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.

De­vel­op­ment of the Next Gen­er­a­tion NKG2D CAR T-cell Man­u­fac­tur­ing Process

Celyad’s view on developing and delivering a CAR T-cell therapy with multi-tumor specificity combined with cell manufacturing success
Overview
Transitioning potential therapeutic assets from academia into the commercial environment is an exercise that is largely underappreciated by stakeholders, except for drug developers themselves. The promise of preclinical or early clinical results drives enthusiasm, but the pragmatic delivery of a therapy outside of small, local testing is most often a major challenge for drug developers especially, including among other things, the manufacturing challenges that surround the production of just-in-time and personalized autologous cell therapy products.

Paul Hudson. Sanofi

New Sanofi CEO Hud­son adds next-gen can­cer drug tech to the R&D quest, buy­ing Syn­thorx for $2.5B

When Paul Hudson lays out his R&D vision for Sanofi tomorrow, he will have a new slate of interleukin therapies and a synthetic biology platform to boast about.

The French pharma giant announced early Monday that it is snagging San Diego biotech Synthorx in a $2.5 billion deal. That marks an affordable bolt-on for Sanofi but a considerable return for Synthorx backers, including Avalon, RA Capital and OrbiMed: At $68 per share, the price represents a 172% premium to Friday’s closing.

Synthorx’s take on alternative IL-2 drugs for both cancer and autoimmune disorders — enabled by a synthetic DNA base pair pioneered by Scripps professor Floyd Romesberg — “fits perfectly” with the kind of innovation that he wants at Sanofi, Hudson said.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 67,100+ biopharma pros reading Endpoints daily — and it's free.

Roger Perlmutter, Merck

#ASH19: Here’s why Mer­ck is pay­ing $2.7B to­day to grab Ar­Qule and its next-gen BTK drug, lin­ing up Eli Lil­ly ri­val­ry

Just a few months after making a splash at the European Hematology Association scientific confab with an early snapshot of positive data for their BTK inhibitor ARQ 531, ArQule has won a $2.7 billion buyout deal from Merck.

Merck is scooping up a next-gen BTK drug — which is making a splash at ASH today — from ArQule in an M&A pact set at $20 a share $ARQL. That’s more than twice Friday’s $9.66 close. And Merck R&D chief Roger Perlmutter heralded a deal that nets “multiple clinical-stage oral kinase inhibitors.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 67,100+ biopharma pros reading Endpoints daily — and it's free.

Ob­sE­va makes case for best-in-class hor­mone sup­pres­sive ther­a­py in pos­i­tive uter­ine fi­broid study

About a month after the Swiss biotech disclosed a failed late-stage study in its IVF program, ObsEva on Monday unveiled positive pivotal data on its experimental treatment for heavy menstrual bleeding triggered by uterine fibroids.

ObsEva in-licensed the drug, linzagolix, from Japan’s Kissei Pharmaceutical in 2015. Two doses of the drug (100 mg and 200 mg) were tested against a placebo in the 535-patient Phase III study, dubbed PRIMROSE 2, in patients who were both on and off hormonal add-back therapy (ABT).

Samit Hirawat. Bristol-Myers Squibb

Bris­tol-My­ers is mak­ing a bee-line to the FDA with pos­i­tive liso-cel da­ta — but is it too late in the CAR-T game?

Bristol-Myers Squibb came to ASH this past weekend with a variety of messages on the new cancer drugs they had acquired in the big Celgene buyout, including liso-cel, the lead CAR-T program picked up in the $9 billion Juno acquisition. And one of the most important was that they had the pivotal efficacy and safety data needed to snag an approval from the FDA next year, with the BLA on track for a filing this month.

J&J team shows off 'break­through' BC­MA CAR-T da­ta, and that could cause a big headache at blue­bird and Bris­tol-My­ers

Just hours after J&J’s oncology team bragged about scoring a breakthrough therapy designation for their BCMA CAR-T drug, they pulled the wraps off of the multiple myeloma data for JNJ-4528 that impressed the FDA. And it’s easy to see why they may well be on a short path to a landmark approval — which may well be making the rival team at bluebird/Bristol-Myers more than a little nervous.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 67,100+ biopharma pros reading Endpoints daily — and it's free.

J&J's Mathai Mammen at an Endpoints News event in Boston, June 2018 (Photo: Rob Tannenbaum for Endpoints News)

J&J fronts $750M cash to grab a failed can­cer drug that’s been re­pur­posed as a pow­er­ful an­ti-in­flam­ma­to­ry

J&J has stepped up with one of its blockbuster drug buys, agreeing to pay Austin-based XBiotech $XBIT $750 million in cash and up to $600 million more in milestones for their late stage-ready anti-inflammatory drug bermekimab — which some longtime biotech observers may recognize as a failed cancer therapy with a disaster-prone past.

The drug targets the IL-1a pathway. J&J $JNJ R&D chief Mathai Mammen is cutting a check for a drug that has produced positive mid-stage data in patients suffering from a skin condition called hidradenitis suppurativa with another mid-stage program underway for atopic dermatitis.

That puts J&J in charge of a drug on the threshold of pivotal — though pricey — R&D work for a broad patient group with other related fields to explore. And it’s a very busy development arena.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 67,100+ biopharma pros reading Endpoints daily — and it's free.

Jake Van Naarden, Josh Bilenker, Nisha Nanda (Credit: Loxo, Aisling Capital)

Josh Bilenker and his Loxo crew are tak­ing the reins on on­col­o­gy R&D at Eli Lil­ly, culling the weak and map­ping a new path

Josh Bilenker, Jake Van Naarden and Nisha Nanda came out of Eli Lilly’s $8 billion Loxo Oncology buyout with a bundle of cash and plenty of choices on what they could do next. Start a new company, go public. Live on the beach in 5-star luxury. Contemplate the stars — in their own observatory.

So what are they doing?

They formed a new executive team that is taking over the management of Eli Lilly’s hundreds-strong oncology R&D group — essentially using Loxo as a base for a bold new experiment in Big Pharma R&D in an attempt to create a true biotech environment with the deep pockets of a top-15 industry player. They’ve recruited David Hyman from Memorial Sloan Kettering to join the team as chief medical officer. And the mandate includes culling out the oncology pipeline, highlighting their star prospects and going after new programs wherever they can find the best prospects.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 67,100+ biopharma pros reading Endpoints daily — and it's free.

Sangamo CEO Sandy Macrae

Pa­tient #9 has been a con­cern, but Sang­amo and Pfiz­er are bull­ish about win­ning the marathon he­mo­phil­ia A gene ther­a­py race

Patient number 9 has given Sangamo and its partners at Pfizer some heart palpitations in their high profile hemophilia A gene therapy program.

After watching his Factor VIII level rise following treatment like the rest, the crucial efficacy gauge they track saw a sudden and significant plunge. At week 13, the FVIII level had dropped below normal. Then it began to rise again.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 67,100+ biopharma pros reading Endpoints daily — and it's free.