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.

The DCT-OS: A Tech­nol­o­gy-first Op­er­at­ing Sys­tem - En­abling Clin­i­cal Tri­als

As technology-enabled clinical research becomes the new normal, an integrated decentralized clinical trial operating system can ensure quality, deliver consistency and improve the patient experience.

The increasing availability of COVID-19 vaccines has many of us looking forward to a time when everyday things return to a state of normal. Schools and teachers are returning to classrooms, offices and small businesses are reopening, and there’s a palpable sense of optimism that the often-awkward adjustments we’ve all made personally and professionally in the last year are behind us, never to return. In the world of clinical research, however, some pandemic-necessitated adjustments are proving to be more than emergency stopgap measures to ensure trial continuity — and numerous decentralized clinical trial (DCT) tools and methodologies employed within the last year are likely here to stay as part of biopharma’s new normal.

Onno van de Stolpe, Galapagos CEO (Thierry Roge/Belga Mag/AFP via Getty Images)

Gala­pa­gos chops in­to their pipeline, drop­ping core fields and re­or­ga­niz­ing R&D as the BD team hunts for some­thing 'trans­for­ma­tive'

Just 5 months after Gilead gutted its rich partnership with Galapagos following a bitter setback at the FDA, the Belgian biotech is hunkering down and chopping the pipeline in an effort to conserve cash while their BD team pursues a mission to find a “transformative” deal for the company.

The filgotinib disaster didn’t warrant a mention as Galapagos laid out its Darwinian restructuring plans. Forced to make choices, the company is ditching its IPF molecule ’1205, while moving ahead with a Phase II IPF study for its chitinase inhibitor ’4617.

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Angela Merkel (AP Photo/Michael Sohn)

Covid-19 roundup: Pfiz­er sub­mits vac­cine for full ap­proval; Merkel op­pos­es Biden pro­pos­al to sus­pend IP for vac­cines

Pfizer and BioNTech said Friday that they’ve submitted a biologics license application to the FDA for full approval of their mRNA vaccine for those over the age of 16.

How long it will take the FDA to decide on the BLA will be set once it’s been formally accepted by the agency.

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, previously told Endpoints News that the review of the BLA should take between three and four months, but it may be even faster than that.

As­traZeneca caps PD-L1/CT­LA-4/chemo com­bo come­back with OS win. Is treme­li­mum­ab fi­nal­ly ready for ap­proval?

AstraZeneca’s closely-watched POSEIDON study continues to be the rare bright spot in its push for an in-house PD-L1/CTLA-4 combo.

Combining Imfinzi and tremelimumab with physicians’ choice of chemotherapy helped patients with stage IV non-small cell lung cancer live longer, the company reported — marking the first time the still-experimental tremelimumab has demonstrated an OS benefit.

For AstraZeneca and CEO Pascal Soriot, the positive readout — which is devoid of numbers — offers much-needed validation for the big bet they made on Imfinzi plus tremelimumab, after the PD-L1/CTLA-4 regimen failed multiple trials in head and neck cancer as well as lung cancer.

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Mod­er­na CEO brush­es off US sup­port for IP waiv­er, eyes more than $19B in Covid-19 vac­cine sales in 2021

Moderna is definitively more concerned with keeping pace with Pfizer in the race to vaccinate the world against Covid-19 than it is with Wednesday’s decision from the Biden administration to back an intellectual property waiver that aims to increase vaccine supplies worldwide.

In its first quarter earnings call on Thursday, Moderna CEO Stéphane Bancel shrugged off any suggestion that the newly US-backed intellectual property waiver would impact his company’s vaccine or bottom line. Still, the company’s stock price fell by about 9% in early morning trading.

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Ad­comm splits slight­ly in fa­vor of FDA ap­prov­ing Chemo­Cen­tryx’s rare dis­ease drug

The FDA’s Arthritis Advisory Committee on Thursday voted 10 for and 8 against the approval of ChemoCentryx’s $CCXI investigational drug avacopan as a treatment for adults with a rare and serious disease known as anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis.

The vote on whether the FDA should approve the drug was preceded by a split vote of 9 to 9 on whether the efficacy data support approval, and 10 to 8 that the safety profile of avacopan is adequate enough to support approval.

UP­DAT­ED: EMA safe­ty com­mit­tee seeks more in­fo on heart in­flam­ma­tion fol­low­ing Pfiz­er Covid-19 vac­cine

The European Medicines Agency’s safety committee said Friday that it’s aware of cases of inflammation of the heart muscle and inflammation of the membrane around the heart, mainly reported following vaccination with Pfizer’s Covid-19 vaccine, known in Europe as Comirnaty.

“There is no indication that these cases are due to the vaccine,” the EMA’s Pharmacovigilance Risk Assessment Committee said.

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Ron DePinho (file photo)

A 'fly­over' biotech launch­es in Texas with four Ron De­Pin­ho-found­ed com­pa­nies un­der its belt

In his 13 years at Genzyme, Michael Wyzga noticed something about East Coast drugmakers. Execs would often jet from Boston or New York to San Francisco to find more assets, and completely miss the work being done in flyover states, like Texas or Wisconsin.

“If it doesn’t come out of MGH or MIT or Harvard, probably not that interesting,” he said of the mindset.

Now, he and some well-known industry players are looking to change that, and they’ve reeled in just over $38 million to do it.

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An­oth­er failed tri­al for Or­p­hazyme's 'pipeline-in-a-pro­duc­t' leaves shad­ow on drug's fu­ture

The tumultuous ride for Orphazyme continued on Friday as the company announced that a pivotal trial for its lead drug arimoclomol failed yet again, this time in the treatment of ALS, seeding doubt in a drug that had recently been cleared by the FDA for priority review. The latest failure casts a darker shadow on the upcoming decision despite Orphazyme’s upbeat outlook.

In a statement, the Danish biotech announced that the drug did not meet its primary or secondary endpoints evaluating function and survival. But the company has not announced any data surrounding the failure, instead saying that it will publish the complete results later this year.