patents protecting Vascepa.

Despite Amarin’s $AMRN pledge to appeal — a process that could take months — the ruling opened the door for generic competition. Hikma Pharmaceuticals, one of three challengers in the Nevada suit, on Friday said that its generic copy of pure EPA, the omega-3 fatty acid that constitutes Vascepa, has been approved by the FDA.

Eric Edwards, Phlow president and CEO (PR Newswire)

BAR­DA of­fers a tiny start­up up to $812M to cre­ate a US-based drug man­u­fac­tur­er — and the CEO comes with a price goug­ing con­tro­ver­sy on his ré­sumé

BARDA has tapped a largely unknown startup to ramp up production of a list of drugs that may be at risk of running short in the US. And the deal, which comes with up to $812 million in federal funds, was inked by a CEO who found himself in the middle of an ugly price gouging controversy a few years ago.

The feds’ new partner — called Phlow — won a 4-year “base” contract of $354 million, with another $458 million that’s on the table in potential options to sustain the outfit. That would make it one of the largest awards in BARDA’s history.

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