Step aside As­traZeneca, Pfiz­er/Mer­ck KGaA jump ahead, get­ting a speedy re­view for their check­point ri­val avelum­ab

Lu­ciano Ros­set­ti, Mer­ck KGaA

Now it’s Pfiz­er’s turn to jump in­to the hot­ly con­test­ed check­point mar­ket.

The phar­ma gi­ant and its part­ner Mer­ck KGaA say that the FDA has ac­cept­ed their first BLA for avelum­ab, with reg­u­la­tors promis­ing a speedy re­view for this lat­est check­point in­hibitor — like­ly rel­e­gat­ing As­traZeneca to an em­bar­rass­ing fifth place fin­ish for its lag­gard.

Pfiz­er and the Ger­man Mer­ck will be tak­ing a shot at first mover ad­van­tage in metasta­t­ic Merkel cell car­ci­no­ma, where in­ves­ti­ga­tors have tracked pos­i­tive da­ta in the JAVELIN Merkel 200 study. The drug is cur­rent­ly in 30 clin­i­cal pro­grams as the two play­ers look to wedge their way in­to a multi­bil­lion-dol­lar mar­ket for drugs that are gain­ing wide use in treat­ing can­cer.

The col­lab­o­ra­tors were en­thu­si­as­tic about the FDA’s de­ci­sion to han­dle this un­der its pri­or­i­ty re­view pro­gram, cut­ting down the process from 10 months to 6.

This drug holds spe­cial mean­ing for both play­ers. Mer­ck KGaA has un­der­gone re­peat­ed R&D or­ga­ni­za­tions over the years, fruit­less­ly seek­ing a ma­jor new ap­proval af­ter go­ing for more than a decade with­out adding a new block­buster to its port­fo­lio. For Pfiz­er, which paid a record $850 mil­lion up­front to part­ner on the drug, adding $2 bil­lion in mile­stones, avelum­ab of­fers a chance to build its pres­ence in the can­cer mark, where it has achieved its great­est suc­cess­es. Pfiz­er re­cent­ly paid $14 bil­lion to ac­quire Medi­va­tion, gain­ing a ma­jor drug for prostate can­cer as well as a late-stage PARP pro­gram.

Their gain is As­traZeneca’s loss. The phar­ma ri­val has been try­ing to play catchup with dur­val­um­ab, which will now join the line­up as the fifth prospec­tive check­point, be­hind Mer­ck, Bris­tol-My­ers Squibb, Roche and this new prospect. As­traZeneca re­cent­ly can­celed a mid-stage ef­fort to gain an ac­cel­er­at­ed ap­proval for dur­val­um­ab as a monother­a­py. It’s now stick­ing with a com­bo ap­proach, though the com­pa­ny al­so had to en­dure a brief par­tial hold in head and neck can­cers so in­ves­ti­ga­tors could check out prob­lems with bleed­ing among pa­tients.

“There are cur­rent­ly no ap­proved treat­ment op­tions for metasta­t­ic MCC, and we are com­mit­ted to work­ing with the FDA to po­ten­tial­ly bring the first ap­proved can­cer im­munother­a­py to pa­tients with this ag­gres­sive dis­ease,” said Mer­ck KGaA R&D chief Lu­ciano Ros­set­ti.

Oxitec biologist releases genetically modified mosquitoes in Piracicaba, Brazil in 2016 [credit: Getty Images]

In­trex­on unit push­es back against claims its GM mos­qui­toes are mak­ing dis­ease-friend­ly mu­tants

When the hysteria of Zika transmission sprang into the American zeitgeist a few years ago, UK-based Oxitec was already field-testing its male Aedes aegypti mosquito, crafted to possess a gene engineered to obliterate its progeny long before maturation.

But when a group of independent scientists evaluated the impact of the release of these genetically-modified mosquitoes in a trial conducted by Oxitec in Brazil between 2013 and 2015, they found that some of the offspring had managed to survive — prompting them to speculate what impact the survivors could have on disease transmission and/or insecticide resistance.

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Pur­due threat­ens to walk away from set­tle­ment, asks to pay em­ploy­ees mil­lions in bonus­es

There are two updates on the lawsuit against Purdue Pharma over its role in fueling the opioid epidemic, as the Sackler family threatens to walk away from their pledge to pay out $3 billion if a bankruptcy judge does not stop outstanding state lawsuits against them. At the same time, the company has asked permission to pay millions in bonuses to select employees.

