As drug­mak­ers seek ways to elude IL-2 flaws, Clin­i­gen se­cures the full rights to orig­i­nal trou­bled IL-2 drug Pro­leukin

Pro­leukin, the trou­bled IL-2 can­cer drug sold by No­var­tis, has found a new home at Clin­i­gen, while oth­ers in the field of im­muno-on­col­o­gy seek ways to cre­ate an im­proved ver­sion of the class of drugs sans the tox­i­c­i­ty that has stymied the use of the orig­i­nal IL-2.

Last year, Lon­don-list­ed Clin­i­gen $CLIN ac­quired the rights to sell the drug out­side the Unit­ed States from No­var­tis $NVS, in a deal where fi­nan­cial de­tails were not dis­closed. The drug, which is used to treat metasta­t­ic re­nal cell car­ci­no­ma and metasta­t­ic melanoma, has gen­er­at­ed rough­ly $80 mil­lion in an­nu­al sales in the last few years, ac­cord­ing to Eval­u­ate Phar­ma. In the year lead­ing up to June 30, 2018, Pro­leukin gen­er­at­ed US sales of $60 mil­lion, ac­cord­ing to Clin­i­gen, cit­ing IQVIA es­ti­mates.

Clin­i­gen, which says it aims to re­vi­tal­ize med­i­cines of im­por­tance that have been side­lined due to chal­lenges, on Wednes­day said it is ac­quir­ing the re­main­ing US rights from No­var­tis in a deal up to $210 mil­lion in cash, in­clud­ing $120 mil­lion up­front. The rest will come in de­ferred and mile­stone pay­ments. The deal is ex­pect­ed to be con­sum­mat­ed by April.

Pro­leukin is cur­rent­ly be­ing in­ves­ti­gat­ed in some 80 ac­tive tri­als for use in a pletho­ra of dis­eases, and Clin­i­gen is “ex­plor­ing op­tions with com­pa­nies who are look­ing to cre­ate ei­ther new dosage ver­sions of (the) Il-2 or com­bi­na­tion reg­i­mens,” a spokesper­son told End­points News, de­clin­ing to elab­o­rate fur­ther on its re­vi­tal­iza­tion strat­e­gy.

The Pro­leukin ac­qui­si­tion will aug­ment Clin­i­gen’s earn­ings, adding at least 25% to its EPS in the first full fi­nan­cial year af­ter the prod­uct tran­si­tions to the com­pa­ny, and is al­so ex­pect­ed to cut its debt bur­den.

The ini­tial IL-2 ap­proach showed the promise of the tar­get, but safe­ty is­sues in­clud­ing a dose-lim­it­ing tox pro­file and im­muno­sup­pres­sion thwart­ed its po­ten­tial. Now com­pa­nies such as Nek­tar Ther­a­peu­tics $NK­TR are work­ing on a next-gen IL-2 ther­a­py, an ef­fort that com­bined with Bris­tol-My­ers’ $BMY Op­di­vo has re­cent­ly hit a snag.

Clin­i­gen al­ready owns three prod­ucts in the US: Fos­cav­ir, Ethy­ol and To­tect, al­though Pfiz­er has won the com­mer­cial li­cense to Fos­cav­ir and Cum­ber­land Phar­ma­ceu­ti­cals to Ethy­ol and To­tect.

Nick Galakatos, Blackstone global head of life sciences

Nick Galakatos and the Black­stone team now have a record $4.6B to in­vest in bio­phar­ma, with a big fo­cus on push­ing com­pa­nies over the top

Nick Galakatos and his team at Blackstone Life Sciences have seen their biggest opportunities swell up in mostly established players who don’t have all the money they need to accomplish everything on the to-do list. And right now, with the industry booming, that’s a long list with some hefty needs.

The Blackstone team has neatly tied up the largest private fund ever raised in life sciences for making big dreams come true in biopharma. Late Thursday, Blackstone put out word that they had closed their highly anticipated fund with the projected $4.6 billion all in.

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UP­DAT­ED: Bio­gen shares spike as ex­ecs com­plete a de­layed pitch for their con­tro­ver­sial Alzheimer's drug — the next move be­longs to the FDA

Biogen is stepping out onto the high wire today, reporting that the team working on the controversial Alzheimer’s drug aducanumab has now completed their submission to the FDA. And they want the agency to bless it with a priority review that would cut the agency’s decision-making time to a mere 6 months.

The news drove a 10% spike in Biogen’s stock $BIIB ahead of the bell.

Part of that spike can be attributed to a relief rally. Biogen execs rattled backers and a host of analysts earlier in the year when they unexpectedly delayed their filing to the third quarter. That delay provoked all manner of speculation after CEO Michel Vounatsos and R&D chief Al Sandrock failed to persuade influential observers that the pandemic and other factors had slowed the timeline for filing. Actually making the pitch at least satisfies skeptics that the FDA was not likely pushing back as Biogen was pushing in. From the start, Biogen execs claimed that they were doing everything in cooperation with the FDA, saying that regulators had signaled their interest in reviewing the submission.

