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.

Brian Kaspar. AveXis via Twitter

AveX­is sci­en­tif­ic founder fires back at No­var­tis CEO Vas Narasimhan, 'cat­e­gor­i­cal­ly de­nies any wrong­do­ing'

Brian Kaspar’s head was among the first to roll at Novartis after company execs became aware of the fact that manipulated data had been included in its application for Zolgensma, now the world’s most expensive therapy.

But in his first public response, the scientific founder at AveXis — acquired by Novartis for $8.7 billion — is firing back. And he says that not only was he not involved in any wrongdoing, he’s ready to defend his name as needed.

I reached out to Brian Kaspar after Novartis put out word that he and his brother Allen had been axed in mid-May, two months after the company became aware of the allegations related to manipulated data. His response came back through his attorneys.

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UP­DAT­ED: An em­bold­ened As­traZeneca splurges $95M on a pri­or­i­ty re­view vouch­er. Where do they need the FDA to hus­tle up?

AstraZeneca is in a hurry.

We learned this morning that the pharma giant — not known as a big spender, until recently — forked over $95 million to get its hands on a priority review voucher from Sobi, otherwise known as Swedish Orphan Biovitrum.

That marks another step down on price for a PRV, which allows the holder to slash 4 months off of any FDA review time.

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Martin Shkreli [via Getty]

Pris­on­er #87850-053 does not get to add drug de­vel­op­er to his list of cred­its

Just days after Retrophin shed its last ties to founder Martin Shkreli, the biotech is reporting that the lead drug he co-invented flopped in a pivotal trial. Fosmetpantotenate flunked both the primary and key secondary endpoints in a placebo-controlled trial for a rare disease called pantothenate kinase-associated neurodegeneration, or PKAN.

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We­bi­nar: Re­al World End­points — the brave new world com­ing in build­ing fran­chise ther­a­pies

Several biopharma companies have been working on expanding drug labels through the use of real world endpoints, combing through the data to find evidence of a drug’s efficacy for particular indications. But we’ve just begun. Real World Evidence is becoming an important part of every clinical development plan, in the soup-through-nuts approach used in building franchises.

I’ve recruited a panel of 3 top experts in the field — the first in a series of premium webinars — to look at the practical realities governing what can be done today, and where this is headed over the next few years, at the prodding of the FDA.

ZHEN SU — Merck Serono’s Senior Vice President and Global Head of Oncology
ELLIOTT LEVY — Amgen’s Senior Vice President of Global Development
CHRIS BOSHOFF — Pfizer Oncology’s Chief Development Officer

A premium subscription to Endpoints News is required to attend this webinar. Please upgrade to either an Insider or Enterprise plan for access. Already have Endpoints Premium? Please sign-in below. You can contact our Subscriptions team at help@endpointsnews.com with any issues.

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Am­gen, Al­ler­gan biosim­i­lar of Roche's block­buster Rit­ux­an clears an­oth­er US piv­otal study 

Novartis $NVS may have given up, but Amgen $AMGN and Allergan $AGN are plowing ahead with their knockoff of Roche’s blockbuster biologic Rituxan in the United States.

Their copycat, ABP 798, was found to have a clinically equivalent impact as Rituxan — meeting the main goal of the study involving CD20-positive B-cell non-Hodgkin’s lymphoma patients. This is the second trial supporting the profile of the biosimilar. In January, it came through with positive PK results in patients with rheumatoid arthritis.

BeiGene and Mus­tang nail down spe­cial FDA sta­tus for top drugs; Roche bags added cov­er­age for Hem­li­bra

→ BeiGene $BGNE is getting a boost in its drive to field a rival to Imbruvica. The FDA has offered an accelerated review to zanubrutinib, a BTK inhibitor that has posted positive results for mantle cell lymphoma. The PDUFA date lands on February 27, 2020. The drug scored breakthrough status at the beginning of the year.

→ BeiGene isn’t the only biopharma company to gain special regulatory status today. Mustang Bio $MBIO and St. Jude Children’s Research Hospital announced that MB-107, a lentiviral gene therapy for the treatment of X-linked severe combined immunodeficiency, also known as bubble boy disease, has been granted Regenerative Medicine Advanced Therapy status.

Trump ad­min­is­tra­tion re­vives bid to get drug list prices on TV ads

The Trump administration is not giving up just yet. On Wednesday, the HHS filed an appeal against a judge’s decision in July to overturn a ruling obligating drug manufacturers to disclose the list price of their therapies in television adverts — hours before it was stipulated to go into effect.

In May, the HHS published a final ruling requiring drugmakers to divulge the wholesale acquisition cost— of a 30-day supply of the drug — in tv ads in a bid to enhance price transparency in the United States. The pharmaceutical industry has vehemently opposed the rule, asserting that list prices are not what a typical patient in the United States pays for treatment — that number is typically determined by the type of (or lack thereof) insurance coverage, deductibles and out-of-pocket costs. Although there is truth to that claim, the move was considered symbolic in the Trump administration’s healthcare agenda to hold drugmakers accountable in a climate where skyrocketing drug prices have incensed Americans on both sides of the aisle.

Ver­sant-backed Chi­nook gets a $65M launch round for its dis­cov­ery quest in a resur­gent kid­ney field

Versant is once again stepping off the beaten track in biotech to see if they can blaze a trail of their own in a field that has looked too thorny to many investors for years.

The venture group and their partners at Apple Tree are bringing their latest creation out of stealth mode today. Born in Versant’s Inception Sciences’ Chinook Therapeutics is betting that its preclinical take on kidney disease can get an early lead among the companies starting up in the field.

Sir An­drew Dil­lon, NICE's first — and on­ly — chief ex­ec­u­tive to step down next year

Using a laptop borrowed from his former employer, South London’s St George’s Hospital, Sir Andrew Dillon set about establishing NICE — launched by the then health secretary Frank Dobson — in 1999.  On Thursday, the UK cost-effectiveness watchdog said its first and only chief executive — Dillon — is stepping down in March 2020.

Back in the day, decisions about which drugs and interventions were funded by the National Health Service (NHS) were made at the local level, but this ‘postcode prescribing’ system was fraught with skewed healthcare deployment making the structure unsustainable. A national system was deemed necessary — and NICE was formed to bridge that gap.