Purdue filed for chapter 11 bankruptcy this week as part of its signed resolution to over 2,000 lawsuits. The deal would see the Sackler family that owns Purdue give $3 billion from their personal wealth and the company turned into a trust committed to curbing and reversing overdoses.

Aerial view of Genentech's campus in South San Francisco [Credit: Getty]

Genen­tech sub­mits a plan to near­ly dou­ble its South San Fran­cis­co foot­print

The sign is still there, a quaint reminder of whitewashed concrete not 5 miles from Genentech’s sprawling, chrome-and-glass campus: South Francisco The Industrial City. 

The city keeps the old sign, first erected in 1923, as a tourist site and a kind of civic memento to the days it packed meat, milled lumber and burned enough steel to earn the moniker “Smokestack of the Peninsula.” But the real indication of where you are and how much has changed both in San Francisco and in the global economy since a couple researchers and investors rented out an empty warehouse 40 years ago comes in a far smaller blue sign, resembling a Rotary Club post, off the highway: South San Francisco, The Birthplace of Biotech.

As Nas­daq en­rolls the fi­nal batch of 2019 IPOs, how have the num­bers com­pared to past years?

IGM Biosciences’ upsized IPO haul, coming after SpringWorks’ sizable public debut, has revved up some momentum for the last rush of biotech IPOs in 2019.

With 39 new listings on the books and roughly two more months to go before winding down, Nasdaq’s head of healthcare listings Jordan Saxe sees the exchange marking 50 to 60 biopharma IPOs for the year.

“December 15 is usually the last possible day that companies will price,” he said, as companies get ready for business talks at the annual JP Morgan Healthcare Conference in January.

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A fa­vorite in Alex­ion’s C-suite is leav­ing, and some mighty sur­prised an­a­lysts aren’t the least bit hap­py about it

Analysts hate to lose a biotech CFO they’ve come to trust and admire — especially if they’re being blindsided by a surprise exit.

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David Grainger [file photo]

'Dis­con­nect the bas­tard­s' — one biotech's plan to break can­cer cell­s' uni­fied de­fens­es

Chemotherapy and radiotherapy are the current gladiators of cancer treatment, but they come with well-known limitations and side-effects. The emergence of immunotherapy — a ferocious new titan in oncologist’s toolbox — takes the brakes off the immune system to kill cancer cells with remarkable success in some cases, but the approach is not always effective. What makes certain forms of cancer so resilient? Scientists may have finally pieced together a tantalizing piece of the puzzle, and a new biotech is banking on a new approach to fill the gap.

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While No­var­tis ban­ish­es Zol­gens­ma scan­dal scars — Bio­gen goes on a Spin­raza 'of­fen­sive'

While Novartis painstakingly works to mop up the stench of the data manipulation scandal associated with its expensive gene therapy for spinal muscular atrophy (SMA) Zolgensma— rival Biogen is attempting to expand the use of its SMA therapy, Spinraza. 

The US drugmaker $BIIB secured US approval for Spinraza for use in the often fatal genetic disease in 2016. The approval covered a broad range of patients with infantile-onset (most likely to develop Type 1) SMA. 

Jason Kelly. Mike Blake/Reuters via Adobe

Eye­ing big ther­a­peu­tic push, Gink­go bags $290M to build a cell pro­gram­ming em­pire

Ginkgo Bioworks is on a roll. Days after publicizing a plan to nurture new startups via partnerships with accelerators Y Combinator and Petri, the Boston biotech says it has raised another $290 million for its cell programming platform to reach further and wider.

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UP­DAT­ED: Speak­er Nan­cy Pelosi to un­veil bill for fed­er­al­ly ne­go­ti­at­ed drug prices

After months of buzz from both sides of the aisle, Speaker Nancy Pelosi will today introduce her plan to allow the federal government to negotiate prices for 250 prescription drugs, setting up a showdown with a pharmaceutical industry working overtime to prevent it.

The need to limit drug prices is a rare point of agreement between President Trump and Democrats, although the president has yet to comment on the proposal and will likely face pressure to back a more conservative option or no bill at all. Republican Senator Chuck Grassley is reportedly lobbying his fellow party members on a more modest proposal he negotiated with Democratic Senator Ron Wyden in July.