Re­gen­eron has a win­ner in Dupix­ent and big sales hopes. So why are so few pa­tients tak­ing it?

One of the true biotech suc­cess sto­ries, New York’s Re­gen­eron has set its am­bi­tions sky high with two block­busters in their back pock­et and some po­ten­tial win­ners in the pipeline. But one of those best­sellers, im­munol­o­gy med Dupix­ent, hasn’t tak­en off quite as ex­pect­ed.

De­spite more than three and a half years on the mar­ket and its par­ent com­pa­nies’ pitch as a bet­ter bi­o­log­ic for eczema, IL-4 med Dupix­ent is still sit­ting at a mea­ger 6% mar­ket share of its 2.2 mil­lion el­i­gi­ble pa­tients in the US, Re­gen­eron ex­ecs said on a fourth-quar­ter earn­ings call with an­a­lysts Fri­day.

The rea­son? Mar­ket ed­u­ca­tion, Re­gen­eron reck­ons — and there’s still a lot of work to be done.

In eczema, al­so known as atopic der­mati­tis, Re­gen­eron and part­ner Sanofi have staked most of Dupix­ent’s growth po­ten­tial as the first-to-mar­ket drug, but physi­cians and pa­tients have tak­en a long time to catch on be­cause there had been “so lit­tle for so long” in terms of treat­ment op­tions, the New York drug­mak­er said. Those lack of pri­or op­tions, in Re­gen­eron’s telling, could mean pa­tients and their spe­cial­ists aren’t ac­tive­ly seek­ing ther­a­pies.

Len Schleifer

Ac­cord­ing to CEO Len Schleifer, Dupix­ent’s in­jectable for­mu­la­tion could al­so be part­ly to blame since pa­tients view ther­a­pies like Dupix­ent as “more se­ri­ous” than oral meds.

“There’s a lot of ed­u­ca­tion that needs to be done,” he said. “There’s a long lega­cy that meds you can take by mouth are not as se­ri­ous drugs as drugs you take by in­jec­tion. Most so­phis­ti­cat­ed peo­ple are be­gin­ning to re­al­ize it’s the bi­o­log­i­cals that are more tar­get­ed, more nat­ur­al and less prone for off-tar­get and on-tar­get tox­i­c­i­ties.”

Even still, with just 6% ac­cess, Dupix­ent is a block­buster med­i­cine — a fact that un­der­scores its po­ten­tial to dri­ve Re­gen­eron’s top line. The drug pulled more than $4 bil­lion in sales in 2020 on a sparkling 75% growth clip, and Re­gen­eron’s ex­pect­ing big read­outs in eosinophilic esophagi­tis and pruri­go nodu­laris this year.

Dri­ven by Dupix­ent’s growth and the con­tin­ued suc­cess of an­ti-VEGF ther­a­py Eylea, Re­gen­eron post­ed $8.5 bil­lion in sales in the year 2020 — a 29% growth rate that should go a long way to bol­ster­ing the drug­mak­er’s lead­ers’ high hopes for the fu­ture.

George Yan­copou­los

In ear­ly Jan­u­ary, Re­gen­eron’s board agreed to re­work Schleifer and CSO George Yan­copou­los’ bonus com­pen­sa­tion, putting $1.4 bil­lion on the ta­ble in fu­ture pay­outs if the drug­mak­er keeps the good times rolling.

Re­gen­eron linked both ex­ecs’ fu­ture com­pen­sa­tion to the cu­mu­la­tive share-price growth over five years with a three-year hold­ing pe­ri­od af­ter the per­for­mance-re­strict­ed stock units (PSU) ful­ly vest. The board set tiered mile­stones for both ex­ec­u­tives’ pos­si­ble awards with a tar­get goal of 65.6% growth on Re­gen­eron’s most re­cent clos­ing share price pri­or to the vote of $478.30. Hit­ting that num­ber on the nose would earn both Schleifer and Yan­copou­los a cool $196.5 mil­lion each.

On the ab­solute high end — 140% share growth over five years at a 19.2% an­nu­al rate — both Schleifer and Yan­copou­los would be due a whop­ping $713.3 mil­lion.

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.

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.

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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.

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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.

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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.

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.

Multiple antibiotic resistant Pseudomonas aeruginosa bacterium

A new way to in­fil­trate (and de­stroy) some of the dead­liest drug-re­sis­tant bugs

About four years ago, Ruben Tommasi, the gregarious scientific chief of antibiotics startup Entasis, walked into a meeting with his top chemist and top biologist to chew over another batch of unchanging results.

“It felt like we were running the same experiment over and over,” Tommasi told Endpoints News. “We had all sort of come to that point in time where we felt like we were banging our heads against the wall.”

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Take­da scores a win for a rare type of lung can­cer, gear­ing up for a show­down with J&J

Four months after J&J’s infused drug Rybrevant scored the industry’s first win in a rare type of non-small cell lung cancer (NSCLC), Takeda is following up with an oral option for the small but desperate patient population.

The FDA granted an accelerated approval to Takeda’s oral TKI inhibitor Exkivity (mobocertinib) in metastatic NSCLC patients with EGFR exon 20 gene mutations who had previously undergone platinum-based chemotherapy, the company announced on Wednesday.

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