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Top biotech an­a­lyst projects a gloomy out­look for Pfiz­er's JAK port­fo­lio

Many in the pharma world are hoping — better yet, expecting — JAK inhibitors to provide one of the next big boons for the industry. Few have invested as heavily in this area as Pfizer, which boasts a portfolio including Xeljanz and at least five mid-to-late stage candidates in the pipeline.

But a top Wall Street analyst is pumping the brakes on just how much good fortune is in store for the Big Pharma.

Gilead boasts of pos­i­tive remde­sivir da­ta on mor­tal­i­ty — but their analy­sis pro­vokes the skep­tics

Gilead is surging again off data that suggest its antiviral remdesivir might improve survival.

The new data come from an analysis Gilead conducted comparing the death rate and recovery time of patients in one of its remdesivir trials to a group of 800 patients “with similar baseline characteristics and disease severity” who received only standard-of-care around the same time. The result, they said, suggested that patients who received remdesivir had a 62% better chance at surviving than those who did not.

Hal Barron, GSK

Win or lose on the mar­ket­ing OK, the FDA just gunned down GSK’s bright hopes for their BC­MA ther­a­py

The FDA’s ODAC — the Oncologic Drugs Advisory Committee — has a well-known bias in favor of adding new cancer drugs to the market, even if efficacy is at best marginal and serious safety issues demand careful management.

Doctors want as many arrows in their quiver as they can get. And when patients are dying after failing multiple drugs, why not give it a go one more time?

GlaxoSmithKline, though, is about to test out how their new BCMA antibody drug conjugate belantamab mafodotin can do after being mauled in an in-house FDA review, ahead of the Tuesday expert panel discussion. Even if the agency goes ahead with an expected green light, this drug will likely be constrained to a small niche — icing any plans they may have for making waves in oncology anytime soon.

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Covid-19 roundup: BioN­Tech go­ing head-to-head with Mod­er­na as PhI­II mR­NA launch looms; Tri­al on Shin­zo Abe’s once-fa­vorite an­tivi­ral is in­con­clu­sive

It’s a race to the Phase III finish line now for the 2 leading mRNA vaccines in the pipeline for Covid-19.

BioNTech chief Ugur Sahin told the Wall Street Journal that his company will start Phase III testing of their vaccine later this month, setting them up to lateral the data to regulators before the end of this year.

That puts them essentially on the exact same schedule as Moderna is dedicated to. The Massachusetts rival to BioNTech also expects to launch Phase III this month. Lots of rumors have circulated about delays and conflict among the scientists advancing the Moderna jab, but the biotech has consistently stuck to its plan to start a late-stage pivotal this month.

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Regeneron CEO Leonard Schleifer speaks at a meeting with President Donald Trump, members of the Coronavirus Task Force, and pharmaceutical executives in the Cabinet Room of the White House (AP Photo/Andrew Harnik)

OWS shifts spot­light to drugs to fight Covid-19, hand­ing Re­gen­eron $450M to be­gin large scale man­u­fac­tur­ing in the US

The US government is on a spending spree. And after committing billions to vaccines defense operations are now doling out more of the big bucks through Operation Warp Speed to back a rapid flip of a drug into the market to stop Covid-19 from ravaging patients — possibly inside of 2 months.

The beneficiary this morning is Regeneron, the big biotech engaged in a frenzied race to develop an antibody cocktail called REGN-COV2 that just started a late-stage program to prove its worth in fighting the virus. BARDA and the Department of Defense are awarding Regeneron a $450 million contract to cover bulk delivery of the cocktail starting as early as late summer, with money added for fill/finish and storage activities.

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An­oth­er four biotechs scratch out the first num­ber and ask for more as IPO boom con­tin­ues

Four more biotechs are raising their offers in an already record year for biotech IPOs.

Softbank-backed Relay Therapeutics scratched out its original $200 million filing and proposed a $250 million raise that would make them a $1.5 billion company. CAR-T developer Poseida Therapeutics bumped itself up $74 million to $224 million. Off-the-shelf cell therapy startup Nkarta upped from $150 million to $215 million — and then priced even higher, at $252 million. France’s Inventiva did its own modest reset, raising its bar from $102 million to $108 million.

Oph­thalmic drugs, can­cer cell ther­a­pies at­tract $340M+ on two HKEX biotech de­buts

Nasdaq may be running the main biotech IPO show, but the Hong Kong stock exchange has some stellar performance on display even as the city confronts a third wave of Covid-19.

Ocumension Therapeutics and Immunotech Biopharm both traded up after making their public debuts on the HKEX’s busiest IPO day of the year so far, with seven stocks getting listed. The former raised close to $200 million while the latter took home $141 million.