Gen­mab out­lines a megablock­buster fu­ture for it­self and J&J as Darza­lex gains mar­ket trac­tion

Gen­mab CEO Jan van de Winkel

J&J tends to be a cau­tious play­er when it comes to pro­ject­ing peak sales for a top drug prospect. But its part­ners at Gen­mab clear­ly be­lieve that the sky’s the lim­it on their myelo­ma drug Darza­lex (dara­tu­mum­ab).

Ini­tial­ly pushed back to the last line of de­fense af­ter mul­ti­ple drug fail­ures, the FDA ap­proved sev­er­al com­bi­na­tions us­ing Darza­lex as a sec­ond-line ther­a­py late last year. And Gen­mab CEO Jan van de Winkel ex­pects to see its end of the deal swell in­to the bil­lions as more stud­ies help ex­pand the mar­ket for their part­nered ther­a­py.

It’s ear­ly days for this block­buster, but the roy­al­ty split for Gen­mab starts at 12% and ends up at 20%. The CEO told an­a­lysts on Wednes­day that the 20% split oc­curs on sales over $3 bil­lion a year. He added:

So hope­ful­ly that will give every­body a bit more clue now, es­pe­cial­ly where some of your mod­els go out fur­ther with sales num­bers get­ting up in­to the US$8 bil­lion or US$10 bil­lion you’ll see a sub­stan­tial amount of the sales will come through that 20% roy­al­ty rate and sales ex­ceed US$3 bil­lion.

But Van de Winkel thinks the av­er­age peak sales es­ti­mate is all wrong. He told Reuters that his own es­ti­mates peg peak po­ten­tial sales at $13 bil­lion, qual­i­fy­ing as a megablock­buster ri­val­ing the biggest earn­ers in the in­dus­try.

“It could work in oth­er blood can­cers as well as in sol­id tu­mours. So that means $13 bil­lion po­ten­tial if it would work in all the in­di­ca­tions,” Van de Winkel told Reuters.

To put that in per­spec­tive, Gen­mab ex­pects up to $2 bil­lion for its split just at the 20% roy­al­ty rate — pro­vid­ed the drug achieves its full set of am­bi­tions.

Gen­mab al­so has a ways to go in col­lect­ing the full set of its $1 bil­lion in mile­stones that the com­pa­ny arranged with J&J in 2012. But these “biobucks” — some­times mocked as an il­lu­sion — are flow­ing.

Gen­mab CFO David Eatwell:

As you know at the end of 2016, we’ve col­lect­ed $310 mil­lion of mile­stones in to date. So in terms of the to­tal mile­stones that will be the po­ten­tial they were pay­ing through of $690 mil­lion of mile­stones to come. So dara­tu­mum­ab mile­stones for de­vel­op­ment and reg­u­la­to­ry events there will be mile­stones for non-mul­ti­ple myelo­ma events and al­so there will be the com­mer­cial of sales to­tal mile­stones as well.

Al­so when we talked about the orig­i­nal $1 bil­lion of mile­stones, we said that slight­ly more than half of those were de­vel­op­ment reg­u­la­to­ry in­clud­ing up to the point of first com­mer­cial sale and that’s there­fore less than half of it, or slight­ly less than half was the sales or com­mer­cial mile­stones and of course we’ve on­ly re­ceived the one com­mer­cial mile­stone to date and that was the $25 mil­lion which pre­clud­ed late in 2016 for the sales ex­ceed­ing $500 mil­lion in one cal­en­dar year.

The biggest ques­tions fac­ing gene ther­a­py, the XLMTM com­mu­ni­ty, and Astel­las af­ter fourth pa­tient death

After three patients died last year in an Astellas gene therapy trial, the company halted the study and began figuring out how to safely get the program back on track. They would, executives eventually explained, cut the dose by more than half and institute a battery of other measures to try to prevent the same thing from happening again.

Then tragically, Astellas announced this week that the first patient to receive the new regimen had died, just weeks after administration.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

What Will it Take to Re­al­ize the Promise and Po­ten­tial of Im­mune Cell Ther­a­pies?

What does it take to get to the finish line with a new cancer therapy – fast? With approvals in place and hundreds of immune cell therapy candidates in the pipeline, the global industry is poised to create a fundamental shift in cancer treatments towards precision medicine. At the same time, unique challenges associated with cell and process complexity present manufacturing bottlenecks that delay speed to market and heighten cost of goods sold (COGS) — these hurdles must be overcome to make precision treatments an option for every cancer patient. This series of articles highlights some of the key manufacturing challenges associated with the production of cell-based cancer therapies as well as the solutions needed to transcend them. Automation, process knowledge, scalability, and assured supply of high-quality starting material and reagents are all critical to realizing the full potential of CAR-based therapies and sustaining the momentum achieved in recent years. The articles will highlight leading-edge technologies that incorporate these features to integrate across workflows, accelerate timelines and reduce COGS – along with how these approaches are enabling the biopharmaceutical industry to cross the finish line faster with new treatment options for patients in need.

Gri­fols drops $1B on Ger­man hold­ing com­pa­ny in con­tin­ued plas­ma push

One Spanish biotech is beefing up its plasma therapy operations, and on Friday, it announced that it’s doing so in a billion-dollar deal.

Grifols is now the largest shareholder of Biotest, a company valued at more than $1.8 billion. By teaming up, the two will try to increase the number of plasma therapies available and increase patient access around the world, Grifols said in a press release.

The company did so by acquiring holding company Tiancheng Pharmaceutical, the Germany-based owner of nearly 90% of Biotest shares, for nearly $1.27 billion. Grifols now owns nearly 90% of Biotest voting rights and almost 45% of the total share capital of Biotest.

Amgen VP of R&D David Reese

Am­gen rolls out da­ta for KRAS in­hibitor com­bo study in col­orec­tal can­cer, hop­ing to move on from ug­ly ear­ly re­sults

With the first win for its KRAS inhibitor sotorasib in hand, Amgen is pushing ahead with an aggressive clinical plan to capitalize on its first-to-market standing. The drugmaker thinks combinations — in-house or otherwise — could offer a path forward, and one early readout from that strategy is bearing fruit.

A combination of Amgen’s sotorasib and its EGFR inhibitor Vectibix posted an overall response rate of 27% in 26 patients with advanced colorectal cancer (CRC) with the KRAS-G12C mutation, according to data from the larger Phase Ib/II CODEBREAK 101 study set to present at this weekend’s virtual ESMO Congress.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 117,600+ biopharma pros reading Endpoints daily — and it's free.

Dan O'Day, Gilead CEO (Jim Watson/AFP via Getty Images)

Eu­ro­pean study finds that Gilead­'s Covid-19 an­tivi­ral remde­sivir shows no clin­i­cal ben­e­fit

Gilead’s remdesivir — or Veklury, as it’s marketed in the US — raked in around $2.8 billion last year as the only FDA-approved antiviral to treat Covid-19. But new data from a European study suggest the drug, which has been given to about half of hospitalized Covid patients in the country, has no actual benefit.

The open-label DisCoVeRy trial enrolled Covid-19 patients across 48 sites in Europe to test a handful of treatments, including remdesivir, lopinavir–ritonavir, lopinavir–ritonavir and interferon beta-1a, and hydroxychloroquine. To participate, patients had to show symptoms for seven days and require oxygen support. A total of 429 patients were randomized to receive remdesivir plus standard of care, while 428 were assigned to standard of care alone.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 117,600+ biopharma pros reading Endpoints daily — and it's free.

Covid-19 roundup: FDA re­veals boost­er ad­comm ques­tion; Eli Lil­ly's an­ti­body cock­tail cleared for pre­ven­tion

The FDA released briefing documents this week from the agency and Pfizer each outlining their arguments for today’s Covid-19 booster shot adcomm, but one thing conspicuously missing was the question on which panel members would be voting. But late Thursday night, regulators published that question.

Adcomm members will be asked whether or not the safety and efficacy data from Pfizer/BioNTech’s original Phase III study “support approval” of a booster shot at least six months after the second dose in individuals older than 16. The question notably excludes the real-world data from Israel and other analyses that Pfizer and the Biden administration had said would be a centerpiece of their arguments for boosters.

A Pfiz­er part­ner wel­comes ex-ADC Ther­a­peu­tics CMO Jay Fein­gold to the team; Amid tough sled­ding, Im­muno­vant choos­es Eli Lil­ly alum as CFO

→ Last week we told you about the CMO revolving door at ADC Therapeutics, as Joseph Camardo replaced the departing Jay Feingold. The next opportunity for Feingold in the CMO slot has opened up at antibody-drug conjugate and mAb developer Pyxis Oncology, which has added several new execs and scientific advisory board members in recent months, including ex-Immunovant CFO Pamela Yanchik Connealy. Before his tenure at ADC, Feingold was Daiichi Sankyo’s VP of US medical affairs and chairman of the Global Medical Affairs Oversight Committee. Within weeks in March, Pyxis struck a licensing deal with Pfizer for two of its ADCs and raked in $152 million from a Series B round.

Ali Tehrani, Zymeworks CEO

Zymeworks squares up with Her­ceptin af­ter HER2 bis­pe­cif­ic aces mid-stage test in esophageal can­cer

Roche’s Herceptin has long stood as standard of care across multiple advanced cancers, but a suite of next-gen players are looking to beat the aging giant at its own game. In HER2-expressing esophageal cancer, BeiGene partner Zymeworks thinks its bispecific antibody could have the juice to get it done.

Zymeworks’ bispecific antibody zanidatamab, combined with one of two chemotherapy regimens, posted an overall response rate of 75% in patients with advanced gastroesophageal adenocarcinoma (GEA) who had not previously received a HER2-targeted cancer therapy, the Vancouver-based biotech said Thursday.

UP­DAT­ED: Gilead keeps push­ing trove of Trodelvy da­ta as it seeks to be­come new stan­dard of care in TNBC

Gilead is continuing to churn out results for its newly approved drug Trodelvy, and #ESMO21 is the latest stop on the data train.

The biopharma put out new quality of life data in second-line patients with metastatic triple-negative breast cancer, saying that a sub-analysis from their Phase III study showed significant and clinically meaningful improvements in health-related quality of life over standard of care.